Q&As

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REACH

Authorisation

a) General / Procedure

Are any substances already subject to authorisation?

Yes. The List of Substances Subject to Authorisation (Annex XIV of the REACH Regulation) includes several substances.

Substances are regularly added to Annex XIV by the European Commission, on the basis of recommendations issued by ECHA. The link to the updated Annex XIV can be found on ECHA's website at: https://echa.europa.eu/authorisation-list.

Further details on the procedure for the inclusion of substances to Annex XIV of the REACH Regulation are available in FAQ ID=127, as well as on ECHA's website at: http://echa.europa.eu/regulations/reach/authorisation.

Where do I find the candidate list?

The Candidate List of Substances of Very High Concern (SVHC) for authorisation (Candidate List) is available on ECHA's website at: http://echa.europa.eu/candidate-list-table.

Additional substances are regularly included in the Candidate List, once these have been identified as SVHC.

How is a substance included in the Candidate List?
When the European Commission or a Member State considers that a substance may meet the criteria for identification as SVHC pursuant to Article 57 of REACH, ECHA (on request of the European Commission) or the Member State prepares an Annex XV SVHC dossier. With this Annex XV dossier ECHA or the Member State proposes the inclusion of the substance in the Candidate List by outlining the scientific evidence for identifying the substance as a SVHC.
 
ECHA's website includes a public registry of intentions in order to allow interested parties to be aware of the substances for which the authorities intend to submit Annex XV dossiers and thus facilitates timely preparation of the interested parties for commenting later in the process.
 
Once an Annex XV SVHC dossier has been prepared, a consultation of the Member States and interested parties is required, as specified in Article 59 of REACH. Further details on this consultation process are available on the ECHA website at http://echa.europa.eu/proposals-to-identify-substances-of-very-high-concern.
 
Following this consultation, the substance may be included in the Candidate List. The Candidate List is made available on ECHA's website in its last updated version at http://echa.europa.eu/candidate-list-table.
How is a substance from the Candidate List included in the "Authorisation List"?

Substances included in the Candidate List may be prioritised for inclusion in Annex XIV of the REACH Regulation (the so called "Authorisation List"). The Authorisation List contains all substances which, after a certain deadline, may only be used and/or placed on the market after a specific authorisation has been granted.

ECHA has to make at least every second year a recommendation of priority substances for inclusion in Annex XIV to the European Commission. Interested parties are invited to submit comments during this process. In addition, the Member State Committee issues an opinion on the recommendation before it is submitted to the European Commission. The European Commission then decides using the comitology procedure which of the recommended substances are to be included in Annex XIV and specifies, based on ECHA's recommendation, the transitional arrangements and, where relevant, exemptions and review periods. Further details on the procedure for inclusion of substances in Annex XIV of the REACH Regulation are available on ECHA's website at http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list .

How are authorisations granted for substances on the "Authorisation List"?

Applications for authorisation need to be made within the deadline (the so called "latest application date") that is specified in the "Authorisation List" for the corresponding substance if the applicant wishes to use the substance without interruption after the sunset date. Authorisation applications need to be submitted to ECHA. Third parties can provide information on alternative substances and technologies during public consultations on the uses that authorisation has been applied for. These are made available on ECHA's web-site. The ECHA Committees for Risk Assessment (RAC) and Socioeconomic Analysis (SEAC) give draft opinions on the application. Applicants will have the opportunity to comment on these draft opinions. RAC and SEAC will adopt final opinions and ECHA sends them to the European Commission. The European Commission decides, using the comitology procedure, whether an authorisation is granted or refused. ECHA will establish a publicly available database that will contain summaries of the Commission decisions. Further details on the application for authorisation procedure are available on ECHA's website under the following links:http://echa.europa.eu/regulations/reach/authorisation http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation

In which language do Applications for authorisation have to be submitted to ECHA?

Applications for authorisation may be submitted in any one of the official EU languages selected by the applicant. This means that the whole application, including the attachments and the Chemical Safety Report, must be submitted in the same language. This is a legal requirement based on Article 104(1) of REACH and Article 2 of Regulation No 1 of 15 April 1958.

Who can apply for an authorisation?

Only manufacturers, importers or downstream users of an Annex XIV substance as well as duly mandated Only Representatives can apply for an authorisation and be holders of a granted authorisation.

Can an Only Representative apply for an authorisation?

Yes. A duly mandated Only Representative ("OR") of a non-EU manufacturer can apply for an authorisation regardless of whether the OR assisted the non-EU entity with the registration of the Annex XIV substance to date. Once the OR has been appointed, it will have to comply with all other applicable obligations under REACH on behalf of the non-EU manufacturer who has appointed them. In cases where a non-EU manufacturer has not yet been appointed an OR, for example due to no obligation to register a substance, an OR may nevertheless be appointed. The OR will then represent the non-EU manufacturer with regard to all applicable REACH obligations.

Will only the person who submitted the authorisation application to ECHA benefit from the granted authorisation?

The holder of an authorisation is the person who submitted the authorisation application to ECHA. However, a downstream user may continue his use of an Annex XIV substance provided that this use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use. Moreover, a manufacturer, importer or downstream user can continue placing an Annex XIV substance on the market for a use for which his immediate downstream user was granted an authorisation.

See supply chain coverage diagram

Who will decide on the granting and conditions of an authorisation?

The European Commission is responsible for taking decisions on Applications for authorisations. ECHA's Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will adopt opinions on the application for authorisation which will be taken into account by the Commission in its final decision.

Will my application be processed if I submit it outside the submission windows?

Yes. Be aware, however, that ECHA recommends applicants to submit their applications within submission windows that are published on its website. This concept ensures a batch wise process and a good synchronisation with the operational schedule of RAC and SEAC committees.

Why should I submit the application before the Latest Application Date?

You should apply before the Latest Application Date to be sure that you will be able to continue to use the substance while your application is being treated by ECHA and the Commission. In other words, you should apply early to take advantage of the transitional arrangements and continue your use after the sunset date even if no decision has been taken by the Commission.

The date of submission of the application will be considered as the date on which your application has been received for the purpose of benefitting from the transitional arrangements described in Article 58(1)(c)(ii), provided that you pass the business rules checks. This date is relevant if you intend to take advantage of these transitional arrangements and continue your use after the sunset date if no decision has been taken by the Commission. The following two situations may occur:

1. You have submitted your application early enough and it passes business rules checks before the latest application date: in this case you will benefit from the transitional arrangements described in Article 58(1)(c)(ii) provided that you pay your invoice in due time.

2. You have submitted your application just before the latest application date but it passes the business rules after the latest application date: in this case you can benefit from the transitional arrangements described in Article 58(1)(c)(ii) provided that you pay your invoice in due time. If your application does not pass the business rules checks you will have to resubmit your application. If you resubmit your application after the latest application date you will not be able to benefit from the transitional arrangements.

Therefore ECHA recommends that you submit your application during the submission window three months earlier than the latest application date. If you choose to submit in the latest submission window, ECHA recommends that you do so at the very beginning of the window.

The date from which the 10 months' time limit for the Committees to prepare their draft opinions starts is the date on which ECHA has received the application fee.

Will my application be processed if I submit it after the Latest Application Date?

Yes, the application will still be accepted for processing and evaluated by RAC and SEAC. However, the transitional arrangements under Article 58 (1)(c)(ii) of the REACH Regulation will not apply. These transitional arrangements would allow the applicant to use the substance even after the Sunset Date if no decision has been taken by the Commission.

Are end points related to the intrinsic properties of Annex XIV more critical than other end points?

If the substance has a threshold you need to demonstrate that the risks associated for the hazard endpoint mentioned in Annex XIV are adequately controlled. If the substance does not have a threshold, you need to demonstrate minimisation of emissions and exposure as far as possible. The Chemical Safety Report (CSR) should therefore focus on the Annex XIV endpoint but information on other endpoints might be necessary for comparing the risks with the alternatives. The alternatives should result in reduced overall risks to human health and the environment. Therefore, it is important not only to consider the risks arising from the Annex XIV endpoint but also on all other possible risks from the Annex XIV substance and the alternatives.

Can the decision taken by the Commission be different for the several uses included in my application?

A decision on authorising a use can be different from one use to another. Thus, if certain uses are authorised and others are not, then the non-authorised uses are no longer permitted.

How RAC and SEAC work together? Can they disagree with each other?

The primary objective of RAC and SEAC is to provide consistent opinions of high scientific quality to support the desicion making of the European Commission. The remits of both Committees are clear and cooperation between them is ensured by agreed procedures.
See also: http://echa.europa.eu/documents/10162/13555/common_approach_rac_seac_en.pdf

Can a distributor be considered as the immediate Downstream User (DU) in the context of article 56(1) (e) and apply for an authorisation?

No. A distributor who only stores the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e) (see Article 3(14) of the REACH Regulation). However, actors can no longer be considered as distributors if they use the substances themselves (e.g. repackaging). Then they are considered as downstream users and, as such, shall apply for authorisation (and may cover uses of their downstream users), unless already covered by an authorisation.

Distributors (i.e. entities who only store the substance) are "transparent" in the supply chain if they do not "use" the substance. Therefore an application granted to a downstream user should be understood as covering the manufacturer/importer of that substance and all the distributors in between. However, this only applies in cases where there are no actors using the substance (e.g. formulators, repackaging companies, etc.) between the downstream user applicant and the manufacturer/importer. Also, distributors have to communicate the relevant information (e.g. safety data sheets, authorisation numbers) to their downstream users.

Can a Downstream User apply for uses upstream in the supply chain?

No. A downstream user (Company B) holding an authorisation for his use(s) (for instance, an end-use) can be supplied by an actor (Company A) up his supply chain (for instance, a formulator) in accordance with Article 56(1)(e). However, the use of Company A (that is the formulation of the Annex XIV substance) cannot be covered by an authorisation granted down the supply chain to Company B. Company A needs to have his use (the formulation) covered by a separate authorisation granted directly to him or to an actor up his supply chain (for instance the manufacturer of the Annex XIV substance). Note that distributors who only store the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e), see Q&A 577 for more details.

See supply chain coverage diagram

I use an Annex XIV substance in a mixture. Should the information in the application be presented for the mixture or for the substance?

Information presented should be for the substance as the authorisation is (or is not) granted for a given substance.
See also FAQ ID=130 in Frequently Asked Questions about REACH.

May an authorisation be reviewed before the expiry of the period for which it has been granted for?

Yes. An authorisation can be reviewed before the expiry of the review period. REACH Art 61(2) specifies that: "Authorisations may be reviewed at any time if: (a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio- economic impact; or (b) new information on possible substitutes becomes available"". In this case, the Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it (i.e. the Commission) will take a final decision.

What rights does the applicant have to challenge the decision of the Commission?

An applicant has the right to contest the decision of the Commission before the General Court.

Who will enforce the authorisation decisions and how?

The enforcement of REACH is a responsibility of each EU Member State, as well as the members of the EEA (Norway, Iceland and Liechtenstein). They must ensure that there is an official system of controls and lay down legislation specifying penalties for non-compliance with the provisions of REACH. See also FAQ ID=3 in Frequently Asked Questions about REACH.

What other key sources of information might ECHA use when evaluating Applications for authorisation?

All information available to ECHA could be used; for instance, CLP notifications, dossier evaluation results or any relevant information arising from the public consultation on alternatives.

When will I receive the decision of the Commission after I have submitted my application?

It will take about 2 years. Article 64 of the REACH Regulation gives many details. Below we give an overall description of the timelines. Once you have submitted the application it takes about 2-3 months for its processing and for the application fee to be received by ECHA. The Committees will prepare their draft opinions within 10 months from that date of receipt of the fee. The applicant can comment on the draft opinions within 2 months before the Committees adopt their final opinions. This will take 2 months. Some weeks are also reserved for sending and receiving the draft opinion. Thus, it takes about 17-18 months for the applicant to receive the final opinions from the date it had submitted the application. ECHA will publish the opinions on its website and send them to the Commission, the Member States and the applicant. A final decision granting or refusing the authorisation shall be taken via a 'comitology' procedure (see the "examination procedure" referred to in Article 5 of Regulation (EU) No 182/2011). All in all, it would normally take about 6 months to have the final decision from the publication of the opinions of the Scientific Committees on ECHA's website.

Are there clear criteria on which the opinions will be based and which could provide more certainty about the outcome of the application?

The criteria for granting an authorisation are clearly defined in Art. 60 of REACH: under the "adequate control route" (Art. 60(2)) an application shall be granted if the risk to human health and the environment from the use of the substance arising from the intrinsic properties specified in Annex XIV is adequately controlled.

 Under the "socio-economic route" (Art. 60(4)), an authorisation may be granted if it is shown that (i) the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and (ii) there is no suitable alternative substances or technologies.

The factors to be taken into account for assessing the availability of suitable alternatives are described in Art. 60(5) and in the Guidance on Applications for Authorisation.

Also, two important documents describe how RAC and SEAC intend to evaluate the applications:

As a downstream user relying on an authorisation granted to a manufacturer/importer up in my supply chain, will I receive a unique authorisation number for all the authorised uses?

No. An authorisation number is unique to each combination of [applicant-substance-use applied for]. If the downstream user is himself an applicant (in either single or joint application), he will get its own authorisation number(s) related to the authorised use(s). If the downstream user is not an applicant but that he relies on an authorisation granted to a manufacturer/importer up his supply chain for his uses, the downstream user will not receive his own authorisation number(s) but he will be informed by his supplier about the authorisation number (which should be mentioned at least on the label of the product). 

Can restrictions be applied on the use of Annex XIV substances in articles?

Yes. After the sunset date, according to Article 69(2), ECHA has the obligation to consider the risks related to the corresponding Annex XIV substance in articles and possibly apply the restriction procedure if the risk to human health or the environment is not adequately controlled. In this case, the Agency shall prepare a dossier which conforms to the requirements of Annex XV. This assessment will have to be done for each Annex XIV substance after its corresponding sunset date.

In addition, Member States or ECHA (on request from the Commission) may propose a restriction at any time on the use of any substance (including SVHCs) in articles if the risks arising from the use of these articles are not properly controlled.
 

Can an Only Representative apply for an authorisation on behalf of several companies located outside the EU?

Yes. The non-EU companies can also be located in different jurisdictions. The application fee will be assessed for each non-EU legal entity the Only Representative represents in the application.

Only Representatives have to sign-up in REACH-IT for each non-EU company they represent and submit the relevant IUCLID dossier using the appropriate accounts. It is not possible to use the same Legal Entity Object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). Similarly as for Registration, Only Representatives must indicate in the "company size" field of REACH-IT the size of the non-EU company they are representing. In the determination of their size, linked and partner enterprises to the company the Only Representative represents should also be taken into account.

In addition, Only Representatives are advised to attach clear documentation of their appointment in their application (for instance, a copy of the appointment) in the field "Assignment from non EU manufacturer" of the IUCLID file (IUCLID section 1.7). Only Representatives are also advised to indicate the list of the importers' names covered by the application in the field "Other importers".

For more details:

 
Will ECHA inform the applicant if it has accepted the justifications for claiming certain information confidential?

No. ECHA will not inform the applicant of its decision on all the confidentiality claims in the application for authorisation.

On the other hand, there may be situations where ECHA finds it necessary to make publicly available information that the applicant claimed confidential. In such cases ECHA will inform the applicant of this decision and allow him to respond appropriately.

An example of such a situation is if insufficient information falling under the broad information of uses is given in the public parts of the application for authorisation ("public versions" of the assessment reports, i.e. the Chemical Safety Report, Analysis of alternatives, Socio-economic analysis, Substitution plan or their annexes). In such a case ECHA has reserved the right under Article 64(2) of REACH to supplement the broad information package for the public consultation on alternatives with the necessary information from the "complete versions" of these assessment reports with the aim to make the public consultation meaningful. ECHA gives the applicant the opportunity to comment its proposal for broad information of uses before the final version is issued and published.

See also Q&A 590, 592 and 594.
How is the time-limited review period set in authorisation decisions?

ECHA has consulted the services of the European Commission on this. As a general principle, if you apply for authorisation before the latest application date, the review period would be counted from the sunset date. In practice, this means that applying early would not shorten your time for placing on the market and/or using the substance after the sunset date as compared to applying closer to the latest application date.

If you apply for authorisation after the latest application date, the placing on the market and use of the substance will no longer be allowed as from the sunset date, unless a decision granting an authorisation has been adopted by then. If the decision is adopted before the sunset date, the review period would in principle be counted from the sunset date. If a decision is adopted after the sunset date, the review period would be counted from the date of entry into force of the decision

I am a downstream user of an Annex XIV substance and the European Commission has not yet decided on the application for authorisation submitted by a company up my supply chain covering my use. The sunset date of the substance has passed.
a) Do I have to stop using the substance?
b) Do I have to notify my use to ECHA?

a) It depends.
You do not have to stop if the application made up your supply chain has been submitted before the substance’s latest application date. In this case, you can continue using the substance after its sunset date, awaiting for the European Commission’s decision.
You have to stop if the authorisation application has been submitted after the substance’s latest application date. You can restart using the substance only if the European Commission decides to grant an authorisation for your use. 

b) Not yet. As long as the European Commission’s decision on the authorisation application covering your use is pending, you cannot notify your use to ECHA. The notification of authorised uses is possible only after an authorisation has been granted. Once the decision to grant an authorisation has been adopted, you then need to submit a downstream user notification of your authorised use (Article 66 of REACH) to ECHA within three months from the first delivery of the substance (see also Q&A 1441).

 

I am a downstream user of an Annex XIV substance and the European Commission has decided to grant an authorisation for my use to a company up my supply chain. Do I have to notify my use to ECHA?

Yes. If you rely on an authorisation granted to an actor up your supply chain, you must notify your authorised use to ECHA. You must submit your notification within three months from the first delivery of the substance following issuing of the authorisation decision. Your notification needs to refer to the relevant authorisation number(s). Authorisation numbers are indicated on the label of the product and the safety data sheet you receive from your supplier. As they are use-specific, you need to select the specific authorisation number(s) which correspond to your use. Authorisation numbers have the format 'REACH/x/x/x' (see also Q&A 750).

Naturally, you need to comply with the conditions of the authorisation, which should be communicated to you by your supplier in the safety data sheet.

For further information on the downstream user notification for authorised uses (Article 66 of REACH), see: 

https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use 

https://newsletter.echa.europa.eu/home/-/newsletter/entry/4_15_downstream-users-notify-echa-if-you-use-an-authorised-substance

 

What environmental release information will ECHA publish as part of the opinions on applications for authorisation?

ECHA will publish the emissions of non-threshold substances such as environmental endocrine disruptors, PBTs, and vPvBs. It will also publish the release factors related to these emissions to the environment in cases where the applicant has not claimed the volumes used to be confidential. In such cases, ECHA will disclose the emissions as such and redacted information on the release factor (see example).

ECHA encourages applicants to be transparent about the release factors. Indeed, in two thirds of applications received to date (March 2020), applicants have provided this information without claiming the information on the release factor and thus the volume used confidential.

Note that the actual release factors and volumes used are always made available to ECHA’s Committees for Risk Assessment and Socio-economic Analysis when they evaluate the applications and give opinions to the European Commission.

Justification:

Article 64(6) of the REACH Regulation says that the Agency shall determine in accordance with Article 118 and 119 which parts of its opinions should be made publicly available on its website. Article 118(2)(c) provides that disclosure of precise tonnage is normally deemed to undermine the protection of commercial interests of the concerned party.

Under the Aarhus Regulation (Article 6(1)), an overriding public interest in disclosure is deemed to exist where a request is made for information relating to emissions to the environment. ECHA thus considers that emission values are non-confidential from a viewpoint of public interest and right to know.  

This policy is consistent with the ECHA’s core values of transparency and efficiency, recognising the overriding public interest in the disclosure of emissions set out in the Aarhus Regulation.

Example:

The volume used of substance is 2 000 kg per year, the release factor is 0.2% and thus the emissions to the environment are 4 kg per year. Unless the applicant has claimed the volume confidential, ECHA will publish this information as part of its opinion.

If the applicant claimed that the volume used should not be disclosed to the public, ECHA would instead publish the volume within a range (e.g. 1 000-5 000 kg), the corresponding release factor also within a range (e.g. 0.1%-0.4 %) and the emission to the environment (4 kg).

The authorisation decision states as a condition that a monitoring programme needs to be established so that the first measurements shall be performed at the latest by a particular date in spring 2020. Due to Covid-19 emergency, it will not be possible to finalise these monitoring programmes within the deadlines of the decision. What should we do?
This question relates to the implementation of the Commission’s authorisation decision and, as such, is a matter for the national enforcement authorities of the Member States. Please contact your national enforcement authority without delay and ask them how to address the issue.
b) Scope

Does the use of a substance listed on Annex XIV require an authorisation when contained in a mixture at a concentration below that specified in Article 56(6) (a) and (b) of REACH?

Authorisation is required for the use of a substance included in Annex XIV of REACH, either on its own or in a mixture. If a substance is used as such, this is a use of the substance on its own, and the exemptions in Article 56(6) (a) and (b) of REACH cannot be applied. If the substance is used in a mixture, then the aforementioned exemptions may be applied. These exemptions apply to SVHCs meeting the criteria of points (d), (e) and (f) of Article 57 of REACH below a concentration limit of 0.1 % w/w, and for all other substances below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.

Does the exemption from the authorisation requirement for substances in mixtures (Article 56(6)b of REACH) depend on their classification in any hazard class or only the hazard classes for which the substance was included in the authorisation list?

The authorisation requirement does not apply to the use of CMR substances when they are present in mixtures below the concentration limits specified in Article 11(3) of the CLP Regulation, which result in the classification of the mixture as hazardous (Article 56(6)b of REACH).

Only the hazard class (or hazard classes) which specifically led to inclusion of the substance in the authorisation list should be taken into account.

The basis for this is to target the intrinsic properties of highest concern, which is the objective of the authorisation process.

This is reflected in the legal provisions of REACH:

  • Article 62(4), which requires an application for authorisation only for the hazard class given in the authorisation list, and
  • Article 60(2), which limits the assessment of a request for authorisation to the hazard class given in the authorisation list under the adequate control route.

 

Is there any tonnage threshold below which Annex XIV substances are exempted from the authorisation requirement?

No. There is no tonnage threshold below which (the placing on the market for) a use of an Annex XIV substance is exempted from the authorisation requirement.

Does the authorisation requirement apply to the use of substances in articles?
No. The placing on the market or the use of an article which contains an Annex XIV substance is not subject to the authorisation requirement. However, if not specifically exempted otherwise, the incorporation of an Annex XIV substance into an article is a use which is subject to the authorisation requirement. Moreover, the Chemical Safety Report of an application for authorisation for a given substance should cover the whole substance service-life for the "use(s) applied for", including the service life of articles and the waste stage (see Article 62(4)(d) and Annex I (5.1.2) and (5.2.2) of REACH).
 
Other legal requirements also apply to substances of the Candidate List present in articles, such as communication obligations along the supply chain and notification to ECHA:
 
Article 33(1) of REACH requires that a supplier of articles containing a SVHC included in the Candidate List for authorisation in a concentration above 0.1% (w/w) has to provide relevant safety information to the recipients of these articles. Upon request of a consumer, the same supplier has to provide relevant safety information about the SVHC available to him also to this consumer (Article 33(2) of REACH). This obligation applies irrespective of the tonnage of the substance used and also applies to imported articles. Importers and producers of articles have to, under certain conditions, notify to ECHA if their articles contain Candidate List substances (as per Article 7 of REACH).
For more information, see: 
 
Does the authorisation requirement apply to a substance in Annex XIV that is present as an impurity in another substance or mixture?

The authorisation requirement applies to the placing on the market and use of a substance on its own as listed in Annex XIV. Therefore, it usually does not apply if the Annex XIV substance is only an impurity or additive or constituent of another substance, unless this is specified in the Annex XIV entry (e.g. substance W and substances X, Y and Z containing substance W in a concentration ≥ x %) or the other substance is also listed in Annex XIV.If a substance listed in Annex XIV is included as a component in a mixture, the authorisation requirement applies for this use (i.e. the formulation of the mixture). Further, the placing on the market and use of such mixtures require authorisation, unless the Annex XIV substance is present in the mixture below the concentration limits set out in REACH Article 56(6).
See also: Guidance for identification and naming of substances under REACH (link to http://echa.europa.eu/documents/10162/13643/substance_id_en.pdf)

Are uses of recovered substances exempted from the authorisation requirement?

No. Uses of recovered substances are not exempted from the authorisation requirement. As in case of use(s) of any other Annex XIV substance, use(s) of a recovered substance whose identifiers correspond to those of an entry in the Annex XIV of REACH is subject to the authorisation requirement, unless the use of the substance is specifically exempted otherwise.
See also: Guidance on waste and recovered substances http://echa.europa.eu/documents/10162/13632/waste_recovered_en.pdf

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to analytical activities such as monitoring and quality control?

Yes. Under Article 3(23) of REACH, scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year. Thus, the use of an Annex XIV substance in analysis is exempted from authorisation under Article 56(3) if the substance is used, on its own or in a mixture, in analytical activities such as monitoring and quality control where these activities are carried out under controlled conditions and in a volume not exceeding one tonne per year and per legal entity. 

The exemption applies to the use of an Annex XIV substance when it is required as part of an analytical method for the measurement of another substance or property (e.g. used as an extraction solvent or reagent, or to validate the technical specification or performance of a product) and the analysis of the Annex XIV substance itself (e.g. for quality or process control). Where these conditions are met, there is no need to apply for an authorisation for this use or to include this task as a working contributing scenario (i.e. PROC 15) in an application for authorisation. 

This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities. However, this exemption does not cover sampling activities (see Q&A 1153).

Does the authorisation requirement apply to a substance listed in Annex XIV of REACH which is used exclusively as an analytical reagent or in routine analysis?
If the substance is used for monitoring or quality control purposes under controlled conditions in quantities below 1 tonne per year, it falls under Article 56(3) of REACH, which exempts substances used in scientific research and development from the authorisation requirement.
Article 2(5), subparagraphs (a) and (b), and Article 56 subparagraphs (4)((a), (b), and (c)) and (5)((a) and (b)) of REACH exempt from the authorisation requirement a number of uses in products (medicinal products, food or feedingstuffs, plant protection products, biocidal products, motor fuels, cosmetic products and food contact materials, respectively) within the scope of, or covered by, the sector-specific Union legislation specified in those provisions. 1. Do these exemptions cover the incorporation of the Annex XIV substance into the product during the manufacturing process? 2. Do these exemptions also cover the life-cycle steps (such as formulation) preceding the incorporation of the substance into the product in question?
  1. Yes, these exemptions cover the incorporation of a substance into the product during the manufacturing process.
  2. Yes, the uses of a substance upstream preceding an exempted end-use are also exempted but only in the volumes ending up in the exempted end-use.  It should be noted that, with regard to uses in cosmetic products and in food contact materials, the exemption only applies when the intrinsic properties specified in Annex XIV for the substance in question concern hazards to human health.
 
Article 56 (4)(d) of REACH contains an exemption from the authorisation requirement for the use as fuels in closed systems. Does this exemption also cover the life-cycle steps (such as formulation) preceding this end-use?

Yes, the uses of a substance upstream, preceding "use as fuels in closed systems", are also exempted under the condition that the control of the risks – i.e., use in closed systems – is also pursued in the upstream life-cycle steps preceding the end-use as a fuel.

Does an application for authorisation for the use of a substance in a medical device regulated by the sector-specific legislation referred to in Article 60(2) 2nd subparagraph of REACH have to be submitted for a substance for which Annex XIV specifies human health hazards only? Does this exemption cover the incorporation of the Annex XIV substance into the product during the manufacturing process? If so, are the life-cycle steps preceding the incorporation of the substance in the medical device subject to authorisation?

Pursuant to Articles 60(2) and 62(6) of REACH, an application for authorisation is not required for a substance used in a medical device regulated under Directives 90/385/EEC, 93/42/EEC or 98/79/EC if that substance has been identified in Annex XIV for human health concerns only.   Nor is an application required in such cases for the incorporation of the substance into the medical device during the manufacturing process or for the uses and corresponding volumes of that substance upstream preceding the end-use.

Article 56 (3) of REACH exempts from the authorisation requirement the use of a substance in scientific research and development (SRD). Does this exemption also cover the life-cycle steps (such as formulation) preceding the end-use in SRD?
Yes, the uses of a substance upstream preceding an exempted end-use in SRD are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to what is set out below.
 
Article 3(23) defines SRD as any scientific experimentation, analysis or chemical research to be carried out "under controlled conditions" and "in a volume less than one tonne per year". Therefore, the exemption in Article 56 (3) covers an activity which is delimited by a certain level of control of risks– i.e., use under controlled conditions and in a volume less than 1 tonne per year. It also applies to the upstream life-cycle stages of the substance preceding its end-use in SRD, for the volumes ending up in that end-use and which, during the upstream life-cycle, are handled and/or used under controlled conditions, even if the volume handled and/or used during the upstream life-cycle stages exceeds 1 tonne per year.

In case of any contradictions between the position expressed in this Q&A and the positions expressed previously by ECHA in the RCOM of 20 December 2011, the position expressed in this Q&A should be considered as the current understanding of the law. It takes precedence over any other views communicated previously by ECHA on this issue.
 
Is the manufacture of a substance, whether for export or placing on the EU market, subject to the authorisation requirement?

The manufacture of a substance is not subject to the authorisation requirement. After a substance has been manufactured it may have to be handled before it is exported or placed on the EU market. Operations which are necessary for the handling of a substance on its own in the manufacturing for export or placing on the EU market are considered to be part of the manufacturing stage (e.g. filling into appropriate containers, storage, addition of stabiliser, dilution to a safer concentration -if necessary for transport safety-), but not other uses such as the formulation of a mixture or incorporation of the substance into articles. The formulation of a mixture or incorporation of the substance into articles are considered "uses" within the meaning of Title VII of REACH and are subject to the authorisation requirement whether or not the mixture or articles will be exported or placed on the EU market. 

Does the exemption for the use of Annex XIV substances in scientific research and development under Article 56(3) of REACH also apply to sampling activities for further quality control analysis?

No. When a sample containing an Annex XIV substance is taken from a production line for further analysis the sampling activity shall be described and assessed e.g. in a worker contributing scenario that is part of the application for authorisation. However, activities considered to form part of the use of the sample in performing analytical activities can benefit from the exemption under Article 56(3) of REACH. See also Q&A 585.

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to analytical activities using in vitro diagnostic (IVD) medical devices (as defined in Directive 98/79/EC) at a laboratory scale?

Yes. The use of an Annex XIV substance when it is required, on its own or in a mixture, as part of an in vitro diagnostic (IVD) method (e.g. in a reagent, calibrator, control material or kit) is considered as scientific research and development and is therefore exempted from authorisation requirements if this activity is carried out under controlled conditions and in a volume not exceeding one tonne per year per legal entity (see Q&A 585). 

Annex XIV substances may be required to provide a range of functions during IVD analysis, including: to remove impurities, to prevent undesired reactions that would lead to false positive results, to stabilise or solubilise proteins during analysis, to inactivate viruses prior to analysis.

The exemption covers also IVD medical devices for veterinary and animal health purposes.

 

 

 

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to the use of an Annex XIV substance in upstream life-cycle stages to produce in vitro diagnostic (IVD) medical devices?

It depends. See the more general Q&As 1498 and 1030, as well as Q&A 1442.

For instance, the incorporation of an Annex XIV substance into an IVD medical device which is an article is not exempted under Article 56(3) REACH. Similarly, the use of an Annex XIV substance in upstream life-cycle stages to produce IVD medical devices which are not articles (e.g. reagents, calibrator, control material or kits) and where the Annex XIV substance is not incorporated into the IVD device is not exempted under Article 56(3) REACH. An example of the latter is the use of an Annex XIV substance to lyse cell membranes during the purification of antibodies that are subsequently used in an IVD medical device which is not an article: that use would require an authorisation. 

 

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) REACH also apply to Annex XIV substances used together with or incorporated in SRD articles?
It depends. The exemption applies, for example, to an Annex XIV substance used together with (but not becoming an integral part of) an article both produced for SRD purposes (e.g. reagent used together with an analytical apparatus). However, the exemption does not apply to an Annex XIV substance which is integrated in (i.e. becoming an integral part of) an article produced for SRD or non-SRD purposes (e.g. mercury in thermometers). Similarly, the exemption does not apply to an Annex XIV substance used to produce an SRD article if the substance is not intentionally incorporated into the SRD article (e.g. used as processing aid or solvent during the manufacturing of the SRD article).
Are uses in Product and Process Orientated Research and Development (PPORD) exempted from the authorisation requirement?

Uses in PPORD are not generically exempted from the authorisation requirement.

However:

  1. Specific entries in the Authorisation List may include an exemption for uses in PPORD below a specified maximum quantity;
  2. Activities to develop products and processes may fall under the definition of Scientific Research & Development (SRD) if they are carried out under controlled conditions in a volume less than one tonne per year. In this case, they are exempted from authorisation.
For more information, see also ECHA’s “Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)”, available at: https://echa.europa.eu/guidance-documents/guidance-on-reach.
c) Format and content of authorisation

What is the format for authorisation applications?

Application for authorisation dossiers shall consist in an IUCLID file, to which a series of specific documents are attached. For the purpose of an application for authorisation, the latest version of IUCLID should be used. Formats for these attachments are provided by ECHA on its website

How can an applicant submit an application to ECHA?

Authorisation application dossiers shall be submitted electronically via REACH-IT. See (http://echa.europa.eu/applying-for-authorisation)

In which language shall I submit my application for authorisation to ECHA?

The whole application can be submitted in any single official EU language. For example, you can submit the whole application in English. However, you cannot submit an application where most of the documents are in English and rest in another language, For details, see question 129.

What will ECHA do if it receives applications that contain documents in more than one official EU language?

ECHA would consider those parts of the Application that are not in the main language as "not received". These documents could be essential for conformity of the application under Article 62 of REACH. If so, the Committees would request the applicant to submit an update of these documents in the main language. If the applicant fails to submit the translations, the Committees would not consider the application to be in conformity with the requirements of Article 62.

What is meant by the "Broad Information on Uses" package and what does it contain?

The Broad Information on Uses (BIU) of the Annex XIV substance refers to a "brief wording" containing:

- information based on the name of the use applied for,
- the use descriptors and function, and
- key information on the conditions of use.

In addition, the BIU contains the following documents:

- the public version of the Analysis of alternatives,
- the public version of the Substitution Plan, if provided in the application,
- the public version of the Socio Economic Analysis, if provided in the application, and
- the public version of sections 9 ("Exposure assessment") and 10 ("Risk characterisation") of the Chemical Safety Report (CSR) covering the use applied for.

For further details and example, see: http://echa.europa.eu/documents/10162/13555/public_information_afa_en.pdf

Will the applicant's name be made public?

Yes. The applicant's name will normally be made public as part of the Broad information Use during the public consultation on alternatives.

How can I provide in my application a "complete" and a "public" version of sections 9 ("Exposure assessment") and 10 ("Risk characterisation") of the Chemical Safety Report (CSR) covering the uses applied for?

Include the complete versions of sections 9 and 10 in your Chemical Safety Report (CSR) and attach the CSR to section 13 of IUCLID (naming it for instance "CSR.pdf").

Attach a public version of sections 9 and 10 naming it clearly (e.g. "Public_version_of_CSR sec9-10.pdf") and attach it as a separate document in section 13 of IUCLID.

If all the information contained in sections 9 and 10 can be made public, then these two sections will be published as they are provided in the CSR.

Do I need to update my Chemical Safety Report (CSR)?

If you (as the applicant) have already registered the Annex XIV substance, the CSR prepared for registration purposes should be the basis for the preparation of the CSR needed in an application for authorisation. However, it is likely that it needs to be updated and adapted to the authorisation context (e.g. regarding the refinement of uses, emissions and exposures, the overall quality of the CSR, etc). When submitting your application you can attach a version of your CSR specifically developed for authorisation. You can use this opportunity in cases, where you may wish to provide – for the authorisation purposes –  only an extract of the latest updated CSR submitted in the registration process. This updated CSR would contain only those parts that are relevant for the authorisation application, but developed in more detail.

Or you can simply refer to the CSR provided in your registration dossier. In the latter case you should – if necessary – update your CSR before you submit your application to ECHA. If you develop a specific CSR for authorisation, you should be aware that as a rule the information contained in the CSR submitted in an authorisation application should be in the CSR provided in the registration dossier.

After the sunset date the applicant will need to update the CSR submitted in the registration in order to remove all uses for which he has not applied for authorisation.

Following the authorisation decision taken by the Commission, the Applicant may also need to further update the CSR submitted in his registration.

How can an applicant provide information in its application which should not be made publicly available?

Applicants can provide information which should not be made public in the "complete versions" of the assessment reports (Chemical Safety Report, Analysis of Alternatives, Substitution Plan, Socio-Economic Analysis). Formats and instructions are available under the "Preparing Applications for authorisation" page (http://echa.europa.eu/applying-for-authorisation/preparing-applications-for-authorisation).

Applicants need to make "public versions" of these "complete versions". In "public versions"  the applicants need to blank out confidential business information. The "public versions" will be published on ECHA's website during public consultation on alternatives. Applicants need to provide solid justifications as to why the information which has been blanked out should not be made public.

What is a joint application?

A joint application for authorisation in REACH is made and submitted simultaneously by a group of applicants (i.e. the submitting applicant and the co-applicants). The submitting applicant starts by uploading the IUCLID dossier in REACH-IT. When the dossier has been successfully uploaded, the submitting applicant receives the joint application name and security token, which he will communicate to the co-applicants.

The submitting applicant and co-applicants indicate the substance-use combinations they are applying for, scope of their use(s) and provide the information on their role in the supply chain by completing the information in REACH-IT. The submitting applicant finalises the joint application after all co-applicants have completed their parts of the information and confirmed their participation. 

 

Is a joint application easier to submit and manage than separate applications?

Due to the possible complexity and technical issues of joint applications, ECHA recommends to prepare and submit a joint application when (i) all co-applicants of the group apply for all uses in the joint application, and (ii) the co-applicants have agreed on a way to share all the information provided in the application.

In complex cases, it may be preferable for each applicant to submit their own application separately. The applicants can cooperate during the preparation of their applications. For details, see the manual ‘How to prepare an application for authorisation manual’.https://echa.europa.eu/manuals, Application for Authorisation Guidance (Appendix 2) and the presentations "Description of uses for authorisation / Broad Information on Uses" and "Joint versus Individual applications" for additional information.

Can an additional legal entity join a group of applicants after the submission of a joint application?

No. In contrast with Joint Registrations, an additional legal entity cannot join the group of applicants which have already submitted a joint application for authorisation.

What is a subsequent application?

An applicant may submit a subsequent application in which he can refer to appropriate parts of an application previously submitted for a use of a substance, provided that the subsequent applicant has permission from the previous applicant(s) to refer to these parts. Furthermore, the subsequent applicant shall update the information taken over from the original application as necessary. This subsequent application will be processed and evaluated on its own merits.

How will ECHA communicate with the applicant once an application has been submitted?

Via REACH-IT and the secured webforms. However, for organisational and practical issues, emails can be used.

I consider that the substance that I will apply for has a threshold. What if RAC disagrees with my assessment?
RAC intends to develop "reference DNELs" and "reference dose response relationships" for substances that have been listed in Annex XIV. The intention is to make these available before the latest application date has expired (see Q&A 752).
 
If you disagree with RAC's view you can justify this in your application. RAC will evaluate this during the opinion making process.
 
If RAC has not made the "reference DNELs" or ""reference dose response relationships" available before the latest application date it will do so during the opinion making. In any case, you and RAC will need to clarify the possible scientific issues relating to the thresholdness of the substance during the opinion making process.
 
If a threshold cannot be demonstrated, it is not possible to apply based on Article 60(2) in relation to adequate control. However, the application can be evaluated based on Article 60(4). In this case ECHA strongly recommends that the application contains a socio-economic analysis(see Q&A 617).
In a joint application, can confidential information from a joint applicant made secret to the other applicants?
No. The submitting applicant (i.e. the applicant submitting the joint application on behalf of the group of joint applicants) has access to all the information contained in the application. Furthermore, during opinion making confidential information is likely to be referred to within the group of joint applicants; for instance, in ECHA's messages in REACH-IT all co-applicants receive a copy of the message. 
 
ECHA will treat a joint application as a whole and has no possibility to make any special arrangements to accommodate confidentiality issues between joint applicants. 
 
See also Q&A 596.
Can I submit a single application covering several substances?

Yes, if they form a group. The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as stated in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, you have to submit a separate application for each substance. See Appendix I of the Guidance on the preparation of an application for authorisation on substance grouping.

When commenting the draft opinions of RAC and SEAC, can I submit additional or new data that I had not provided when the committees were preparing them?

When reading the Committees' draft opinions you may have noticed misinterpretations, misunderstandings or even errors that need to be addressed in the draft opinions. ECHA encourages you to provide all the necessary clarifications with the relevant supporting evidence during the commenting period. However, the Committees will only take into account new data or information (e.g. new measurements, figures) that are related to such misinterpretations, misunderstandings or errors noted by the applicant. It is the obligation of the applicant to provide the necessary relevant data at the time of the initial submission of the application or in response to earlier requests from the Committees.

If a suitable alternative is available in general -- but not technically or economically feasible for the applicant -- and it therefore submits a substitution plan, can an authorisation be granted under the socio-economic route?
Yes, under certain conditions. Pursuant the General Court’s judgment (Case T 837/16, Sweden vs European Commission), the applicant is required to prepare a substitution plan if there are suitable alternatives available in general (see the Commission’s note of 27 May 2020). Under the socio-economic route, an authorisation may still be granted in such cases if it is shown (i) that those alternatives are not technically or economically feasible for the applicant and (ii) that the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance. RAC and SEAC will provide their assessment of the credibility of the substitution plan and of its consistency with the analysis of alternatives and the socio-economic assessment, so that the Commission can decide on the granting of the authorisation. ECHA has adapted the format for the substitution plan to take into account the Court’s interpretation and updated its instructions on how to organise and present the substitution plan.
d) Authorisation fees and invoicing

How is the fee for an application for an authorisation calculated?

Several scenarios can be envisaged: A base fee is payable, which covers one substance and one use. An additional fee applies for each additional use and substance. No additional fee for additional applicant(s) is levied, though. However, the levels of the base fee and of the additional fees per use and substance depend on the size of the largest company that is party to the application - .i.e. if in joint applications companies are of a different size, the highest applicable fee will be levied.  

For example, in the case of an application submitted by four parties with ten three uses and two substances in total, the relevant fee will be the base fee applicable to the largest applicant + three additional applicant fees + nine two additional use fees applicable to the largest applicant + one additional substance fee applicable to the largest applicant.

The table below shows four examples of calculated fee for applications for a single substance where the (largest) applicant is a large company.

Table: Fees depend on the number of uses, not applicants

Examples A B C D
Applicants 1 2 1 2
Uses 1 1 2 2
Fee €54 100 €54 100 €102 790 €102 790

The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as defined in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, a separate application must be submitted for each substance.

Further information: ECHA Fee Calculator: a tool provided by ECHA to estimate the possible amount of a fee related to a given application for authorisation.

On the REACH Fee regulation: see more information on REACH Legislation -page and Commission Implementing Regulation (EU) 2018/895 of 22 June 2018

 

Application for one applicant and one substance only

If you submit an application for an authorisation on your own, you will have to pay a base fee. That fee covers one use and one substance. If you need to apply for authorisation for more uses, you will need to add an additional fee for each additional use you want to cover. Thus, if your application covers three uses, the fee that you will have to pay is the sum of the basic fee + two additional use fees. The level of the base fee and the additional fees depend on the size of your company; reduced fees apply if you are a micro, small, or medium-sized enterprise.

How will ECHA calculate the fee and send the invoice in the case of joint applications?

ECHA will calculate the fee based on the Fee Regulation. It has made available a Fee Calculator to help the applicants to know in advance the amount that they would expect to pay.

ECHA will send the invoice always to the legal person that submitted the application. Thus, in a joint application ECHA will send the invoice to that applicant that submitted the application. It is then up to this applicant to split the invoice according to the agreement that the applicants have made between themselves. For clarity, ECHA is not in a position to send separate invoices to each of the parties covered by the application. 

How will the applications be invoiced and paid?

ECHA sends the applicant an invoice in about 8 weeks after the submission.  

The applicant has 14 calendar days to pay the invoice with a possibility to extend it by another 7 calendar days. Thus, all in all the applicant is given 21 days to pay the invoice from the date it received the invoice.

If the payment is not made by the extended payment due date, the application for authorisation will be considered as not received by ECHA. In this case the application is not processed further. The only way to proceed is to re-submit the application.

The Fee Regulation (EC No 340/2008) related to the fees for Applications for authorisation has been amended by Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013. Updated articles 8(2) and 9(2) state that "the Agency shall issue one invoice covering the base fee and any applicable additional fees". How will these additional fees be levied?

The necessity to impose an additional fee will reflect ECHA's workload associated with processing and evaluating the application. The calculation of the base fee and any applicable additional fees is described in Q&A 600. An application would lead to additional workload if the number of ‘uses applied for' and/or exposure scenarios is greater than one. One "use applied for" shall be covered by at least one exposure scenario. However, the number of uses vs the number of exposure scenarios might not be identical. Thus, in order to reflect the additional workload, ECHA calculates the fee based on the highest number of uses vs. exposure scenarios.

Example 1: Iif you apply for two uses that are covered together in your Chemical Safety Report by one generic exposure scenario, ECHA will calculate the invoice based on two uses.

Example 2: If you apply for two uses which are covered by three different exposure scenarios, ECHA will estimate whether the evaluation of the additional exposure scenario increases ECHA's workload and whether the fee can be based on three uses.

Is there a fee for confidentiality claims in Applications for authorisation?

No.

Will ECHA consider one exposure scenario for article service life as equivalent to one use for determining the fee?

No. Currently ECHA will not impose a fee for an exposure scenario covering an article service life. ECHA needs to gain experience with the first applications for authorisations. ECHA reserves its right to re-evaluate this approach if, based on the experience gained with handling this type of exposure scenarios in the context of an Applications for Authorisation, ECHA concludes that the associated workload warrants a fee. It is also possible that a fee may be imposed for instance, in conjunction with a review of the Fee Regulation in the future.

e) Preparing for authorisation application

What is the purpose of the teleconference based information sessions?

Teleconference based information sessions (TIS) give an opportunity for future applicants to clarify regulatory and procedural aspects of the authorisation application process, and for ECHA to have a better understanding of the practical issues related to Applications for authorisation. ECHA organised earlier “Pre-submission information sessions” (PSIS). TIS are a more focussed, teleconference based way of fulfilling the same purpose as with PSIS.

For further details see ECHA's Support webpage on teleconference based information sessions (link to: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).

When and how can I request a teleconference based information sessions?

You can make a request for a teleconference based information session (TIS) either when notifying ECHA of your intention to submit an application for authorisation, or later. You should nevertheless send your request for a TIS at least eight months before the planned date for the submission of your application for authorisation. Although you can still notify less than eight months in advance of the submission of your application, this may have an impact on ECHA's availability to organise a TIS for your company. Please bear in mind the TIS should take place within one month after the meeting request and that you probably would like to have sufficient time after the TIS to potentially further work on your application before submitting it to ECHA.

Requests for TIS are made via a secure web form, available on ECHA's website. For further details see ECHA's Support webpage on TIS (link to: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).

How can I have access to the Lead Registrant's Chemical Safety Report (CSR) data if he is not taking part in the application for authorisation? What can I do if the data owner refuses to give me access to its data? Can I use the information available on ECHA's dissemination website?

A CSR has to be submitted as part of the application. This CSR can be (i) the applicant's own CSR for authorisation, or (ii) a reference to CSR submitted by the same applicant for registration, or (iii) a reference to CSR of a previous applicant (case of subsequent applications for authorisation). If the applicant for authorisation is a Downstream User (i.e. not a registrant) and he generates his own CSR for the authorisation, this CSR can be based on updated information from the registrant's CSR as long as he has the right to use the information from the respective data owners.

However, data sharing obligations as specified under Art 30 of REACH do not apply for authorisation. The reproduction or further distribution of information from Registration Dossiers and Notifications to the C&L Inventory which are published on ECHA's dissemination website may be subject to copyright protection. Furthermore, the use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner. The Agency does not take responsibility for any copyright or other infringements that may be caused by using the information.

Potential applicants are reminded that they shall ensure that they have adequate rights to submit this information to the Agency and acknowledge that this information can be used for the purpose of the application for authorisation.

See also question 916

Will a pre-submission information session (PSIS) be available for the whole group of applicants participating in a joint application or will there be a separate PSIS for each co-applicant?

In joint applications, only one PSIS will be available, and this session is for the group of applicants as a whole. Due to the limited availability of places for the PSIS, it is for the group of applicants to decide who would be the most appropriate to represent them in the session.

How should I develop the ‘uses applied for' and exposure scenarios in my application?

The description of the ‘uses applied for' and of the related exposure scenarios is key step in the preparation of an application for authorisation. The concept of "use applied for" in the context of applications for authorisation might significantly differ from what industrial actors usually understand by a "use" in their day-to-day practice. The ‘use applied for' description, scope and level of details are not only related to the risks linked to the exposure/release of the Annex XIV substance but also to the analysis of alternatives and, where relevant, to the socio-economic analysis and substitution plan. The following documents describe this issue in more details:

 
Which DNEL should I use?

The demonstration of adequate control or minimisation of the risks should be made in the Chemical Safety Report (CSR) of the application for authorisation. REACH Annex I defines the Derived No-Effect Level (DNEL), i.e. the level of exposure above which humans should not be exposed and the way the risk characterisation for the human population should be performed, based on the DNEL (if a DNEL can be determined). DNELs derived according to the ECHA guidance are therefore the reference data for the demonstration of adequate control. 

It should be noted that the Committee for Risk Assessment (RAC) has derived reference DNELs for  some substances on Annex XIV and intends to continue doing so for other Annex XIV substances. 

For more details, see:

How many pages should an application contain?

An application for authorisation is not a matter of pages but rather how convincing the argumentation is. All the necessary information for the ECHA Committees for making their opinions and for the Commission to make its decision should be included in the application in a clear and convincing way. Overall in a well-argued application, strong or clear messages should not be diluted or obscured by lengthy text. Also you can consider using appendixes to provide additional, complementary information.

Would the application be in conformity according to Article 62(4)(d) of REACH if it took as a premise the ‘Reference DNEL' or ‘dose response relationship' adopted by RAC and published on ECHA's website?

Yes, as long as the application is in conformity with the rest of Article 62 and the applicant decides to use in his assessment the DNELs or dose response relationships derived by RAC for the intrinsic properties of the substance specified in Annex XIV. In this case the applicant does not need to provide the hazard data necessary to derive DNELs or dose response relationships.

See also Q&A 752 and 912

Do I need to include Part A in the Chemical Safety Report (CSR), when I submit it as part of my application for authorisation?

Yes, the Chemical Safety Report shall always include the "Part A" duly completed. Part A contains the Summary of Risk Management Measures and the declarations that these measures are implemented and communicated. See also Q&A 611.

f) Analysis of alternatives

Do I need to consider also Substances of Very High Concern (SVHC) in my Analysis of Alternatives?

Usually not. A suitable alternative should results in an overall reduction of risks to human health and the environment compared to the Annex XIV substance. An alternative substance having a similar (eco)toxicological profile to the Annex XIV substance (for instance a SVHC substance) is unlikely to meet the overall reduction of risks criterion. However, even if the alternative does not lead to an overall reduction of risk, this alternative substance should still be part of your analysis of alternatives but the conclusion regarding the overall reduction of risks should be relatively straightforward. As a consequence, you may consider whether a detailed analysis of its technical and economic feasibility is necessary in such a case.

How will the ECHA Committees (RAC and SEAC) take into account third parties' comments submitted during the public consultation on alternatives?

As a result of the eight-week public consultation both the "complete" and the "public" versions of the comments on the alternatives are made available to the Rapporteurs and the Committee members. The Rapporteurs will use this information as any other information during an evaluation process. The relevance, validity and reliability of the information will be assessed. The applicant will have a possibility to respond to the "public versions" of the comments. The Rapporteurs may pose follow-up questions to the third parties. They may also pose questions or require additional information from the applicant, as a result of the information provided by third parties.

What is the scope of the Analysis of Alternatives and the Socio-economic Analysis? The applicant's perspective or the society as a whole?

Both the applicant's and society's perspectives are relevant in the application. The applicant's perspective is relevant in the Analysis of Alternatives to assess how feasible it would be for the applicant to adopt any alternatives which are available to him. This would include the alternative of ceasing use of the substance altogether. This analysis can be used to identify the non-use scenario(s) which would pertain, if authorisation is not granted. The use and non-use scenarios should be assessed from society's perspective to provide an assessment of whether authorisation is justified from a social perspective or not, based on a comparison of the benefits of authorisation and the risks.

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the scope should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. One qualification to this is that alternatives might be suggested through the public consultation of which the applicant was previously unaware or would not normally consider. He might wish, therefore, to extend the normal scope of his analysis in anticipation of this.

It is not possible to generalise about the exact scope of the socio-economic analysis, as this will vary on a case-by-case basis. The principle is that all factors should be incorporated to the extent that they might make a material difference to the conclusions. An iterative approach to developing the analysis, as well as consultation and input from socio-economic analysis experts, can be helpful in establishing the appropriate scope in any given situation.

More details in the presentations of the seminars on application for authorisation:

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation/afa

I will submit an Analysis of Alternatives for a threshold substance. I have R&D activities to develop and implement safer alternatives that are neither suitable nor available yet. Can I submit a Substitution Plan with my application?

A Substitution Plan should be provided if suitable alternatives are available (cfr. Article 62(4f)). A Substitution Plan is a commitment to take the actions needed to substitute the Annex XIV substance with a suitable alternative substance or technology within a specified timetable. If you conclude that the alternatives you have identified are neither suitable nor available yet, you should not submit a separate Substitution Plan. You should rather include all the relevant information on R&D activities in your Analysis of Alternatives. Refer to the Guidance on Application for Authorisation for more information.

Is it appropriate to provide a socio-economic analysis under the adequate control route?

There is no requirement to submit a socio-economic analysis when submitting an application for authorisation under the adequate control route. However, ECHA recommends that a targeted socio-economic analysis is also prepared under the adequate control route. This would be helpful in particular to the Committees when proposing to the Commission the duration of the review period. Furthermore, if the ECHA Committees do not support the applicant's assessment according to which the risks are adequately controlled, the application can still be evaluated on the provided socio-economic analysis.

How should the "economic feasibility" criteria be interpreted?

Based on Articles 60(4) and 64(4)(b) of the REACH Regulation the Committee for Socio-economic Analysis (SEAC) needs to state in its opinion, if the alternatives to the substance that is applied for are suitable. Economic feasibility is one aspect of this. It is recognised that the evaluation of economic feasibility is intrinsically linked with the evaluation of the other aspect of suitability of the alternatives, i.e. technical feasibility. Usually the more difficult (or easy) it is to substitute a substance the more expensive (or cheap) it is to do this. The note below describes how SEAC intends to evaluate economic feasibility as part of applications for authorisation recognising the link with technical feasibility.

What is the level of details needed for the analysis of alternatives?

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the level of detail should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. However, as stated in the guidance on applications for authorisation: "It is strongly recommended that the applicant demonstrates that a comprehensive and adequate assessment of alternatives has been done. This is because the Agency in its opinions and the Commission in its assessment of whether suitable alternatives are available will take "all relevant aspects" into account {Art. 60(5)}, including information submitted by interested third parties." However, regarding the assessment of the risks arising from the use of the alternative and the comparison of these risks with the ones arising from the use of the Annex XIV substance "the applicant is not required to generate new hazard data or provide a chemical safety assessment for each of the alternatives. Nor is it required that the risks associated with alternative substances or technologies are assessed in the same detail as the risks associated with the Annex XIV substance."

In conclusion, the level of effort that needs to be put into the analysis of alternatives will be a matter of judgment for the applicant and should reach a point where the applicant is comfortable in defending its analysis in front of the ECHA Committees.
 

Should I consider in my socio-economic analysis the aspects outside the EU?

Yes, if they are relevant. However, the focus of the socio-economic analysis should be the EU but information on effects outside the EU may be relevant as well. See chapter 2.4.3 in the "Guidance on the preparation of socio-economic analysis as part of an application for authorisation"[PDF] for more information. 

g) Technical instructions for specific Annex XIV entries

The entry for Hexabromocyclododecane (HBCDD) indicates 2 EC entries and 5 CAS entries. How should the substance identification sections (1.1 and 1.2) in an IUCLID application for authorisation dossier be filled in?

The Annex XIV entry for HBCDD is a relatively broad entry, which might be considered to describe UVCB substances (with undefined Br positions), as well as multi-constituent substances (containing more than one defined diastereoisomers at concentrations between ≥10% and <80%), and mono-constituent substances (one diastereoisomer ≥80%).

If the application concerns one particular HBCDD substance (either UVCB, or multi- or mono-constituent), then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals).

Should the application concern more than one substances covered by the HBCDD entry (for instance due to different manufacture processes by one manufacturer, or in case of a joint application with applicants manufacturing/importing significantly different HBCDD substances), the application can still be considered as an application for "one Annex XIV substance". Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.

In this latter case, for technical reasons in section 1.1 of the IUCLID application dossier the following information should be filled in: IUPAC name: Hexabromocyclododecane; Type of substance – Composition: other: multiple substances under Annex XIV entry. The actual compositions of the substances applying for can be listed individually as different compositions in section 1.2 by using the repeatable block-function. In the "Brief description" field of each listed composition, please indicate also a remark, e.g. "substance manufactured from manufacturing site A" or "substance manufactured/imported by applicant B".

It is reminded that the REACH Annex XIV substance entry number (for HBCDD this number is "3") shall always be given in section 1.3 of the IUCLID dossier.

General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals)

Can an application for authorisation for chromium trioxide cover the use of the chromic acids and their oligomers generated from adding chromium trioxide to water?

Yes. The reasoning and some example are provided below.

When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid (further referred as "Chromic acids and their oligomers"). These chemical species are all identified as substances of very high concern (SVHC) and included in Annex XIV1 as two separate entries. Latest Application Date (21 March 2016) and Sunset Date (21 September 2017) are identical for both entries.

Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the authorisation requirements, it may be justifiable in some situations to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide.

The generation of chromic acids and their oligomers by adding chromium trioxide to water is a use of a substance under REACH. This may be a discreet use of chromium oxide by a formulator or part of an integrated process in the use of chromium oxide. Considering this in the context of applications for authorisation, this operation should be considered as a "use applied for" and be addressed in the chemical safety report (CSR), the analysis of alternatives and, if appropriate, in the socio-economic analysis. Hence, applications for authorisation that are meant to cover further uses down the supply chain after the initial step in which chromium trioxide is brought in contact with water, have to refer to the chromic acids and their oligomers.

This answer is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. The system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The answer should thus not be applied by analogy to any other substance.

The table below describes possible scenarios in the case of an application for authorisation is made by the manufacturer/importer/user of chromium trioxide and/or chromic acids and their oligomers. Technical instructions are provided in the last column of the table.

As a general rule, sections 1.1, 1.2 and 1.3 of IUCLID should always refer to the substance applied for (i.e. the substance indicated in the third column - "Application for authorisation" of Table 1). In addition, if there is more than one substance which is imported/used (scenario #2 below) or if the substance actually imported/used is different from the substance applied for (scenario #3b below) this information should be described in section 1.2.

For each use, the assessment performed in the assessment reports (CSR, analysis of alternatives (AoA) and socio-economic analysis (SEA)) should relate to the substance relevant for that use. The substance at the use level (e.g. chromic acids and their oligomers - used in electroplating) might indeed differ from the substance applied for (e.g. chromium trioxide) in terms of hazard, physical form / potential for exposure to Cr(VI), alternatives, etc.

Table 1 - Possible scenarios in the case of an application made by the manufacturer/importer of chromium trioxide and/or chromic acids and their oligomers2

 

Scenario # Actor / Scenario Application for authorisation Explanation / Technical instructions
1 Manufacturer / importer/User of chromium trioxide who generates chromic acids and their oligomers in water applies for an authorisation for this use and the further uses of chromic acids and their oligomers (by itself and/or its downstream users) One application for authorisation for chromium trioxide covering the further uses of the chromic acids and their oligomers Substance ID in IUCLID
  • Section 1.1:indicate chromium trioxide as reference substance
  • Section 1.2: describe the actual composition of chromium trioxide
  • Section 1.3: indicate the A.XIV entry 16 (entry number for chromium trioxide)
Assessment reports in IUCLID (CSR, AoA, SEA):
  • Assessment to be based on the relevant substance per use (chromium trioxide or chromic acids and their oligomers). The two substances may differ e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.
2

Importer/User of both
- chromium trioxide
and
- chromic acids and their oligomers generated in water from chromium trioxide

applies for an authorisation for the generation in water  of chromic acids and their oligomers and their further uses (by itself  and/or its downstream users)
 

One application for authorisation for chromium trioxide covering the further uses of the chromic acids and their oligomers

The application should be made for chromium trioxide making clear that chromic acids and their oligomers are also imported/used.

Substance ID in IUCLID:

  • Section 1.1: indicate chromium trioxide as reference substance
  • Section 1.2: describe as first composition the actual composition of chromium trioxide and as second composition the actual composition of chromic acids and their oligomers. In addition, indicate in the "brief description" field that both chromium trioxide and chromic acids and their oligomers are imported/used.
  • Section 1.3: indicate the A.XIV entry 16 (entry number for chromium trioxide)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on the relevant substance per use (chromium trioxide or chromic acids and their oligomers). The two substances may differ e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.
3 Importer/User of chromic acids and their oligomers generated in water from chromium trioxide applies for an authorisation for the further uses of chromic acids and their oligomers (by itself and/or its downstream users) One application for authorisation either for
  1. chromic acids and their oligomers generated from chromium trioxide covering the further uses
  2. or for
  3. chromium trioxide covering the further uses of chromic acids and their oligomers

In case the importer/user decides to apply for an authorisation for chromic acids and their oligomers in an application for chromium trioxide (case b), it has to become clear from the application that what is actually imported/used are chromic acids and their oligomers:

Substance ID in IUCLID:

  • Section 1.1: indicate as reference substance the substance applied for: either chromic acids and their oligomers (case a) or chromium trioxide (case b)
  • Section 1.2:
    • in case a): describe the actual composition of chromic acids and their oligomers
    • in case b): for technical reasons describe as first composition the composition of chromium trioxide (100% purity) and as second composition the actual composition of chromic acids and their oligomers. In addition, indicate in the "brief description" field that what is actually imported/used are chromic acids and their oligomers.
  • Section 1.3 indicate the A.XIV entry of the substance applied for: 17 if applying for the chromic acids and their oligomers (case a) or 16 if applying for chromium trioxide (case b)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on chromic acids in terms of e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.

 

4 Manufacturer/Importer/User of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water3
or
Importer/User who is unaware of the manufacturing methods of the chromic acids and their oligomers applies for an authorisation for the further uses of chromic acids and their oligomers (by itself and/or its downstream users)
One application for authorisation for chromic acids and their oligomers covering the further uses

The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known.

Substance ID in IUCLID:

  • Sections 1.1: indicate as reference substance: chromic acids and their oligomers
  • Section 1.2: describe the actual composition of chromic acids and their oligomers
  • Section 1.3: indicate the A.XIV entry 17 (entry number for chromic acids and their oligomers)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on chromic acids and their oligomers, in terms of e.g. hazard, form / potential for exposure to Cr(VI), alternatives etc.

 

Please see also Q&A=804 (Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?)

1  Entry#17: 'Acids generated from chromium trioxide and their oligomers. Group containing: chromic acid, dichromic acid, and oligomers of chromic acid and dichromic acid' And Entry#16: 'chromium trioxide'

2  Chromic acids and their oligomers generated from chromium trioxide could be described in IUCLID sections 1.1 and 1.2 e.g. as a UVCB substance with IUPAC name "Acids generated from chromium trioxide and their oligomers" and Brief description "complex composition typically including oligomers of chromic and dichromic acids in equilibrium with each other". As constituents there could be listed i) chromic acid, ii) dichromic acid, and iii) oligomers of chromic and dichromic acids.

3  Further clarification may be needed as to whether alternative methods would lead to similar equilibrium as for aqueous solutions

The entries for 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (entry 42) and 4-Nonylphenol, branched and linear, ethoxylated (entry 43) cover several substances each. How should the substance identification sections (1.1 and 1.2) in an IUCLID application for authorisation dossier be filled in?

These Annex XIV entries are relatively broad entries, covering well-defined substances and UVCB substances, polymers and homologues.

If the application concerns one particular substance within the scope of one of these entries, then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation.

If the application concerns more than one substance covered by the applicable entry (i.e., either entry 42 or entry 43 in the authorisation list), the application will still be considered as an application for "one Annex XIV substance" for that specific entry. Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.

In this latter case, for technical reasons section 1.1 of the IUCLID application dossier should contain the following information:

  • IUPAC name: the name of the entry as it appears in the Authorisation List (“4-Nonylphenol, branched and linear” or “4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated” accordingly);
  • Type of substance – Composition: “other:” “multiple substances under Annex XIV entry”.

In this case, in section 1.2 the available information about the actual compositions of the substances applying for can be provided, listed as different compositions by using the repeatable block-function.

It is reminded that in all cases the REACH Annex XIV substance entry number (for these entries the number is "42" and “43” accordingly) shall be given in section 1.3 of the IUCLID dossier.

General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation.

It is noted that in the case the application concerns both entries (42 and 43) a single multi-substance dossier will need to be submitted. In this case, ECHA will charge a fee for two substances and the IUCLID dossier shall accordingly contain two substance datasets, according to the instructions provided in the manual.

The substance I use has been identified as ‘nonylphenol ethoxylated’ (CAS# 9016-45-9). Should I consider that this substance is listed under entry 43 of the Authorisation list?

Yes, given the method of manufacture of this type of substance. The commercially manufactured nonylphenol ethoxylates predominantly consist of C9 alkyl substituents in position 4 (para-) of the phenol ring. Therefore a substance defined as nonylphenol ethoxylated is covered by the entry 43 for ‘4-Nonylphenol, branched and linear, ethoxylated’.

h) Changes of legal entity

What is a change of legal entity that needs to be notified for applications for authorisation or granted authorisations?

A change of legal entity is a change of the legal person who is the applicant of an authorisation or an authorisation holder. This change can take place, for instance, as the result of a merger, a split or an asset sale (sale of a production site or business). See Q&A 1242. Also purely administrative changes such as a change of corporate name or address and a change of Only Representative (OR) of a non-EU company need to be notified. See Q&A 1253.

 

Does a change of corporate name of an applicant or an authorisation holder need to be notified to ECHA and how?

Yes. 
Please submit the notification as follows:

  • Go to REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.
  • Then notify ECHA via email: legal-entity-changes-authorisation@echa.europa.eu. Please mention the affected submission number (of application) or authorisation number (of granted authorisation), and confirm that you have updated the name in REACH-IT.

In this manner ECHA can quickly process the change. ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

Can an application for authorisation or a granted authorisation be transferred?

Yes. An application for authorisation or a granted authorisation can be transferred as long as the transfer is the result of the change of legal entity referred to in Q&A 1239 and the person to whom it is transferred qualifies as manufacturer, importer or downstream user with regard to the substance(s) and the use(s) covered by the application for authorisation or the decision. For details, see Q&As 1239 and 1242. On Only Representatives, see Q&A 1250.

Please note that a change of legal entity cannot extend the scope of the original application for authorisation or of the authorisation, e.g. to cover different uses.

How can I notify a change of legal personality regarding an application or an authorisation?


Please follow the next steps:

  • If relevant, create a new REACH-IT account for the successor legal entity. This is relevant when the new legal entity did not have a REACH-IT account before.
  • Log into the REACH-IT account of the original legal entity and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions. For the submission, include two attachments:
  1. Evidence of change, for instance the merger agreement or the agreement of the sale of assets.
  2. Filled announcement using the format indicated below. This describes the change of legal entity and the concerned application(s) or authorisation(s), as well as provides an analysis of the key impacts. It needs to be signed by both the original and the successor legal entity.

See also Q&A 1247.
Remember, that if the original entity has other REACH assets (e.g. registrations), the change of legal entity may need to be notified, too, via the same functionality in REACH-IT. See ECHA’s Practical Guide and technical instructions provided in the REACH-IT tool.

 

Do I have to pay a fee when notifying my change of legal entity?

Currently no fee needs to be paid for this notification for the purposes of authorisation.

 

The application was submitted before the Latest Application Date. If the legal entity changes, do the transitional arrangements set out in Article 56(1)(d) of REACH continue to apply to the legal successor?
Yes, provided that the change does not imply an extension of the scope of the original application (see Q&A 1241).
What will ECHA and the European Commission do and by when, following a notification of a change of legal entity regarding i) a pending application or ii) authorisation decision?

If the change concerns a pending application for authorisation, ECHA will communicate whether the notified change corresponds to the requirements described in Q&A 1241 and is properly documented. Furthermore, it will give its view on whether the change is minor (i.e. purely administrative changes and changes that would not have material implications on the content of the application or the terms of the RAC and SEAC opinions) or major (i.e. all other cases). ECHA endeavours to process notifications in two weeks. If the change is confirmed, ECHA will provide to the original legal entity a token. The original legal entity will need to communicate the token to the successor legal entity, who will need to accept the legal entity change in REACH-IT. The change is considered valid as of the date of the notification.

In this case ECHA will amend its database concerning the change of the legal entity. If the change is major, the RAC and the SEAC might need additional time to assess the implications of the change during the opinion-making process. If ECHA has already adopted an opinion, it will send its assessment to the European Commission so that it can take this into account when deciding on the authorisation.

In cases concerning granted authorisations, ECHA will send its assessment on the nature of the change to the European Commission, including its assessment on whether a review of the authorisation should be triggered on the basis of Article 61(2) of REACH.

The timelines for the assessment about any implications for the RAC and SEAC opinions or for the authorisation decision (potential trigger of a review of the authorisation) depend on the stage in the process at which the notification was made.

ECHA or the Commission may request for clarifications or additional information concerning your notification.

 

How should an applicant or an authorisation holder inform ECHA about a legal entity change?

An applicant for authorisation or an authorisation holder should inform ECHA about any legal entity change as soon as it has taken place (i.e. when they have the documentary evidence) using the ‘Legal entity change’ functionality in REACH IT. To reduce uncertainty you can also consult ECHA on the specific case in advance, provided you have sufficient information about the foreseen change. For any questions, please contact ECHA at legal-entity-changes-authorisation@echa.europa.eu.

I am preparing an application for authorisation while knowing that a change of legal entity will take place in the near future. How should I address this in the application?
As you foresee a change of legal entity, to the extent feasible we recommend to also describe this in the application and analyse the potential consequences of this change in your assessment. This would facilitate the assessment of the application by ECHA / the Commission once such change has occurred. You are advised to use the same format as in Q&A 1242 for reporting your analysis of the key impacts on the information in the application.
Does a change of an Only Representative (OR) concerning an application for authorisation or a granted authorisation need to be notified to ECHA and how?

Yes.

Please proceed as follows:

  • Create a new REACH-IT account for the new Only Representative. 
  • Log into the REACH-IT account of the original Only Representative and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions.

ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

Does a change of corporate name of an applicant or an authorisation holder need to be notified to ECHA and how?

Yes.

Please submit the notification as follows:

  • Log into REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.

ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

i) Review reports

What is difference between a Review Report and the Application for Authorisation?

The Review Report updates the Application for Authorisation (AfA), and it must be sent to ECHA. The fee is the same as the one for an AfA. The Review Report will follow the same process as for an AfA. The greater the relevant technical and other progress during the review period, the greater the need to update the information. The information elements are the same. In other words, a Review Report should include an updated version of the assessment reports submitted in the original application (Chemical Safety Report, Analysis of Alternatives and – when relevant – an updated Socio-economic Analysis and an updated Substitution Plan). The use description may also need to be updated e.g. to reflect a more narrow scope. 

See Section 6 of the Practical Guide “How to apply for an authorisation” at https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676
All the Q&As related to Applications for Authorisation are also valid for Review Reports mutatis mutandis.

I have submitted my Review Report on time i.e. at least 18 months before the end of the review period. The Commission has not issued its decision before the end of the review period. Can I continue to use the substance according to the authorisation decision until the Commission issues its decision?
Yes, until a decision on the review (maintaining, amending or withdrawing the authorisation) is adopted - see also Q&A 0571; 0572; 0573 which relate to the submission windows and the (latest) submission dates. The Q&As are also applicable to Review Reports.
I have submitted my Review Report too late i.e. less than 18 months before the end of the review period. The Commission has not issued its decision before the end of the review period. Can I continue to use the substance according to the authorisation until the Commission issues its decision?
No, the substance cannot be used after the end of the review period. You will have to wait the Commission’s decision before you can continue using the substance.
Can I submit a Review Report for a use that has not been authorised?
No. To submit a Review Report, the use has to be the one for which you have an authorisation. But you can submit a new Application for Authorisation.
Can I narrow down the scope of the authorised use in a review report to be more specific?
Yes. As long as your use is within the scope of the authorised use, but more narrowly defined, you can prepare a Review Report for the review of the authorisation. No need to make a new application in this situation. 
In the Review Report, can I split my use which was originally authorised into two or more specific, more narrowly defined different uses?
Yes you can, as long as each of the new redefined uses are within the scope of the previously authorised use. Please explain this clearly in the explanatory note to be submitted with the review report. In this case an updated version of the Chemical Safety Report, Analysis of Alternatives and – when relevant – a Socio-economic Analysis and a Substitution Plan must be submitted for each use. Splitting the use will have an effect on the fee (i.e., an additional charge will be imposed for the second use). At the same time in some cases this may make your Review Report clearer and more focussed, which helps ECHA’s scientific committees’ evaluation and the Commission’s decision making.
Will ECHA’s Scientific Committees use the information gathered from the downstream user notifications (based on REACH Article 66) during the evaluation?
Yes.
Will ECHA’s Scientific Committees use information from enforcement authorities?
Yes. Authorisation holders should use this information too, when preparing the Review Report.
Will I be able to submit another Review Report after this one as a result of a new Commission’s decision?
Yes.
I was unable to demonstrate adequate control of risks for a threshold substance in the original application that I submitted originally. Will I need to do so in the Review Report?
No, you do not have to. However, it would be advisable to do so. Moreover, you shall ensure and demonstrate in the review report that the exposure is reduced to as low level as is technically and practically possible. 
How will I submit the Review Report?
You can submit it to ECHA in the same manner as the original application, using the formats available for that purpose on the ECHA’s website. However, you will naturally need to indicate that it is a Review Report and make a link to the original application. You will also need to write an explanatory note which briefly explains what is different in the review report compared to the original application. For details see the Guide “How to apply for authorisation”: https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676
CoRAP and Substance Evaluation

When a substance is included in the CoRAP, are there any mechanisms by which a registrant can challenge the inclusion or provide input into the evaluation process?

Registrants cannot challenge the inclusion of a substance into the CoRAP (Community Rolling Action Plan).

However, registrant(s) may provide input into the evaluation process. Registrant(s) of a substance in the CoRAP, particularly those substances on the current year of the CoRAP are encouraged to contact the evaluating Member State Competent Authority (eMSCA) early on in the evaluation process. The contact details for the eMSCA are published in the CoRAP. If the dialogue has not already started, the eMSCA will usually contact the lead registrant when the evaluation starts and offer the opportunity to meet to discuss technical issues related to substance evaluation. The registrants should consider nominating a representative for interacting with the eMSCA. The interaction between registrant(s) and the eMSCA at this phase of the evaluation is informal.

When the outcome of a substance evaluation is that an information request to clarify the suspected concern is deemed necessary (i.e. the evaluating MSCA prepares a draft decision on substance evaluation), the registrant(s) will get the opportunity to formally comment within 30 calendar days on any draft decision as part of the decision making process (Articles 50-52 of the REACH Regulation). The evaluating MSCA shall take the comments of the registrant(s) into account and decide whether the draft decision needs to be amended on the basis of the comments/additional information provided by the registrant(s) (Article 50(1) of REACH).

ECHA communicates to the registrant(s) the draft decision as notified to the other MSCAs and ECHA and the received proposals for amendment. At this stage, the registrant(s) will have the opportunity to comment on the proposals for amendment (Article 51(5) of REACH). Registrants are reminded of their obligation to always keep their registration dossier up to date, cf article 22(1).

What is substance evaluation?

Substance Evaluation is an integral part of the REACH implementation. It aims to clarify whether a substance, which has been identified as being of potential concern, poses an actual risk to human health and/or the environment. To clarify the risks, the registrants may be asked for more information on the substance. Substance evaluation shall be carried out by the Member States, whilst ECHA coordinates the procedure. The substances to be evaluated annually are listed in the CoRAP (Community Rolling Action Plan).

Which Member States will evaluate the listed substances?

Member States may volunteer to evaluate a substance. Two Member States may also decide to make a joint evaluation. However, in all cases only one Member State will be designated as the responsible Member State for the evaluation. Final allocation of the substances to the Member States is decided with the adoption of the CoRAP by ECHA, based on the opinion of the Member State Committee (MSC) on the draft CoRAP. Thus, the CoRAP will include for each substance on the list the Member State responsible for the evaluation. The contact information of the responsible competent authority will also be reported for the substances to be evaluated in the first year, to inform the stakeholders about the body handling each substance.

In case of joint evaluations by two Member States, the co-evaluating Member State is also indicated in the CoRAP.

What happens after the CoRAP is adopted?

From the publication of the CoRAP, the respective Member States have one year to evaluate substances listed for the first year (n) and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The evaluation of the substances listed for the second and third year starts only after the publication of the CoRAP update in year n+1 and year n+2 respectively.

What is the difference between dossier evaluation and substance evaluation under REACH?

Dossier evaluation comprises the examination of testing proposals and compliance check of registration dossiers. Testing proposals are triggered by the REACH information requirements and all testing proposals submitted by the registrants must be examined by ECHA. The aim of this examination is to decide on the most appropriate testing in order to fulfil the REACH information requirements. ECHA can perform a compliance check on any registration dossier to verify whether the REACH information requirements are met. Dossiers can be chosen for compliance check based on random selection or prioritised based on a specific concern.

The substance evaluation process is triggered as a result of risk-based concerns and aims to clarify whether a substance poses a risk for human health or the environment. Substance evaluation is targeted at substances (including aggregated tonnages, all uses, etc.). Under substance evaluation any information (beyond the REACH requirements) can be requested provided that it is considered necessary for the purposes of risk assessment of the substance.

Substance evaluation is carried out by the Member States, while ECHA is responsible for dossier evaluation.

The decision making process is essentially the same for both processes.

What is the added value of substance evaluation?

Substance Evaluation may identify risks that could otherwise be missed. This process can further create additional value in respect of:

  • Concerns that go beyond the control of the individual registrant, like regional risks or the potential additional risk caused by aggregated exposures of a (sub)population or releases into the environment.
  • The assessment of groups of similar substances to predict cumulative effects and potentially increased risk levels from exposures to the different substances in the group. 
  • If considered scientifically necessary and proportionate, the request for additional information can go beyond the standard information requirements in REACH.
Why is a substance on the CoRAP list? Which criteria have been used?

The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. The legal text defines that prioritisation shall be on a risk-based approach. According to Article 44(1): "(...) the criteria shall consider:

hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

exposure information; tonnage, including aggregated tonnage from the registrations submitted by several registrants".

The criteria have been refined by ECHA in cooperation with the Member States and are published on ECHA's website: Selection criteria to prioritise substances for Substance Evaluation (2011 CoRAP selection criteria) http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf.

These criteria are applied in the initial step of the identification of substances with potential concerns. A further screening and selection process takes into consideration whether the substances are already subject to regulatory measures and the effectiveness of the substance evaluation to clarify the concern by requesting further information on the substance. Thus, meeting the risk-based criteria alone does not automatically mean an inclusion of the substance in the CoRAP.

According to Article 45(5) of the REACH Regulation, a Member State may notify ECHA of a substance, whenever it is in possession of information suggesting that the substance is a priority for evaluation. Thus, the CoRAP may also contain substances that have been included based on notifications from Member States.

Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances. In the first CoRAP with many substances, the initial concerns are generally related to potential PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive or consumer use(s) and/or high tonnages. In general, the uses of these substances cover various areas and do not focus on any particular industrial, professional or consumer uses.

The final published CoRAP also contains a general indication of the reasons why the substance was prioritised and selected for substance evaluation (grounds for concern). Before inclusion in the CoRAP, the substances have not been evaluated and thus the indicated grounds for concern are just an indication of the possible areas of risk, based on the selection criteria. The initial grounds for concern should not be taken as a statement on a known risk or as a statement on what the evaluation will cover. During the evaluation, other areas of concern may be identified and investigated further. Only after the substance evaluation is completed, risks can be defined and communicated. The Member States have agreed that from the first update of the CoRAP in 2013, more detailed justification documents regarding selection of each substance will be prepared and published.

What does a known or suspected property mean in the grounds for concern in the CoRAP?
For example, the difference between known and suspected CMR-property is the following: "Known" means that the substance has either a harmonised classification and labelling or a self-classification chosen by the registrant(s) for one or more of the CMR-properties. "Suspected" means that e.g. non-conclusive information on intrinsic properties or results of structural prediction models indicate that the substance could have CMR-properties.
 
(CMR = carcinogenic, mutagenic, toxic to reproduction)
When was the first CoRAP adopted?
ECHA submitted a draft CoRAP to the Member State Competent Authorities and the ECHA Member State Committee in October 2011. The draft CoRAP was also published on the ECHA website to inform the stakeholders. The Committee gave its opinion on the draft CoRAP in February 2012. On the basis of the Committee's opinion, ECHA adopted the first CoRAP on 29 February 2012.
Is the CoRAP a new "black list" of chemicals?
The CoRAP list is neither a black list nor a sunset list, i.e. it will not cause a substance to be taken off the market. Instead, substance evaluation is a mechanism to evaluate and get more information on the substances listed therein, when there are concerns that the substances may pose a risk to human health or the environment. The evaluation can result in the conclusion that the concern is resolved and thus no further action is needed. If the initial concern is confirmed in substance evaluation, the Member State may consider further risk management options such as harmonised classification and labelling, restriction or authorisation to control that risk for a respective substance. However, that would be subject to a separate process.
What is the impact of substance evaluation on my business?

The listing of a substance on the CoRAP does not in itself have any legal impact on the registrant and thus does not require any further action by the registrants. When the CoRAP is adopted/updated, the registrants of substances listed for the first year of the CoRAP may expect to receive a draft decision requesting further information after the evaluation period of 12 months. At that point of time, the registrants will be given an opportunity to comment before any final decision to request further information is taken. The final decision will contain a deadline by which the additional information must be submitted.

On the other hand, if the evaluating Member State comes to the conclusion that no further information is necessary to clarify the risk, the substance evaluation process is concluded without a decision to request further information.

Inclusion of a substance in the CoRAP does not automatically mean that the substance poses a risk to human health or the environment, but rather that there is a concern that it may pose a risk, which needs to be clarified (confirmed or dismissed). It also does not automatically trigger, for example, the restriction or authorisation process. However, the Member State responsible for the evaluation of a substance may consider these options once the evaluation is finished, if the risk is confirmed.

Once adopted, is CoRAP fixed?
The CoRAP list will cover a period of three years. The first CoRAP thus includes substances planned for evaluation in the years 2012, 2013 and 2014. The plan should be annually updated. ECHA will make a proposal for the annual update at the latest by 28 February each year. However, currently ECHA plans that the updated CoRAP could already be adopted by the end of February and thus the draft for the CoRAP would be prepared and communicated already in October/November of the previous year. Thus, the first update is expected in February 2013. The rolling nature of the plan means that the list of prioritised substances included for evaluation during the second and third year may change when the plan is updated (e.g. a substance may be dropped or new ones introduced) and that each year a new subsequent year is added.
Is there any interaction between the evaluating Member State and the registrants/stakeholders?

The REACH Regulation does not foresee any formal interaction during the 12 month evaluation process i.e. before the possible draft decision is prepared. Once the draft decision is issued, the registrants will be contacted via REACH-IT. During the decision making procedure registrants will be consulted on any prepared draft decision and proposals made to amend this draft decision. The registrants may submit comments that will be taken into account in the decision making of the evaluating Member State and by the Member State Committee, if the draft decision is referred to the Committee.

The possibility for registrants/stakeholders to interact with the evaluating Member State during the evaluation phase may differ between Member States and substances that are evaluated. However, interaction between the registrants / stakeholders and the evaluating Member State is appreciated in general under substance evaluation. Thus, all relevant information available to the registrants of the substances should be included in the registration dossiers by the start of evaluation (i.e. March each year).

What is the outcome of substance evaluation?

If the evaluating Member State considers that further information is necessary to clarify a potential risk caused by the substance, it may draft a decision specifying the additional data requests. The initially identified concern in the CoRAP does not limit the evaluation made by the Member States and thus the potential request can address any property or exposure scenario of the substance. The registrants of that substance will have an opportunity to provide comments on the draft decision. Such a draft decision will be reviewed and agreed by the other Member States and ECHA, and in the case of proposals for amendment also by the Member State Committee. After this procedure, ECHA will take the final decision in line with the agreement in the Member State Committee. If no unanimous agreement is reached by the Member State Committee, the decision will be taken by the European Commission. The decision will contain a deadline by which the registrants must submit the requested information. It may also be that no request for information is needed because the risks can be clarified with the information already available.  In such cases, the substance evaluation is considered to be completed.

Once the registrants submit the requested information, the responsible Member State has another 12 months to assess this information and decide whether a further request for information is necessary or whether the evaluation can be concluded. In this latter case, the responsible Member State should consider whether and how to use the information obtained for the purposes of Community level risk management measures. The Member States may conclude:

  • EU-wide risk management measures are necessary (e.g. EU wide restriction, EU-wide authorisation, EU-harmonised classification and labelling, occupational exposure limits, measures for the protection of the environment under the Water Framework Directive) or
  • Actions at national level should be taken.

The conclusion can also be that the risks are sufficiently under control with the measures already in place. ECHA informs the European Commission, the registrant and the other Member States about the conclusions.

The decisions on data requests and evaluation reports will be made publicly available once finalised. It should be noted that as the production of the information requested may, in some cases, take several years (e.g. in the case of long term studies and annual environmental monitoring) finishing a final evaluation report may also take several years from the adoption of the CoRAP.

After adoption of the CoRAP, when can a possible first decision requiring further information on a substance be expected? If further information is requested, when would this become available?

From the publication of the CoRAP (March each year), the Member States have 12 months to prepare a draft decision for a substance included for evaluation during the first year, i.e. by end of February of the following year. After that, the decision making process may take approximately four to eight months depending on whether the Member State Committee is involved or not. Thus under favourable conditions, first decisions are likely to be taken between the middle and end of the following year after CoRAP inclusion. The registrants will have the opportunity to comment on the draft decision before the final decision is taken.

The decision will define the deadline by which the registrant(s) must provide the necessary information. Depending on the type of information, the deadline may be between some months and several years.

What is the follow up of substance evaluation?

"Follow up" under substance evaluation means: once the requested information is available and evaluated by the Member State, it will consider whether and how to use the information obtained for the purposes of Community level risk management measures.  The follow up can either be no action or recommendation to take further actions, such as to propose EU wide risk management measures.

A follow up conclusion under substance evaluation is not directly initiating further risk management measures. Any proposed Community-wide actions will be subject to a separate decision making process and Member States need to file a notification for this purpose. For authorisation, restriction and/or harmonised classification under the REACH and the CLP Regulations, stakeholders are consulted at all relevant stages of the process and decisions are taken on the basis of the opinions adopted by the ECHA Committees.

Are substances in the (draft) CoRAP going to be included in the authorisation/restriction processes?
There is no direct link between the CoRAP and the authorisation/restriction processes. While inclusion in the CoRAP means that a substance is going to be evaluated by a Member State to clarify whether there is a potential risk by asking further information, the restriction or authorisation processes aim to control known risks, which cannot be managed by other risk reduction measures. Thus, a follow-up to substance evaluation may be that a Member State wishes to start an authorisation or restriction process.
Where can I get more information on the CoRAP substances?

Information on the substances is available on the ECHA website. This website contains non-confidential information on the properties and uses of the substances that have been retrieved from the registrations for each substance.

Decisions on requests of further information and substance evaluation reports prepared by the Member States will also be published on the ECHA website, when they are available.
Dissemination portal:
http://echa.europa.eu/information-on-chemicals/registered-substances

CoRAP-substances:

https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table

Cosmetics

If a chemical is only used in a cosmetic product, and if there is a potential for worker exposure during the manufacturing process, will testing on animals be required under REACH?

Where exposure to workers in the EEA is established, the REACH requirements apply. Note that the REACH provisions under Annexes VII to XI encourage the use of adaptations; animal testing should be performed as a last resort only (Article 25 of REACH).

Consequently, testing on vertebrate animals will be required only if there is no available information which meets the information requirements, and where no adaptation possibility under column 2 of REACH Annexes VII to X, or under Annex XI can be applied.

This will represent the only means to assess the potential human health risks arising from exposure to workers. 

In practice, how can an adaptation of an information requirement be exercised by a Registrant where the substance is solely used in cosmetics?

As for every adaptation of an information requirement in a registration dossier, you need to insert a justification in each of the relevant endpoints of the IUCLID dossier.

Two main types of scenarios have been identified:

  1. Where the substance is imported into the EEA in a cosmetic product that is not further processed in the EEA: in addition to following the instructions provided by ECHA (see below), you shall add, to the respective endpoint(s) in IUCLID, an explanatory note stating that the substance is solely used in cosmetics, imported in the finished state and not further processed nor repackaged inside the EEA;
  2. Where the substance/cosmetic product is further processed in the EEA, but where absence of worker exposure can be demonstrated: you may avail yourself of the regular adaptation possibilities, pursuant to Annex XI, section 3.1 of REACH, to waive the testing requirements addressed by sections 8.6 and 8.7 (repeated dose toxicity and reproductive toxicity respectively) of Annex VIII to REACH and the test in Annex IX and X.

When applying these adaptations, for the purpose of the justification required according to Annex XI, section 3.2, you do not need to consider the life-cycle stages related to the use of the finished cosmetic product, as these are regulated separately under the Cosmetics Regulation.

While testing for acute toxicity cannot normally be waived under Annex XI, section 3.2, for the purpose of registrations dossiers that cover only cosmetic uses, a similar waiver containing the elements of Annex XI, section 3.2 may be used for this endpoint.

See section 5.1 of the Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements for further details on how to make use of this adaptation possibility.

Furthermore, ECHA provides further specific recommendations to follow below when you create or update your registration dossier.

How can a Registrant indicate the request for adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and not further processed in the EEA?

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier.

Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is only imported in the EEA in a cosmetic product in its final state (neither further processed nor repackaged inside the EEA), the waiving possibility is only relevant for human health endpoints and is only based on the fact that there are no uses in any stage of the life-cycle which may be relevant to REACH (no exposure to workers; exposure to professionals and consumers is covered by the Cosmetics Regulation).

The following specific data waivers can be used only for human health information requirements (Sections 8 of REACH Annexes VII-X).

 

 

IUCLID section

Field

Selection / entry

Substance dataset

Any Endpoint Study Record– Annexes VII to X *

Data waiving

’study waived due to provisions of other regulation’

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

Justification for type of information

The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state (i.e. the product is from the time of import neither further processed nor repackaged inside the EEA).

Waiving of animal testing requirements for human health endpoints is proposed based on the absence of uses other than in finished cosmetic products.

Section 3.5.5 – Consumer uses **

Product category ***

PC39

Dossier

Dossier header

Dossier submission remark

“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state. The product is from the time of import neither further processed nor repackaged inside the EEA.” 

Updates only

Dossier header

Spontaneous update, ‘Justification' ****

‘other' +  ”Cosmetics Regulation / 2013

* Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
** The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5

**** A separate justification should be entered for each reason for the update.

How can a Registrant indicate an adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and further processed in the EEA, without exposure to workers?

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier. Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is further processed inside the EEA, i.e. it is imported or manufactured in the EEA, and still further formulated or re-packaged, before or after inclusion in the final cosmetic product, you need to demonstrate the absence of exposure to workers to benefit from the adaptation possibility.

This case also covers situations where you do not need to provide an exposure assessment: either no CSR is required due to the low tonnage of the substance manufactured or imported, or no exposure assessment is required because the substance does not require classification.

Consequently, you should document the absence of exposure as appropriate, using exposure scenarios and/or other approaches. You can apply for the following specific data waivers, specifically for the human health information requirements (Sections 8 of REACH Annexes VII-X).

 

IUCLID section

Field

Selection / entry

Substance dataset

Endpoint Study Record corresponding to: *

-Annex VII

-Annex VIII (except sections 8.6 and 8.7)

Data waiving

‘study waived due to provisions of other regulation’

 

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

 

Justification for type of information

The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.

Waiving of animal testing requirements for human health endpoints is proposed, since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:”
<registrant to choose the appropriate option(s)>

  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).

 

Endpoint Study Record corresponding to: *

-Section 8.6 and 8.7 of

 Annex VIII
-Annex IX
-Annex X

Data waiving

‘exposure considerations'

 

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

 

Justification for type of information

“The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.

Waiving of animal testing requirements for human health endpoints is proposed since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:
<registrant to choose the appropriate option(s)>

  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).

 

Section 3.5.5 – Consumer uses **

Product category ***

PC39

 

       

 

Dossier

Dossier header

Dossier submission remark

“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and /or further processed inside the EEA before/ after inclusion in the final cosmetic product. All manipulation of the substance outside the cosmetics use takes place under strictly controlled conditions.”

 

Updates only

Dossier header

Spontaneous update, ‘Justification' ****

‘other:' + “Cosmetics Regulation / 2013”

 

 

*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5.

**** A separate justification should be entered for each reason for the update.

See also: https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf

I received a decision under REACH imposing the requirement to provide information performing an animal test. The decision was adopted before March 2013 and I have not yet started the test. Am I still required to comply with the decision?

Yes, the ECHA decision is legally valid and binding, so you have to comply with it.

However, if the substance is used exclusively in a cosmetic product and falls under one of the scenarios described, i.e. animal testing would only serve the purpose to address human health risks resulting from the exposure to the finished cosmetic product, you should be able to comply with the decision you received by requesting use of waiving possibilities, as per the REACH Annexes.

Illustration of cosmetics-based waiving scenarios.

It is only where the required testing relates to potential human health effects for workers that animal tests may be required. In such circumstances, the tests are performed to meet the requirements of REACH.

Does the entry into force of the total marketing ban for animal tested cosmetic products/ingredients affect the compliance of the registration dossiers I already submitted?

No, the entry into force of the total marketing ban under the Cosmetics Regulation (EC) No 1223/2009 does not influence the REACH requirements.

However, if your registered substance is exclusively used in cosmetics, ECHA recommends that you spontaneously update your registration dossier to clearly indicate the uses, should you wish ECHA to take this into account in any subsequent examination. Please follow the instructions provided according to the scenarios described in Q&A 991.

If you have not registered your substance already, ECHA recommends that you follow the instructions provided according to the scenarios described in Q&A 991.

Where do I find more information on the Cosmetics Regulation and the animal testing/marketing ban?
  • For more information regarding the Cosmetics Regulation and the requirements therein, please visit theEuropean Commission website
  • For more information on the interface of REACH and the Cosmetics Regulation, you may consult the factsheet ECHA has published in consultation with the European Commission.
  • You may also contact the ECHA Helpdesk.
Data Sharing

A. Data sharing, general

How can communication within a joint submission be facilitated?

At an early stage, the co-registrants can already agree that one company takes over the organisation of the information exchange and the preparation of the joint submission. This is not, however, compulsory, as REACH does not set any conditions in this respect.

Where the information for exchange is considered commercially sensitive by one or more potential registrants (e.g. because of an impurity content that can indicate a production process), they can, for example, propose a confidentiality agreement or the use of an independent third party or trustee who can handle the confidential information on behalf of the potential registrants. Any other form of organisation is equally possible, as long as it is agreed by all existing and/or potential new co-registrants.

Detailed information on how to organise and improve communication between co-registrants can be found in the Guidance on data sharing.

Can I continue using SIEFs after the registration deadline of 2018 and what is the difference between a substance information exchange forum (SIEF) and a consortium?

There are several possible ways in which companies can organise their cooperation under REACH. These forms of cooperation can vary from loose ways of cooperating (e.g. IT tools to communicate between all members of a joint submission) to more structured and binding models (e.g. consortia created by means of contracts).  

Participation in a SIEF (substance information exchange forum) was mandatory for phase-in substances until the last REACH registration deadline of 31 May 2018. After the end of the phase-in period, however, the Commission Implementing Regulation 2019/1692 of 9 October 2019 encourages co-registrants to use similar informal communication platforms to enable them to meet their continuing registration and data sharing obligations under REACH and Commission Implementing Regulation 2016/9. 

Membership of a consortium is, on the other hand,  entirely voluntary. If some or all participants of one or more informal communication platforms decide to form a consortium, they are free to decide the arrangements regarding scope, purpose, duration, conditions for membership or leaving etc., as long as these do not contravene EU competition rules. 

Additional information on forms of cooperation can be found in the Guidance on data sharing.

What is a letter of access (LoA) under REACH?

When a registrant does not own a study report that they require for their registration, they need to agree with its owner on the conditions of using the study report for REACH registration purposes. The owner of the data and the registrant are free to define the rights that will be granted.

If the robust study summary of a study has already been submitted to ECHA, a registrant can, for instance, refer to that study in their dossier, provided that they have permission to do so. In that context, the registrant and the data owner must agree on the conditions of the right to refer. The LoA is a term often used to describe the agreement on the sharing of data and granting a right to refer. The intellectual property rights of the data owner must in any case be respected by the potential registrant.

I am having difficulty cooperating with a previous registrant. What can I do?

It is the common responsibility of the potential and the existing registrant(s) to negotiate and agree on the content of the joint registration dossier, submitted by a lead registrant. In the case of information submitted less than 12 years prior to the inquiry, Article 27 of the REACH Regulation requires that both potential and previous registrants make every effort to reach an agreement on the sharing of the data and its costs in a fair, transparent and non-discriminatory way. You can find here practical advice on data sharing negotiations. 

In case you fail to reach such an agreement, you may, as a last resort measure, contact ECHA in accordance with Article 27(5) of the REACH Regulation. Please find more details under point 5 here.

How are the costs of data shared and can I receive support from ECHA if costs do not seem justified?
The costs of shared data for each substance may vary significantly, depending on the costs of the studies involved, the number of registrants sharing the data and other factors.
 
An agreement on cost sharing usually requires parties to agree on:
Reliability, relevance and adequacy of the data ("data quality");
Economic value of the data ("data valuation"); and
How the agreed value is shared among parties ("cost allocation and compensation").
 
Registrants need to make every effort to reach an agreement on data sharing and its costs in a fair, transparent and non-discriminatory manner. Registrants need to share the costs of information that they are required to submit to satisfy their registration requirements. Companies cannot be forced to pay for studies that they do not need. 
 
ECHA has published generic advice on what to take into account during the data-sharing negotiations. Additionally, practical advice for data sharing negotiations is available.
 
ECHA will not participate in the discussions between (potential) registrants and has no remit in regulating or assessing the costs of sharing data. ECHA cannot assist a potential registrant in its negotiations with previous registrants or data owners. As a last resort, ECHA can assist in resolving data sharing disputes between existing and potential registrants. For further detail on data-sharing disputes, please refer to the corresponding page on ECHA’s website.
 
The Guidance on data sharing provides more details. 
B. Data sharing, registration

How do I get access to data submitted more than 12 years ago for notifications under Directive 67/548/EEC?

When submitting an inquiry, you show the data requirements needed for the tonnage band you intend to register. You will then receive access to the co-registrants page in REACH-IT, which gives you information on the previous and potential registrants (inquirers). Additionally, ECHA specifies whether (some of) the data has been submitted more than 12 years ago. It is important to distinguish the date of submission from the date of the performance of the study, which pre-dates the submission itself.

The 12-year rule applies from the moment the particular study is submitted, regardless of when it was performed. The date a specific test result was submitted to the competent authority is not necessarily the same as the original notification date. Indeed, the test may have been submitted afterwards (e.g. after a tonnage band increase up to the next level of testing) and hence the 12-year period may not yet have expired. Further information can be found in the new (draft) Guidance on data sharing chapter ‘4.6.1. The “12-year rule” ‘.

The study summaries or robust study summaries submitted in the framework of a registration of the same substance under REACH at least 12 years previously are attached as an annex to the ECHA communication sent to the inquirer. However, the information in the endpoint summaries that ECHA provides may not be sufficient to pass the technical completeness check (TCC), because:

  • certain data were not migrated into the required IUCLID format and will need to be manually corrected; and/or
  • certain administrative information may be missing in some fields or sections.

Similarly, the quality of the data provided needs to be assessed by the potential registrant. You may need to contact the previous registrant to ask for more details or may consider other sources to obtain better information if quality is too low. ECHA also informs the previous registrants that   an inquiry about one of their substances has been submitted.

If you are interested in receiving data submitted more than 12 years ago to use for read-across, you can contact ECHA to request such data in accordance with Article 25(3) of REACH. Note that you are required to:

  1. Show your real intentions to register or update your registration dossier, by providing ECHA with the pre-registration numbers, registration numbers or inquiry numbers and the EC number for your substances;
  2. Provide a description of why you need the data and how you intend to use it (e.g. for read-across);
  3. Submit a declaration that "The data provided shall be only used for registration purposes under the REACH Regulation";
  4. List the endpoints that you would require information for.

Also note that access to data does not provide ownership of the data. According to REACH, any data submitted more than 12 years previously can only be used for the purposes of registration.

Do I have any data-sharing obligations after I have submitted my registration?
You can have further duties to share data even after you have submitted your registration. This can happen in the following cases:
 
  • When potential registrants are informed of the previous and other potential registrants (and vice versa) by ECHA following an inquiry pursuant to Article 26 REACH;
  • After the successful submission of the registration dossier, whenever new information becomes available. In such cases, according to Article 22 REACH, registrants have to update the joint registration dossier. This may require prior data sharing and may have an impact on decisions on the classification and labelling. It can also lead to the need to change the chemical safety report;
  • As a consequence of dossier evaluation by ECHA (compliance check or the assessment of a testing proposal) or substance evaluation. These processes may lead to a request to submit further information, which would need to be addressed among all registrants of the same substance. For substance evaluation cases, these are not necessarily limited to the tonnage band related information requirements. Registrants should agree on the generation of requested information and on the sharing of the data and costs. In certain cases, also registrants who ceased manufacture may be requested to provide additional information. Therefore, data sharing does not only apply to "existing" studies but also to studies which will be needed to ensure that the registration is compliant with REACH.
How to obtain data submitted less than 12 years previously from a previous registrant?

The situation:

The substance has been registered but the relevant studies were submitted less than 12 years before the inquiry. ECHA informs the potential registrant of the names and addresses of the previous registrants but cannot provide a copy of the (robust) study summaries. Rights and obligations - For the purposes of data sharing, the potential registrant will need to contact the previous registrants (and/or the other inquirers) identified by ECHA.

A request for sharing information must be made for any studies involving vertebrate animals. However, a potential registrant has to request data from the previous registrants if that data does not involve testing on vertebrate animals. The previous registrant and the potential registrant have to make every effort to reach an agreement on the sharing of the data requested and its costs. The obligation to make every effort applies to any information requested, whether it concerns vertebrate or non-vertebrate animal studies.

The process:

Once a data sharing request for studies submitted less than 12 years ago has been made, both the previous and potential registrants must make every effort:

  • to reach an agreement on the sharing of the information requested by the potential registrant;
  • to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way.

See Q&A 102 for access to data submitted more than 12 years previously. 

What can I do to extend the waiting period of the new registrant to benefit from the provisions of Article 27(8)?

The situation:

A previous registrant and a potential registrant have agreed on the sharing of information submitted less than 12 years previously or, following a data-sharing dispute, ECHA grants the potential registrant a permission to refer to the data. Rights and obligations - Ahead of the submission of their   registration dossier by the potential registrant, the previous registrant may, according to Article 27(8), ask ECHA to extend the registration waiting period by an additional four months. Accordingly, the potential registrant, upon receipt of confirmation of the successful registration, will have to wait for an extra period of four months before being entitled to manufacture or import the substance.

The process:

The previous registrant can make the request to ECHA using the following email address: datasharing (at) echa.europa.eu. The previous registrant will need to provide the Communication number (such as INQ-C-xxxxxxxxxx-xx-xx) received from ECHA following the inquiry of the potential registrant. As a result, ECHA will inform, through REACH-IT, the potential registrant that the previous registrant requested to extend the registration waiting period by an additional four months.

ECHA may check the effective data sharing with the potential registrant.

Upon receipt of their registration number, the potential registrant will have to wait until the expiry of the additional waiting period before being entitled to manufacture or import the substance on the European market.

If I have pre-registered but cease to manufacture or import before the deadline, do I still have obligations?

The objectives of data-sharing are to avoid the duplication of work and in particular to reduce testing involving animals. These objectives are still fully relevant after the end of the phase-in scheme. Therefore, it is in line with the objectives of data sharing under REACH, as well as in the interest of potential registrants and in your own interest (as you will get compensated) to share data with potential registrants.

Can I use existing study reports for my registration without having the owner’s consent?

The use of published data to satisfy your information requirements requires you to have the right to refer to the full study report. Therefore, if you want to refer to a published full study report in your registration dossier, you have to check with the copyright owner to what extent you are allowed to use it in your own dossier.

In this case, you should negotiate a license or other form of agreement (e.g. letter of access) that will allow you to refer to the published data. For efficiency reasons, such an agreement should ensure that all the members of the joint submission have the right to refer to the data.

Copyright covers only the form of expression but not the facts and data included in the work. Therefore, facts and data can be included in the dossier without the consent of the copyright owner provided that the text of the study is not copied as such into your registration dossier. In other words, you can use the data to produce your own study summary but you have to make appropriate references and quotations to the original study to acknowledge the source of information. In addition, also in cases where you produce the study summary yourself, you must have the right to refer to the full study report for your registration. For more information, see the Guidance on data sharing, section 3.3.3.8.

Do potential registrants of a substance in a low tonnage band need to apply the classification and labelling attributed to the same substance at a higher tonnage band, if they have no access to the relevant study? Do they have to contribute to the cost of this study?

All potential registrants of a substance must examine all available information and apply the relevant classification and labelling for their substance as it has been mutually agreed within their SIEF. 

If they disagree with this classification, they may decide to ‘opt-out’ from this information requirement and propose a different classification, as long as they appropriately justify their decision (Article 11(3)(c), REACH).

Nevertheless, potential registrants of a substance in a low tonnage band do not have to contribute to the cost of a study if this study is not required for a registration in their tonnage band (Article 11(2), REACH).

I need data for a read-across. How can I contact the Lead Registrant of another joint submission?

There is no formal procedure to get in contact with the joint submission of another substance for read-across purposes. You can look up the details in our dissemination portal for registered substances, and contact any of the registrants whose name appears, asking for the lead registrant’s contact details. You can then contact them in order to find a data sharing agreement.
Alternatively, you can use our contact forms and request ECHA to share your contact details with the lead registrant of the joint submission of interest. We will then contact the said lead registrant and encourage them to contact you.

Please note that data sharing between different substances for read-across purposes is not mandatory. However, the Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data sharing underlines the benefits of data sharing between different substances. Therefore, data sharing between similar substances is strongly recommended, but it cannot be imposed by ECHA.

C. Third Party Representative (TPR)

Can a third party representative register?

No, under REACH, a third party representative (TPR) cannot register. A TPR can be appointed by a manufacturer, importer or downstream user for data sharing issues and discussions with other manufacturers, importers or, where relevant, downstream users. Unlike an only representative, a TPR only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations.

What should I do if I change my Third Party Representative (TPR)?

If a (potential) registrant changes its Third Party Representative (TPR), the new TPR will have to create a REACH-IT account (provided he does not have one yet).
In case of a change of TPR, the following steps have to be taken by the (potential) registrant in order to update the details of its TPR:

To update a TPR in a registration submission: Go to menu -> Search -> Reference numbers -> Input the number in the search criteria -> Click on the results -> Click on Edit under Third party representative -> Add the new TPR.

No fee is required if the TPR is updated in a registration dossier.

Can I hide my identity in the registered substances page on the ECHA website using a third party representative?

No. The identity of the registrant will be published unless a confidentiality claim on the identity of the registrant is included in the registration dossier and the justification accepted as valid by the Agency.

A third party representative (TPR) can only be used to represent potential registrants in discussions with other manufacturers, importers and downstream users on data sharing and the joint submission of data as specified in Article 4 of REACH. The identity of the TPR is not published on the ECHA website. It will only be visible in:

  • the potential registrants tab in the REACH-IT co-registrants page, if included in a successful inquiry notification;
  • the registrants tab in the REACH-IT co-registrants page, if included in a successful registration dossier;
  • and in the joint submission, if included during creation (lead registrant) or confirmation (member registrant) of the joint submission in REACH-IT.
What should I do if I do not want to reveal my identity to my competitors?

You can nominate a Third Party Representative (TPR) to represent you in the joint submission discussions and in data sharing activities. This will keep your company name confidential vis-à-vis other co-registrants.

NB: The manufacturer or importer legally remains the registrant. The TPR must not be confused with the third party holding information (i.e. data holders), nor with an Only Representative. The TPR must also not be confused with the possibility to keep confidential the registrant’s name for registration purposes (Article 10(a)(xi) REACH).

For more information, see the Guidance on data sharing, section 3.2.3.1. Q&A 352 explains how to assign a TPR in REACH-IT.

During the Inquiry process: We display on the co-registrants page in REACH-IT the contact details of the TPR to registrants and successful inquirers. However, we communicate the result of the inquiry process to the inquirer and not to a designated TPR.

After the Inquiry result/ after Registration: It is also possible to appoint a TPR acting on behalf of the registrant after having registered a substance for data-sharing negotiations. You can appoint or change your TPR by updating your registration dossier. See Q&A 0063.

A TPR ensures that the potential registrant does not appear on the co-registrants page. To ensure confidentiality of the same company after the registration number has been granted, see Q&A 401.

D. Data sharing, downstream user

Can a downstream user share data?

Yes, they can, and are encouraged to do so if they hold significant data that will be valuable for registrants when compiling their registration dossiers. In practice, downstream users have to submit certain information (substance identification, contact details) to ECHA to be recognised as a data holder for a substance, after which ECHA puts them in contact with the potential registrants.

Data holders are entitled to be compensated for their data used for registration. More detailed information is available in the Guidance on data sharing, Section 3.2.3.2.

How do I proceed if I have concerns about confidential business information (CBI) when discussing substance sameness?

Consider taking specific measures in the SIEF to protect information that you consider CBI, but you nevertheless need to share with the SIEF to conclude on the substance sameness. You can, for example:

  1. Have confidentiality agreements that limit access to documents or other information to specific named persons, or departments; and
  2. Allow access to certain documents in a ‘reading room’ only (where copying is not allowed); and
  3. Agree to have certain documents reviewed and/or assessed only by a third party expert (independent consultant) or a trustee.

You can strengthen this by having additional personal confidentiality agreements for those who get access to the CBI documents. 

As a minimum, you should specify to the other SIEF members that the information is indeed CBI and, therefore, you communicate it and it can be used only for purposes of the verification of substance identity under REACH.

For more information on CBI, see the Guidance on Data-sharing, section 9.

Downstream users

A. Downstream users, regulatory

Can downstream users continue to use a substance, if it has not been registered?

Downstream users can use substances, irrespectively of whether they have been registered or not. In this regard use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. Placing on the market is however not to be regarded as a use. See Q&A 40 for further information.


Please note that for the use of substances (whether registered or not) certain requirements related to restrictions, authorisation and risk management may apply. Guidance on how to comply with these requirements is provided in the Guidance for downstream users available on the ECHA website.

The workers of transport companies can be exposed to chemicals, for example while loading and unloading chemicals, or fitting and opening of transfer pipelines. Should transport companies be regarded as downstream users in these cases?

The carriage of hazardous substances and mixtures by rail, road, inland waterway, sea or air is exempted from the scope of the REACH Regulation (see Article 2(1)(d)). Transporting activities (including loading and unloading) by transport companies are not "uses" under REACH.

The loading and unloading operations performed by the workers of the transport company are covered by the Carriage of Dangerous Goods legislation, and hence they are outside of the scope of the REACH Regulation. Compared to that, the site-related activities before loading and after unloading will often be "uses" under REACH, which may need an exposure scenario and a chemicals safety assessment.

It is also important to note that the transfer of substances and mixtures occurring exclusively within an industrial plant is covered by REACH, even if this includes transportation carried out by an external company.

What information can a downstream user communicate to his suppliers in order to cooperate in preparing for REACH registration?

Downstream users may make uses known to the suppliers in their supply chain, before the manufacturer or importer submits his registration, with the aim of making these uses identified uses. This right is enshrined in Article 37(2) of the REACH Regulation. When registrants base their assessment on information from downstream users, this helps to ensure that the advice they receive is directly applicable and that the handling of exposure scenarios is easier.


The information to registrants flows most efficiently through sector organisations, many of whom are developing use maps that describe the typical uses of their sector. Use maps describe the typical uses and conditions of use in an agreed template. Downstream users should check whether their sector organisations are preparing a sector use map that covers their use(s). Individual companies can also use these templates if they need to communicate any niche applications to registrants.

http://echa.europa.eu/csr-es-roadmap/use-maps

What are my downstream user obligations, when I use substances subject to authorisation or restriction?

If a substance is subject to authorisation (Annex XIV):

  • You must use the substance according to the conditions laid down in the authorisation granted for that specific use to an actor up your supply chain or apply for an authorisation yourself if the authorisation of your supplier does not cover your use(s);
  • You must notify to ECHA within 3 months after first supply, the use of the substance subject to authorisation.

If a substance is subject to restrictions (Annex XVII):

  • Comply with the restrictions for placing on the market or use of substances as listed in Annex XVII of the REACH Regulation.

Suppliers must include information on authorisation and restriction in Section 15 of the safety data sheet or in other information provided in accordance with Article 32 of the REACH Regulation.

How do I document that my suppliers have appointed an only representative?

If your suppliers are located outside the EU and decide to appoint an only representative, they will confirm this to all the importers. You should preferably also obtain confirmation in writing from the only representative that your imported tonnage and use is indeed covered by the registration dossier.

This would not only provide you with a contact point with whom you can make your use known, but would also clearly document that your imports are indeed covered by the registration of the only representative.

You need to keep exact documents on which imported quantities of the substance are covered by the only representative registration and which imported quantities are not. For further information see the Guidance on registration, chapter 2.1.2.5 "Only representative of a non-EU manufacturer".

B. Downstream users, SDS and eSDS

What are my downstream user (DU) obligations as a DU of a substance for which an extended safety data sheet is required?
As a downstream user you should follow the risk management advice and the operational conditions of use described in the extended safety data sheet (eSDS) received from the supplier, including the exposure scenarios. If relevant, forward the advice to actors further down the supply chain. If you as a downstream user produce a mixture, you must ensure that the eSDS for that mixture includes all relevant information received from the suppliers of the individual components. Please note: This was also a duty of downstream users under previous legislation. The new element under REACH is the receiving and forwarding of use-specific risk management advice and risk management measures relating to exposure to humans or the environment.
 
If as a downstream user you receive information from your customers intended for the purpose of making a use known, you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the preparation and eventually carry out your own downstream user Chemical Safety Assessment (CSA).
 
If you as a downstream user hold information that puts into question the hazard or risk management information received from a supplier, you should communicate this information to the supplier.
 
An overview of the possible obligations of downstream users can be found in ECHA website: http://echa.europa.eu/regulations/reach/downstream-users
We are formulators. We routinely generate exposure scenarios for our mixtures to communicate to our customers. What are our legal obligations relating to the exposure scenarios?
When your customer use is not covered in the supplier exposure scenarios, and you decide to include it, you have to take action to ensure it is covered. The options include communicating with your supplier or preparing a downstream user chemical safety report.
 
If you prepare a chemical safety report, you have to provide the relevant exposure scenarios to the recipients (Article 31(7)).It might be the case that you generate exposure scenarios for your mixtures voluntarily. This could be for commercial reasons, or for better communication of the appropriate conditions of use. In such cases, the obligation to report to ECHA does not apply.
 
You need to ensure that the conditions of use in any exposure scenarios you generate are covered in the exposure scenarios you receive. To facilitate this process, you can provide your suppliers with generic exposure scenarios that you or your sector organisation have generated and provide to customers, and request that your supplier covers them.
My substance has been registered by my supplier. What are the implications for me as a downstream user?

If a safety data sheet (SDS) is required for your substance, you will continue to receive it. However, when the SDS is updated after registration, you will see the registration number under section 1.1. You should also notice a change in that the updated SDS may contain one or more exposure scenarios as annexes, if your supplier has registered the substance for 10 tonnes/year or more. These exposure scenarios outline the conditions of safe use of the substance for specific uses.

You need to identify which exposure scenario(s) apply to your use(s) and check whether your conditions of use are in line with them. You will also need to take this information into account when communicating on safe use for the products that you place on the market.

Note that the exact time for updating the SDS is not defined under REACH and will depend, among other things, on whether any new information on the hazards and risk management measures have been generated in the course of the registration process.

Downstream users (DU) have 12 months to fulfil their duties related to the exposure scenario (ES) attached to a safety data sheet (SDS). Does the 12 months start as soon as the DUs receive the ES or when they receive the registration number?

According to the legal text the 12 months starts as soon as the DU receives an SDS containing a REACH registration number (Article 39(1) REACH). Nonetheless, it is understood that the DU requires an ES to be attached to the SDS, or at least for “uses advised against” to be included in Section 1 of the SDS, in order to determine if their uses are indeed included or excluded in the registration dossier. In cases where the required information has not been provided in the SDS, it is advisable that the DU communicates with his supplier to check why, record this communication, and the date when they receive an ES.

What are the obligations of a downstream user when their use or their conditions of use are not covered by the supplier’s registration and are not included in the eSDS?

If a downstream user uses the substance (as such or in a mixture) under conditions that are not communicated by the supplier in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, they may choose one of the following options:

  1. Ask your supplier to include your use or conditions of use in their chemical safety report and to provide you with an exposure scenario for it. You need to make sufficient information available to your supplier to enable them to carry out your Chemical Safety Assessment (CSA). Your sector organisation may have developed a convenient means of supplying this information specifically to your sector.
  2. Implement the conditions of use described in the exposure scenario you have received. This option may require an adaptation of your processes to meet the conditions described in the eSDS.
  3. Substitute your substance with a safer alternative.
  4. Find another supplier who can provide the substance with a safety data sheet and an exposure scenario covering your use.
  5. Carry out your own chemical safety assessment and prepare your own downstream user chemical safety report (DU CSR) for your uses and conditions of use, unless exemptions apply – see our practical guide How to prepare a downstream user chemical safety report for details. Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.

If a downstream user holds information that puts into question the hazard or risk management information received from the supplier, they should communicate such information upstream to the supplier.

For further information, we advise to consult the Guidance for downstream users:

  1. An overview of how to decide whether or not your use is covered by the exposure scenario can be found in Section 4 Downstream users and exposure scenarios
  2. Information on how to make a downstream user chemical safety report is given in Section 5 Use not covered: preparing a downstream user chemical safety report (DU CSR)

More information is also available in the Downstream user responsibilities section and the practical guide How downstream users can handle exposure scenarios (section 2.2.2 What to do if the use and/or conditions of use are not covered by the exposure scenario).

C. Downstream user report

I am a downstream user. When do I need to report to ECHA?

You have to report to ECHA within 6 months of receipt of the safety data sheet for a registered substance when you:

  • Need to prepare a downstream user chemical safety report; or
  • Wish to benefit from the exemption to prepare a chemical safety report either because:
  • you use the substance in total less than 1 tonne per year; or
  • You use the substance for product and process oriented research.

You also have to  report to ECHA  if your classification of a substance differs from that of all of your suppliers. Reporting is not required if the downstream user uses the substance or mixture in a total quantity of less than one tonne per year.

If you use a substance included in the Authorisation List, for which an authorisation has been granted that covers your use, you have to notify ECHA of your use within three months of the first supply of the substance.

What is the difference between a downstream user chemical safety report and a downstream user report?

A downstream user chemical safety report documents the results of the chemical safety assessment undertaken by the downstream user. The assessment establishes conditions to ensure that the risk for the use(s) not covered in the received exposure scenarios is adequately controlled. The downstream user chemical safety report itself does not need to be submitted to ECHA.

A downstream user report is a report by a DU to ECHA when:

  • He has to prepare a downstream user chemical safety report or is claiming exemption
  • His classification of the substance is different to that of his supplier
  • A downstream user notification is required when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use.
I purchase chemicals from several suppliers. The classification of the same chemical is sometimes different from different suppliers. Do I need to report to ECHA under Article 38(4) of REACH?
Article 38(4) states that "a downstream user shall report to the Agency if his classification of a substance is different to that of his supplier". This is taken to refer to all of his suppliers.
You do not need to report to ECHA as long as your classification is the same as one or more of your suppliers. However, if you generate an entirely new classification, you shall report to ECHA. You are exempt from reporting to ECHA if you use the substance or mixture in a total quantity of less than one tonne per year, as per Article 38(5).
 
The reporting procedure is described in Q&A 491. Note that the requirement to report a new classification applies to all substances, registered and not registered.
If a downstream user, as part of his own chemical safety assessment, concludes that a study on vertebrate animals is needed to complete the assessment and makes a testing proposal, who conducts the study?

A downstream user can make a testing proposal. ECHA examines this proposal and decides on appropriate testing in accordance with Article 40 of REACH. It is the responsibility of the downstream user to perform the test, unless other downstream users or registrants are also interested in carrying out such a test.The interested parties can agree on who will perform the test on behalf of all of them. If agreement is not reached, the Agency shall designate one of the parties to perform the test on behalf of all. All parties concerned share the cost of the study.

D. Downstream user report, technical

How do I submit a downstream user report?
There are two options available for submitting a Downstream User report, (i) a Webform and (ii) via REACH-IT/IUCLID.
  • Option (i): The webform is the simpler option. It is recommended for most downstream users, especially those who have not used IUCLID before.
  • Option (ii): Reporting via REACH-IT is recommended for downstream users who already use IUCLID and want to maintain all their report records in the REACH-IT/IUCLID system.Downstream users who need to report if their classification is different to that of their supplier can only use option (ii), via REACH-IT.
A downstream user notification (when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use) can be submitted using a webform.
 
Downstream users should go to the web page on downstream user reports, and select the preferred reporting option:
 
 
What data has to be submitted in a downstream user report?
The information to be provided for unsupported uses (uses not covered in the supplier's extended safety data sheet) includes:
  • the identity and contact details of the downstream user;
  • the registration number of the substance, if available;
  • the identity of the substance;
  • the identity of the supplier;
  • a brief general description of the unsupported use(s) and conditions of use; and
  • a proposal for additional testing on vertebrate animals if this is considered necessary.
 
Note that a proposal for additional testing is not required for substances falling under the exemption of Article 37(4)(c) of REACH (< 1 tonne/year total use).
Is it possible to create one downstream user report for multiple substances, multiple uses, multiple legal entities or multiple sites?
A downstream user can only report on one substance per downstream user report. Nonetheless, a downstream user can include multiple uses and multiple sites, belonging to the same legal entity, in one report.
 
As a downstream user, you cannot submit a downstream user report on behalf of other legal entities or on behalf of a group of downstream users.
I need to report my new classification to ECHA according to Article 38(4) of REACH. How do I do this?
This reporting is done with IUCLID 6 and REACH-IT. Please take the following steps:
  1. Prepare a Downstream user report dossier in IUCLID 6 as explained in  the manual How a downstream user report
  2. In the IUCLID 6 dataset, enter information on your classification and labelling of the substance as explained in the manual How to prepare a classification and labelling notification
  3. Create the downstream user report dossier and export it as explained in the downstream user manual
  4. Submit the report to ECHA via REACH-IT

 

Is the submission of a downstream user report to the Agency subject to a fee?

No fee is charged for the submission of a downstream user report. ECHA fees and charges for services and their amounts are stated in the REACH Regulation and in Regulation (EC) No. 340/2008 (Fee Regulation).

How do I withdraw or amend my downstream user report?
If the report was submitted using the webform, it is necessary to submit a new downstream user report.
 
In the tab for "REASONS"/further information, please tick the box "other reasons" under the tick box "the use is not covered..". In that text box please enter "amending [report number]"or "withdrawing [report number]" as appropriate.
 
It is necessary for you to fill in the report again. However, if there is lengthy information, you can refer to your original report where the information is the same.
 
If the report was submitted via REACH-IT, submit an updated IUCLID dossier, indicating that the unsupported use previously reported has been amended or resolved.
Is it possible that a reference substance is not included in the reference substance inventory?

It is possible that a reference substance does not exist in the downloadable reference substance list. In this case, you will need to create the reference substance yourself. The reference substance needs to be included in the substance dataset. You can find more information on how to create a reference substance in section 6.1 of the manual How to prepare registration and PPORD dossier. 

Why does a downstream user have to fill in Section 1.3 - Identifiers in IUCLID?

Downstream users have to provide all the information as required by Article 38 of the REACH Regulation.Section 1.3 of IUCLID is where you provide the supplier's registration number for the substance, as required by Article 38(2)(b). If the registration number is not available to you, you must provide a justification for this in the same section.

Additionally, when updating a downstream user report, you should also include in this section the downstream user report's reference number.

Therefore, it is advised to follow the instructions included in the manual How to prepare a downstream user report.

What are my downstream user obligations when my use is not covered by the eSDS?

If as a downstream user you use the substance (as such or in a mixture) outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, you may choose one of the following options:

  • Adapt your conditions of use to those described in the eSDS.
  • Implement or recommend an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to you. Make the use known to the supplier with the aim of making it an identified use based on the manufacturer's chemical safety assessment.
  • Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 1 tonne/year or more). Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.
  • Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.

If as a downstream user you receive information from your customers intended to make a use known you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the mixture and eventually carry out your own downstream user Chemical Safety Assessment (CSA).

If as downstream user you hold information that puts into question the hazard or risk management information received from the supplier you need to communicate this information to the supplier.

An overview of how to decide whether or not your use is covered by the exposure scenario can be found in section 6-'Deciding if the use is not covered by the exposure scenario' in the Guidance for downstream users. Information on how to make a downstream user chemical safety report is given in Section 7-'Making a downstream user chemical safety report' of the same guidance available at the ECHA website: https://echa.europa.eu/guidance-documents/guidance-on-reach

 

Is a downstream user or distributor obliged to check the registration status of the substances on their own or in a mixture they place on the market according to the REACH Regulation?

Downstream users or distributors must check the registration status of the substances on their own or in a mixture they place on the market, in order to comply with the obligation imposed by Article 5 of REACH to place on the market only substances that comply with the registration requirements under REACH.

Manufacturers and importers of a substance on its own or in a mixture are encouraged to communicate with the downstream users or distributors of the substance with regard to whether and by when they intend to register the substance to enable the downstream user or distributor to seek alternative sources of supply if necessary. Once the substance has been registered, there is an obligation for the supplier to communicate the registration number down the supply chain either in the safety data sheet according to Article 31 or, if applicable, according to Article 32 of REACH.

 

What are the obligations of a Downstream User (DU) who uses a registered substance, as such or in a mixture, for the purpose of product and process orientated research and development (PPORD)?

The obligations under REACH for a DU using a substance for the purpose of PPORD may differ, depending on whether or not the PPORD activity is covered by a PPORD notification made by the manufacturer or importer of the substance.

A DU, who is listed in a PPORD notification submitted by the manufacturer or importer as one of the customers, operates under the responsibility of his supplier and must respect any conditions set in accordance with Article 9(4) of REACH and/or communicated to him by his supplier. If the DU stops using the substance for the purpose of PPORD and, by this, ends the cooperation with his supplier, he needs to inform his supplier, as the supplier will need to update his notification to remove the DU from the list of customers.

Alternatively, a DU can use a substance for the purpose of PPORD under his own responsibility and initiative. Since a DU does not have the registration obligation of Articles 5 and 6 of REACH, there is no need for the DU to submit a notification under Article 9 of REACH to be exempted from the registration obligation.

If he adequately controls the risks to human health and the environment in accordance with the requirements of legislation for the protection of workers and the environment, the DU is not required to prepare a DU CSR, even if his conditions of use are not covered in the extended SDS of his supplier or  the use is advised against (Article 37 (4) (f)). According to Art 38(1)(b), the DU must report to ECHA if using a registered substance at greater than 1 tonne for the purposes of PPORD and availing of the exemption in Art. 37(4)(f).
 

Evaluation

Compliance checks

What is the impact of the Integrated Regulatory Strategy on ECHA’s compliance checks?

The Integrated Regulatory Strategy, developed in consultation with the Member State competent authorities, aims to encourage registrants to comply with REACH and to improve their chemical safety assessments.

The Integrated Regulatory Strategy has three main pillars: 1) efficient selection of substances which may raise potential concern; 2) generation of the necessary information through compliance check for assessing their safety; and 3) assurance that any remaining concerns are subsequently addressed through the most suitable regulatory risk management instrument.

It can therefore be assumed that the selected substances that raise potential concern will be more likely addressed with further regulatory risk management measures, and that the substances that demand most urgent action will be part of the prioritisation.

More information is available at the Integrated Regulatory Strategy -page.

How are dossiers selected for compliance check?
ECHA and the Member States first identify substances and their dossiers using an IT-based screening, and then carry out further checks by a manual screening. The main criteria for selecting a dossier for compliance check are:
  • high tonnages;
  • suspected data gaps in the higher-tier human health or environment information requirements;
  • high potential for exposure of humans or environment (e.g. widespread uses or uncertain information on uses).
A detailed description of what is considered as high potential for exposure is available in the screening definition document.
 
Furthermore in accordance with Action 2 from the REACH joint action plan (June 2019), ECHA will assign all substances > 100tpa to 3 possible pools, depending on whether they are i) of priority for regulatory risk management, ii) currently of low priority for further regulatory action, or iii) need more data for a judgement to be made. Substances in pool iii) are candidates for further compliance check and/or substance evaluation. 
 
More information is available in the REACH Evaluation Joint Action Plan and in the related News Release.
What happens if my dossier is selected for compliance check?

If your dossier meets the criteria for selection (see Q&A 0647), ECHA will start a compliance check assessment, focusing on selected information requirements (or properties) (see Q&A 0654).

At that stage, the information on the dossier evaluation status page will be updated. From then on, you can follow the progress of the evaluation through the entire process (see Q&A 1572 ).

If the information requirements (or properties) assessed are found to be non-compliant, the relevant members of the joint submission will receive a draft decision from ECHA.

If I get a draft decision from ECHA, does that mean that ECHA has checked the entire dossier and found it non-compliant?

No, by default ECHA assesses specific information requirements (or properties) (see Q&A 0654) primarily focusing on dossiers of substances manufactured or imported at more than 100 tonnes per year. 

ECHA may also target its checks to different information requirements; then the decision will indicate the scope of the assessment undertaken. 

REACH does not limit the number of compliance checks per dossier. Therefore you may receive multiple draft decisions on the same dossier.

When can we provide the (new) data ECHA has requested?

The updated dossier containing the information requested needs to be submitted at the latest by the deadline set in the (adopted) decision (Article 22(2) of REACH). The updated registration dossier will be assessed after the deadline set in the decision has passed (Article 42 of REACH), on whether it contains the information requested in the decision.

This is however without prejudice to your legal obligation to update your dossier with any (new) relevant information “without undue delay” (Article 22(1)).

What are the target endpoints that ECHA is checking in the dossiers?

Under ECHA’s Integrated Regulatory Strategy (see Q&A 0646), the compliance check of dossiers submitted for substances manufactured or imported at more than 100 tonnes per year mainly focuses on eight key information requirements (or properties): genotoxicity, repeated dose toxicity, pre-natal developmental toxicity, reproductive toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation.

The goal is to focus on the information requirements (or properties) that matter most for human health and the environment, with special emphasis on those which are related to the persistent, bioaccumulative and toxic (PBT) or carcinogenic, mutagenic or toxic to reproduction (CMR) properties of a substance.

More information on the strategy on compliance checks is available at compliance checks page.

 

How do I know whether ECHA has started to assess my substance or my dossier?
ECHA does not inform you of the start of a compliance check on your dossier. However, you can find out whether ECHA has initiated a compliance check for a particular substance by regularly monitoring ECHA’s ‘Dossier evaluation status’ page (see Q&A 0650), and subsequently follow the progress through the evaluation process. You will also be able to see when ECHA has initiated the evaluation of your testing proposal.
 
Search your substance on the Dossier evaluation status page:
 
  • By using the filtering options, you can find out whether ECHA has started its assessment of a given dossier:
  • these are marked as ‘Under assessment’ in the ‘Status’ column,
  • the start date is displayed in the ‘Latest update’ column.
  • Once the dossier moves forward to the next stage in the process, the date in the ‘Latest update’ column changes. You can therefore also follow the progress. You should check the dossier evaluation status page regularly if you want to be up to date with the evaluation process.
Search your substance using the Search for Chemicals/ Infocard page:
 
If you find a ‘Dossier evaluation status’ entry under the header ‘REACH’, then a dossier evaluation process has been initiated. By clicking on this entry, you can see the number and the stage of the evaluation process(es) for your substance.
 
To learn more about other regulatory activities under REACH and CLP, you can also consult the Public activities coordination tool (PACT).
I have received a draft decision. What should I do?

If you have received a draft decision, it means that there are non-compliant information requirements (or properties) in your dossier or in the jointly submitted registration dossier.

Check in the decision which members of your joint submission have received the draft decision, and get promptly in touch with them.

You have 30 days to provide your comments on the content of the decision. ECHA strongly recommends that you provide your comments collectively, in one consolidated set. ECHA only accepts comments submitted using the webform. A link to the webform is provided in the notification letter accompanying the draft decision.

For more information, see also the ‘Decision under dossier evaluation’ under recommendations to registrants and the practical guide ‘How to act in dossier evaluation’

I have a dossier containing information requirements which I have opted out from and I have received a (draft) decision. What are my obligations to bring my dossier into compliance?
As of January 2019, ECHA sends its (draft) decision to all non-compliant registrants of the joint submission. If you have opted out for one or more information requirements (Article 11(3) of REACH) and your information is found to be non-compliant, you also receive a separate (draft) decision.
 
You and the other recipients of the adopted decision will need to coordinate, at least, the following:
 
  • If the requested information already exists, you will need to agree on the costs and sharing of the existing data.
  • If the requested information needs to be generated, you will need to:
    • agree on the test to be performed, including on the testing material to be used as representative for all registrants;
    • inform ECHA of who will perform the test; and
    • share the costs and new data
Where can I find support material on the evaluation processes under REACH?

For increased transparency on evaluation and other processes, ECHA has published supporting information on the following pages:

For more information, see also ‘Decision under dossier evaluation’ under the Recommendations to registrants and check the practical guide ‘How to act in dossier evaluation’.

I am a member of the joint submission. Why have I received a draft decision?

As of January 2019, ECHA addresses its (draft) decisions to all registrants relying on non-compliant information requirements. Similarly, ECHA addresses its (draft) decisions on testing proposals to all those registrants intending to rely on the proposed tests to fulfil their information requirement.

Substance information exchange forums (SIEFs) ceased to exist as of 1 June 2018. Nevertheless, the registrants of the same substance continue to be bound by the obligation to submit jointly the information on their substance.

By setting out clearly how the information requirements apply at each tonnage band, ECHA’s decision gives the registrants greater certainty and clarity on their individual legal obligations, which helps ensure that all registrants within the joint submission become compliant.

Addressing evaluation decisions to all non-compliant registrants also aims to supports data and cost sharing as well as collaboration and communication between co-registrants regarding their joint submissions.

All recipients must comply with their information requirements, and will need to share existing/new data while respecting their legal obligation to avoid unnecessary (vertebrate animal) testing.

 

Until when can I update my dossier so that the update is considered in the dossier evaluation process?

Dossier updates will be taken into account only until the date ECHA issues the draft decision. Therefore, make sure that information on your tonnage, uses and registration type are regularly updated to match the actual use of the substance, so that ECHA can assess its safe use in Europe.

Your legal obligation is to keep your dossier up to date – in other words, to update your dossier without undue delay if you become aware of new information. Therefore, the initiation of a compliance check should not be a trigger for updating your dossier. 

When ECHA starts the evaluation of a dossier, information on the dossier evaluation status can be found at Dossier evaluation status page

Therefore, you have the opportunity to verify and (if necessary) update your dossier especially regarding use and tonnage information before a draft decision is issued.

Once a draft decision is issued, ECHA will only take into account information submitted in your comments to the draft decision, in the evaluation “decision making process”. If you are in possession of new information that may remove (a) request(s) from the draft decision (e.g. a new experimental study), you must submit such information in your comments. ECHA will consider the new information and may amend the decision accordingly.

Comments indicating an intention to downgrade the registered tonnage band or remove certain uses will not be taken into account in the decision-making process.

In the specific case where you cease manufacture or import of your substance after receiving the draft decision, please see Q&A 1580.

For more information, see also ‘Decision under dossier evaluation’ under the Recommendations to registrants and check the practical guide ‘How to act in dossier evaluation’.

 

We cannot provide comments by the deadline set in the notification letter accompanying the draft decision. Can we have more time?

The REACH Regulation sets the deadlines which apply during the decision-making procedure. The deadlines will not be extended, unless there are technical reasons (e.g. malfunction of the submission tools) or the commenting period falls during closure periods of the Agency.

Similarly strict timelines are in place for the proposals for amendment by Member State competent authorities, the referral to the Member State Committee (MSC), your comments on the proposals for amendment, and the agreement-seeking on the draft decision by the MSC.

For more details, see the practical guide ‘How to act in dossier evaluation’.

What happens if I decide to cease manufacture or import after I have received a draft decision?

If you decide to cease manufacturing or importing your registered substance upon receipt of the draft decision, you should inform ECHA of your intention using REACH-IT (see Q&A 1439). When you confirm that you have ceased/are ceasing manufacture or import, ECHA proceeds by invalidating your registration number in line with Article 50(3), after which you are not allowed to manufacture or import the substance into the EU/EEA market.

Consequently, you will not receive the adopted decision (if you have already received an adopted decision, see Q&A 1580).

If you start to manufacture or import the substance again, you will have to register the substance once more and you may have to share the costs accrued for the maintenance and update of the registration dossier due to an evaluation process or for other reasons.

For more information, see also the practical guide ‘How to act in dossier evaluation’ and ECHA’s Recommendations to registrants.

Follow up to dossier evaluation decisions

Can the deadline of the dossier evaluation decision be extended if we cannot provide the requested information on time?

No, ECHA cannot alter the deadline of the decision, because it is unanimously agreed by the representatives of the Member States.
ECHA acknowledges that technical difficulties in testing a substance may lead to delays or to the inability to provide the requested information by the deadline set in the decision. 

In any case, we advise you to submit an update of your dossier by the deadline set in the decision, including any relevant explanations and evidence concerning the possible delay and the expected submission date. You should then update your dossier again as soon as the missing information is available.

However, if you believe that the technical difficulties prevent you from testing altogether, you can, on your own responsibility, adapt the standard information requirements (see Q&A 1064).

After the deadline, ECHA will check whether a dossier update is submitted and whether the information provided fulfils the information requirements. If during the follow-up evaluation ECHA finds that some or all of the requested information is missing, the national enforcement authorities will be informed.

Is it possible to have a teleconference/meeting with ECHA to discuss the request in the (draft) decision?

No. ECHA considers that after 10 years of REACH implementation, there is broad knowledge in all industry sectors, and that they are well placed to support you.

However, if you have questions regarding a (draft) decision, you may submit your enquiry to ECHA using a contact form and we will assess your specific question.

Is it possible to discuss (in writing) with ECHA the scientific arguments an adopted decision was based on?

No, ECHA cannot discuss the content of the adopted decision after it has been unanimously agreed by the Member States representatives.

If you have general questions on ECHA’s decisions or processes, you may submit a request to the ECHA Helpdesk and we will assess your concerns.

Is it possible to adapt the standard information requirements requested in a decision by using read-across, weight-of-evidence or alternative tests instead of the study requested?

Yes. If you believe that you have scientific grounds to fulfil the requested information by adapting the requests in the decision, you may do so on your own responsibility.

Any adaptation must fulfil the specific rules outlined in Annexes VII to X or the general rules of adaptations specified in Annex XI to the REACH Regulation.

See also ECHA’s Recommendations to registrants.

What if the information submitted is not sufficient?

Once the deadline set in the decision has passed and after ECHA has assessed whether the information you submitted is sufficient, ECHA will address the non-compliance through a new decision-making process according to Articles 50 and 51 of REACH.

This means that you will receive a new draft decision informing you that the information you submitted is not sufficient and that you still need to address the request in the original decision in order to fulfil the information requirements for the endpoint(s).

This decision has no deadline. Once the decision is adopted by the Member States, ECHA will inform the national enforcement authorities of the countries where the registrants are located.  

What happens if I decide to cease manufacture, or import, or downgrade tonnage band after I have received an adopted decision?

If upon receipt of the adopted decision, you cease the manufacture or import of your substance, or if you downgrade the tonnage band of your registration, you will have to comply with the decision, regardless. See also Q&A 1586.

For more information, see also the practical guide ‘How to act in dossier evaluation’ and ECHA’s Recommendations to registrants.

I am a member and I have received an adopted decision. What should I do?

See also Q&A 1574.

Check the end of the decision for the list of addressees of the decision and contact them. You will need to collectively agree on who will perform the test(s) (see Q&A 1583) and inform ECHA about this within 90 days of the adoption of the decision.

If no agreement is reached, ECHA will designate one of the registrants to perform the studies on behalf of all other addressees of the decision. For more information, see the practical guide ‘How to act in dossier evaluation’.

How do we inform ECHA of the name of the registrant(s) who will perform the test(s) listed in the adopted decision?

After you have collectively agreed on who will perform the test(s), you have to inform ECHA accordingly within 90 days from the receipt of the adopted decision (Article 53(1) of REACH).

Please use the link to the webform provided in the notification letter accompanying the adopted decision:

You must indicate a name for each request listed in the decision, even if it is the same for all requests. If you fail to do so, ECHA will have to designate one of the recipients of the decision, for each test lacking an identified registrant.

Who is responsible for generating the requested data and submitting the information to ECHA?

All recipients of the same decision are collectively responsible for fulfilling the requests in the decision that are relevant to their registered tonnage band.

After you receive the adopted decision, you need to agree collectively on who of the recipients is going to perform the requested studies. This is independent from the fact that the lead registrant is the one who submits the information “acting with the agreement of the other assenting registrants” (Article 11(1) of REACH).

The recipients of the decision are expected to agree on the testing to be performed as per their data (and cost) sharing obligations. You also need to agree on the material to be tested for each study requested, ensuring that it produces appropriate information and is representative of the registered substance as manufactured by all members of the joint submission.

You are also collectively responsible for the submission of the requested information by the (lead) registrant appointed to do so, on behalf of the other registrants of the joint submission.

Who enforces ECHA’s adopted decision if I cease manufacture, or import, or downgrade tonnage band after receiving it?

If you do not update your registration by the deadline set in the decision, because you ceased manufacture, or import, or downgraded tonnage band after you received the adopted decision, ECHA will inform the Member State competent authorities and the national enforcement authorities of the country you are located in (see Q&A 1065). 

Your authorities are responsible for any enforcement actions related to evaluation decisions according to your national legislation. 

 

Who is responsible for submitting the requested information if there is a change of lead registrant after the decision has been received?

Any registrant receiving the adopted decision, because they are not compliant with their information obligations, remains legally responsible for providing the information requested in the decision (see Q&A 1583). 

Consequently, a change of lead after you receive the adopted decision does not change the legal responsibility of the other recipients. 

In addition, if ECHA identifies that the registrants have failed to submit and comply with the information requirements, it will notify the enforcement authorities of all the countries where the incompliant registrants are located. Any enforcement actions related to evaluation decisions will be decided according to their national legislation, where appropriate. 

Can ECHA let me know whether my proposed adaptation is acceptable before the deadline in the decision expires?

No. ECHA will only check whether a dossier update is submitted once the deadline set in the decision has passed. ECHA will then evaluate whether the submitted information (test or adaptation) fulfils the requests in the decision (see Q&A 1064). This is part of the follow-up evaluation process.

In other words, ECHA does not perform any evaluations before the deadline in the decision has expired.

What happens if we do not update the registration dossier by the deadline in the decision?

Once the deadline set in the decision has passed ECHA will assess the dossier. In case the information requested in the decision are not submitted, ECHA will inform the Member State competent authorities and the national enforcement authorities of the respective Member State about the failure to respond to the request(s) in the decision.

When ECHA sends information to national enforcement authorities, the responsibility for handling the non-compliance with REACH is transferred to the national authorities, which then consider and decide on enforcement actions, where appropriate. 

Consequently, ECHA will not evaluate any subsequent dossier updates unless the respective national authority asks ECHA to do so.

You should direct all questions to your national authorities.

The global situation due to Covid-19 has caused delays and we cannot provide the information requested in the adopted ECHA decision by the set deadline. Can ECHA grant an extension?

ECHA appreciates that the current global emergency has affected several registrants in the EU. For this reason, ECHA extended certain deadlines in the registration and evaluation processes, for a limited period of time, to take account of the current global situation (see more here).

However, the Agency is not in a position to alter the final deadlines set in adopted decisions. This is because these are decisions that have been agreed in close consultation with the Member States.

As usual, ECHA will initiate the follow-up evaluation of the updated registration dossier for the substance subject to dossier evaluation process that you mentioned in your document when the deadline in the decision has passed. Then, ECHA will establish whether the new information submitted in an updated dossier corresponds to the requests in the decision.

If you think you will not be able to provide all the information requested in the decision by the deadline set, we advise you to anyway update your registration dossier by the deadline and, if necessary, include all relevant explanations and proof concerning the status of ongoing tests and the reasons for the delay, including the expected submission date. As soon as the missing information becomes available to you, you should update your registration dossier again.

According to Article 42(1), ECHA needs to examine all of the information submitted as a response to a testing proposal and compliance check decision. The Agency also has to draft any appropriate decisions, if necessary.

If the information provided in the dossier update does not fulfil the information requirements, the Member State competent authorities will be informed. They will then have to consider your argumentation and decide on any enforcement actions, where appropriate.

For further information on the follow-up to dossier evaluation decisions, please see the steps in the Evaluation process and the answers to the most frequently asked questions on Evaluation on the ECHA website.

Information requirements and test methods and quality of data

According to which test methods and standards should new tests be performed?

When you perform new tests you have to follow the Test Method Regulation (Commission Regulation No 440/2008) or another method recognised by the European Commission or ECHA (Article 13(3) of REACH).

In REACH Annexes VII to X on standard information requirements, the use of various OECD test guidelines is required (e.g. OECD TG 414, 421 and 422).

The OECD methods can be found at: http://www.oecd-ilibrary.org/

The text of the Test Method Regulation can be found at: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:142:SOM:EN:HTML

Note that changes occurred in the Annexes VII and VIII requirements in 2016 for the following endpoints: skin and eye irritation, skin sensitisation and acute dermal toxicity, making non-animal testing the default.

Information may be generated using other methods (Article 13(3)) provided the conditions defined in Annex XI are met. These include amongst others that the result is sufficient for the purposes of classification and labelling and/or risk assessment, and that adequate and reliable documentation of the applied method is provided (see Annex XI for more information).

Furthermore, a specific requirement exists for ecotoxicological and toxicological tests: new tests have to be carried out in compliance with the principles of good laboratory practice (GLP) provided for in Directive 2004/10/EC, as no other international standard has so far been recognised as being equivalent. For physicochemical testing, it may be desirable but it is not mandatory to have tests performed according to the GLP standard.

The Guidance on Information Requirements and Chemical Safety Assessment contains specific integrated testing strategies for each endpoint (e.g. for aquatic toxicity, mutagenicity), which should be consulted before new tests are performed. You can find this document at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

Are there "other international test methods" recognised by the Commission or the ECHA and referred to in article 13(3) of REACH?
For the time being, no "other international test methods" within the meaning of Article 13(3) of the REACH Regulation have been recognised by the Commission or by ECHA.
Is there a list of GLP-certified testing laboratories?

The European Commission has published the lists of inspected test facilities provided by national GLP monitoring authorities. You can access the document at:
http://ec.europa.eu/DocsRoom/documents/8575/attachments/1/translations/en/renditions/native

Good laboratory practice (GLP) certification of laboratories is the responsibility of national authorities that administer the national monitoring programmes.

If the laboratory is located in the EU, Norway or Switzerland, the corresponding authority can be found at the website of DG Enterprise and Industry of the European Commission at:
http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice/index_en.htm

If the laboratory is located in another country, you should check the section on GLP of the OECD website:
http://www.oecd.org/chemicalsafety/testingofchemicals/goodlaboratorypracticeglp.htm

After you have identified the relevant GLP monitoring authority, you can consult this authority to find out the laboratories with GLP certification in the corresponding country.

Additionally, laboratories can be inspected by a GLP monitoring authority even if located in a country which has not joined the OECD mutual acceptance of data system. Information on these laboratories can be obtained from the GLP monitoring authority who has inspected them (see also Q&A 122 ).

Are reference books and databases regarded as reliable sources of substance data?

In general, there is the possibility to use data from reliable, scientifically accepted reference literature or databases, provided that the substance to be registered and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc.

The documentation of similarity needs to be submitted in the registration dossier. References to literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert.

Some useful reference books and data compilations containing peer reviewed data are listed under each endpoint in the Guidance on Information Requirements and Chemical Safety Assessment, Chapters R.7 a, b, c: Endpoint specific guidance available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment.

For some endpoints, these data from reference literature or databases may be used on their own to fulfil the information requirement. However, in general they will have to be combined to other pieces of evidence and submitted as part of a weight-of-evidence approach or read-across approach to support the justification proposed to adapt the requirement.

What is the OECD mutual acceptance of data (MAD) system?

The OECD decision on mutual acceptance of data (MAD) provides for data generated by testing of chemicals in an OECD member country in accordance with OECD test guidelines and OECD principles of good laboratory practice (GLP) to be accepted in other member countries for purposes related to the protection of human health and the environment.

This system also covers non-OECD countries, which have requested adherence to the OECD GLP and to join the MAD system. These non-OECD countries can be divided into two groups:

  1. Countries that are full adherents to the OECD MAD system.
  2. Countries that are provisional adherents to the OECD MAD system.

Countries that are full adherents to the OECD MAD system will accept data from OECD member countries and other adhering countries generated under MAD conditions. In addition, non-clinical safety data developed in these countries must be accepted by the OECD and adhering countries.

Countries that are provisional adherents to the OECD MAD system need to accept data from OECD member countries and other adhering countries generated under MAD conditions. However, during the period of provisional adherence, GLP monitoring activities conducted by the GLP monitoring authority located in the country of the provisional adherence do not have to be accepted by the full members of the OECD MAD decision.
http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm
 

What studies does ECHA accept as GLP studies?

In general, ECHA accepts data as GLP data where this data comes:

  • from countries that are OECD member states or full adherents to the OECD mutual acceptance of data (MAD) system; and
  • (from countries that are provisional adherents to the OECD MAD system and in which laboratories have been inspected jointly by the GLP monitoring authority concerned and by an OECD GLP monitoring authority.

Studies that are conducted in a laboratory situated in a country which has not joined the OECD MAD system can be accepted by ECHA as GLP compliant studies under the following conditions:

  • Before performing the study, the GLP compliance of the laboratory has been inspected by: an EU GLP monitoring authority (including Norway through EEA agreement); or GLP monitoring authorities in Israel, Japan and Switzerland with whom the EU holds mutual recognition agreements; or other GLP monitoring authorities of OECD member states or full adherents to the OECD mutual acceptance of data (MAD) system on a case-by-case basis; and
  •  The laboratory has been found to be operating in compliance with GLP principles.

http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm

See also Q&A 119.

Registrants who submit a proposal for testing in accordance with Annexes IX and X of REACH may waive 28-day studies if certain conditions are fulfilled. However, if there are no results for a 28-day repeated dose toxicity study because a testing proposal for a 90-day repeated dose toxicity test is made, it is not possible to derive a DNEL. Which interim risk management measures (RMM) could be recommended in this situation?
Interim RMM are to be included into the Chemical Safety Report (CSR) and to be communicated to the users of the substance (either under Article 31 or 32 of REACH, in form of Exposure Scenario (ES) or otherwise). Such RMMs need to describe how to handle a substance in an appropriate way in the absence of sufficient toxicological information and while waiting for the results of proposed testing for long-term hazards. If no Derived No-Effect Level (DNEL) is available, the registrant is expected to carry out a qualitative risk characterisation referring to the identified uses and the expected exposure and justifying that the measures are sufficient to control the risks (based on the available knowledge). Typical RMM applicable in such case are listed in the Table E.3-1 of Part E: Risk Characterisation of the Guidance on information requirements and chemical safety assessment available at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
 
Where no or not enough hazard information on the substance is available, the registrant should demonstrate control of risks by minimizing the emission and/or exposure to the substance. In doing so, he can use a combination of containment and/or Local Exhaust Ventilation (LEV) and/or Personal Protective Equipment (PPE) as interim RMM to protect workers from exposure. Due to the interim nature of the measures, PPE may play a more prominent role compared to what is suggested in table E.3-1 of the abovementioned Guidance.
 
The registrant may need to update his CSR and ES once he receives the result of the test proposal and is able to derive a DNEL (or identify that minimisation of emission/exposure is required if "no threshold" effects had been identified in the testing). This applies in particular if the interim measures had been based on PPE instead of containment or other engineering measures.
When a substance is classified only as an eye irritant, does a full risk characterisation as part of the chemical safety assessment (CSA) need to be carried out?

Not necessarily. The scope of the risk characterisation, that you have to carry out as part of the CSA, depends on the hazard profile of the substance. It has to address every hazard, not just those that lead to a classification (points 0.5 and 6 in Annex I to REACH).

Firstly, you have to consider each physical, health and environmental hazard identified, even if classification is not required. This includes collecting the predicted or derived no-effect levels or minimal effect levels (PNECs, DNELs or DMELs) if appropriate.

You should also consider the relevant timescales, environmental compartments, human populations, health effects, and routes of exposure.

DNELs for irritation/corrosion can only be derived if dose-response information is available. Therefore, for endpoints such as eye irritation where no DNEL can be derived, a more qualitative approach to assessing and controlling such risks is necessary. This may be the case where the pH led to the classification or where only QSAR data are available.

For information about this approach, see Chapters R.8 (Part E) and R.10 of the Guidance on Information Requirements and Chemical Safety Assessment: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment.

If there are no other hazards, then it is sufficient to describe the measures which ensure that the risks to eyes are avoided or managed in the exposure scenarios (ESs). If there are other hazards identified, then your assessment should address these also.

The exposure assessment and the subsequent risk characterisation should cover all stages of the life cycle of the substance resulting from the substance's manufacture, and the identified uses.

The Practical Guide on How to undertake a qualitative human health assessment and document it in a chemical safety report is a helpful document when undertaking a qualitative human health assessment: http://echa.europa.eu/practical-guides

Tip: Using Chesar will help you determine the scope of exposure assessment and the type of risk characterisation. For more details on this see the ‘Chesar User Manual, Part 1, Section 6' available at: http://chesar.echa.europa.eu/web/chesar/support/manuals-tutorials

What are the criteria for deciding if a substance is highly insoluble in water or poorly water soluble?

For aquatic toxicity testing (Section 9.1 Annexes VII and VIII), Column 2 adaptations include two complementary concepts related to solubility in water.

The concept of "highly insoluble in water" is associated with the likelihood for aquatic toxicity; consequently a general threshold cannot be established. The use of this concept for waiving aquatic toxicity testing requires substance-specific assessment.

In the waiving statement, registrants should justify that aquatic toxicity is unlikely to occur at the limit of the water solubility. This may require specific information, such as that obtained from transformation/dissolution studies or from the identifying the components of the water accommodated fraction (see the webinar presentation: Hints and Tips on Physicochemical, environmental and human health related endpoints - Aquatic Toxicity).

If registrants cannot demonstrate that aquatic toxicity is unlikely to occur, the substance should be considered as "poorly water soluble", not as "highly insoluble in water", and therefore long-term testing has to be considered.

The concept of "poorly water soluble" is associated with the need to consider long-term tests instead of short-term tests. The ECHA Guidance on Information Requirements and Chemical Safety Assessment section R.7.8.5 (Endpoint Specific Guidance R.7.b) suggests that water solubility below 1mg/L or below the detection limit of the analytical method of the tested substance should be used for considering the substance as poorly water soluble and performing the long-term tests instead of the short-term tests:
http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment


For further details regarding testing on aquatic toxicity please consult OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures available at:
http://www.oecd-ilibrary.org/environment/guidance-document-on-aquatic-toxicity-testing-of-difficult-substances-and-mixtures_9789264078406-en
 

Inquiry

A. Inquiry, regulatory

When do I need to prepare an inquiry?
In principle, there is always an obligation to make an inquiry before registering a substance, in accordance with Article 26(1) of the REACH Regulation (referred to as ‘Type 3’ in IUCLID). The purpose of the inquiry process is to put potential registrants and previous registrants of the same substance in contact with each other. This is to share data and its costs and, where relevant, to submit the information jointly.
 
An inquiry should also be made in situations when a registrant reaches the next tonnage threshold and there is an increase in tonnage band (Article 12(2), referred to as ‘inquiry Type 4’ in IUCLID). Similarly, this also applies in case a registrant updates its dossier from ‘intermediate (i.e. following the information requirements of Article 17(2) or 18(2)) to ‘full’. 
 
In both the above scenarios, in case relevant studies are available and the negotiations to share this data with the previous registrants fail, the inquiry is a pre-condition for submitting a data sharing dispute pursuant to Article 27 REACH. 
 
It must be noted that not making an inquiry may be regarded by the enforcement authorities as a breach of Article 26 of REACH. This is particularly relevant in case of increase of tonnage band, where Article 12(2) provides that an inquiry must be made as soon as the next tonnage threshold is reached. Having made an inquiry may show to enforcement authorities that the registrant is diligently taking steps to obtain the data required at the next tonnage threshold. The above considerations are also relevant for lead registrants, in particular since other registrants of the substance may have submitted relevant data in an opt-out dossier.
 
In the table below the following are grouped:
 
  • The scenarios that a (potential) registrant may encounter
  • (potential) registrant’s obligation to submit an inquiry dossier
  • the type of inquiry to be specified in section 14 of the IUCLID dossier.

 

My situation Should I submit an inquiry? Type of inquiry
I am planning to register a substance There is always an obligation to make an inquiry before registering a substance, in accordance with Article 26(1) of the REACH Regulation.This guarantees that you are put in touch with all previous registrants of the substance as well as other potential registrants. Inquiry for a substance before its registration (Type 3)
I am the Lead registrant and I want to increase the tonnage band of the joint submission Yes, an inquiry should be made in situations when a registrant reaches the next tonnage threshold (Article 12(2)). Inquiry for tonnage band increase (Type 4)
I am a member of a joint submission and I want to update my registration from intermediate to full Yes, an inquiry should be made to transition between the information requirements of Article 17(2) or 18(2) to the information requirements stemming from Article 10. Inquiry for tonnage band increase (Type 4)
I am a member of a joint submission and I want to increase my tonnage band within the tonnage band covered by the joint submission but I don't have data Yes, in accordance with Article 12(2 Inquiry for tonnage band increase (Type 4)
I am a member of a joint submission and I want to increase my tonnage band within the tonnage band covered by the joint submission If the information is available in the joint submission and there is an agreement in place on sharing additional data you might want to contact directly the lead registrant. Otherwise, submit an inquiry to ECHA. Inquiry for tonnage band increase (Type 4)
I am a registrant with an individual registration, and I want to increase the tonnage band of my registration or change the registration type from “Intermediate” to “Full”. Yes, in accordance with Article 12(2), if you need to comply with new (higher) data requirements for the update.   Inquiry for tonnage band increase (Type 4)
I am the Lead registrant and I want to change the registration type of the joint submission from “Intermediate” to “Full”. Yes, in accordance with Article 12(2), if you need to comply with new (higher) data requirements for the update.   Inquiry for tonnage band increase (Type 4)

 

Further details on the inquiry procedure can be found on ECHA’s website.

Why do I need to make an inquiry?

The Inquiry process aims to put potential registrants and previous registrants in contact with each other to share data so that the joint submission obligations can be met.

Studies involving vertebrate animals should not be repeated and available studies need to be shared. By doing so, it reduces registration costs and avoids unnecessary testing, especially on vertebrate animals.

Further details on the inquiry procedure can be found on ECHA’s website at: http://echa.europa.eu/regulations/reach/substance-registration/inquiry.

Does the analytical data included in an inquiry dossier have to be generated on the manufactured or imported substance?

In principle, the analytical data included in an inquiry or a registration dossier must reflect the substance as manufactured or imported. Hence, if you are an EU manufacturer, you must submit analytical data generated from a sample that you have manufactured. If you import from outside the EU, you must submit analytical data generated from a sample manufactured by the non-EU manufacturer.

We are aware that this can be problematic if you have to register your substance before taking up manufacture or import. For such cases we may accept submitting analytical data from another source.

For these exceptional cases, you need to explain the following in your inquiry dossier:

  • Why the analytical data cannot be generated on the manufactured substance.
  • Why the substance you intend to manufacture or import will be the same as the one used to generate the analytical data. For example, a statement that the manufacturing process and/or plant specification used to produce the analysed substance will mirror that for the inquired substance.

You also need to provide the following information in your inquiry dossier:

  • The source of the analysed substance i.e. manufacturing site name and address.
  • A short description of the production process and the raw materials for both the inquired substance and the analysed substance.
  • The foreseen manufacturing or import volume for the inquired substance.
  • A statement from the owner of the analytical data indicating that you have their permission to use their analytical data

You are required to update the substance identification information in the registration dossier within 6 months after the submission to reflect the substance as manufactured or imported. If the registration is not updated, ECHA may initiate a targeted compliance check on substance identity.

How do I prepare an inquiry dossier for an intermediate?

Inquiry dossier should be prepared the same way regardless it is for intermediate or for full registration. The purpose of the inquiry process is to ensure data sharing by all registrants and potential registrants of the same substance, so that the joint submission obligations are met. Thus, despite of the type of registration you plan to submit (full or intermediate) it should contain sufficient analytical information to ensure the accurate identification of the substance.

What should be included in an inquiry?

An inquiry dossier should contain: 

  • Information about the potential registrant. 
  • Information about the identity of the inquired substance. The analytical data (qualitative and quantitative data) provided in the inquiry dossier should be sufficient to verify the identity and composition of the substance.  
  • Information requirements where the potential registrant would need to carry out new studies, including those involving vertebrate animals. 

As a result of submitting an inquiry the potential registrant is put in contact with previous registrants and other potential registrants of the substance. By doing so, we ensure that data is shared by all registrants of the same substance and that the joint submission obligations are met. 

B. Inquiry, technical

How can I check if my inquiry dossier contains all necessary information to be processed by ECHA?

Before submitting any dossier, we recommend that you use the "Validation Assistant", which will identify the fields of your dossier which deserve particular attention. You can download it via the IUCLID 6 website https://iuclid6.echa.europa.eu/.

The Validation Assistant supports the preparation of your IUCLID 6 dossier in two ways:

  • It performs a check of most of the business rules applied to dossiers in REACH-IT. This enables the user to detect and correct failures before submitting the dossier to ECHA. For further information on the business rule check, you can consult the Manual How to prepare registration and PPORD dossiers, available at: https://echa.europa.eu/manuals
  • It performs a so-called "Substance Identity check", identifying the IUCLID fields of an inquiry dossier that should be filled in or that need particular attention. It is advisable to use the Validation Assistant both for preparing the inquiry substance dataset and the final dossier. We strongly recommend addressing all the reported inconsistencies and shortcomings. Please note that the "Substance Identity check" will not assess whether the information submitted is adequate but only if all required fields are filled in. 

 

How do I submit an inquiry if I am not certain about the substance identifiers?

If you are uncertain about your substance’s identity, do not include any numerical identifiers (i.e. EC, CAS) in the reference substance of your inquiry dossier. Instead, write “tentative name” followed by a proposed representative chemical name in the IUPAC name field (e.g. tentative name, Reaction mass of A and B). Refer to any other relevant identifier in the "Other substance identifiers” field. See screenshot for clarity.

After receiving the appropriate identifiers for your substance as part of the inquiry outcome, make sure you update the IUPAC name field accordingly when preparing the registration dossier.

How do I submit an inquiry if I am certain about the substance identifiers?

If you have unambiguously identified your substance, you should include any available numerical identifiers (i.e. EC or CAS) in the reference substance field of your inquiry dossier. After your inquiry is assessed, ECHA will grant you full access to the Co-registrants page of your substance.

If the EC number is not available to you and the substance does not have a CAS number but you are already in contact with the lead registrant, you can request the identifier from the lead. Otherwise, you may request the identifier from ECHA using the web form: http://echa.europa.eu/en/web/guest/contact 

 

I submitted an inquiry which was successfully processed. Does it mean my registration dossier will successfully pass technical completeness check (TCC)?

ECHA does not check the completeness of the substance identity information submitted as part of the inquiry process. The completeness check will only be performed on the registration dossier, in accordance with Article 20 (2) of the REACH Regulation. 

However, you can minimise the risk of failures before you submit the registration dossier by using the IUCLID Validation assistant tool. We advise you to validate the dossier and correct the information by following the advice reported in the tool. 

If the Validation assistant does not indicate any failures, it is not an automatic confirmation that your dossier is complete, since the technical completeness has been complemented with additional verifications done by ECHA staff that are not displayed in the Validation assistant report. Information on the areas of the additional verifications can be found at: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf

C. Inquiry, after submission

What happens after I submit my inquiry in relation to data sharing?

Following an inquiry the potential registrant will receive a communication from ECHA on whether the substance has previously been registered (or notified under Directive 67/548/EC on classification, labelling and packaging of dangerous substances). In that case, ECHA will inform the potential registrant of the names and addresses of the previous registrants and, if appropriate, other inquirers. This communication will enable the potential registrant to request the sharing of existing data.

If the potential registrant did not, at the time of the inquiry, list the endpoints they require to register, ECHA will only inform them about the identity of previous registrants.

In the inquiry, the potential registrant can indicate to ECHA the information requirements applicable to them.

  • See Q&A 102 for further information if studies were submitted at least 12 years previously.
  • See Q&A 424 for further information if studies were submitted less than 12 years previously.

Note that if studies have been submitted less than 12 years previously, the potential registrant has to request directly from the previous registrants the (robust) study summaries they require to register. Such a request must be made for any studies involving vertebrate animals, and may be made for studies not involving vertebrate animals.

How is an inquiry dossier processed?

Once you have submitted your inquiry dossier to ECHA, REACH-IT executes a series of verifications. After these are completed, for most already registered or successfully inquired substances, ECHA directs inquirers to the relevant Co-Registrants page in REACH-IT where they can find contact details of other registrants and potential registrants of the same substance.  

In contrast, for substances where no registrants or potential registrants exist or with ambiguous identifiers, ECHA verifies the substance identity information. In that case, the assessment can lead to two outcomes:  

  1. If ECHA is able to process your inquiry dossier, you will receive the following:
    1. A communication in REACH-IT with the inquiry number as well as details of available (robust) study summaries, as appropriate.  
    2. A link to the co-registrants page in REACH-IT, which will contain the contact details of the registrants and successful inquirers of the same substance. 

      If you were assigned a list number and a list name, you will need to download the list number in .i6z file format (see Q&A 1485).

  2. If ECHA is not able to process your inquiry dossier, due to missing and/or inconsistent substance identity information, you will receive a communication in REACH-IT describing the necessary changes to submit a successful inquiry dossier.  In this case you will need to address the described issues in the substance dataset and then submit a new inquiry dossier. 

The REACH Regulation does not impose any timeframe on ECHA for processing an inquiry dossier. However, ECHA aims to provide the inquiry outcome in 20 working days. 

My inquiry could not be processed by ECHA because of missing/inconsistent information. Is there a deadline for submitting a new inquiry dossier?

No. There is no deadline for submitting a new inquiry dossier to ECHA.

Can I submit my registration before I receive the result of my inquiry?

No. Before submitting your registration, you need to wait until you have received a communication from ECHA which includes the inquiry number. We will also provide you with the link to the relevant co-registrants page in REACH-IT, where you will find the details of registrants and successful inquirers of the same substance. This will support you in complying with your obligations to share data and submit a joint registration.

My inquiry contains a request for information. How will this information be communicated?

Availability of data submitted AT LEAST 12 years previously

  • if the data requested was submitted at least 12 years previously (e.g. under the previous legislation), you will see the comment "attached" and you will receive a copy of the corresponding robust study summary (as attachment to the inquiry annotation);
  • if such data is not available, you will see the comment "not available";

Availability of data submitted LESS THAN 12 years previously

  • if the data requested were submitted less than 12 years previously, the name of the company that submitted the data for the given endpoint will be displayed. You can find their contact details in the Co-Registrant Page;
  • if such data is not available, you will see the comment "not available".

The analysis performed by ECHA of the availability of data is based on the existing registration dossier(s) which passed the completeness check of the technical dossier.

Can I begin vertebrate testing before I receive the result of my inquiry?

No. You need to wait until you have received the communication from ECHA, which states your inquiry number together with the list of the requested (robust) study summaries available to ECHA. This will then allow you to determine which further studies may need to be conducted. REACH requires that new testing of a substance involving vertebrate animals can only be carried out as a last resort.

For chemicals manufactured or imported in a quantity of 100 tonnes or more, you are not allowed to conduct any vertebrate testing for the information requirements specified in Annexes IX and X of REACH. Instead, you must submit a testing proposal in your registration dossier. We will then evaluate whether the testing proposal is adequate before allowing you to perform the test.

How can I find other joint submissions in REACH-IT?

If a potential registrant has inquired about a substance, they can find the Joint Submission and the Lead Registrant’s details by using the Joint Submission functionality and by ticking the option ‘Show other joint submissions’. See the example screenshot below and watch the explanation in this YouTube video 

Joint submission

If a potential registrant  has not  inquired about a substance, and the Lead registrant accepts to publish their contact information, they will be able to find the name of the Lead registrant on our website: https://echa.europa.eu/registration-statistics-infograph. The List of the lead registrants can be downloaded at the bottom of the info graphic. 

If a potential registrant has not  inquired about a substance and the Lead registrant does not accept to publish their contact information, they can only find the Joint Submission and the Lead Registrant’s details if: 

Here you can find further information on how to find your co-registrants.

D. Inquiry, information on chemicals

Does ECHA disclose or publish the information submitted in an inquiry dossier?

ECHA will not publish any substance identity information submitted as part of an inquiry.

ECHA uses the information submitted for the purposes of inquiry solely to determine whether the same substance has been previously registered or inquired about. We make available the contact details and list of information requirements only within the relevant Co-Registrants page in REACH-IT. The EC/list name, EC/list number and/or EC/list description is the only substance identity information disclosed to registrants and successful inquirers of the same substance.

E. Co-registrant page

How do I know if there’s a company inquiring about my substance?

Each time a new potential registrant successfully inquires about a substance or a registrant requests for additional information for a substance, an email notification is sent to all co-registrants in REACH-IT, informing them that a new member registrant is potentially entering the market. The new member will most likely only interact with the lead registrant, but for transparency reasons, all co-registrants are informed about it (see screenshot below).

 

How can I find other existing and potential registrants in the co-registrants page?

The co-registrants page helps registrants fulfil their data sharing and joint submission obligations. It is accessible to existing and potential registrants who have successfully inquired. It displays their contact details and, in case of inquirers who requested endpoints data, the list of requested information. Also the role of the registrants within the joint submission is visible for all, so the lead can be easily identified and directly contacted for the purpose of data sharing negotiations.

Registrants can see different information depending on their status:

  • Potential registrants, during the 1 year after successfully submitting their inquiry, can see all registrants. However only the leads are identified.
  • Potential registrants, beyond the 1 year of their successful submission and if they have not registered, can only see new potential registrant(s) or registrant(s) that have inquired. They can no longer see the existing registrants that did not inquire.
  • Registrants can see the roles of all co-registrants, i.e. whether they are lead or member and can see the potential registrants.
Why are the contact details of a company that notified a substance under the previous legislation (Directive 67/548/EEC) not shown in the co-registrants page?

The contact details of the companies which did not claim a registration number for a substance notified under the previous legislation are not available in REACH-IT and therefore cannot be displayed. Following an inquiry, we send registered mails to those companies that did not claim their registration number to inform them that there is an inquirer for a substance they have notified.

On the co-registrants page, is the Third Party Representative (TPR) or the Only Representative (OR) specific to the inquiry/registration dossier?

Yes. The Third Party Representative (TPR) or the Only Representative (OR) displayed on the co-registrants page is specific to the inquiry/ registration dossier. Consequently, if the same TPR has been nominated in several inquiry or registration dossiers, the same contact details (of the TPR) are displayed multiple times.


This also applies for several non-EU manufacturers: the OR is listed as many times as they have submitted an inquiry/registration for a specific substance.

Intermediate

Do I have to register intermediates?

It depends under which type of intermediate as described under Article 3(15) of the REACH Regulation your intermediate falls, whether you have registration obligations or not.

  • Non-isolated intermediates:

For the use of a substance as a non-isolated intermediate, there are no obligations under the REACH Regulation.

  • On-site isolated intermediates:

A manufacturer of on-site isolated intermediates in quantities of 1 tonne or more per year needs to register their substances (if they are not otherwise exempted from registration (see FAQ ID=30). However registrants of on-site isolated intermediates can provide reduced registration information according to Article 17(2) of the REACH Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3) of REACH.

  • Transported isolated intermediates:

A manufacturer or importer of transported isolated intermediates in quantities of 1 tonne or more per year needs to register his substances if they are not otherwise exempted from registration. However, a registrant of transported isolated intermediates can provide reduced registration information according to Article 18(2) of the REACH Regulation if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under Article 18(4) of REACH. In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.
When and how the specific provisions for the registration of intermediates under REACH can be used are described in the Guidance for intermediates: http://echa.europa.eu/guidance-documents/guidance-on-reach.

More information can be found at: http://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_en.pdf
 

Can a substance that is imported into the EU for use as a transported isolated intermediate; maintain its intermediate status where it undergoes a purification step prior to its use as an intermediate?

As described in Appendix 4 of the Guidance on Intermediates (page 35)" due to the practical nature of manufacturing processes and to the fiscal attributes of manufacturing sites, one or more steps between the manufacturing of the substance (A) and its use in the manufacturing of substance (B) may be necessary to facilitate/ensure proper chemical processing in the synthesis of substance B." Therefore, necessary purification of the intermediate, which takes place after its manufacture and before the synthesis, does not prevent it from being considered an intermediate.

Article 3(15)(c) of the REACH Regulation does not require that the manufacture of the transported isolated intermediate and its synthesis is done on sites operated by the same legal entity.

However, in order to benefit from the reduced information requirements for registration dossiers submitted under Article 18 of the REACH Regulation, the registrant must ensure that the substance is handled under strictly controlled conditions throughout its lifecycle - also if it undergoes a purification. It must also be ensured that the substance is always manufactured for and consumed in or used in the synthesis of another substance.

The Guidance on Intermediates is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

How is a non-isolated intermediate defined under REACH?

A non-isolated intermediate is defined as an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.

For further information see the Guidance on registration:

Can the use of Anthracene Oil (AO) andCoal tar pitch, high temperature (CTPHT) in the manufacture of coke electrodes for the aluminium industry be regarded as the use of an intermediate?

Yes, under the conditions specified in the reasoning provided below.

Manufacturing of coke electrodes

Coal tar pitch, high temperature (CTPHT - EC number 266-028-2) and Anthracene oil (AO - EC number 292-602-7) are used in the manufacture of electrodes for applications in electrolytic processes in the aluminium industry (i.e. aluminium smelters). These substances are used specifically to manufacture the following types of electrodes:

  • Søderberg electrodes – these are first manufactured directly in the electrolytic cell and subsequently used in the same cell. 
  • pre-baked electrodes - they are manufactured in dedicated units and later used in the electrolytic cells. Electrodes manufacturing units may be located in the same site as the electrolytic cells or in another site.

In both cases, the manufacturing process of the electrodes consists of the following stages:

  1. Mixing of the raw materials (so called filler grains usually petroleum coke or calcinated coke + CTPHT and/or AO) 
  2. Shaping (to give the electrode the final shape which is required to fit it into the housing of the electrolytic cell)
  3. Baking

The outcome from the baking process is "Coke", a new substance. The new substance is manufactured from petroleum coke or calcinated coke, AO and CTPHT that contribute to its structure.

In more detail the baking process works as follows:

  1. Coke substances are carbonaceous materials obtained from coking processes such as baking at relatively high temperature. These substances are characterised by a high carbon elemental content and can display unique structures presenting a high carbon-to-hydrogen ratio. The exact composition of coke is generally complex and depends on the source used and the conditions applied for the coking. As a source of carbon, coke substances find applications in processes such as aluminium manufacturing by electrolysis. In this specific case, CTPHT and AO are themselves chemically transformed into coke during the manufacturing process of pre baked and Søderberg electrodes. These transformations involve complex chemical reactions including polycondensation and polymerisation of the constituents which CPTHT and AO consist of. These reactions begin during the baking process in a low oxygen atmosphere at temperatures of ~400 C. The transformation process into coke is completed at around ~700 C with the condensation of all polyaromatic hydrocarbons. The transformation leads to a carbonaceous material of high carbon elemental content and CTPHT and AO contribute to the structure of the coke substance intended to be manufactured. In this case, the baking process is carried out in the presence of readily available coke filler grains. The result is a homogenous coke displaying specific electrical conductivity (a required feature for the coke to be used as an electrode) and mechanical strength. In this specific case, the resulting coke would in principle not have the chemical structure that would enable its use as a source of carbon in electrolytic processes without the combined use of the AO and CPTHT as precursors and readily available coke grains.
  1. The outcome from the manufacturing process (i.e. the coke electrode) is, in this specific case, a substance under REACH and not an article as defined in Article 3(3) of REACH. The shape of the electrode is decided to fit it into the housing of the electrolytic cell, which can be different from case to case. Furthermore, during theuse of the electrodethe carbon from coke is consumed. The specific shape, surface and design given to the electrodes during their manufacture are therefore less relevant for its use in the aluminium production process than its chemical composition.

Regulatory analysis

According to Article 3(15) of REACH, an intermediate is a substance which is "manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (…referred to as synthesis)".

Whenever a substance is used to achieve another function than its transformation into another substance (e.g. as an individual step in the production process of an article), it cannot be regarded as an intermediate. It is also recognised that, due to the practical nature of manufacturing processes and to the fiscal attributes of manufacturing sites, one or more steps between the manufacturing of a substance (A) and its use as an intermediate in the manufacturing of another substance (B) may be necessary to facilitate/ensure proper chemical processing in the synthesis of that other substance (B) (see Appendix IV of ECHA's Guidance on intermediates, December 2010).

In the current case, if all stages a, b and c are an integrated part of the coke manufacturing process installations, the use of AO and CTPHT may be considered the use as an intermediate.

However, whenever the mixing of AO, CTPHT and filler grains (stage a) is not carried out on the same site, this may indicate that the mixing step is not performed to facilitate/ensure proper chemical processing in the synthesis of the coke. In that case and AO and CTPHT cannot be regarded as intermediates.

Invoicing and Payments

Invoicing and payments, general

Who sets ECHA's fees?

ECHA fees and charges payable under Regulation (EC) No 1907/2006 ('the REACH Regulation') are set by the European Commission, with the agreement of the EU Member States. They are laid down in the Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency (OJ L 107, 17.4.2008, p. 6, "the REACH Fee Regulation"), as subsequently amended by the Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013 (OJ L 79, 21.3.2013, p. 7), by the Commission Implementing Regulation (EU) No 211/2014 of 27 February 2014 (OJ L 67, 7.3.2014, p. 1), by the Commission Implementing Regulation (EU) 2015/864 of 4 June 2015 (OJ L 139, 5.6.2015, p. 1) and by the Commission Implementing Regulation (EU) 2018/895 of 22 June 2018 (OJ L 160, 25.6.2018, p. 1), and are subject to regular reviews.

For more information, please consult the European Commission website: https://eur-lex.europa.eu/legal-content/en/TXT/HTML/?uri=CELEX:02008R0340-20180715&from=EN

Why is ECHA's invoice without value added tax (VAT)?

ECHA does not carry out an economic activity within the meaning of Directive 2006/112/EC on the common system of value added tax. This means that no VAT has to be paid on the fees defined in Regulation (EC) No 340/2008 ('the REACH Fee Regulation'). For the reason above, ECHA has no VAT number and ECHA's invoices are exempt from VAT. ECHA's Finnish Business ID number is 2139942-8 and it is always mentioned on ECHA's invoices. However, this number is not a VAT number.

Why are the activities of ECHA not taxable?
It is important to note that ECHA is not a private company or a service provider but a European public authority established by Regulation (EC) No 1907/2006 ('the REACH Regulation') which is directly applicable in all Member States. Article 102 of REACH provides that the Protocol of Privileges and Immunities of the European Communities shall apply to the Agency. This Protocol is part of the EU Treaties also directly applicable in all Member States, and according to the Protocol, the Agency is exempt from all taxes.
 
The exclusion of ECHA activities and transactions from taxation also results from Article 13(1) of Directive 2006/112/EC (2 on a common system of value added tax, which stipulates:
 
"States, regional and local government authorities and other bodies governed by public law shall not be regarded as taxable persons in respect of the activities or transactions in which they engage as public authorities, even where they collect dues, fees, contributions or payments in connection with those activities or transactions".
 
As it is not a taxable person, ECHA does not have a tax residence in any Member State and thus has no taxation number in Finland.
 
The invoices that ECHA sends to companies relate to fees for PPORD notification, registration and other submissions that ECHA collects pursuant to Regulation (EC) No 1907/2006 ('the REACH Regulation') and Commission Regulation (EC) No 340/2008 ("the REACH Fee Regulation"). Thus, they do not concern private transactions but are fees under public law applicable in all Member States. Based on Directive 2006/112/EC and particularly Article 13(1), these fees are not subject to taxation in any Member State. In the absence of taxation of the fees in any Member State or elsewhere, ECHA shall not be bound to complete any formalities imposed on taxable persons for the avoidance of double taxation.
 

Thus it is important to note that ECHA is unable to provide registrants a VAT or a withholding tax / tax at source residence certificate. As ECHA has no tax residence in any Member State. In QA 739 ECHA has published a financial identification form confirming its Finnish business ID.

1) OJ C 310, 16.12.2004, p. 261
2) OJ L 347, 11.12.2006, p. 1
What is the contact address of ECHA's accounting department (accounts receivable)?

For any enquiry, please contact ECHA by using the ECHA Helpdesk web form that is available at http://echa.europa.eu/contact.

REACH invoicing

What will the amount of the invoice be?

Fee amounts are specified in the Commission Implementing Regulation (EU) No 2018/895 of 22 June 2018 amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency ("the REACH Fee Regulation").

Information related to the chargeable confidentiality claims can be found in chapter 3.5 of the manual “Dissemination and Confidentiality under the REACH Regulation” at: https://echa.europa.eu/manuals.

ECHA encourages to run the Fee calculator plugin before submitting the IUCLID dossier in REACH-IT. A potential fee mismatch will enable you to identify and correct a mistake in your dossier before the submission.

Fee Calculator Plugin

How will I receive ECHA's invoice?
After your REACH submission has been received by ECHA, you will receive an electronic invoice only, via REACH-IT. This electronic invoice can be downloaded from your REACH-IT account in PDF format.
When do I have to pay ECHA's invoice?

The timelines for payment of fees levied under the REACH Regulation are specified in the REACH Fee Regulation as subsequently amended by the Commission Implementing Regulation (EC) No 340/2008 and its subsequent amendments (see QA 716) and the precise payment due date is set out in ECHA's invoice.

Fees invoiced for initial and update registrations

In the case of fees for registrations submitted, as well as in the case of updates of a registration, the initial payment due date of the fee is set at 14 calendar days from the date on which the invoice was notified to you. 

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline for payment. This second deadline (extended payment due date) is 60 calendar days from the initial payment due date.

If the payment is not made by the extended payment due date, the registration fails the completeness check and will be rejected.

For updates of a registration unrelated to tonnage band changes, the registrant has the possibility to request a further extension of the second deadline for fee payment before its expiry. In practice, this request for extension of the second deadline for payment applies only to:

  • Fees levied for new chargeable confidentiality claims included in updates;
  • Fees levied as a consequence of a legal entity change.

The request for extension should be submitted before the expiry of the second deadline via the ECHA Helpdesk using the contact form on ECHA's website.

If the payment is not made by the deadline of the extension, the update fails the completeness check and will be rejected.

Fees invoiced (PPORD) exemptions and for requests to extend PPORD exemption.

Fees for notification of PPORD exemptions: the initial payment due date of the fee is 7 calendar days from the date on which the invoice was notified to you. Requests to extend a PPORD exemption: the initial payment due date of the fee is set at 30 calendar days from the date on which the invoice was notified to you.

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline. This second deadline (extended payment due date) is 60 calendar days from the initial payment due date.

Where the payment is not made by the expiry of the second deadline, the notification or the request for an extension will be rejected.

Fees invoiced for Legal Entity Change (LEC)

Fees for Legal Entity Change: the initial payment due date of the fee is 14 calendar days from the date on which the invoice was notified to you.

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline. This second deadline (extended payment due date) is 30 calendar days from the initial payment due date.

Where the payment is not made by the expiry of the second deadline, the Legal Entity Change will be rejected.

Fees invoiced for Applications for Authorisation (AfA)

Fees for Application for Authorisation: the initial payment due date of the fee is 14 calendar days from the date on which the invoice was notified to you.

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline. This second deadline (extended payment due date) is 7 calendar days from the initial payment due date.

Where the payment is not made by the expiry of the second deadline, the Application for Authorisation will be considered as not received by ECHA. In this case the application is not processed further. The only way to proceed is to re-submit the application. 

How should I react to an invoice reminder?
ECHA sends you one invoice reminder for an unpaid invoice. The reminder contains an extended payment due date. The invoice reminder is automatically sent by REACH-IT one day after the initial payment due date. (see QA719).
 
If you receive a reminder but you have already paid the invoice, you can ignore the reminder.
 
If you have not yet paid the invoice when you receive the reminder, please make sure that you respect the extended payment due date as your REACH submission will be rejected.
 
Please note that there are separate instructions for appeal fees.
 
How can I see that ECHA has received and validated my payment?

ECHA does not send confirmations of receipt of payment, but you can check the status of your payment in REACH-IT. Open the submission report and look at the “Submission processing steps” section; the "Financial completeness check" step will be green when your payment has been received and accepted by ECHA.

Please note that it may take several days before ECHA receives the payment depending on the payment method. A SEPA payment is transmitted within three bank business days.

A submission is subject to both a technical and a financial completeness check. Therefore, a fully paid invoice does not necessarily indicate an accepted submission of your REACH dossier.

Does ECHA send credit notes?

When an invoice is cancelled (e.g. due to incorrect information on the invoice, such as billing information, company size, etc.), you will receive a credit note for the whole amount and, if needed, a replacement invoice. These electronic documents can be downloaded from your REACH-IT account in PDF format. If you receive two invoices and one credit note, the reference number you should indicate in your bank transfer is the reference number of the latest invoice.

If you pay an invoice for which ECHA later issues a credit note, the paid amount will be credited back to your company by either reallocating the received amount to another open invoice or refunding the amount to you.

Please be informed that ECHA doesn't provide any credit notes in case the invoice was not paid in full and your registration was rejected.

Do ECHA invoices have to be electronically signed?
After your submission has been received by ECHA, you will receive your invoice electronically via REACH-IT – no paper invoice is sent. Invoices can be downloaded in PDF format from your REACH-IT account.
 
The requirements mentioned in Directive 1999/93/EC on electronic signatures do not apply to invoices issued by ECHA. The rule on electronic signature of invoices is based on Article 233 of Directive 2006/112/EC ('the VAT Directive'), which according to Article 220, only applies to taxable persons. However, ECHA is not a taxable person, but an EU public body that does not carry out any economic activity.
 
In any case, the purpose of the provisions of the VAT Directive relating to electronic invoices is to guarantee the authenticity of the origin and the integrity of the content. For invoices notified by ECHA, this objective is met in a more efficient way. Invoices issued by ECHA are notified to their recipient through REACH-IT, which is a secured online platform through which only ECHA can notify information to individual registrants in confidence.
What information about my company appears on ECHA's invoice and credit note?
The following information about your company will be visible on the invoices, invoice reminders and credit notes:
 
  • Company name and billing address indicated by the registrant (the information filled in the tab "Billing company information" in REACH-IT is the one that will appear on the invoice);
  • Customer ID number (= Legal entity UUID);
  • DUNS number and VAT number (if provided by the registrant during the sign-up, can be modified later on in the company information section);
  • Purchase order number (if provided by the registrant when submitting the dossier or when accepting a legal entity change).
Before submitting the dossier, please make sure that all the above mentioned information is correctly indicated in your REACH-IT account if you require it to be visible on ECHA's invoice.
Does ECHA need a purchase order for my submission?
When submitting a dossier or accepting a legal entity change, you are able to indicate your own internal purchase order number. It is not possible to add any forgotten purchase order number or modify it afterwards.
 
As you register online in REACH-IT you should not send any purchase orders by ordinary mail or email to ECHA. Please make sure that your system does not send any purchase orders automatically to ECHA. Your purchase order is only for your internal purposes. ECHA will not confirm your internal purchase order or provide information to or access third party platforms for handling your purchase orders.
 
My company information has changed and the invoice is not correct; does ECHA issue updated invoices?

If your invoice has not been paid yet, ECHA will be able to cancel it and create a new one with your updated company information. If the invoice has already been paid, ECHA cannot modify the invoice.

ECHA is unable to update any company information in REACH-IT. It is the responsibility of the REACH-IT account owner within the company to make sure that the information is up-to-date.

To receive an invoice with updated company information update your information in REACH-IT. Go to Menu >> Manage Company >> Company information. Here you can modify and update your information by clicking on "Update" at the top right corner of the page. Always remember to save your changes. Additional information on how to update your company information can be found in the ECHA Accounts Manual for Industry Users

After the company details have been updated, you need to contact the ECHA Helpdesk by using the web form available on the ECHA website.

Company size information

If the changes in your company information are related to a change in the company size or to an incorrectly declared company size, please refer to the SMEs section on the ECHA website.

Who is entitled to a fee waiver?

You are entitled to the fee waiver if:

  1. Your substance is a phase-in substance and considered to be low risk (i.e. does not meet the Annex III criteria of REACH); and
  2. You submit a standard registration dossier for 1-10 tonnes per year voluntarily providing the full set of information listed in Annex VII.

The fee waiver does not apply if:

  • Your substance is considered to be low risk (i.e. does not meet the Annex III criteria) and you submit a registration dossier for 1-10 tonnes per year with only physicochemical information (listed in section 7 of Annex VII); or
  • Your substance is not considered to be low risk (i.e. meets the Annex III criteria) and therefore, you must provide the full Annex VII information; or
  • Your substance is a non-phase-in substance.
The above is based on REACH Regulation Articles 12(1)(a) and 74, taking into account Recital 34.

Important notes
In a joint submission, the tonnage band of the other member registrants does not influence the applicability of the fee waiver for your own dossier.

You need to actively claim the fee waiver in IUCLID to benefit from it – the system does not grant it automatically.

More information on the Annex III criteria and their applicability can be found here.

 

How can I add a Purchase order to my Invoice?

When submitting a dossier or accepting a legal entity change, you are able to indicate your own internal purchase order number in the third step of your dossier creation wizard (see screenshot). The indicated purchase order will be linked to the invoice issued for the dossier submission or the legal entity change.

For the submission report or an already issued invoice, it is not possible to add any forgotten purchase order number aor modify it afterwards.

invoice of purchase order

 

As you register online in REACH-IT you should not send any purchase orders by ordinary mail or email to ECHA. Please make sure that your system does not send any purchase orders automatically to ECHA. Your purchase order is only for your internal purposes. ECHA will not confirm your internal purchase order or provide information to or access third party platforms for handling your purchase orders.

REACH payments

How do I pay ECHA's invoice?

Bank transfer is the only accepted payment method. Other types of payment, such as cheque, banker's draft or cash, are not accepted by ECHA.

Payments should be executed in Euros only and it must be ensured that the full amount of the invoice is received by ECHA. Deductions of bank charges, from exchange rate differences or of any other costs will lead to an underpayment of the invoice.

The following bank details are indicated on all invoices issued under the REACH Regulation as from 01.07.2019:

Bank: 		ING Belgium, Avenue Marnix 24, 1000 Brussels, Belgium

IBAN: 		BE93 3631 8789 1767

BIC/SWIFT: 	BBRUBEBB

Please note that separate instructions for the payment of Appeal Fees exist. These are explained in the relevant section of the Board of Appeal on ECHA's webpage.

In the payment instruction, the invoice number should be indicated as the reference number. According to Article 17(1) of the REACH Fee Regulation (EU) No340/2008, in its latest version (see Q&A 716), every payment must indicate the invoice number. Thus, in the free text message/communications or reference field of the payment you should indicate only the payment reference indicated on the invoice. It is comprised of eight digits and you will find it next to ECHA's bank details on the invoice. This is very important, as your payment is automatically processed by REACH-IT. Please instruct your accounts payable/payments department and your bank accordingly.

What are the consequences of not paying an invoice within the extended payment due date?

Where the payment of a fee is not made by the extended payment due date or by the extension of the second deadline, the submission will be rejected or deemed not to be received. In the above mentioned cases, a rejection due to non-payment is not related to the status of the technical completeness check (TCC). Your submission will be rejected regardless of a given prolonged deadline to fulfil information requirements by submitting further information. Furthermore, if your submission is rejected, the REACH Fee Regulation (EU) No340/2008, in its latest version (see QA 716), stipulates that the fees paid in relation to that submission before its rejection shall not be refunded or otherwise credited to you. After you have received the rejection letter, you are able to start your submission process from the beginning.

How long does it take until ECHA receives my payment?

Since 1 November 2009, a SEPA payment must be transmitted within three banking business days. The bank statement of any given day is available to ECHA only on the next banking business day. Therefore, it normally takes up to five banking business days before ECHA can handle your payment and confirm the invoice as paid in REACH-IT. Please note that the handling time may be longer if your payment cannot be dealt with automatically. By following ECHA's instructions regarding payments you can significantly reduce ECHA's handling time of your payments (see QA 721).

How does ECHA handle my payment?

On the basis of the daily electronic bank statement, REACH-IT automatically matches your payment with your open invoice if you have indicated the correct payment reference (invoice) number in your payment message and you have paid the correct amount. An additional condition is that you pay each invoice separately as a single payment. One bank transaction per invoice therefore ensures the fast registration of your payment.

ECHA strongly advises you not to pay two or more invoices in the same transaction ("multiple invoice payment"). If you however include more than one invoice in the payment, please make sure that the invoice references are mentioned in full. Otherwise, the payment has to be manually handled by ECHA's accounting department. This may delay the processing of the payment and thus also the overall completeness check of your registration. If, for some reason, you cannot avoid sending multiple invoice payments and you are unable to indicate the full reference numbers in the payment, please make sure to follow the instructions in QA 732, which describes the sending of payment advices.

How can I help ECHA to swiftly deal with my payment ensuring a successful registration?
Your payment can be swiftly dealt with by ECHA if the guidelines below are followed when making your bank transfer:
  1. Pay one invoice per transaction (single payment);
  2. Indicate the correct reference number (eight digit invoice number);
  3. Ensure the invoiced amount is paid in full (no charges or exchange rate differences);
  4. Instruct your bank to send a SEPA payment with shared cost.
If you discover a mistake after your payment has been made, please immediately contact ECHA via the ECHA Helpdesk web form available at http://echa.europa.eu/contact.
 
When should I provide ECHA with a payment advice?
A payment advice can either be an extract from your accounts payable department attached to your email message in PDF format or simply a list of the invoice numbers paid, their total amount and the payment date in the email message itself.
 
A payment advice must be sent in the following cases:
- your payment reference (invoice) number was incorrect;
- in the case of a multiple invoice payment where each invoice number is not mentioned in the bank payment message;
- by request of ECHA's accounting department.
 
If you have indicated the reference (invoice) number in your payment message and it is correct, ECHA does not need any separate payment advice.
 
A payment advice should be sent to the email address of ECHA's accounting department which is: payments@echa.europa.eu.
Please indicate 'Payment advice and the payment date' in the subject field. Example: "Payment advice 19 March 2016".
 
No payment advice by conventional mail is required unless ECHA exceptionally requests it.
What is a proof of payment and when does it need to be sent to ECHA?
The proof of payment can either be a copy of your bank statement or a separate confirmation stamped by your bank.
 
The bank statement can serve as proof that you paid ECHA's invoice by the extended due date. The bank statement copy or the document stamped by your bank must clearly show the date when you ordered the bank transfer.
 
If ECHA has received your proof of payment but has not received the payment within a time period judged normal for bank transfers, ECHA's accounting department will contact you.
 
Please observe that a payment advice printed from your accounting programme is not a valid proof of payment. A proof of payment needs to be issued or officially certified by your bank.
 
Proofs of payment should be sent as scanned PDF attachments to the email address of ECHA's accounting department: payments@echa.europa.eu.
 
No proofs of payment by conventional mail are required unless ECHA exceptionally requests them.
 
What are the rules for a refund?
In certain cases of double payment or overpayment, ECHA will refund the received amount paid in excess. Moreover, fees or charges paid after the rejection of the submission are refunded as undue payments.
 
For the payment of refunds, ECHA will request the bank account information of your company. In addition, ECHA requires your company to complete and sign the following two forms in order to process the refund:
 
"Legal entities" which can be found at:
and "Financial identification" that can be found at:
 
You can choose your preferred language. Please also read the privacy statement.
 
However, please note that fees or charges paid in relation to a submission before its rejection cannot be reimbursed or otherwise credited pursuant to Articles 3(7), 4(7), 5(7), 7(5), of the Fee Regulation and Article 20(2) of the REACH Regulation (Regulation (EC) No 1907/2006).
 
For more details on the rules and procedure, please refer to ECHA Decision ED/61/2008 on refund of fees and charges pursuant to Article 10(4) and 20(1) of the Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013 amending Regulation (EC) No 340/2008. The Decision on refund of fees and charges is available at: http://echa.europa.eu/documents/10162/13559/ed_61_refund_fees_charges_en.pdf
How can I prepare my accounts payable department or my accounting company in view of ECHA's invoices?

All the information you need for proceeding with the payment is visible in the invoice itself. However, depending on your internal administrative procedures, it is advisable that your accounting/accounts payable department is prepared for the payment of ECHA's invoices.

We therefore recommend that you set up ECHA's bank account information in the accounting system well in advance of the first invoice's due date.

PLEASE NOTE OUR NEW BANK DETAILS SHOWN ON INVOICES AS FROM 01 JULY 2019.

As from 01 July 2019 ECHA changed the bank account details shown on its fees and charges invoices. The Agency’s new house bank is ING Belgium NV. New ECHA’s financial identification form covers all the details needed for this new bank account

If you use an external accounting company, please ensure that all required information about ECHA and REACH is passed on, in order to ensure the smooth handling of ECHA's invoices. It is also advisable that you ensure beforehand that there are no misunderstandings related to ECHA's status as an EU body which is exempt from any national tax or any value added tax. Please refer to Q&A 725 and Q&A 726.

Please make sure that the persons handling the payments of ECHA's invoices are aware that the payment should be made at the full amount so that any possible bank charges are not deducted from the payment.

Please inform your accounting department that if the invoice is paid after the extended due date, the REACH dossier submission will be rejected and the paid fee will not be refunded.

Please ensure that ECHA’s invoice number is stated in the payment instruction (see Q&A 721).

How much is the registration fee?

The registration fee for a substance depends on the tonnage of the registration, size of the company and the type of submission. Additionally:

  • Lower fees apply to joint submissions as compared to individual submissions. This does not apply in case you decide to opt-out of the joint submission;
  • SMEs benefit from a reduced fee in all categories;
  • An additional fee is levied for confidentiality.

No fee is required for the registration of substances if you are entitled to a fee waiver. Further information related to the fee waiver can be found under Q&A 1237

 

All these provisions are specified in Articles 12(1)(a) and 74 of REACH, taking into account Recital 34 of the regulation. The fee amounts can be found in the REACH Fee Regulation (No. 340/2008, and subsequent amendments).
Further information can be found under Invoicing and Payments..

Joint submission of data by multiple registrants

A. Joint submission, general

Do the registrants have to submit all their data jointly?

An overview of what must and what may be jointly submitted for registration based on Article 11 of the REACH Regulation is provided in Section 6.2- 'Overview of the part of the technical dossier that may be jointly submitted for Registration' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Some information of the registration has to be submitted jointly whereas other information needs to be submitted separately. Additionally, there is information the registrant(s) may decide themselves whether to submit jointly or separately, according to the criteria defined in Article 11(3) of REACH.

The following information must be submitted jointly: information on the classification and labelling of the substance, (robust) study summaries and an indication as to which of the submitted information on classification and labelling, study summaries and robust study summaries has been reviewed by an assessor. Under specific conditions, which should be explained in the dossier, a separate submission of these data is allowed (see also Q&A 109).

Additionally, each registrant must submit individually: the identity of the manufacturer or importer, the identity of the substance, information on the manufacture and use(s), exposure information for substances in quantities of 1 to 10 tonnes and an indication of which of the submitted information on manufacture and use has been reviewed by an assessor. The registrants may decide to submit the following information jointly or separately: guidance on safe use of the substance, a Chemical Safety Report (CSR) when required and an indication which of the information submitted for the CSR has been reviewed by an assessor.

What information can be submitted separately?

Member registrants can submit the following information separately, as specified in Article 10(a) (iv), (vi), (vii) or (ix) of REACH:   

  • The classification and labelling;
  • Study summaries of the information derived from the application of Annexes VII to XI;
  • Robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; and
  • Proposal for testing where listed in Annexes IX to X.

Article 11(3) of REACH allows an "opt-out" under specific conditions. Such an "opt out" can only cover some or all of the endpoints submitted by the lead registrant on behalf of all member registrants. However, the member registrants have to remain part of the joint submission regardless of whether information is shared.

Can different classifications of a substance be included in the joint submission dossier?

According to Article 29(2) of the REACH Regulation, one of the main aims of the SIEF is to agree on classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.

Nevertheless if all member registrants agree, the lead registrant may include different classifications of the substance in the joint part of the registration dossier, e.g. if different impurity profiles lead to different classifications.

In this case, member registrants should leave the pertinent section of their member dossier empty to avoid being treated as an opt-out for the classification and labelling of the substance.

If the member registrants cannot agree on the inclusion of all the different classifications of the substance in the joint part of the registration dossier, one or more of the member registrants may decide to provide their substance classification separately (by filling in the respective section in their member dossier). If this is the case, a justification in accordance with Article 11(3) of REACH is required. In addition, in cases where a harmonised C&L for a substance is provided in Annex VI to the CLP Regulation, then that harmonised C&L must be used.

Further information can be found in the manual ‘How to prepare registration and PPORD dossiers

Should all available studies be included to the joint submission dossier?

Yes. According to Annex VI to the REACH Regulation any physicochemical, toxicological and ecotoxicological information that is available and relevant must be provided in the registration dossier.

In practice, after gathering and assessing all existing information, the registrant has to select the information that is reliable, relevant and adequate.

For key studies, robust study summaries have to be provided; for supporting studies, study summaries are sufficient.

Further guidance on information gathering and evaluation is also provided in chapters R.3 and R.4 of the Guidance on information requirements and chemical safety assessment.

Can member registrants of a joint submission submit the same generic spectral data or chromatograms?

According to Article 11(1) of the REACH Regulation, the information specified in Article 10(a)(ii), i.e. details on the substance identity including spectral data and chromatograms, have to be submitted separately by each member registrant of a joint submission.

This information is necessary for ECHA to be able to check the sameness of the substance submitted by the different member registrants. Therefore, generic spectral data or chromatograms must not be used. Each member registrant of a joint submission has to provide the specific spectral data and chromatograms for the substance they intend to register.

Can a company resign from its role as lead registrant?

The REACH Regulation does not prevent the change of a lead registrant.

It is up to SIEF participants to agree on who is the lead registrant, who acts with the assent of the other registrants for the same substance. The SIEF/co-registrants can agree to transfer the lead role to another registrant at any point.

Information on how to transfer the lead role in REACH-IT can be found in Q&A 0380.

 

How do I know which joint submission to join?

Multiple registrants of the same substance share two main obligations under the REACH regulation: data sharing and joint submission obligations. Registrants can identify who else has registered their substance and therefore shares common obligations under REACH.

It is the common responsibility of all (potential) registrants, yourself included, to form a single joint submission. ECHA strongly recommends that all registrants use this new page as a tool to ensure compliance with these obligations. For example, no role is displayed next to a registrant that has submitted a registration dossier outside of an existing joint submission. They are required to contact the lead registrant, as they share the same responsibility as the other multiple registrants. Registrants of the same substance are obligated to make every effort and to ensure that they are part of the same joint registration dossier. Existing registrants outside the joint submission are required to negotiate access to the joint submission with their co-registrants – regardless whether they need to share data or not.

For further information see Guidance Chapter "6 Registration: Joint Submission" Please also note the partial exceptions applicable for intermediate registrants.

B. Joint submission, creation/deletion

Deleting a joint submission

To delete a joint submission search for your joint submission in REACH-IT and use the ‘Delete joint submission’ functionality.

You can only delete the joint submission if:

  • There are no members in the joint submission (active or inactive)
  • There are no submissions linked to it (failed or passed)

If the above options do not apply, ECHA can delete the joint submission upon your request. In order to do so, please contact ECHA using the contact form.

Please take into account that once the deletion has taken place, ECHA will not be able to revert the action.

Creating a joint submission by manually selecting the substance identity

The joint submission is created by the lead registrant using the pre-registration number, inquiry number or the registration number.

When none of these identifiers are available, or the pre-registration number refers to a submission that does not correctly define the substance identity, you should proceed as follows: Select Menu >> joint submission >> Create new.

Read carefully the information provided on the right side of the page. If you are certain that you do not have any reference number, click on the link ‘substance identity manually’ and follow the wizard.
create submission

Creating a joint submission for a UVCB substance without numerical identifiers (EC/CAS)

When forming a joint submission, you are required to first agree on the substance’s chemical name with all of your co-registrants. Therefore, we recommend that you first read ECHA's "Guidance for identification and naming of substance under REACH and CLP" chapter 4.3. UVCB substances. Also consult our Sector-specific support for substance identification, on certain UVCB substance types (e.g. oleochemicals, essential oils, metals, etc.).

The chemical name of the UVCB substance must be reported in the ‘IUPAC name’ field of the reference substance in section 1.1. of your IUCLID dossier. This applies even if the naming conventions for UVCB substances do not follow the IUPAC nomenclature.

The spelling of the chemical name is important, the name needs to be identical both in your joint submission in REACH-IT and in IUCLID dossier section 1.1 ‘Identification’. This is important in order to pass the business rules check. The name should not contain spelling errors or additional spaces between words or characters.

Creating a joint submission

  1. Start your registration by creating a new joint submission. Use the ‘insert the substance identity manually’ link, found in the checklist of joint submission creation wizard (see picture).


     
  2. In the next step, search for your substance name and then create the joint submission by its ‘chemical name’ (see picture).


     
  3. Select ‘other name’ or ‘IUPAC name’ depending on the naming convention of your substance as the ‘chemical name type’ and insert the derived name of your UVCB substance into the field and click continue (see picture). This will be the name of your substance in REACH-IT.



     
  4. REACH-IT might suggest other already pre-registered or registered constituents with similar names; please ensure that you select ‘your constituent’ at the bottom of the page and click ‘continue’ (see picture).



     
  5. The name has now been added to the section ‘selected constituents’ (see picture). Click ‘continue’ and confirm you substance identity and continue with the joint submission creation wizard.



     

Prepare and submit your dossier as part of the joint submission you created.

Remember to report all the identified constituents of your UVCB substance in IUCLID dossier section 1.2 ‘composition’. For further information on composition requirements for UVCB substances consult our guidance “How to prepare registration and PPORD dossiers.” on page 32. Also, fill in the ‘Description’ in section 1.2 including the identity of the starting materials and a description of the production process used to manufacture the substance. For Manufacturing process description see Q&A 1199.

Once you have submitted your dossier

A numerical identifier will be issued to your substance once it has passed the business rules check. Export the EC number from the joint submission page and use it in the reference substance in any future updates. Members submitting after the lead has passed the business rules check should export the issued EC number from the joint submission page and use the numerical identifier and the correct IUPAC name in section 1.1 of the IUCLID dossier. Instructions on how to download and export the EC number can be found in Q&A 1258.

 

What is a joint submission status? Can I change my closed joint submission to active?

Joint submissions have a status of either active or closed. Registrations can only be submitted to an active joint submission. Upon creation, the joint submission will automatically have the status active. Within the joint submission, a deadline to submit a lead dossier that at least passes the business rules verification step is clearly displayed. If no submission takes place until the given deadline, the joint submission’s status will turn to closed.

Closed joint submissions will remain in the system, but no submissions can be made into them. A closed joint submission will not block the creation of another joint submission for the same substance and same scope (full or intermediate). Therefore, once a joint submission’s status has been changed to closed, any (potential) registrant can create a new joint submission for the same substance.

Closed joint submissions cannot be turned back to active. If the joint submission is still needed, the lead registrant can create a new joint submission, using the same substance identifiers. However, a new name will be required, as joint submission names cannot be recycled.

C. Joint submission management, lead registrant

A NONS notifier (Directive 67/548/EEC (NONS) successfully claimed a registration number. Can this notifier become the Lead Registrant (LR) of a joint submission?

Yes, it is possible. It is the common responsibility of multiple registrants/notifiers of the same substance to submit only one joint registration dossier.

A NONS notifier who successfully claims a registration number for a notification under the Dangerous Substances Directive (67/548/EEC) can propose to the existing (potential) registrants that they themselves (i.e. the notifier) become the lead registrant of the joint dossier.

If there was not yet another lead registrant and the notifier’s role has been accepted, they must, firstly, update their registration dossier to fulfil the data requirements for registrations under REACH and, secondly, create a joint submission.

In parallel, the lead registrant needs to communicate with other (potential) registrants both on the choice of data (and the related costs) and on the token (to confirm joint submission membership). Similarly, existing registrants must update their dossiers, after they confirm their membership, as a member dossier of the joint submission.

For more information see the Guidance on Data Sharing.

How can the lead registrant role in REACH-IT be transferred to another member of the joint submission?

If the current lead registrant does not want to continue in their role as lead, it is up to the SIEF members to choose a new member, who will take over the lead role. In order to transfer the role, the following shall be observed:

  • The current and the future lead registrant need to agree on the handover. Then, the following actions must be performed within the Joint Submission in REACH-IT:
    • The current lead registrant will need to assign the lead role to the future lead registrant using the ‘Assign New Lead’ button. The future lead registrant, should already be a member of the joint submission.

      assign new lead

    • Then, the future lead registrant should accept the assignment by clicking ‘Confirm Lead’ button and subsequently become the lead registrant in the Joint Submission.

      assign new lead

  • The new lead registrant needs to submit a lead dossier containing all the information to be provided on behalf of the joint submission. If the new lead registrant has previously submitted a registration dossier for this substance, the lead dossier should be submitted as a spontaneous update.
The initial lead registrant is still technically considered as the lead registrant of the joint submission until all above mentioned technical steps are carried out.
Can a joint registration be updated even though another joint submission for the same substance exists?

For the time being, any active registration that is part of a joint submission can be updated without any limitations, as long as you are not changing the type of your registration. For intermediate joint submissions, changing your registration to both intermediate and full or only full is only possible, if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission.

However, we highly encourage you to start negotiating with the other joint submission on merging into one, as in the future it will be unavoidable. For further information see Q&A 1170.

What is the List of lead registrants?

a) When creating a Joint Submission the lead registrant can accept to publish their contact details.

ECHA publishes the contact details of these lead registrants on the List of lead registrants. The list includes the substance identity, registration type and creation date and whether or not the lead dossier has been submitted. The list includes non-confidential information on substance identity, registration type, creation date and whether or not the lead dossier has been submitted.

Joint Submission information are not published if the substance identity has been claimed confidential in all registrations dossiers of the joint submission. The information on the List of lead registrants mirrors the information published on ECHA’s dissemination webpage.

b) When creating a Joint Submission, the lead registrant can refuse to publish their contact details.

In this case, the contact details of the lead registrant will not be publicly available on the List of lead registrants and the entry will be marked Available in REACH-IT.
This means that only companies, that have registered or inquired about this substance will be able to find the contact details in REACH-IT.
 
There may be other reasons, why a substance is not included to the List of lead registrants:
  • There are no registrations for the substance and no lead registrant has been appointed.
  • The lead registrant has been appointed, but has not yet created the joint submission.
  • There is a joint submission, but all members have claimed their substance identity confidential.
  • There are only individual registrants and no joint submission has been created.
  • The annual quantity of the substance manufactured or imported by the individual suppliers is below 1 tonne per year, therefore the manufacturers/importers have no registration obligations for this substance.
How can the lead registrant increase the Joint Submission’s tonnage band?

To increase the Joint Submission tonnage band, the Lead Registrant needs to submit a spontaneous update. Please note, that the increase of tonnage band of the Joint Submission may require additional data to be provided in the Lead Dossier.

In Dossier Creation Wizard

Step 1

The tonnage band indicated in submission type (IUCLID 6 template) represents the tonnage band of the Joint Submission. Please pick the same submission type as was used from the last successful submission at a higher tonnage band.
 

 

Step 2

The administrative information of the dossier represents the data of the Lead Registrant. The tonnage band indicated in this step represents the tonnage band of the Lead Registrant’s own registration.

Keep in mind that the lead registrant can have his tonnage band different from the tonnage band of the Joint Submission, while the information required for the lead dossier is based on the highest tonnage band of any Joint Submission member. If the Lead Registrant increases his own registration’s tonnage band, a new invoice will be triggered.

Mark the dossier as an update, add the last successful submission number and chose ‘change of tonnage band’ from the drop-down menu as justification for the spontaneous update.

How can the lead registrant decrease the Joint Submission’s tonnage band?

Step 1

Before decreasing the Joint Submission tonnage band, the Lead Registrant needs to make sure that all members of the Joint Submission, except for the Lead himself, have the tonnage band equal or below the decreased (new) JS’s tonnage band. Members can update their own tonnage band by submitting a spontaneous update.

The tonnage band of Intermediate registrations do not affect the tonnage band of the full joint submission, therefore, a member with an intermediate registration can have a higher tonnage band than the decreased Joint Submission.

Step 2

The Lead Registrant has to contact ECHA via the contact form and request that ECHA performs the decrease of the Joint Submission tonnage band.

If a consultant is representing the Lead Registrant, a signed request by the Lead Registrant needs to be submitted.

Step 3

After ECHA has decreased the Joint Submission tonnage band, the Lead Registrant has to submit a spontaneous update using the same submission type (IUCLID template) that was used for the last successful submission, but at a decreased tonnage band.

In the same update, the Lead Registrant has to update its own registration’s tonnage band (administrative information) to be equal or lower than the decreased tonnage band.

Mark the dossier as an update, add the last successful submission number and chose ‘change of tonnage band’ from the drop-down menu as justification for the spontaneous update.

Please note: If a final decision from ECHA was sent to the Joint Submission members, they will need to comply with such decision even after the tonnage band decrease.

Can the tonnage band of the lead registrant be below the Joint Submission tonnage band?

Yes. If the lead registrant wants to lower his tonnage band below the tonnage band of the Joint Submission, the Lead needs to submit a spontaneous update.

In Dossier Creation Wizard

Step 1.

The tonnage band indicated in submission type (IUCLID template) represents the tonnage band of the Joint Submission and should remain the same as used during the last successful submission.

Step 2.

The administrative information of the dossier represents the data of the Lead Registrant. The tonnage band indicated in this step represents the tonnage band of the Lead Registrant’s own registration, which can be equal or lower than the tonnage band of the Joint Submission, indicated in submission type.

 

How can the lead registrant change the registration type of the Joint Submission?

If there is full agreement among the members of a Joint Submission and there is no Joint Submission of the different type, the lead registrant can send a formal request to ECHA so that ECHA can apply the necessary changes.

N.B. A Joint Submission type can change from full to intermediate only if there are no full members present.

How can a lead registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current intermediate registration dossier?

Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.

Before changing your registration, please consider the following flowchart:

Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.

Data sharing negotiations.

In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.

For further information on how to transfer the lead role to the member of a joint submission see Q&A 380.

D. Joint submission management, member registrant

How can a member registrant confirm their membership in a Joint Submission in REACH-IT before they submit their registration dossier?

The lead registrant of a joint submission will provide you with a combination of joint submission name and security token outside of the REACH-IT environment (e.g. by email, phone). To confirm your membership, log in to REACH-IT and use the ‘Join existing Joint Submission’ functionality and follow the wizard.
joint submission

Member registrants will also need to indicate their membership to a joint submission by adding the joint submission name during the submission of their registration dossier in REACH-IT.

Member registrants are able to indicate their membership to a joint submission in section 1.5 of IUCLID 6 registration dossier. This information can be used for your own administrative purposes, but will not be verified against the information derived from REACH-IT.

Member registrants cannot submit their dossiers until the lead dossier has been accepted for processing by ECHA. The status of the lead dossier can be checked in the joint submission in REACH-IT.

How can a member registrant change from an individual to a joint submission?

An individual registrant who wants to become part of a joint submission needs to submit a spontaneous update and indicate that their registration is part of a joint submission. Before submitting, they have to confirm membership of the joint submission, in this case the lead registrant needs to provide the joint submission name and the security token.

Once the information required is obtained, they can confirm the membership by signing in to REACH-IT >> Select Menu >> Joint Submission >> Join existing and enter the joint submission name and security token and follow the wizard.

When updating the dossier in IUCLID pay attention to the following:

  • Enter the registration number in section 1.3 of your substance dataset
  • Create the registration dossier by right-clicking the substance and selecting "create dossier" and follow the wizard
  • Choose the template "REACH Registration member of a joint submission –general case/ - intermediate" depending on your submission.
  • Indicate the reason for update as "Change from individual to joint submission"
What are the ‘one substance, one registration' (OSOR) rules?

If you are an individual registrant and no other company has registered the same substance, you will not face any constraints when updating your registration. If there are other registrants for the same substance, you will have to fulfil certain criteria to be able to update. Below you can find the scenarios of your case:

  • A joint submission exists for the same substance and same registration type and your registration is outside of this: You cannot update your dossier, until you join the joint submission.
  • A joint submission exists for the same substance and same registration type and your registration is part of it: You can update your registration without any limitation, as long as you are not changing the type of your registration. For intermediate joint submissions, changing your registration to both intermediate and full or only full is only possible if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission.
  • No joint submissions exist for the same substance and for the same registration type (full or intermediate), but other individual registrations have been submitted: You can update your registration without any limitation, as long as you are not changing the type of your registration or until a joint submission is created. For intermediate registrations, changing your registration to both intermediate and full or only full is only possible if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission
Can a registrant update their individual dossier without creating/joining a joint submission, even though multiple registrants exist?

As long as your registration fulfils the criteria listed below, you are allowed to update it, even if there are other individual registrations in the system:

  • There are only individual registrants and no joint submission exists in REACH-IT.
  • You are not changing your registration type with your update. For intermediate registrations, changing your registration to both intermediate and full or only full is only possible if there is no other full and intermediate registrant (either as part of a joint submission or as individual registrant).

If any potential or existing registrant creates and submits a joint registration, this joint registration will block all the individual registrants of the same substance and same registration type from being able to update their dossiers, until they join the joint submission.

A registrant submitted an individual registration and ECHA requested that they update their dossier. Can the individual registrant perform the update without creating/joining a joint submission?
  • If there is a joint submission for the same substance you will need join the joint submission in order to submit the update.
  • If there is no joint submission, but there are individual registrants for the same substance, you should create a joint submission and take up the role as lead registrant before submitting the update.
  • If there is no joint submission and you are the only individual registrant, you can update your registration without creating the joint submission.
  • None of the above applies, if the update requested is linked to a technical completeness check (TCC) failure. In this case you should submit an update as individual registrant.
How can a member registrant increase their registration tonnage band above the tonnage band of the joint submission?
  1. The member has to communicate their intention to upgrade their tonnage band to the lead registrant.
  2. The lead registrant submits a dossier update using the IUCLID template corresponding to the higher tonnage band (submission type). The dossier will include all data required for the higher tonnage band. When creating the dossier, in the dossier header, the lead registrant should indicate their own tonnage band, which will in this case be lower than the used template (administrative information).
  3. Once the lead has successfully submitted the lead dossier, the member can submit their updated member dossier indicating the new, higher tonnage band in the dossier header (administrative information) and pay the corresponding fee.

Fees
There is no cost linked to the increase of the joint submission tonnage band, fees are levied only for the increase of the tonnage band of a registration. Therefore, as long as the lead registrant only increases the tonnage band of the joint submission, but not their own registration, they will not incur any additional fee. On the other hand, when the member registrant submits their updated dossier at an increased tonnage band, they will receive a new invoice.
Member registrants of a joint submission (including the lead registrant) contribute only to the cost of the data they need and the applicable administrative charges. If only one member registrant needs additional studies, they alone will need to pay for the cost of that data. Should later on another registrant require the new, higher tonnage band, then the costs of the data / studies performed need to be shared amongst the registrants who require those.

Opt-out
In case the data that is required for the higher tonnage band is only available for the specific member registrant, who wishes to update their dossier, they can decide not to share it with the lead registrant, but instead include it in their own dossier and submit an opt-out for the higher tonnage band.
By submitting an opt-out dossier you will not be entitled to the reduced joint submission fees. Furthermore, any registrant who in the future wishes to update their registration to this higher tonnage band would have to include the data in their dossier separately. For this reason, ECHA recommends that the lead registrant’s dossier contains all information, regardless of their tonnage band. Alternatively, and only if the majority of co-registrants support it, the member registrant can take over the lead role of the joint submission.

How can a member registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current dossier?

Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.

Before changing the member registration, please consider the following flowchart:

Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.

Data sharing negotiations

In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.

My lead registrant is no longer active, because it ceased manufacture, the company was closed, or its registration was revoked. What should I do?

You should appoint a new lead registrant together with the other registrants of the substance as soon as possible. Of course, you can offer to become the lead registrant.

A lead registrant is a legal requirement under Article 11 REACH. Moreover, there are important practical reasons why you should have a lead registrant. As such, you have an own interest in ensuring that there is a lead registrant to your registration.

For example, a lead registrant is needed to give potential registrants access to the joint submission and to confirm that they may refer to the information in the lead dossier. A lead registrant is also a natural first contact point for data sharing negotiations, and thus facilitates all registrants’ compliance with their data sharing obligations.  In addition, a lead registrant is needed to update the information that was jointly submitted for a substance. Without a lead registrant, each registrant must update its registration individually with new information about the substance.

After the lead registrant has disappeared, the remaining registrants need to discuss among each other to appoint a new lead registrant as soon as possible. Once you have agreed on a new lead registrant, you should contact ECHA via the contact form, and request the transfer of the lead registrant role.

If you know that your lead registrant for a substance will disappear, you and the other registrants are encouraged to appoint a new lead registrant before the disappearance. Like that you ensure that there is no time without a lead registrant. This is easier to do in practice, because the old lead registrant can hand over the lead registrant role within REACH-IT. Q&A 0380 explains what to do step-by-step.

E. Joint submission, opt-out

How can a potential registrant opt out of a Joint Submission?
a) Reasons for opting out
In case there is a disagreement regarding a specific endpoint, you may opt out of information according to Article 11(3) (or 19(2) in case of intermediates) if:
it is disproportionately costly to submit this information jointly; or
it would lead to the disclosure of information which is considered to be commercially sensitive and may cause substantial detriment; or
there is disagreement on the selection of this information.
In such cases, a member registrant can submit a partial or full opt-out of the joint submission and include all endpoints the co-registrant wants to opt out for.
 
b) Duties of a member registrant who opts out of the joint submission
A registrant that submits an opt-out (partial or full) must remain a member of the submission and participate in data-sharing negotiations. Even a member who fully opts out of the joint submission may be requested to share administrative costs associated with the management of the joint submission.
In case of an opt-out, you are required to:
remain part of the joint submission,
submit your own information to cover the data requirement,
submit a clear and reasoned justification for opting out,
include opt-out information in section 14 of IUCLID dossier.
 
c) Preparation of a member registrant’s dossier:
If a member registrant relies on the information provided by the lead registrant, he should not fill in any data to sections 2.1, 4, 5, 6, 7 and 8 of the member dossier;
If a member registrant submits a dossier with any of these sections filled in, the submission is regarded as an opt-out (see picture below):
 

opt out

Only the section 2.1 and 4-7 endpoint study record documents that you link to the section 14 endpoint ‘Opt-out information for REACH registration’ will be included in the dossier. Ensure that you have linked all the study record documents that you planned to include in the dossier to this section 14 endpoint before you finalise the dossier creation.
 
If you have different justifications for the data that you opt-out with, group the linked documents per blocks so that the justification you provide is relevant for the documents in the same block. Endpoint summaries are not considered as opt-out information but are still required if you are opting-out with endpoint information or are providing your own Chemical Safety Report.
 
When opting-out, some of the sections that are mandatory for a complete dossier are not automatically pre-selected for inclusion in the IUCLID dossier when you use the joint submission member template. Therefore, when creating your dossier, endpoint summary records including section 6 ‘Ecotoxicological information’ and section 7 ‘Toxicological information’ must be selected manually.
 
Guidance on preparing an opt-out dossier can be found in sections 9.9.2 and 10.2 of the manual How to prepare registration and PPORD dossiers.
 
d) Opt-out status of member registrants in REACH-IT:
The opt-out status is marked no, if the member registrant did not opt out, or has only opted out of section 2.1 (Classification & Labelling and PBT assessment).
The opt-out status is marked yes, if the member registrant opted-out of any other sections (i.e. 4, 5, 6, 7).
 
Under what circumstances can a registrant submit partially or fully separate data from other members of the joint submission?

Registrants must always submit their information within the framework of a joint submission. However, registrants can submit some information separately, if: 

  • it would be disproportionately costly for them to submit some information jointly, or
  • submitting the information jointly would lead to the disclosure of commercially sensitive information that would likely cause substantial commercial detriment, or
  • they disagree with the lead registrant on the selection of information.

Registrants who fall under any of the above circumstances can submit some or all data on their own: these are respectively called partial and full opt-out. Technical implementation of the opt-out is described in Q&A 396.

I want to justify opting-out due to disproportionate cost. What information should I provide?

A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7. 

Information expected in the justification:

  • Cost of accessing the jointly submitted data. You should have received this information from the lead registrant. If you have not been able to obtain this information from the lead registrant you should explain the actions you took to try and obtain this information and the lead registrant’s response.
  • Cost of completing and submitting your opt-out dossier. Bear in mind your own possible internal costs related to preparing the dossier. You should not provide a figure of zero for this answer.
  • Explain why submitting this data jointly would be disproportionately costly. See below some examples for the basis of your explanation:
  • Your registration type being different from the joint registration.
  • Your registration tonnage band and the associated data requirements being different, e.g., Annex VII requirement fulfilled with an Annex VIII study.
  • Type of data, e.g., data publicly available, own data available, other data available at lower cost (e.g. QSAR).
  • Cost breakdown quality and clarity.
  • Explain the measures taken to agree on the cost of accessing the jointly submitted data.
I want to justify opting-out due to commercially sensitive information that could cause substantial commercial detriment. What information should I provide?

A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7. 

Information expected in the justification:

  • You need to specify precisely which information is commercially sensitive.
  • You need to explain why you believe submitting this information jointly would cause substantial commercial detriment. You explanation should show your reasoning for believing substantial commercial detriment would be caused.
I want to justify opting-out due to disagreement on the Annex VII-X data submitted. What information should I provide?
A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click on the ‘Insert existing templates’ icon). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7. 
 
Information expected in the justification:
 
  • You need to explain why you disagree on the data selected. Question 1 of template ‘c’ includes a list of elements that can be relevant to this explanation.
  • You need to describe what actions you had taken to try and add your data to the lead dossier and why it had not been possible to reach an agreement to add this data.
I want to opt-out for classification and labelling information. Do I need to provide a justification?

The opt-out justification requirement also applies when opting-out only for classification and labelling (C&L) information. A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided. This justification must be included in the 'Justification' field of the endpoint 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. For further information on how to provide a valid justification see Q&A 1722.

Before opting-out for C&L information, you should bear in mind that this information can be jointly submitted in the lead registration dossier even if it differs from the C&L of the other registrants in the joint submission. In this case, the lead registration dossier should have a separate C&L record in section 2.1 with a link to a relevant ‘boundary composition of the substance’ in section 1.2. If you decide to opt-out for the C&L information, you should therefore explain in your justification why an agreement to include the information in the lead registration dossier could not be reached. For further information on how to report the boundary composition you can consult the Q&As on Substance identity profile.

When opting-out of a joint submission, how can the endpoint summaries be added to the dossier?

Endpoint summaries are not considered as opt-out information but are still required if you are opting-out with endpoint information or are providing your own Chemical Safety Report.

When opting-out, some of the sections that are mandatory for a complete dossier are not automatically pre-selected for inclusion in the IUCLID dossier when you use the joint submission member template. Therefore, when creating your dossier endpoint summary records including section 6 ‘Ecotoxicological information’ and section 7 ‘Toxicological information’ must be selected manually. Guidance on how to include the endpoint summaries in the opt-out dossier can be found in the manual ‘How to prepare registration and PPORD dossiers’, section 9.2 How to include endpoint summaries in an opt-out dossier.

I want to justify opting-out due to a disagreement on the classification and labelling information. What information should I provide?
When opting-out classification and labelling data, a justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification a template (d) ‘Disagreement on the classification and labelling information’ is available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7.
 
Information expected in the justification:
 
  • The reason for the disagreement with the lead registrant on the classification and labelling information. See below some examples for the basis of your argumentation:
  • Quality (reliability, adequacy) of data used in deriving the classification
  • Difference in interpretation of data for classification
  • Difference in concentrations of constituents / impurities / additives influencing classification
  • Difference in (nano)forms of the substance influencing classification
  • An explanation of the differences in the classification and labelling information that you wish to submit separately compared to the jointly submitted information. For each different classification, provide a reference to the data underlying the classification. This reference may be to information submitted in your own dossier as a (robust) study summary, or alternatively, references to publicly available literature may be provided.
  • An explanation of the actions you have taken to include your classification and labelling in the Lead dossier and your reasoning as to why it was not possible to include this information.
Legal entity

A. Legal entity management

How do I update my company size in REACH-IT?

The company size can be updated in REACH-IT via the ‘Company size’ functionality from the main menu and selecting the ‘Update company size’ functionality. 

update company size

This will open a wizard that will guide you through the process of updating the company size. Read carefully the instructions and have the documentary evidence at hand to substantiate the companies involved in the ownership structure.

Note: By declaring that your company is an SME, you become eligible to an SME fee reduction. ECHA routinely verifies the SME status of legal entities who self-identify as SMEs. We recommend that you keep your company size information up-to-date in your REACH-IT account.

B. Legal entity change

What documentary evidence is considered adequate if a legal entity change involving a total "sale of assets" occurs? Does ECHA verify the adequacy of the submitted documentation?

The final decision on what documentation is considered adequate evidence of a ‘sale of assets’ is determined on a ‘case by case' basis in accordance with the relevant national principles of private and corporate law of the Member State where the entity is established. For this reason ECHA Practical Guide 8 – How to report changes in identity of legal entities limits itself to the general example of the asset sales agreement and does not provide further information in this regard.

The relevant documents should be presented to the national enforcement authorities upon request. Ultimately, the REACH duty holders bear responsibility for the submission of adequate documentary evidence. To ensure that it complies with the national legal order they may seek legal advice from in-house or private practice lawyers, for example.

More information on changes in identity of legal entities can be found in the aforementioned Practical Guide 8 – available at http://echa.europa.eu/practical-guides

What is the outcome of a legal entity change?

Transferred items (i.e. registrations/notifications)

If a registration/notification for a substance is transferred from the legal initiator to the legal successor, who already has a valid registration/notification for the same substance, the status of the transferred registration/notification will be marked ‘Annulled’, because a legal entity can only have one registration for the same substance.

Tonnage band update

For transferred registrations when the originating legal entity has registered the same substance as the legal successor and the tonnage of the originating legal entity is higher than the registered substance of the legal successor, the system will keep track of the legal successor's right to a higher tonnage band. The legal successor will need to submit a spontaneous update to indicate the higher tonnage band. No fee applies for this update.

Transfer of joint submission roles linked to Registrations

Where the initiating legal entity has submitted registrations as part of a joint submission, the joint submission role (e.g. Member or Lead registrant) are transferred together with the registrations to the legal successor. If no registrations were submitted, the roles are not transferred. The legal successor need to confirm their membership to the joint submission. 

Invoicing

The Agency will issue an invoice for the legal entity change pursuant to Commission Regulation (EC) No 340/2008 Article 5 (Fee regulation) if the item list contains one or more payable items.

  • Items that trigger a fee during a legal entity change are: Registrations, Registration of on-site isolated intermediate, Registration of transported isolated intermediate.
  • Items that do not trigger a fee during a legal entity change are: Pre-registrations, Product and Process Oriented Research and Development (PPORD) notifications, Classification and Labelling (C&L) notifications, Inquiry notifications.

Where an invoice is needed (i.e. the legal entity change includes at least one payable item), only one invoice will be issued per legal entity change. Invoices are issued to the legal successor. The company size of the legal successor after the change of legal personality will determine the fee. Pursuant to Commission Regulation (EC) No 340/2008 Annex III Table 3, a reduced fee will be invoiced to SMEs. After the invoice is paid in full, the transfer of items will take place and the legal entity change be completed in REACH-IT. If the invoice is not paid within the extended due date the legal entity change is deleted from the system and items will not be transferred. Information about the fee regulation can be found here.

For more information, see the guide How to report changes in identity under REACH and CLP.

How can I download the dossier that I acquired via a legal entity change?

When a legal entity change (LEC) takes place, a new submission number is created to keep track of the asset transfer. These submission numbers are assigned for administrative purposes and are not linked to a dossier.

To download the latest submitted dossier after a (LEC) follow these steps: 
 

1. Go to REACH-IT Menu >  select ‘Reference numbers’

request IUCLID file

 

2. Select the reference number linked to the dossier you wish to download

Reference number history

 

3. Scroll to the middle/bottom of the page, and open the tab ‘Reference number history’

 

4. Select the last successful submission number (initial submission or submission update in the Event column) that took place before the legal entity change.

 

5. Click on request IUCLID file

C. SME Verification

Do I need to take into account any linked or partner non-EEA companies, when determining the SME status?

Yes, according to Article 12 of the Fee Regulation (EC) No 340/2008 and the references therein to the definitions concerning micro, small and medium-sized enterprises as set out in the Annex to the European Commission Recommendation 2003/361/EC, both EEA and non-EEA companies are to be considered for the classification of partner and linked enterprises during the determination of the SME status of a company. Moreover, the non-EEA company is the very entity under consideration, in case when a submission is made by an Only Representative, as specified in Article 12 of the Fee Regulation.

What documents are needed in REACH-IT for SME fee reductions under REACH?

Under REACH, registrants and applicants can benefit from reduced fees established for micro, small and medium enterprises (SMEs).

Companies declare their SME size at the time of dossier submission, based on which ECHA issues an invoice. At a later stage, ECHA carries out an ex-post assessment, to verify the correctness of the company size. The SME verification process is important to ensure that only genuine SMEs benefit from the reduced fees and that correct fees are collected.

Before declaring the SME status in REACH-IT, companies should be familiar with the rules set by the Commission Recommendation 2003/361/EC on SME definition.

Companies should upload documentary evidence to their REACH-IT account to support SME status claims. This is only required for those submissions, which are related to SME fee reductions.

The documentary evidence should include:

  • Information about the ownership structure (upstream, downstream) at the time of the submission.
  • The financial statements (consolidated, if available) together with accompanying notes for the two latest accounting periods before the time of the submission.
  • Official certificate/information confirming the average number of employees for each of the two latest accounting periods before the time of submission.

The documents listed above shall be provided for all partner and linked enterprises, as defined by Article 3 of the aforementioned Commission Recommendation.

In case of Only Representatives, the assessment on whether the SME reduction applies is done by reference to the headcount, turnover and balance sheet information of the non-EU company represented and its linked and partner enterprises.

All documents uploaded to REACH-IT are treated confidentially by ECHA and used exclusively for size verification purposes. For transparency and traceability reasons, documents cannot be deleted. It is, however, possible to add supplementary documentation to your REACH-IT account at a later stage. The documentation is not assessed immediately, but only once the size verification process has been initiated.

The list of documentary evidence accepted by ECHA can be found in SME verification -page.

Instructions on how to upload documents and other useful information about REACH-IT can be found at Discover REACH-IT -guide.

More information on company’s size assessment and links to the relevant legislation can be found at SME fees under REACH and CLP -page

When do the documents submitted for SME verification require a certified translation?

If the original version of any document is not in one of the official languages of the European Union, a certified translation should be provided.

Legal basis for certified translations is Article 13(3) of the amended Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Please see it at: 

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:079:0007:0018:EN:PDF

A certified translation is the one which is accompanied by a signed statement that the translator is competent in the source and target languages (a sworn translator) and that the translation is an exact and accurate translation of the source document. The certified translator should have a certificate or a stamp that identifies the services provider and his qualification.

How does a cessation of manufacturing or import of substances affect the SME verification process?

The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. Ceasing to manufacture or import of substances have no consequence on that obligation.

If after registering a substance, you have decided to stop manufacturing or importing it, you should still pay the applicable registration fee in full in case ECHA found that you were not eligible for the claimed SME fee reductions. Once the registration fee is paid and, therefore, your registration can be considered complete, you can indicate in REACH-IT that you have ceased the production or import of a substance. If at a later stage you decide to restart manufacturing or importing it, you would only need to report it again in REACH-IT and the registration would still be valid. Otherwise, you would need to submit a new registration and pay a new registration fee.

In case the balance to the correct registration fee is not paid, such registration will be de-activated in ECHA’s database and the rejection of the registration will be communicated to you by a decision.

How does termination of the Only Representative (OR) contract with non-EU enterprise affect the SME verification process?

The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. The termination of the OR agreement has no consequence on that obligation.

Since your represented company benefited from reduced SME fee at the time of registration, therefore you, as the appointed OR at that time, are still liable to demonstrate the eligibility for the SME fee reduction obtained, once ECHA initiates the verification of your represented company size. The failure to provide complete documentation would result in ECHA finding your represented enterprise as non-eligible for the claimed SME fee reductions. In such case, the OR would be liable for the difference between the fee already paid and the correct registration fee, as well as the applicable administrative charge.

NONS-Registrants of Previously Notified Substances

Does a potential registrant have to register a substance he is manufacturing or importing if this substance has previously been notified under Directive 67/548/EEC by another manufacturer or importer and is, thus, regarded as registered under the REACH Regulation?

Yes, a notification under Directive 67/548/EEC as amended by Directive 92/32/EEC is nominal so that only the notifier benefits from the provision that notified substances are being considered registered. Therefore, any other parties manufacturing or importing the substance in quantities of more than one tonne per year who have not notified this substance, must register it unless another exemption from the duty to register applies. More information on notified substances can be found in Article 24 (2) of the REACH Regulation and in Section 2.2.4.3- 'Notified substances according to Directive 67/548/EEC' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

A company who notified a substance under Directive 67/548/EEC fails to claim its registration number for the notified substance. Is this substance still considered as registered? If this is the case and an inquiry is subsequently submitted for this substance by a potential registrant can this notifier be listed as the registrant?
In accordance with Article 24 of the REACH Regulation, ECHA assigns a registration number to each notification submitted under Directive 67/548/EEC and the substance is considered registered according to REACH. The owner of the notification needs to claim the registration number from ECHA via REACH-IT in order to have valid evidence of a registration for the previously notified substance.

If an inquiry for this substance is submitted to ECHA by a potential registrant, the contact details of the notifier are communicated to the potential registrant according to Article 26(3) of REACH. In this respect, claimed and non-claimed registration numbers are treated equally in REACH-IT.

A letter with contact details of the potential registrant will also be sent to the notifier. In the same letter ECHA will again remind the notifier to claim the registration number.
If I have already notified a substance under Directive 67/548/EEC, what do I have to do if I increase my tonnages?

Under REACH, substances notified in accordance with Directive 67/548/EEC (known as NONS: Notification of New Substances) are regarded as registered by the manufacturer, importer, or sole representative who submitted the notification. You, as owner of the notification, can claim a registration number from ECHA for the tonnage notified. For practical details please see the Questions and Answers on NONS:

http://echa.europa.eu/support/qas-support/qas.

If the quantity of the manufactured or imported substance which you have notified reaches the next tonnage threshold, (1, 10, 100 or 1000 tonnes/year), you need to update your registration without 'undue delay'. You do not need to stop your manufacturing/importing while your updated dossier is processed unless otherwise indicated by ECHA.

When updating your registration dossier you need to comply both with:

  • the information requirements of the new tonnage band; and
  • the information requirements from the lower tonnage bands.

For example, if you increase your tonnage to 10 tonnes/year or more, you need to submit the information required for 10 tonnes or more (Annex VIII), the chemical safety report; and also the information required for 1 tonnes or more (Annex VII).

In order to avoid unnecessary testing on vertebrate animals, you have to inform ECHA immediately of the additional information requirements for the new tonnage level by submitting an inquiry dossier. Upon receipt of this information, ECHA acts as in the inquiry process which is further described in the chapter 'Update of registration dossier for substances regarded as being registered under REACH' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach. ECHA should inform you of the names and addresses of the previous registrants and of any relevant study summaries already submitted by them in order to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated.

Does the phrase "classified as [...] in accordance with Directive 67/548/EEC" in Article 23(1)(a) and (b) of the REACH Regulation refer only to substances listed with a harmonized classification in Annex I of this directive?
The wording of Article 23(1)(a) and (b) of the REACH Regulation "classified as [...] in accordance with Directive 67/548/EEC" refers to both, substances listed in Annex I with their harmonised classification and to self-classified substances.
 
It may be inferred from Articles 4 and 6 of Directive 67/548/EEC that substances shall be classified (by manufacturers/importers) according to the criteria in Annex VI of that Directive. In addition, Annex I of that Directive contains the list of substances classified by the Commission, following discussions in expert groups. As the Directive covers both situations, substances should therefore be considered as classified in accordance with Directive 67/548 not only when listed with their harmonised classification in Annex I, but as soon as they meet the criteria for classification set out in Annex VI of that Directive, i.e. also when self-classified by the registrant, should the substance not (yet) be listed in Annex I. Both situations should be considered as "classification in accordance with Directive 67/548/EEC".
 
This interpretation is borne out by the very spirit of REACH and in particular the aim and objective of the deadlines provided for in Article 23 of REACH. The aim of the earlier deadline for registration of substances with properties of very high concern is to gather earlier the necessary information on the substances, on their uses and for industry to develop and recommend appropriate risk management measures. Given the specific health and/or environmental concerns in this case the objective was not to defer the application of the REACH provisions for further years. To this end, the aim of the legislature in setting the earlier registration deadlines was clearly to cover both cases, as there is no difference in the protected public interest. Substances with non-harmonized classification are equally a ground for the same concern as substances with harmonised classification.
 
A consequence of this interpretation is that, as from 1 December 2010, as soon as a manufacturer or importer obtains evidence that his substance fulfils the classification criteria set out in Art. 23(1)(a) or (b) of REACH after that date, he will be obliged to register that substance immediately.
How do I prepare IUCLID 6 dossier in case of a NONS update?

A distinction should be made between updates due to a tonnage band change, becoming a lead of a joint submission and other updates.

For a NONS registration update due to increase in the tonnage band or becoming a lead of a joint submission, a complete dossier in IUCLID 6 format has to be submitted to ECHA like for any other standard or transported isolated intermediate registration.

For other NONS updates, certain information is not required and may be waived until the next tonnage threshold is reached, provided that explanatory derogation statements are included in the dossier header.

In order to successfully update your registration dossier you should follow the steps outlined below:

  1. Migrate the SNIF file to IUCLID 5.6 and then import it to IUCLID 6 You can request your notification migrated into IUCLID format (IUCLID substance dataset) from your relevant Member State Competent Authority, or migrate it yourself using the SNIF migration plug-in tool available on the IUCLID web site http://iuclid.echa.europa.eu/.
  2. Update the substance dataset according to the REACH requirements. Please note that all registration updates undergo a technical completeness check according to the requirements of Article 20(2) of the REACH Regulation. You are advised to first check your tonnage band in REACH-IT, as described in Q&A 686.

    To be considered as complete, your dossier should be filled-in as specified below:
    • When updating a dossier due to an increase of tonnage band or becoming a lead of a joint submission, the registrant must be aware that the updated dossier must fully comply with all REACH information requirements. The update should not only contain the information required by REACH which corresponds to that higher tonnage threshold, but also any information which corresponds to lower tonnage thresholds. If your update involves a registration at or above the 10 tonnes threshold, a complete chemical safety report (CSR) should be included in section 13 of your IUCLID 6 dossier unless the conditions for not submitting a CSR as set out in Article 14(2) of the REACH Regulation are met (in which case a justification should be provided in section 13 instead).

      For further information please consult the manual "How to prepare registration and PPORD dossiers" at: http://echa.europa.eu/manuals.

    • For updates to include the classification and labelling according to the CLP Regulation. You have to update your registration dossier to include the classification and labelling according to Regulation (EC) No 1272/2008 (‘CLP Regulation') in case you manufacture or import your NONS substance in a volume of more than or equal to 1 tonne per year. For NONS notified below 1 tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Inventory will have to be made, and the registration dossier does not need to be updated.
    • If you only need to update the classification and labelling but your tonnage band remains unaltered, you only need to provide a minimum of information as explained in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.

    • For updates to the joint submission status of the claimant, select an appropriate dossier template for your submission.

      The lead of a joint submission uses a standard template accordingly to the tonnage band covered by the joint submission. The tonnage band of the lead registrant is indicated in the dossier header.

      Members of a joint submission need to select a special template for a joint submission member. Two different kinds of member templates exist: general registration and intermediate registration. Intermediate template is used if the member registers only an isolated intermediate (transported or on-site).

      When creating the dossier, the tick box ‘Joint submission' must be ticked in the dossier header. When submitting the dossier in REACH-IT, the submitter must select ‘joint submission:' and provide the name of the joint submission.

    • For other types of updates, Other updates concern all other cases indicated under Article 22(1) of the REACH Regulation and updates following a decision made by the MSCA according to Article 16(1) or 16(2) of Directive 67/548/EEC. For such updates, the dossier does not need to include information requested under the REACH Regulation that was not required under the previous legislation (i.e. Directive 67/548/EEC).. The minimum information which needs to be submitted in these types of updates (when the tonnage band remains unaltered) is provided in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.
    IMPORTANT NOTE:
    • In Section 1.3 ‘Identifiers' of your IUCLID 6 dossier, do not forget to specify your notification number under Directive 67/548/EEC, as well as your reference number under the REACH Regulation (the one you received when claiming your NONS via REACH-IT).
    • In Section 1.7 ‘Suppliers' of your IUCLID 6 dossier, do not forget to attach all necessary contractual agreements if you are representing a non-Community manufacturer.
  3. Update your confidentiality claims.

    In case you wish to keep confidential the information which was accepted as such under Directive 67/548/EEC, you are required to write in the justification field adjacent to each confidentiality flag the text ‘Claim previously made under Directive 67/548/EEC'. This will allow ECHA to invoice correctly and validate the claims already presented under Directive 67/548/EEC. confidentiality

    Please note that ECHA will only charge a fee for those confidentiality claims associated with new information submitted, or new confidentiality claims for existing information. This means that there will be no fee for confidentiality claims successfully made under Directive 67/548/EEC, provided that this is confirmed by the registrant in their dossier as indicated above.

    Please note that the information listed below could not be claimed confidential under Directive 67/548/EEC.

    • The name of the notifier (which under REACH is considered to be part of the information contained in the safety data sheet).
    • The information contained in the safety data sheet (including registration number, uses and uses advised against).
    • The trade name of the substance.
    • If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous.

    For these claims, a full justification needs to be provided and the claim will be subject to the corresponding fee under REACH.

    Please be aware that dissemination of information listed in Article 119(1) of the REACH Regulation includes the IUPAC names of substances included in Annex I to Directive 67/548/EEC and that, as a general rule, information listed both in Articles 119(1) and 119(2) of the REACH Regulation will be disseminated.

    ECHA will not disseminate the information listed in Article 119(2) for which a party has submitted a justification, accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned.

    More information about the confidentiality claims which are possible under REACH is available in the document "Dissemination and confidentiality under the REACH Regulation" at: http://echa.europa.eu/manuals.

    You are able to simulate which information from your dossier will be made available on the ECHA website by using the dissemination tool available in IULID 6

  4. Create the IUCLID registration dossier

    Once you have prepared your substance dataset, you need to create your registration dossier. To do this:

    • Choose the correct IUCLID Template. Make sure that the template selected corresponds with the intended submission Further information in "How to prepare registration and PPORD dossiers " manual available at http://echa.europa.eu/manuals.
    • Complete the dossier header information. For the specific case of NONS registration updates, you have to fill in the dossier header in IUCLID in the following way (see also screenshot below):
      • Tick the box "Is the submission an update?".
      • Indicate the submission number in the "Last submission number" field (the one you received when you claimed your registration number via REACH-IT) .
      • Tick the box "Spontaneous update".
      • Select the justification of the update. If there is more than one reason for your spontaneous update (e.g. change of tonnage band and change of classification and labelling), you should create several repeatable blocks under ‘Spontaneous update'.
      Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.

Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.

Other types of updates. In case of other types of spontaneous updates, you will have to select the proper justification. If you select ‘other', indicate clearly the reason for updating in the adjacent field.

For the specific case of an update according to Article 135 of the REACH Regulation (Transitional measures regarding notified substances), select ‘other' in the justification field and indicate the new information that you are updating in the free text field: "Article 135 of REACH – submission of test (specify test)".

Specific Submissions

Once you have created your IUCLID dossier, you need to submit it through REACH-IT. See Instructions in "How to prepare registration and PPORD dossiers" manual at: http://echa.europa.eu/manuals.

In the case that you are an Only Representative representing several non-Community companies under the REACH Regulation you need to submit a separate updated registration for each of the non-Community manufacturers you represent.

For a tonnage band increase (and only in this case). Before you submit your registration update you are required to inform ECHA of the additional information you would need to comply with the information requirements for the new tonnage level (Article 12(2) of the REACH regulation). In order to facilitate this process, you are required to submit an inquiry to ECHA. Upon receipt of this information, ECHA acts as in the inquiry process (Article 26(3) and (4) of the REACH Regulation) and will inform the registrant of the names and addresses of any previous registrants (and any potential registrants) and of any relevant study summaries already submitted by them. The purpose for this is to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated. The inquiry for a tonnage band increase should be submitted according to the procedures outlined in the manual "How to prepare and submit an inquiry" at: http://echa.europa.eu/manuals.

 

What information in a NONS dossier can be claimed confidential under REACH?

REACH has extended the scope/range of information for which a confidentiality claim can be made as compared to previous legislations. Additional data can, therefore, be claimed confidential under REACH which was not possible under NONS, such as:

  • The name of the notifier (which under REACH is considered to be part of the information contained in the safety data sheet)
  • The information contained in the safety data sheet (including registration number, uses and uses advised against).
  • The trade name of the substance.
  • If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous.

Further information can be found in the manual on Dissemination and Confidentiality under the REACH Regulation.

ECHA gives the same possibilities for claiming confidentiality to NONS notifiers as to other REACH registrants. Therefore, if your company considers that some information should not be published on the ECHA website, you can claim such information confidential. The confidentiality claims need to be properly justified and a fee for claiming this information confidential in accordance with article 119(2) will be issued.

Additional Question and Answers on NONS can be found here.

How do I claim a registration number for a notified substance?

According to Article 24 of the REACH Regulation all notified substances under Directive 67/548/EEC (NONS) are considered already registered under the REACH Regulation at the relevant tonnage band.

A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from his notified substance as being considered registered (Cf. Section 1.6.5.3 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation).

In principle, any other parties intending to manufacture or import a notified substance but who have not notified such substance themselves cannot be assigned a registration number under Article 24 of the REACH Regulation. Such parties should submit an inquiry and subsequently register the substance in accordance with the provisions of the REACH Regulation. The European Chemicals Agency (ECHA) has assigned registration numbers to all notifications made in accordance with Directive 67/548/EEC.

These registration numbers can be requested from ECHA by the owner of the notification via the REACH-IT system using the "Claim Notified Substances" module. This procedure will confirm to ECHA the identity of the notifier and to whom the registration number should be sent to. In addition, the REACH-IT database will be updated with the latest contact details of the notifiers, which will also enhance the data-sharing process.

If the claimant's details specified in REACH-IT match those for the notification, ECHA will provide the registration number. If the claimant's details do not match, ECHA will not be able to allocate any registration number and the notifier is advised to contact its relevant Member State Competent Authority (MSCA) to resolve this issue. Claimants need to sign-up in REACH-IT for each type of role they had under Directive 67/548/EEC for the notified substance in question.

There are four potential types of claimant (role) that may request a registration number for a notified substance:

  • The claimant was a Domestic Manufacturer under Directive 67/548/EEC (i.e. the Manufacturer was established within EU).
  • The claimant was an Importer under Directive 67/548/EEC.
  • The claimant was a Sole Representative under Directive 67/548/EEC.The claimant is a newly appointed Only Representative and will take the duties of a previous notifier (Sole Representative). Note that Only Representatives must sign up in REACH-IT for each non-community manufacturer they represent and submit a claim using the appropriate account.

    It is not possible to use the same legal entity object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). In case of a Sole Representative or newly appointed Only Representative, one registration number will be allocated per non-Community manufacturer represented. The claimant will have to submit, in REACH-IT, written evidence of the validity of his request. This provision is in line with the implementation already in place for an Only Representative in case of registration.

 

How do I request a registration number for my notified substance?

Once you have signed-up in REACH-IT and specified your company details, you can proceed with the request of your registration number. The distribution of registration numbers by ECHA will be made following your request via the "Claim Notified Substance" module in REACH-IT.

  • Log-in to REACH-IT >> Menu >> Registration >> Claim notified substance
  • Put the Notification number (standard format) without the 2 last digits corresponding to the version of the notification (you should specify XX-XX-XXXX in REACH-IT). And Put the ELINCS number of the notified substance and follow the wizard

If all the information specified is correct and matches with that in the notification dossier:

You will instantly receive a submission number, and a reference number via REACH-IT. You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.

If the information specified does not match with that in the notification, ECHA will not be able to allocate the registration number to you. You are advised to contact your relevant Member State Competent Authority to resolve the situation. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.

How many NONS registration numbers will I receive for my role(s)?

Depending on your role(s), you will usually only receive one registration number. The table below highlights the combinations of roles and indicates the corresponding number of requests and registration numbers received.

combination of roles

What must I do in case of change of legal entity and transfer of my NONS notification to another company?

A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from being considered registered according to Article 24 of the REACH Regulation. Cf. Section 1.6.5.3 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation

Nevertheless, it may happen that a company with a legal personality that has notified a substance has transferred the responsibilities for manufacture and import of that substance to another company. In such circumstances the original notifier may have transferred its notification to the company that has taken over the original notifier's activities relating to the manufacture or import of the notified substance. Such an event may happen for example after a merger of two companies or, the company splits.

For instruction on the steps to take please consult "Practical guide 8: How to report changes in identity of legal entities" available at: http://echa.europa.eu/practical-guides

How do I verify the information recorded in REACH-IT for my notification

In a handful of cases, the New Chemicals Database (NCD) has not been adequately updated to reflect the current details for some notifications, in particular, for tonnage bands. As a result, this information may appear incorrectly in REACH-IT and the system may be unable to correctly accept a potential update of the registration dossier.

It is extremely important and very easy to check that the tonnage band of your notification is correctly indicated in REACH-IT before you submit any update of your registration dossier to ECHA to avoid potential delays in the submission process as a result of a business rules failure.

To confirm that the correct tonnage is indicated in REACH-IT:

  • Log in to REACH-IT >> Menu >> Search>>Reference numbers >> Search reference number using the criteria displayed Click on the Reference number link >> Tonnage band info is displayed under "Dossier type".

There are several tonnage bands mentioned in REACH-IT because under the REACH Regulation there are three possible registration types: standard registration, transported isolated intermediate (TII), and on-site isolated intermediate (OSII). Under Directive 67/548/EEC there was no such specific distinction and only one type of standard notification was required. All NONS notifications are initially regarded as standard registrations in REACH-IT. Therefore, your notified substance will initially not include any tonnage for isolated intermediates.

In the ‘Reference number' page you will also find under "Payment information" the tonnage band information which will be taken into account for invoicing purposes ( i.e. "Maximum tonnage band" and "Maximum transported isolated intermediate")

Paymrnt Information

Initially, here you will see the same tonnage bands indicated for the standard registration as for the transported isolated intermediate (TII). This is to ensure that ECHA does not charge fees for tonnage band updates in cases where this would not be legitimate.

In case you submit an update of your registration for a tonnage band that is different to what is reported in REACH-IT, you should select in your dossier header that the reason for the update is a change of tonnage band.

Who do I contact if the information in REACH-IT is not correct?

In case the information recorded in REACH-IT for your substance does not match with what was indicated in your notification, you will need to make a request for an amendment. This is achieved by contacting your relevant Member State Competent Authority, who will in turn confirm that an amendment is necessary and provide ECHA with the correct details.

You can find the contact details of all the Member State Competent Authorities at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities

How is the NONS information transferred from SNIF to IUCLID 5

Information for a notification under Directive 67/548/EEC was initially submitted to the Member State Competent Authority in the Summary Notification Interchange Format (SNIF). Thereafter, all the SNIF files were transmitted to the former European Chemicals Bureau (ex-ECB) at the Joint Research Centre. This information, stored in a central database called the new chemicals database (NCD) at the ex-ECB, was migrated into IUCLID 5 format and distributed back to the responsible Member State Competent Authority in 2 formats (read-only and editable).

Claimants (owners of the notification) should contact their Member State Competent Authority to receive their files in IUCLID 5 format. The editable format will enable them to fulfil their obligations under REACH, in particular when they need to update their registration in the case where the next tonnage threshold is reached.

The tool developed to migrate the SNIF file to IUCLID 5 format is also available to industry as an add-on to IUCLID 5 on the IUCLID web site http://iuclid.echa.europa.eu/. Please note though, the SNIF migration plug-in can only be used with IUCLID version 5.1.

In order to migrate to IUCLID 6, first migrate to IUCLID 5.1 and then import to 5.6 and after import to ICUID 6.

Please pay attention to the migrated file results and check the generated IUCLID 5 substance dataset carefully (e.g. Legal entity, confidentiality claims, endpoint study records, classification and labelling…) before using it for updating your registration via REACH-IT.

In which cases shall I update my NONS registration?

The registration dossier must be updated if at least one of the cases described in Article 22 or Article 24(2) of the REACH Regulation applies. This would also include any update referring to the inclusion of the information required under Article 40 of the CLP Regulation (notification to the Classification & Labelling Inventory).

It is important to verify the information available for your notification in REACH-IT before you start the dossier update. When updating a NONS registration, the following three scenarios have to be taken into account:

  • Tonnage band update
  • Update to become the lead or a member of a joint submission
  • Other updates

For more details please continue to Annex 4 of the "How to prepare registration and PPORD dossier" manual at: http://echa.europa.eu/manuals/.

What will happen after I submit my NONS dossier?

Your dossier will undergo a series of initial administrative checks called "business rules". A dossier is accepted for processing by ECHA only if all of the relevant business rules are satisfied. Once your dossier has been accepted for processing:

  • Your dossier will be allocated a submission number.
  • Your dossier will undergo a completeness check.
  • You will receive an invoice, if applicable, for an appropriate fee (for tonnage band upgrades and chargeable confidentiality claims not made under Directive 67/548/EEC).
  • Your dossier will be regarded as complete once ECHA has verified the completeness of the information you submitted and received the payment of the relevant fee in accordance with Article 20(2) of the REACH Regulation.
In the case of an update of a registration in accordance with Article 135 of the REACH Regulation, the submitted information will be evaluated by ECHA pursuant to Article 42 or by the requesting MSCA pursuant to Article 48, depending on the legal basis of the original request of the MSCA under Directive 67/548/EEC.

Will ECHA publish information from my NONS dossier on the website?

Yes. REACH requires that certain information on chemical substances, which is kept in ECHA's databases, is made available to the public, free of charge, over the internet. This concerns, in particular, information specified in Article 119 of REACH. ECHA is already providing public access via the internet to such information from registration dossiers on its website at:http://echa.europa.eu/information-on-chemicals/registered-substances.

Information from NONS notifications will be released in a stepwise approach in order to allow NONS registrants to adapt the content of their dossiers to the REACH format, and insert adequate confidentiality claims if required. NONS registrants who have claimed their notification are being individually informed of the timelines for publication and the actions they need to take in relation to their dossier via a message in REACH-IT.

Please refer to chapter 2.5 of "Dissemination and confidentiality under the REACH Regulation" manual at: http://echa.europa.eu/manuals.

I notified as a Sole Representative under Directive 67/548/EEC and I will take up the duties of the Only Representative under REACH, what are the next steps?

Any Sole Representative agreements are invalid after 31st May 2008. Where the intention is to appoint an Only Representative under REACH, new documentation/contract from the non-Community manufacturer(s) you represent needs to be drawn up.

The company claiming the registration number must indicate in REACH-IT that he/she is entitled to act as the Only Representative.

Please note that Only Representatives have to sign-up in REACH-IT for each and every non-Community manufacturer they represent for the same notification and submit a claim for NONS using the appropriate accounts.

Once you have indicated the notification specifics in the ‘Claim notification module' follow the wizard and:

  • Declare that you have the agreement and the consent of the non-Community manufacturer to become the Only Representative under the REACH Regulation and that you are entitled to claim the registration number (tick the relevant box).
  • Specify the non-Community manufacturer that you will represent as Only Representative for the notified substance.
  • Attach the following documentation from the non-Community manufacturer you represent:
  • Individual letter(s)/contract(s) from the non-Community manufacturer declaring that you are entitled to become their Only Representative under the REACH Regulation for the notified substance. The letter(s) should be in PDF format and written in one of the official Community languages.

 

If all the information specified is correct and matches with that in the notification:

You will instantly receive a submission number, and a reference number for the non-Community manufacturer you represent via REACH-IT.

You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities .

If the information specified does not match with that in the notification, ECHA will not be able to allocate any registration number to you.

You are advised to contact your relevant Member State Competent Authority to resolve the situation (http://echa.europa.eu/contacts-of-the-member-state-competent-authorities).

I notified as a Sole Representative AND as a Domestic Manufacturer AND/OR Importer under Directive 67/548/EEC, what are the next steps?

Once you have indicated the notification specifics in the ‘Claim notification module':

You must first sign-up in REACH-IT for each type of claimant you are (role) for the notified substance in question under Directive 67/548/EEC and submit a claim for NONS using the appropriate REACH-IT account.

In addition, as a former Sole Representative you have to sign-up in REACH-IT for each non-Community manufacturer you represent and submit a claim for NONS using the appropriate accounts.

You should then first request your registration number as a domestic Manufacturer AND/OR Importer (see Q&A 683).

Then you should request your registration number as a Sole Representative (see the process described before).

Nanoforms of substances

A. Registration obligations

I am manufacturing both non-nanoforms and nanoforms of a substance. What determines the tonnage band for registration and for the hazard data?

The REACH Regulation states that the tonnage band is calculated per registrant per substance, including non-nanoforms and nanoforms. Thus, the registration obligation depends on the total yearly tonnage of the substance that you manufacture or import, including both non-nanoforms and nanoforms. If the overall volume of the substance is above 1 tonne per year, nanoforms within that total volume also need to be registered, even if they represent a volume of less than 1 tonne per year.

Similarly, the overall quantity of the substance, cumulating the quantity of both non-nanoforms and nanoforms, determines the applicable information requirements. The information requirements of the total volume apply to the non-nanoform and each of the nanoforms of the substance, even if their individual volumes represent a lower tonnage band.

For more information see the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification, section 2.1 Registration obligations.

Do I need to register nanoforms which are manufactured as dispersions?
Yes, nanoforms manufactured as a dispersion must be registered.
Is it possible that a polymer is a nanoform? Does it remain exempt from registration?

Yes, a polymer can also meet the definition of a nanoform.

The obligation to submit information on nanoforms as set out in REACH Annexes VI to X only applies to substances subject to registration. Polymers are exempt from registration. Nevertheless, any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain, if the conditions set out in Article 6(3) of REACH are met.

For specific cases we recommend contacting our helpdesk for a more detailed reply.

If a nanoform is introduced into a polymer during the polymerisation phase, do we have to register it, knowing that the nanoform is present in the final polymer without emission?

Before being introduced into the polymer during the polymerisation phase, the nanoform has to be manufactured or imported. If you manufacture or import in a quantity above 1 tonne per year the substance of which nanoform is introduced in the polymer, you must register the nanoform, even if it is then used in the manufacturing of a polymer.

However, if you buy a nanoform from a supplier in the EU, you do not have to register it, but the manufacturer or importer in the supply chain must do so. In the latter case, you have to ensure that your use of the nanoform is covered by the registration of the manufacturer/importer. 

Finally, if you import the polymer you must submit a registration for the nanoform if it has not already been registered by an actor up the supply chain and if the conditions set out in Article 6(3) of REACH are met (see Q&A 1674).

If we act as downstream users of nanomaterials, e.g. making formulations, lacquers etc., do we also have to register the used nanomaterials?
If you buy a nanoform in the EU and use it without modification, you do not have to register it. However, the manufacturer or importer in your supply chain must have registered it. As a downstream user, you must ensure that your use of the nanoform is covered by its registration or prepare a chemical safety report yourself.
B. Definition of nanoforms

What is the impact of the revision of the European Commission’s nanomaterial definition on the definition of nanoform under REACH?
The revision of the European Commission’s nanomaterials definition does not impact the current definition of a nanoform used in REACH. REACH Annex VI contains a definition for a nanoform and this definition must be applied to determine the requirements applicable under REACH.
What is understood as batch-to-batch variability when a nanoform is defined?

A batch-to-batch variability results from the variation of process parameters inherent to a manufacturing process that is defined by a series of parameters (e.g. starting materials, solvents, temperature, order of manufacturing steps, etc.).

If the variation in a parameter is only due to batch-to-batch variability, then these are still considered as being the same nanoform. However, if there are deliberate changes to the process parameters, then these are different nanoforms.

Can two nanoforms with very similar characterisers but from two different manufacturing processes be reported as one nanoform?
No. Only variations in nanoform characterisers arising from batch-to-batch variability are allowed for a particular nanoform (Q&A 1678).  However, as different manufacturing processes may result in nanoforms with almost identical characterisers, these different nanoforms can be registered as part of a set of similar nanoforms, provided that explicit conditions are meet:
 
  1. The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set
  2. The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly. This justification is substantiated by supporting data on the nanoforms in the set.
For more details, see Q&A 1681.
C. Characterisation of nanoforms

If X-ray diffraction didn't provide sufficient information to determine crystalline structure, which analytical assessment are we required to perform?
Registrants are free to choose the analytical techniques as long as the data requirement is fulfilled. For questions concerning a specific nanoform, please submit the question using our contact form.
D. Sets of similar nanoforms

How can a registrant justify a set of nanoforms?
A set of nanoforms must be based on a justification demonstrating that the hazard assessment, exposure assessment and risk assessment of the nanoforms in the set can be performed jointly. The justification must apply generically to all the applicable information requirements, including the new nanoform-specific endpoints like Annex VII point 7.14 bis Dustiness. The justification must always be substantiated by supporting data.
 
More specifically, the justification must fulfil the conditions below:
 
  1. The justification must address separately each characteriser listed in section 2.4 of Annex VI. To this end, it must follow the structure of the text template available in the IUCLID section 1.2 field 'Justification for reporting set of similar nanoforms' and address all applicable points in it.
  2. The justification must be substantiated by scientific evidence addressing the physicochemical, environmental fate, ecotoxicity and toxicity properties of nanoforms that are within the boundaries of the set of nanoforms. For each characteriser, the justification must summarise the supporting data.  
  3. Each scientific evidence summarised in the justification must be submitted in the form of a (robust) study summary
    • The  (robust) study summary can be provided by attaching it in the section 1.2 field ‘Attached information’;
    • A reference to a (robust) study summary can also be made by linking the corresponding record in the IUCLID dossier via the section 1.2 field ‘Cross-reference’; 
    • Alternatively, references to publicly available literature may be provided instead of a robust study summary.
     
    In all the above cases, the findings from these studies and the characterisers of the nanoforms used in the studies must be summarised in accordance with the points listed. 
  4. For each characteriser, the justification must explain how the scientific evidence demonstrates that all the nanoforms in the set can be assessed jointly. This explanation must include a demonstration that the nanoforms used to generate the supporting data are representative of all the nanoforms included in the boundaries of the set.
  5. The justification must always be provided in full in the field 'Justification for reporting set of similar nanoforms' or in the field ‘Attached information’. The justification cannot refer to explanations provided elsewhere in the dossier.
The justification provided in the field 'Justification for reporting set of similar nanoforms' and ‘Attached information’ is manually verified by ECHA staff during completeness check.
What is the impact for an already registered set of nanoforms if one or several nanoforms are added in the registration of the substance?

If the registration will be updated to cover additional nanoforms, the decision needs to be made whether the nanoforms will be registered (i) on their own as separate nanoforms; (ii) as a new set of nanoforms; or (iii) by modifying the already registered set of nanoforms. 

If the nanoforms are added to the registration as separate nanoforms or as a new set of nanoforms, they will not impact the already registered set of nanoforms. Similarly as for the existing set, they need to be registered by including in the dossier the appropriate characterisation of the set, the set justification and the Annex VII-X information corresponding to the set.

If the nanoforms are added to the registration in an existing set of nanoforms, you need to ensure that the nanoforms fit within the clearly defined boundaries of characterisers of the existing set. If this is not the case, you need to analyse whether the boundaries of the set can be expanded without affecting the joint hazard assessment, exposure assessment and risk assessment of all the nanoforms covered by the set. This analysis must be reflected in the provided justification for the set.

Can I include nanoforms within one set of nanoforms, which contradict the limitations set out in Guidance, if I can justify that the hazard, exposure and risk assessment of the nanoforms in the set can be performed jointly?

The principles described in the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification for forming a set of nanoforms give advice to the registrants on how to build a set of nanoforms. Following the principles in the Guidance reduces the need for development of complex justifications for the set. 

The limitations for the formation of sets of nanoforms are based on presumptions resulting from a scientific consensus. The stronger the consensus, the stricter the limitation. For the strictest restrictions (e.g. fibres and sphere shapes must be addressed in different sets of nanoforms), the scientific consensus is such that the presumption is considered not rebuttable.   

For other restrictions, deviating from the principles set in the Guidance will increase the complexity of a justification as well as the supporting evidence required, and this will increase the level of scrutiny given to the justification. 

In any case, for each set of nanoforms a robust justification that the hazard, exposure and risk assessment can be performed jointly for all nanoforms in the set must always be provided. It is the responsibility of a registrant to develop the justification and provide the data supporting the justification.

The completeness of the justification is checked during the technical completeness check and its compliance in a potential compliance check.

How can I justify a set of nanoforms if I do not have data? Do I need to generate the data on the Annex VII-X properties for each of the nanoforms in the set?

In order to create a set of nanoforms, you need to clearly define the boundaries of your set of nanoforms, and provide a justification to demonstrate that the hazard assessment, exposure assessment and risk assessment of the nanoforms in the set can be performed jointly for all nanoforms included in the set, without exceptions. This demonstration may require you to test some of these nanoforms. Indeed, this justification must be substantiated by scientific evidence addressing the physicochemical, environmental fate, ecotoxicity and toxicity properties of nanoforms that are within the boundaries of the set of nanoforms. Each scientific evidence summarised in the justification should correspond to a (robust) study summary. For further information on how to justify a set of nanoforms, refer to Q&A 1681.

Once a set of nanoforms has been established and scientifically justified, the complete Annex VII-X information must be provided for the set of nanoforms. It is not necessary to generate data on the Annex VII-X properties for each nanoform included in the set. Indeed, as mentioned above, the justification for the set of nanoform must prove that the hazard, exposure and risk assessments of the nanoforms can be performed jointly for all nanoforms in the set. However, the data provided for each information requirement must be representative for the whole set of nanoforms.

For every information requirement as per Annex VII-X, the registrant must submit either (i) studies performed on the nanoforms concerned; or (ii) studies on other forms of the substance accompanied by endpoint-specific justifications as to why this information is adequate for assessing the nanoforms concerned; or (iii) relevant adaptations as foreseen by Annex XI of REACH or Column 2 of the relevant Annex VII-X.

As explained in chapter G. Joint submission, the Annex VII-X information can be submitted by the lead registrant on behalf of the other assenting registrants, or separately by co-registrants via the opt-out mechanism.

E. Particle size distribution

What is the definition of a constituent particle and what is the difference between constituent and primary particle?
Please refer to the Joint Research Centre’s (JRC) report An overview of concepts and terms used in the European Commission's definition of nanomaterial, Section 2.7.
Which method should be used for measurement of particle size distribution?

The legal requirement under Annex VI of REACH is to report the number-based particle size distribution with indication of the number fraction of constituent particles in the size range within 1-100 nm. You are free to choose the measurement method as long as the data requirement is fulfilled. We recommend using at least one electron microscopy technique.

If laser diffraction can provide that information, it can be used. In many cases, this may not be the case. All the measured particles must be taken into consideration when the number fraction of constituent particles is determined.

F. Reporting and submission

Do I need to report each nanoform separately?
In principle, each nanoform has to be reported separately. However, REACH allows reporting of a set of similar nanoforms when two conditions are fulfilled:
 
  1. The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set;
  2. The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly. The justification must be supported by data on the nanoforms in the set. For more information on the set justification, refer to Q&A 1681.
Can I register a nanoform and pass the completeness check if I lack some of the information requirements due to ongoing measurements that have been commissioned with test labs but that are not yet concluded?

The completeness check ensures that all the required information is reported in the dossier. Therefore, you cannot pass the completeness check by providing placeholders for missing information, even if the tests have been commissioned. If you cannot address the information requirement with available data or an adaptation (or, in the case of Annex IX-X information requirements, with a testing proposal), you will not pass the completeness check for this information requirement. 

If you fail the completeness check, you will be given a standard deadline of four months to provide the missing/incomplete information. Therefore, if you fail the completeness check at first attempt and in the meantime obtain the test results, you can amend the dossier and pass the completeness check at second attempt. The submission date will correspond to the submission of your first attempt. 

For advice on how to report unfinished tests that were commissioned in response to an ECHA (draft) requesting you to carry out a test, please refer to the document Information on manual verification at completeness check, chapter 2.

G. Joint Submission

How to handle joint submission of different different nanoforms of the substance?
Each registrant is responsible for registering the nanoforms that they themselves manufacture or import. Therefore, each registrant has the obligation to characterise the nanoforms (either individually or through sets of nanoforms) they manufacture/import and to ensure that a specific hazard data set is provided for each nanoform or set of nanoforms. 
 
The information required by Annex VI, including the characterisation of nanoforms, must always be submitted separately by each registrant in their IUCLID dossier. 
 
It is up to each co-registrant to identify their own nanoform(s). It is then up to the co-registrants in the joint submission to decide whether to submit the hazard data (i.e. information requirements of Annexes VII to X) on the nanoforms of the substance jointly or separately. 
 
By derogation to the obligation to provide hazard data on each single nanoform, co-registrants can identify sets of nanoforms with clearly defined boundaries if they can justify that the hazard, exposure and risk assessments can be performed jointly for the nanoforms included in the set. In this case, one set of hazard data can be submitted for all nanoforms within the set.
 
Therefore, first, registrants must decide how they want to cover the nanoforms they manufacture or import, either as single nanoforms or in a set of nanoforms (subject to the conditions described above) or both. 
 
Second, registrants must decide whether their nanoforms will be covered by the hazard information jointly submitted. In that case, they need to agree on the data to be jointly submitted. The data jointly submitted can concern single nanoforms or set(s) of nanoforms.
 
  • If the information is jointly submitted, the co-registrant only has to identify his nanoform(s) under Annex VI, but he does not have to submit himself the hazard data that cover his nanoform(s). Instead, the co-registrant must link in his registration dossier his nanoform(s) to the corresponding hazard data submitted in the lead dossier. To this end, the co-registrant must refer to a boundary composition record of the lead dossier in the field ‘Reference to related composition(s)’ of each section 1.2 legal entity composition record. This boundary composition must be relevant to the co-registrant’s nanoform or set of nanoforms, and must be linked to the Annex VII-X information submitted to cover the information requirements for it. 
  • Note that if the jointly submitted information concerns a set of nanoforms, the co-registrant must ensure that his own nanoform(s) fall within the characterisers reported for a boundary composition for a set of nanoforms in the lead dossier, and that the justification provided for the set of nanoforms in this same boundary composition covers his nanoforms.
  • If the information is submitted separately by the co-registrant, he must ensure that a specific hazard data set is provided for his nanoform(s) via an opt-out, as foreseen in Article 11(3) of REACH. In this second case, the co-registrant must submit all the hazard data required for his nanoforms in sections 4-7 of IUCLID.
Do we need to update the member dossier after the lead dossier has passed the completeness check to include a link to the boundary composition(s) in the lead dossier that are relevant to our nanoforms?

If you have submitted your member dossier but rely on the lead dossier for Annex VII-X information for your nanoform of the substance, ECHA could not verify the completeness of this data. Therefore, ECHA reserves the right to assess the completeness of your dossier in relation to the information on the Annex VII-X requirements, whenever this information is submitted by the lead registrant. 

Once the lead registrant has submitted their dossier, you must update your registration to link your nanoforms with the relevant Annex VII-X information in the lead dossier. This is done by referring to the corresponding boundary composition name(s) of the lead dossier, in the section 1.2 Legal entity compositions of your own dossier by using the field ‘Reference to related composition(s)’.

Do we need to set up a read-across approach in our member dossier for the nanoform of the substance for the endpoints where we rely on the studies on the non-nanoform submitted by the lead?

Yes. Due to the differences between non-nanoforms and nanoforms you need to demonstrate for each endpoint and each nanoform why the information generated on the non-nanoform of the substance  is adequate for assessing the nanoform, i.e. that the prediction from the non-nanoform to each nanoform is reliable and accurate, and does not underestimate the hazard. 

To report the read-across in your dossier, follow the advice given in the manual “How to prepare registration and PPORD dossiers”, chapter 9.6.3 ‘How to report read-across in IUCLID'.

H. Annex VII-XI Information requirements

Do we need to report dustiness when the product/nanoform is manufactured as well as supplied in a water dispersion only?
According to column 2, Annex VII, 7.14.bis the study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.
Do you have any recommendation on the method to measure dustiness?
The CEN standard EN 17199-1:2019 “Workplace exposure - Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles - Part 1: Requirements and choice of test methods” gives advice on the methodology and provides guidance to choose the most adequate test method. It is recommended to choose the methods more relevant to simulate the operations/tasks expected to be performed.
How to deal with data which have been generated using guidelines not revisited by either JRC or the Malta project?
Similar to non-nanoforms of a substance, ECHA will assess on a case by case basis the information provided in the endpoint study record (e.g. material and methods, characterisation of test material, raw results, conclusion) to establish the relevance and reliability of the provided information.
Only Representative of non-EU manufacturer

Who can appoint an only representative?
According to Article 8(1) of REACH, a natural or legal person established outside of the EU who manufactures substances (to be used on their own, in mixtures and/or to produce articles), formulates mixtures or produces articles, can nominate an only representative located within the EU to carry out the required registration of their substances that are imported (as such, in mixtures and/or in articles) into the EU. Distributors are not mentioned in Article 8(1) of REACH and thus cannot appoint an only representative.
The reference to the EU covers both the EU countries and the EFTA countries that have adhered to the EEA (European Economic Area) Agreement, that is Iceland, Liechtenstein and Norway.
The only representative will have to fulfil the registration obligations of importers (Title II of REACH) and comply with all other obligations of importers under the REACH Regulation. More information on the only representative role is provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach
Who can be appointed as an only representative?

A non-EEA company (that can appoint an only representative, see FAQ ID=15) may, by mutual agreement, appoint a natural or legal person established in the European Economic Area (EEA) to act as his only representative. According to Article 8(2) of REACH this representative shall comply with all obligations of importers under REACH. Therefore the only representative is required to have sufficient background in the practical handling of substances and the information related to them. More information on the only representative is also provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

What is meant by the "sufficient background" of an only representative?
There are no detailed requirements or criteria regarding what is regarded as "sufficient background in the practical handling of substances and the information related to them" other than what is laid down in Article 8(2) of REACH.
Is there a special procedure to appoint an only representative?
The issue of becoming an only representative is a question of mutual agreement between the "non-EU manufacturer" and the natural or legal person established in the EU who is being appointed as an only representative.
"Non-EU manufacturers" need to send a letter confirming this appointment to their only representative who must have it available in case of inspection by the relevant Member State's enforcement authority. No such letter has to be sent to ECHA. However, when compiling the registration dossier in IUCLID 5 the only representative is advised to attach this letter of appointment to the registration dossier in the field "Official assignment from non EU manufacturer" in section 1.7. More information on the duties of the only representative is provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition the "non-EU manufacturer" shall inform the importer(s) within the same supply chain of the appointment of the only representative according to Article 8(3) of the REACH Regulation. These importers shall be regarded as downstream users.
Can an only representative represent more than one company?

Yes, an only representative can represent one or several non-EU companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance.

If an OR is appointed by several non-EU companies, then the OR needs to create several OR accounts in REACH-IT, one for each non-EU company they represent. There should be a 1-to-1 correspondence between an OR account in REACH-IT and the non-EU company they represent. If the same legal entity covers the role of a manufacturer/importer and the role of an OR, then they will need to create two different accounts in REACH-IT: one account for their role as manufacturer/importer and another account for their role as OR.

More information on the duties of the only representative is provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration.
How can "non-EU manufacturers" help their only representative or importers to prepare for registration?
The importer or the only representative is responsible for submitting a registration dossier or a pre-registration to take advantage from the extended registration deadlines for phase-in substances. In order to assist these actors under REACH, the "non-EU manufacturer" may wish to make himself aware of the information requirements laid down in REACH and start to collect the relevant information. This may include correct identification (CAS or EINECS/ELINCS/NLP) number and naming of the substance and information on its composition. This is explained in more detail in the Guidance for identification and naming of substances under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach.
The "non-EU manufacturer" may also assist in providing all available information regarding the intrinsic properties of the substances (see Annex VII to XI of REACH). However, these supporting measures of the "non-EU manufacturer" cannot relieve the only representative or the importer from the duty to comply with all relevant obligations of the REACH Regulation.
More information for "non-EU manufacturers" can be found at: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries
As an only representative, do I need to specify in the registration dossier the identity of the "non-EU manufacturer" I am representing?
An only representative must be able to document who he is representing (i.e. the name of the non-EU manufacture should be given in section 1.7 of IUCLID) and is advised to attach a document from the "non-EU manufacturer" appointing him as only representative in section 1.7 of IUCLID. It is not mandatory to include this information in the registration dossier, but it needs to be presented to the enforcement authorities upon request. Furthermore an only representative is advised to include the "list of importers" in section 1.7 in IUCLID.
Have registered a substance as an only representative of a non-EU manufacturer. Does a change of the importers of the non-EU manufacturer trigger the need for an update of the registration, and would this update be subject to a fee?
The change of importers of a substance supplied by a non-EU manufacturer who appointed an only representative to register this substance does not trigger the requirement to update the list of importers indicated in section 1.7 of the IUCLID 5 dossier. However, the only representative is required, in accordance with Article 8 (2) of REACH, to keep available and up-to-date information on quantities imported and customers sold to.
Information on the importers may be reported in section 1.7 of IUCLID 5. Practical information on how to do this is provided in the Data Submission Manual 5, section 4.1.7: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals
The update of this list of importers is not subject to any fee.
What are the obligations of polymer importers (or ORs appointed by non-EU polymer manufacturers), if an OR has already been appointed by the non-EU monomer producer up the non-EU supply chain, but this OR does not want to take on the legal responsibility envisaged in Article 8 of REACH for the polymer importers?
In the case of polymer imports, the condition "have already been registered up the supply chain" in Article 6(3) REACH can only be fulfilled if an OR appointed up the non-EU supply chain (e.g. the OR of the non-EU monomer manufacturer) has decided to also cover the polymer imports with their registration (i.e. included the volumes concerned in their registration and took over the obligations in Article 8(2) and 8(3) of REACH). If the OR of the non-EU monomer manufacturer decides not to take legal responsibility for these volumes, the polymer importer cannot rely on the exemption from registration and is obliged to register the volumes of monomer they import. Alternatively, an OR appointed by the non-EU polymer manufacturer could register on behalf of the polymer importers.
If ORs have been appointed to fulfil the registration obligations of non-EU manufacturers but not their authorisation obligations, can the EU importer instead apply for authorisation? If so, under which role (importer or downstream user (DU))?

EU importers of a non-EU manufacturer can apply for an authorisation irrespective of whether they are covered by an OR for registration of the Annex XIV substance. If the appointment of the OR does not extend to also cover the fulfilment of the obligations of the importers with regard to authorisation, then the importers themselves can apply for an authorisation. In such a case, the importers will apply in their role as importers of an Annex XIV substance. Furthermore, the importers are not required to indicate the name of the non-EU manufacturer or the OR in their application for authorisation sent to ECHA, since the OR's appointment and their respective obligations are limited to the registration of the Annex XIV substance.

I represent a manufacturer based outside the EU. The company will be absorbed by another non-EU company. As an only representative, do I have to notify ECHA about this change?

Yes, you need to notify ECHA about this change. You represent the non-EU manufacturer and, therefore, you need to communicate changes in their legal personality. You can notify ECHA using the legal entity change functionality in REACH-IT.

To change the legal personality in this case you need to:

  • Create a new account in REACH-IT for your company to represent the new legal entity, reflecting their size. Note that in the "Company Size" information, you must indicate the size of the non-EU/EEA manufacturer you are representing and not the size of your own legal entity.
  • Initiate a legal entity change (only representative changes)
  • Include documents which clearly explain how you represent the new non-EU manufacturer
  • Update the IUCLID files, in particular section 1.7 ‘Only Representative information'
  • Submit a spontaneous update in the new legal entity to report the change in the dossier

You may need to pay a fee to complete the process. More information related to the outcome of a legal entity change can be found at Q&A 388.

What are my duties as an only representative?

As an only representative, you are fully responsible and liable for fulfilling all obligations of importers for the substances you are responsible for. These do not only pertain to registration but also to all other obligations of importers under REACH. As an only representative, you need to register the imported quantities depending on the contractual arrangements with the ‘non-EU manufacturer'.

You can represent one or several ‘non-EU manufacturers'. If you act on behalf of several ‘non-EU manufacturers', you must submit a separate registration for each of these manufacturers.

Your registration dossier should contain all uses of the importers covered by the registration. You need to keep an up-to-date list of importers within the same supply chain of the ‘non-EU manufacturer' and the tonnage covered for each of them, as well as information on the supply of the latest update of the safety data sheet.

For further information see chapter 2.1.2.5 "Only representative of a non-EU manufacturer" in the Guidance on registration:

Polymers and monomers

Do I have to register polymers?
According to Article 2(9) of REACH polymers do not have to be registered, but according to Article 6(3) of REACH, the monomer substance(s) and other substances of the polymers that have not already been registered by an actor up the supply chain, are to be registered if both the following conditions are met:
- the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) (i.e. free or unbound monomers shall not be considered when checking this condition);
 
- the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up in the final polymer unbound or chemically bound to the polymer)
 
The REACH Regulation defines polymers in Article 3(5) and monomers in Article 3(6) of REACH.
 
The European Commission may according to Article 138(2) of the REACH Regulation present legislative proposals with requirements for the registration of polymers once a practicable and cost-effective way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established.
 
Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Can I register monomers as intermediates in accordance with Article 17(2) or 18(2) of the REACH Regulation?
According to Article 6 (2) of REACH, the reduced registration provisions with regard to on-site isolated and transported intermediates do not apply to monomers. This means that a full registration dossier must be submitted even if a monomer is used as an intermediate under strictly controlled conditions.
What is an impurity in a polymer?

An impurity in a polymer is defined as an unintended constituent present in the manufactured polymer substance. It may originate from the starting materials, such as the monomers or any other reactants, or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added. Examples of impurities in a polymer include unreacted monomers or other reactants, residual polymerisation catalyst, or any contaminant from the manufacturing process. The definition and detailed guidance on how to handle impurities can be found in Section 4.2.- 'Substances of well defined composition', Section 4.3.- 'UVCB substances', and Chapter 5- 'Criteria for checking if substances are the same' of the Guidance for identification and naming of substances Under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach

What is an additive in a polymer?
Some substances are commonly added to polymers for the purpose of adjusting or improving their appearance and/or the physicochemical properties of polymeric material.
 
Additives which are necessary to preserve the stability of a polymer must be regarded as a part of the polymer in accordance with Article 3(1) of REACH. Any other unbound "additive" must be regarded as a component of a mixture and not as an additive in accordance with Article 3(1) of REACH.
 
Thus, the importer of a polymer containing additives does not need to register these additives provided that the additives are added to preserve the stability of the polymer. Note however that there is the general obligation to register substances imported in a polymer mixture in quantities of at least 1 tonne per year. Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Beside registration requirements, do I have other obligations for polymers under REACH?

The provisions under the REACH Regulation with regard to information in the supply chain (Title IV), authorisation (Title VII), restrictions (Title VIII) and classification and labelling C&L (Title XI) may also apply to polymers. Further information on this issue is provided in Section 3.2.2- 'Application for authorisation', Section 3.2.3- 'Compliance with restrictions', 3.2.4- 'Classification and labelling', and Section 3.2.5- 'Information down the supply chain' of the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Are there registration obligations for manufacturers and importers of natural polymers that have not been chemically modified?3
Natural polymers are understood as polymers which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not fulfil the criteria set out in Article 3(39) of the REACH Regulation).
 
Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered.
 
According to Article 6(3) of the REACH Regulation any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that meet the criteria mentioned in the respective article. However, monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) in natural polymers can, for practical reasons, be treated as "non-isolated intermediates" and do not have to be registered.
 
3This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.
Are there registration obligations for manufacturers and importers of natural polymers that have been chemically modified?

Natural polymers are understood as polymers, which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not meet the criteria set out in Article 3(39) of the REACH Regulation).

Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered. This includes natural polymers, which are chemically modified (e.g. post-treatment of natural polymers).

Monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) originating from the natural polymer can for practical reasons be treated as "non-isolated intermediates" and do not have to be registered. The substances used to chemically modify the natural polymer and which are chemically bound within the final polymer need to be registered according to the REACH requirements.

This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.

Importers of polymers are obligated to register monomers or other substances chemically bound to the polymers. Do they have to submit spectral data and chromatograms of the original substances used to manufacture the polymers?

Yes. The registration of a monomer or other substance chemically bound to a polymer has to include spectral data and a chromatogram of the original monomer or other substance used to manufacture the polymer.

If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons need to be clearly stated. Generic spectral data or a generic chromatogram cannot be accepted as this would not reflect the actual composition of the monomer or other substance used to manufacture the polymer.

It may be the case that a company imports a type of polymer from different sources, and therefore a monomer or other substance used in the manufacture of this polymer probably also stems from different sources. Even when a company imports a polymer from just one source, it can happen that a monomer or other substance used in the manufacture of this polymer stems from different sources.

In these cases, the importer of the polymer is responsible for assessing the sameness of the monomer or other substance from the different sources. If they consider that the substances from the different sources are the same, they have to submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process, they might still have found out that the substance from the different sources has different impurity profiles. They need to then refer to these different compositions of the substance in their registration dossier.

Are natural proteins and hydrolysed natural proteins polymers as defined in the REACH Regulation?

Natural proteins may be considered as polymers under REACH provided that they have at least 50 weight percent of polymer molecules (in this case, molecules including a sequence of at least four amino acid monomer units) and the content of molecules presenting the same molecular weight remains below 50 weight percent.

Similarly, hydrolysed natural proteins may be considered as polymers if they fulfil the abovementioned criteria. If the degree of hydrolysis is to such an extent that less than 50 percent of the weight of the substance consists of polymer molecules (as defined in chapter 2.2 of the Guidance for monomers and polymers) and/or the amount of polymer molecules presenting the same molecular weight is at least 50 weight percent, the hydrolysed natural protein is not a polymer and, hence, is not covered by the registration exemption for polymers under REACH.

How is a polymer defined under REACH?

A polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer unit. Such molecules must be distributed over a range of molecular weights. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.

Under REACH, a polymer is defined as a substance meeting the following criteria:

  1. Over 50 percent of the weight consists of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and,
  2. The amount of molecules presenting the same molecular weight must be less than 50 percent of the weight.

For further information see chapter 2.2.3.7 of the Guidance on registration:

Full details on polymers are available in the Guidance for monomers and polymers:

Pre-registration

May pre-registered substances that are manufactured or imported before the relevant registration deadline be placed on the market after this deadline without a registration?

REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). The registration obligation does not apply to downstream users or distributors. Therefore, the registration obligation does not apply to you if you have:

  • manufactured or imported pre-registered substances before the registration deadline; and
  • completely ceased such activities and only used the substances and/or supplied them after that.

For example, importers for whom the last batch of the substance was imported on 31 May 2018, at the latest, may continue to use and/or supply that substance after the deadline without a registration, without time-limitation. Since the pre-registered substance has not been registered, there is no obligation to notify ECHA of the cessation of manufacture/import. Article 50(2) and (3) of the REACH Regulation does not apply to this situation.

If you have not ceased your activities before the registration deadline, you have an obligation to register the substance according to Article 6 of REACH.

If you are a downstream user (or any other actor down the supply chain) who is not subject to the registration obligation, you can continue to use, without time-limitation, and/or supply quantities of the substance that were manufactured or imported before the registration deadline.

For the obligations of a downstream user or distributor and whether they are obliged to check the registration status of the substances on their own or in a mixture, please see Q&A 155

What are phase-in substances?

Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with Article 3(20) of the REACH Regulation:

  • Substances listed in the European Inventory of Existing Commercial chemical Substances (EINECS);
  • Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1 June 1992;
  • Substances that qualify as a so-called ‘no-longer polymer’.

Detailed information can be found in the Guidance on registrationSection 2.3.1. – Phase-in substances vs non phase-in substances.

Where can I find the list of substances that have been pre-registered?
ECHA publishes the list of pre-registered substances at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances.
Information published will include:
  • Substance EINECS and CAS number (if available) and other identity codes;
  • The first envisaged registration deadline;
  • The names and other identifiers of related substances that pre-registrants have, i.e. those for which the available information may be relevant for performing adaptation of testing requirements using read across, (Q)SARs and/or grouping of substances.
The list published by ECHA does not show the identity of the pre-registrants. Thus, to find out whether a substance has been pre-registered in a particular supply chain, downstream users should ask their suppliers or other actors further up their own supply chain.
This information is also visible in REACH-IT to those who have pre-registered the same substance and those who have pre-registered related substances for read-across
What is the status of pre-registrations?

The pre-registrations are not valid as of 1 January 2020 following the Commission Implementing Regulation (EU) 2019/1692.

Companies must register substances that they manufacture or import in quantities of more than one tonne per year in the EU/EEA before they start these activities, unless the substances are exempt from registration.

Preparing a registration dossier in IUCLID

I have existing data to support the waiving of a study. How should I report this in my IUCLID dossier?

If you are adapting the information requirement based on existing data according to REACH Annex XI section 1, you should provide the applicable data (e.g. read-across study, Q(SAR)) as an endpoint study record, marked with the appropriate ‘Adequacy of study’ and ‘Type of information’. You should not report existing data as a data waiving record.

If you are waiving (omitting) the information requirement based on the provisions of Column 2 of the relevant requirement, or Sections 2 or 3 of Annex XI, you should include a data waiving record clearly documenting the justification for the waiving. Any available data that support this justification (e.g. a property of the substance, classification) should be reported in the relevant IUCLID section. For transparency, you may wish to link this information in the data waiving record using the ‘Cross-reference’ field.

For further information on how to complete endpoint study records in IUCLID, please refer to chapter 9.7 of the manual How to prepare registration and PPORD dossiers available on the ECHA website.

I am preparing a data waiving record in IUCLID. When inserting the justification in the field ‘Justification for data waiving’ I noticed there is a character limit in the text field next to the option 'other'. For complex discussions on waivers this character limit is often inadequate. How can I ensure all necessary information is included to support my waiving justification?

A: If the character limit in the free text field next to the value ‘other:’ does not allow you to provide sufficient information to justify the waiving, you can use the following IUCLID fields in the Administrative data part:

  • ‘Remarks’ field below the picklist value ‘other:’
  • ‘Justification for type of information’ – this field has a higher character limit and allows for a longer argumentation.

In addition, should you need to provide further information in the form of a report or schematic, you can use the field ‘Attached justification’ to attach the supporting document. To refer to information provided elsewhere in the dossier, you can also use the field ‘Cross-reference’.

However, it is important to note that the main argumentation for the data waiving has to be included in the fields ‘Other’, ‘Remarks’ or the field ‘Justification for type of information’ of the relevant endpoint study record. Only referring to somewhere else in the dossier (e.g. another section, an endpoint summary) or to an attachment is not a valid approach to justify the data waiving and such a record will not pass the completeness check.

I am preparing a registration dossier for a substance with a tonnage above 1000 t/y. I want to wait for the results of another test to finalise the study design of the extended one-generation reproductive toxicity study (EOGRTS). How should I report this in IUCLID?

At Annex X, the EOGRTS is the standard information requirement to address reproductive toxicity. If you would like to wait for the results of another test (e.g. results from a 90-day study or from a prenatal developmental toxicity study) before starting the EOGRTS, you should indicate this in IUCLID section 7.8.1 with an endpoint study record flagged as testing proposal.

To indicate an endpoint study record as a testing proposal for EOGRTS, set the field ‘Type of information’ to ‘experimental study planned’ and choose in the field ‘Endpoint’ one of the picklist values referring to the EOGRTS. In the testing proposal record you can explain the sequential testing and the test guideline(s) that you intend to follow. ECHA will evaluate this testing proposal and may set a timeline to allow this sequential testing.

I am preparing a registration dossier for a substance with a tonnage between 100 to 1000 t/y. I want to wait for the results of another test to know if I need to perform the extended one-generation reproductive toxicity study (EOGRTS). How should I report this in IUCLID?

At Annex IX, it is indicated in Column 1 of 8.7.3 that the extended one-generation reproductive toxicity study (EOGRTS) must be performed “if the available repeated dose toxicity studies (e.g. 28-day or 90-day studies, OECD 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity”. Therefore, the EOGRTS is not an automatic requirement at Annex IX, but relies on the indication of adverse effects from other tests.

If you are awaiting the results of such test(s) to determine if you need to conduct the EOGRTS, you can indicate this in an endpoint study record flagged as data waiving in IUCLID section 7.8.1. To indicate an endpoint study record as a data waiving for EOGRTS pending the outcome of another study, set the field ‘Data waiving’ to ‘study not scientifically necessary’ and choose in the field ‘Endpoint’ one of the picklist values referring to the EOGRTS. In the data waiving record, select under ‘Justification for data waiving’ the value ‘other:’ and explain that you are awaiting the outcome of another study. Be explicit on which study/studies you refer to, preferably by indicating the relevant section(s) in the field ‘Cross-reference’. If you have any ECHA/authority decision on the test, also include the decision number in the data waiving justification.

By following this approach, you do not need to submit a testing proposal for the EOGRTS at Annex IX, before you know if this study is needed. Once the repeated dose toxicity study is finalised, you should without delay submit an update of the registration, and in addition to reporting the results of the finalised test, in section 7.8.1 either (i) amend the data waiving record to explain that no adverse effects in line with Column 1 of 8.7.3 were observed in the test; or (ii) replace the data waiving record with a testing proposal for the EOGRTS.

I am preparing to update my registration dossier for a substance with a tonnage above 1000 t/y. I have previously submitted a testing proposal to ECHA for the pre-natal developmental toxicity (PNDT) study and have received the decision to carry out the test in two different species. I have started the testing in the first species, but I would like to wait for the results of this test before starting the test in the second species. If I need to submit an update of the registration in the meantime, how should I report this in IUCLID?

REACH Annex X requires registrants to provide two pre-natal developmental toxicity studies in different species. For each of the two species, you need to provide an endpoint study record in IUCLID section 7.8.2 indicated as key study, weight of evidence, data waiving, or testing proposal.

In the situation you refer to, you have received the decision to carry out the PNDT test in two species, and you have started the testing in the first species. However, you would like to wait for the results of the PNDT test in the first species before initiating the second species study. In this situation, you should include in IUCLID section 7.8.2 the following endpoint study records:

First species record:

  • You should indicate the endpoint study record for the ongoing first species PNDT test as a data waiving. Set the field ‘Data waiving’ to ‘other justification’. Under ‘Justification for data waiving’ select the value ‘other:’ and type the following sentence in the adjacent text field: “This information will be submitted later based on ECHA decision number TPE-F-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the decision number issued to you by ECHA.

Second species record:

  • You should indicate the endpoint study record for the second species PNDT test as a data waiving. Set the field ‘Data waiving’ to ‘other justification’. Under ‘Justification for data waiving’ select the value ‘other:’ and type the following sentence in the adjacent text field: “The second species PNDT test may be performed sequentially once the first species test results are available. This information will be submitted later based on ECHA decision number TPE-F-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the decision number issued to you by ECHA.

Once a study is finalised, you must without delay submit an update of the registration, and report the results of the finalised test in IUCLID section 7.8.2.

Note that the only reasons for why the testing in the second species could be permanently waived based on the results of the first species study are listed in REACH Annex X, section 8.7.2, column 2.

For further information on the information requirements for the PNDT studies, please read the Newsletter, issued on October 2014.

I am preparing a registration dossier for a substance with a tonnage above 1000 t/y. I am planning to address the information requirement for the pre-natal developmental toxicity (PNDT) study with a testing proposal. However, I would like to wait for the results of the test in the first species before starting the test in the second species. How should I report this in IUCLID?

REACH Annex X requires registrants to provide two pre-natal developmental toxicity studies in different species. For each of the two species, you need to provide an endpoint study record in IUCLID section 7.8.2 indicated as key study, weight of evidence, data waiving, or testing proposal. Before carrying out a test in vertebrate animals to fulfil information requirements for REACH Annexes IX and X, you need to first submit a testing proposal to ECHA and receive the decision to carry out the test.

In the situation you refer to, you are about to submit a testing proposal for the PNDT study at Annex X. You should therefore include in IUCLID section 7.8.2 the following endpoint study records:

First and second species records:

  • You should create separate endpoint study records for the first and second species and indicate each of them as a testing proposal by setting the field ’Type of information’ to ‘experimental study planned’. Provide information on the ‘Guideline’, ‘Test material information’ and ‘Species’ of the planned test.
  • In addition, ensure to include in the field ‘Justification for type of information’ of both records the considerations for why the adaptation possibilities offered by the REACH Regulation cannot be used to address the information requirement and animal testing is necessary.
  • Finally, include in at least one of the records in the field ‘Attached justification’ the clarification of that you propose to carry out the testing of the two species in a sequential manner (depending on the results of the PNDT study in the first species).

Once a study is finalised, you must without delay submit an update of the registration, and report the results of the finalised test in IUCLID section 7.8.2.

Note that the only reasons for why the testing in the second species could be permanently waived based on the results of the first species study are listed in REACH Annex X, section 8.7.2, column 2.

For further information on the information requirements for the PNDT studies, please read the Newsletter, issued on October 2014.

When is the description of article service life expected and why?
REACH requires that all the life-cycle stages of a substance are addressed in the registration dossier. This includes also the life-cycle stages subsequent to the use of the substance as such or in mixture. Substances having been processed into or onto an article may be released during the service life or at end of service life of this article, leading to exposure of humans or the environment. This exposure may even be higher than the exposure occurring during the production of the article in industry or the application of coatings to article surfaces by professionals. Examples for significant release potential during or after service life include migration to skin and washout from textiles, migration of substances from plastic articles or leaching from surfaces due to water contact.  
 
An article service life is to be reported in section 3.5.6 of IUCLID when the substance (or its reaction products) is expected to be present in an article. This applies for example for the following substance functions:
  • Substance is meant to present in the material matrix forming an article. Typical technical functions include plasticisers, fillers, flame retardants, pigments or stabilisers in plastic articles; dyes, finishing or sizing agents in textile, paper and leather; or alloying elements in metal articles.
  • Substance is meant to be present in the surface layer protecting an article or delivering a certain appearance. Typical technical functions include binders (film formers), driers, pigments, plasticisers, stabilisers in the coatings for metal articles or wooden/mineral elements in building and construction. 
  • Substance is meant to be present on the article surface to promote or prevent adhesion to other surfaces. Typical technical functions include adhesion promoters, binders in adhesives, antiadhesives, release agents remaining on surfaces of mineral construction elements.    
  • Substance is meant to be present on article surface during longer periods of article service life, such as polishing, waxing or impregnation agents.   
  • Substance is a component in printing inks applied to packages or print media. Typical technical functions include binder, pigment, dyes. 
  • Substance is meant to be present in a plastic compound (or master-batch) in order protect the material against degradation by heat during processing (heat stabiliser).  
While the technical functions listed above mostly imply that the substance is included in articles, in some cases functions such as dye or stabiliser are also delivered in products not leading to article service life (for example lubricants, fuels, cleaning products). For such uses, it is compatible with the technical function that no article service life is reported.
 
An article service life should not be reported in section 3.5.6 of IUCLID when the substance (or its reaction products) is not expected to be present in the article after use. This applies typically to substances which are meant to remove material from solid surfaces, substances which are part of functional fluids and fuels, or substances that are meant to evaporate during their application to the article surface. Examples include:
  • Anti-freeze agents and de-icers
  • Cleaning and chelating agents
  • Etching agents
  • Flocculation or floatation agents
  • Fuels and fuel additives
  • Agents in hydraulic fluids, heat transfer fluids or other functional fluids
  • Lubricating agents
  • Solvents 
When describing the substance functions in section 3.5 of IUCLID, the information should also be consistent with other elements of the use description.
  • Within a use, report the technical functions that relate to the product(s) relevant for the use described. 
  • Functions excluding each other (e.g. flame retardant and fuel) should not be included in the same use.
  • The technical function should be consistent with the selected environmental release categories (ERC), which systematically distinguish between inclusion and no-inclusion into/onto articles
  • It should be also compatible with the indication in field ‘Subsequent service life relevant for this use’ of IUCLID.
More practical considerations and examples on how to report uses of substances becoming part of articles, can be found in ECHA’s Practical Guide for Industry: Describing uses of additives in plastic material for articles and estimating related exposure. Although focussed on additives in plastic, the core principles explained are there also applicable for substances in other materials for articles.
REACH-IT

A. REACH-IT, general

Which web browsers are supported by REACH-IT?

REACH-IT has been tested with:

  • Google Chrome 48.0 and higher on a Microsoft Windows platform
  • Internet Explorer 11.0 and higher on a Microsoft Windows platform
  • Mozilla Firefox 44.0 and higher on a Microsoft Windows platform

The use of untested browsers may reduce REACH-IT functionalities and cause application errors in REACH-IT. Using an older version of the browsers, or different software platform, may cause incompatibility issues with REACH-IT functionalities. Therefore, users are advised to upgrade their internet browser as mentioned above.

How can I update and synchronise my legal entity (LEO) information?

There is no need to synchronise the company details in REACH-IT and IUCLID. The legal entity information is always extracted from the information in REACH-IT.

However, if you wish to do so, we recommend updating the information in REACH-IT, and later exporting it to your IUCLID 6. If you update your LEO information in your IUCLID 6 application, remember also to update your LEO information in REACH-IT.

For more information, see the manual How to prepare registration and PPORD dossiers, chapter 2.1, How to update and synchronise the LEO information.

What format of attachments does REACH-IT and IUCLID support?

REACH-IT and IUCLID support the following file types: jpg, jpeg, pdf, doc, docx, rtf, txt, tiff, mol, png and gif.

If you attach a file, which is unsupported by REACH-IT or IUCLID, you could be contacted by the Agency with a request to update your submission.
 
How do I download the EC number from REACH-IT and import it to IUCLID 6?
Once the assigned EC number has been exported, go back to the IUCLID home page and click on ‘Import’ as shown below.

The EC number can be downloaded from REACH-IT either from the Joint submission Object, the Inquiry or the Pre-SIEF page.

  1. Log in to REACH-IT, go to the relevant submission page and click on the button ‘Export assigned EC number or Export EC substance’, as shown below:


  2. Once the assigned EC number has been exported, go back to the IUCLID home page and click on ‘Import’ as shown below.


  3. Once the assigned EC number has been imported go back to the IUCLID home page and click on ‘Reference substance’ as shown below.


  4.  Click on the button ‘New reference substance’ as shown below.


  5. Add’ the newly uploaded reference number to the reference number inventory by putting the name of the reference substance and click create and open.


  6. Fill in the reference substance identity information and save the entry.
B. Business rules

How can a registration dossier be corrected in case a mistake was made in the preparation of the dossier?

After you have submitted your registration dossier to ECHA you may realise that you made a mistake during its preparation. This might be the case, for example, if you accidentally introduced faulty information in the dossier (e.g. incorrect information in one of the study summaries) and noticed this only after you submitted the dossier to ECHA. In this case you should without undue delay submit the amended dossier as a spontaneous dossier update via REACH-IT, indicating in the dossier header the reason(s) why you are spontaneously updating it as well as the references of the previous valid submission (i.e. the "last submission number"). Such an update would not be subject to a fee, unless the mistake is related to a chargeable element such as an increase in tonnage band, or confidentiality claims for information listed in Article 119(2).

Some mistakes may prevent a successful submission of the dossier to ECHA. These are failures in the business rules or the completeness check. If your submission fails either of these checks, you will be alerted to the failure in the form of a task in REACH-IT, which prompts you to amend the dossier.

My submission failed BR215. What should i do?

Following the entry into force of the ‘Commission Implementing Regulation (EU) 2016/9 on Joint Submission of Data and Data Sharing', new checks were put in place to ensure that all submissions are in line with the ‘one substance, one registration' (OSOR) principle. According to the OSOR principle there can only be one joint registration per substance per registration type (full or intermediate).

Furthermore, if an active joint submission already exists (i.e. the lead registrant has successfully submitted the lead dossier), individual registrants (i.e. not part of the joint submission) for the same registration type (full or intermediate) are blocked from updating their dossiers, unless they become members of the joint submission.

ECHA advises you to take the following steps:

  • Find your co-registrants.
  • Establish substance sameness and negotiate on data sharing.
  • For the scenarios described in Q&A 1171, you can partially or fully opt-out from information submitted jointly by your co-registrants. However, your submission still has to be in the framework of the joint submission. Therefore, certain administrative fees may be applicable towards the joint submission.
  • If you cannot agree on the data and cost sharing, you can file a data-sharing dispute with ECHA. The dispute mechanism should be used as a last resort and you will need to demonstrate that you have made every effort to reach a voluntary agreement.
  • If you wish to submit a partial or full opt-out, but cannot come to a voluntary agreement with the lead registrant on the conditions for joining the joint submission, you can also use the above-mentioned dispute mechanism.
My submission failed BR027. What should I do?

Business rule 027 (BR027) failure occurs if the substance identifier in your IUCLID dossier does not match the substance identifier on the REACH-IT joint submission page. To avoid BR027 failure in your future submissions, see the following check list and carry out the steps that apply to your case.

  • Check that you have selected the correct joint submission in REACH-IT when submitting your IUCLID dossier.
  • Check that the EC number in your IUCLID dossier is the same as the EC number of the joint submission in REACH-IT. You can export the assigned EC number either from the REACH-IT joint submission page, from the Pre-SIEF page, or from the inquiry submission report page. Import the EC number into IUCLID and assign it to your reference substance, as specified in Q&A 1258.
  • If no EC number exists for your substance yet, check that the spelling of your substance name on the REACH-IT joint submission page is identical to the spelling in your IUCLID dossier section 1.1 IUPAC name. Pay attention to additional spaces and special characters.
  • If your substance is a multi-constituent substance (e.g. a reaction mass of…), make sure that all the constituents indicated in section 1.2 of IUCLID are identical to the constituents included in the REACH-IT joint submission page.
  • If you are a lead registrant of a new joint submission for a substance of Unknown or Variable composition, Complex reaction products or Biological origin (UVCB) with no valid pre-registration or inquiry number, and have tried the above mentioned fixes, please contact ECHA using the ECHA contact form to receive further instructions on how to successfully submit a registration.

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

My submission failed BR034. What should I do?

Business rule 034 (BR034) failure occurs when you submit a spontaneous update instead of requested update. When your previous submission fails the technical completeness check (TCC), you are expected to submit a requested update. A communication regarding the TCC failure is sent to you via REACH-IT. You also receive an update request under ‘Tasks’ in your REACH-IT account with instructions on how correct the TCC and submit a requested update.

When you create your dossier update, you must tick the boxes 'The submission is an update' and 'Further to a request/decision from a regulatory body’.

Add your last submission number, in this case, the submission that failed the technical completeness check. In the box below, enter the communication number in the ‘Number’ field, as shown in the screenshot.

You can find the submission number and the communication number in REACH-IT under ‘Tasks’ and also under ‘Key documents’.

While creating your dossier, we also advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

My submission failed BR035. What should I do?

Business rule 35 (BR035) failure occurred because the last submission number you have indicated in your dossier is incorrect. To address the failure, you will need to indicate the last successful submission number for the particular substance in the dossier header in IUCLID, and then re-submit the dossier in REACH-IT.

You can find your previous successful submission number in REACH-IT by going to ‘Substances’ and searching for your registration using the substance name or EC number. The submission number is presented in the results page, as shown in the screenshot below (1).

If you are expected to submit an update due to technical completeness check failure, you need to use the ‘In progress’ submission number (2).

Assign the correct submission number in the IUCLID dossier creation wizard by ticking the box ‘The submission is an update’ and insert the last submission number, as shown in the screenshot. 

 

While creating your dossier, we also advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

My submission failed BR038. What should I do?

Your submission has failed business rule 038 (BR038) because you already have a successful submission for the substance and you are expected to submit an update.

To address the failure, you need to assign the last successful submission number of the substance you are submitting the update for in the IUCLID dossier header. Indicate the reason for the update by choosing the appropriate update type, ‘Spontaneous update’ or ‘Further to a request/decision from a regulatory body’.

You can find your last successful submission number in REACH-IT by going to ‘Substances’ and searching for your registration using the substance name or EC number. The last successful submission number is listed on the results page, as shown in the screenshot below. 

 

For a spontaneous update, carry out the following steps, as shown in the screenshot below (Desktop view and IUCLID Cloud view).

  1. Assign the submission number in IUCLID dossier creation wizard by ticking the box ‘The submission is an update’ and inserting the last successful submission number that corresponds to the substance.
  2. Select the type of update, ‘Spontaneous update’.
  3. Select the appropriate justification for the update. Create a block by clicking the button "New item" and make a selection from the drop down list. If you select ‘other’, you are required to give the reason in the adjacent free text field.

 

For a requested update, refer to the assessment outcome communication sent to you via REACH-IT. You can find the communication on the submission page under the ‘Key documents’ tab. The communication provides full details on what information is missing from the dossier and a deadline by when you should submit this information.

For a requested update, carry out the following steps, as shown in the screenshot below (Desktop view and IUCLID Cloud view).

  1. Assign the latest submission number in IUCLID dossier creation wizard by ticking the box ‘The submission is an update’ and inserting the last successful submission number, which corresponds to this substance.
  2. Select the type of update, ‘Further to a request/decision from a regulatory body’.
  3. Create a block by clicking the button "New item" and insert the annotation number that corresponds to the submission for which further information was requested (e.g. assessment outcome communication number XXX-X-0000000000-00-00/X). In the ‘Remarks’ field, enter your remarks as free text.

 

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

My submission failed BR053. What should I do?

Your submission has failed business rule 053 (BR053) because the EC/list number in section ‘1.1 Identification’ your IUCLID dossier does not match the EC/list number of the inquiry indicated in section ‘1.3 Identifiers’.

To address the failure, you need to ensure that:

  • the substance identification in section ‘1.1 Identification’ of the IUCLID dossier corresponds to the substance identification associated to the inquiry number indicated in section ‘1.3 Identifiers’;
  • the inquiry number indicated in section ‘1.3 Identifiers’ has been copied/typed in the correct format.

To select the EC/list number provided by ECHA as a result of your inquiry assessment, you need to export this EC number from REACH-IT in .i6z format into IUCLID. For instructions on how to export the EC number from REACH-IT to IUCLID, see Q&A 1258.

You can find your inquiry number in REACH-IT by going to ‘Substances’ and searching for your inquiry using the substance name or EC number. The inquiry number (e.g. 06-0000000000-00-0000) will be listed on the results page.

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392. Please address any detected failures before re-submitting your registration dossier to ECHA via REACH-IT.

My submission failed BR119 . What should I do?

Business rule 119 (BR119) failure occurs when the lead registrant indicates in their dossier update that they will not provide the optional information (i.e. chemical safety report (CSR) and guidance on safe use (GoSU)) on behalf of its members although in the previous submission they had indicated that they would provide this information.

The following scenarios may trigger BR119 failure:

If the lead registrant initially indicated that they would provide the CSR and/or GoSU on behalf of all members of the joint submission but no longer wishes to do so, they should contact ECHA using the ECHA contact form and request the modification of the joint submission coverage. Before contacting ECHA:

  • The lead registrant should first ensure that the changes will not affect any members of the joint submission.
  • Members relying on the CSR and/or GoSU provided by the lead registrant need to submit a spontaneous update indicating that they will provide individual CSRs and/or GoSUs.

Once ECHA has performed the changes, the lead registrant will need to submit a spontaneous update.

When submitting the spontaneous update, member or lead registrants should indicate in the IUCLID dossier the submission type as ‘spontaneous update’,  the ‘Justification’ select the reason ‘New or update of CSR or guidance of safe use’ as well as entering a clarification in the ‘Remarks’ text box.

While creating the dossier, we advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier. For further instructions on how to use the validation assistant please refer to Q&A 392.

My submission failed BR130. What should I do?

Business rule 130 (BR130) failure occurs when a lead registrant submits a dossier update in which the joint submission tonnage band indicated is lower than the joint submission tonnage band for the previous submission. The tonnage band of the joint submission is derived from the submission type (IUCLID template) chosen for the substance when the lead dossier was first created.

The individual tonnage band(s) specific to the lead registrant can be indicated in the dossier header.

If the lead registrant wishes to lower their individual tonnage band, they can refer to Q&A 1300 for further instructions.

If the lead registrant wishes to lower the tonnage band of their joint submission, they can refer to the Q&A 1299 for further instructions. 

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392. Please address any detected failures before re-submitting your registration dossier to ECHA via REACH-IT.

Registration

A. Registration, general

What are the options for an importer of a mixture when he is unable to obtain the relevant information from his supplier on the components of the mixture?
To fulfil his duties as a registrant an EEA-based importer of mixtures has to have information on the composition of the mixtures he imports into the EEA. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under REACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.
 
If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:
- identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
- propose to the non-EEA formulator that he appoints an only representative in accordance with Article 8 of the REACH Regulation,
- establish the composition of the mixture by analytical means,
- find an alternative supplier who is prepared to provide all required information for the mixture.
I would like to cooperate with a company in another Member State by ‘chemical leasing'. Does this business model influence my registration obligations under REACH?
Business models such as ‘chemical leasing', where the purchase is based on the fulfilled functions performed by the chemical and where the value-based units, such as the number of painted articles, are the main basis for payment, or any other business models do not influence your registration obligations. 
 
It is still the manufacturer or the importer to the EU who is responsible for registering the relevant substances under REACH.
When do I have to register my substance?

A substance must be registered before the manufacture or import can start at an annual quantity of one tonne or more. Before the registration of such substances, the manufacturer or importer has to make an inquiry to ECHA regarding any previous registration for the same substance.
 
Upon registration, the registrant may have to wait for three weeks after the registration dossier is submitted before starting or continuing the manufacture or import of the substance (Article 21 of the REACH Regulation).

How do I document substances under customs supervision?

If substances are in temporary storage with a view to re-exportation and remain under customs supervision, they are not subject to REACH.

To rely on this exemption, you need to document that the following conditions are fulfilled:
1.The substances are put in a free zone or free warehouse as defined under customs legislation or placed under another relevant customs procedure (transit procedure, temporary storage).
2.The substances are kept under the supervision of the customs authorities.
3.The substances do not undergo any form of treatment or processing during their stay in the EU. A free zone or a free warehouse in the EU territory is part of the EU.

For further information see the Guidance on registration, chapter 2.2.2.2 ‘Substances under customs supervision’.

How do I communicate that I ceased manufacture/import?

You can cease manufacture due to the following scenarios:

  • You ceased manufacture/import due to commercial reasons according to Article 50(2) of the REACH Regulation. The registered volume in your registration is updated to zero and the status of your registration is changed to "inactive". If you restart manufacture/import of the substance, you should inform ECHA via the 'Restart manufacture or import' button available on the reference number page in REACH-IT.
  • You ceased manufacture following a draft decision according to Article 50(3) of the REACH Regulation. The status of your registration will be changed to "Revoked". A new registration must be submitted if you wish to restart manufacturing/importing your substance.

Before ceasing manufacture, we recommend that you read Q&A 0054 that explains the duties of registrants that cease manufacture and import.

Below are the steps on how to cease/restart manufacture in REACH-IT.

 

You should use the functionality ‘restart manufacture or import’ to reactivate the reference number, when a substance is manufactured/imported again.

I now have my registration number. What happens next?

Your registration remains your responsibility, so keep it always up-to-date.

Safety Data Sheet
If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.

SME verification
If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.

Joint Submission management and Data sharing
We strongly recommended that you put in place a mechanism discuss within your joint submission and for dossier update, when necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.

Dossier evaluation
ECHA will check the compliance of at least 20% of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, ECHA will examine the testing proposals included in the dossiers. This will happen by 1 June 2022 for registrations submitted for the deadline of 31 May 2018, and within 180 days for other registrations.

ECHA will communicate with you via REACH-IT, if the information of your registration dossier is being assessed, so we invite you to check your account regularly.

B. Registration, registrant

Should the importer always be considered as the same legal entity as the consignee stated on the simplified administrative document (SAD) used by the customs authorities? Does this imply that the consignee is considered to be responsible for registration?

No. The importer is the natural or legal person established within the European Union (EU, for REACH and CLP also covering the European Economic Area, EEA) who is responsible for import, i.e. the physical introduction (of goods) into the customs territory of the EU (Article 3(10) of REACH).

The responsibility for import depends on many factors such as who orders, who pays, and who deals with the customs formalities or the "INCOTERMS" chosen, but these might not be conclusive on their own. In many instances, the end receiver of the goods (the consignee) will also be the legal entity responsible for the import. However, this is not always the case.

If, for example, you order goods from a company (Company B) established in the EU, which acts as a distributor, you probably do not know where the goods originate from. Company B may choose to order the goods from either an EU-based manufacturer or from a non-EU-based manufacturer.

If the Company B chooses to order from a non-EU-based manufacturer, the goods may be delivered directly from them to you to save on transportation costs. If this happens, your company will be stated as the consignee on the simplified administrative document form and customs handling will take place in your country. Payment for the goods will, however, be settled between you and Company B.

Company B should be considered the legal entity responsible for the physical introduction of the goods into the customs territory of the EEA (importer). You would then be a downstream user. The obligation to register would consequently lie with Company B.

You, on the other hand, will have to be able to prove through documentation to the enforcement authorities that you are a downstream user, for example, by showing that the order was placed to the distributor.

In addition, when interpreting the term "importer" according to the REACH Regulation, it is not possible to fall back upon the Community Customs Code (Regulation (EEC) No. 2913/92), recast in Regulation (EU) 952/2013.

Who has to register substances?

Only a natural or legal person established within the European Economic Area (EEA)/EU can be a registrant. Registration must take place when this person:
1. manufactures a substance within the EU in quantities of 1 tonne or more per year;
2. imports a substance into the EU of quantities of 1 tonne or more per year; or
3. has been appointed as an only representative according to Article 8 of REACH (see FAQs on Only Representative of non-EU manufacturer).

The national law of each country provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.

A company not established within the EU does not have direct obligations under REACH. For obligations of a non-EU company, please see to Q&A 12.

You can use the Navigator tool to determine your obligations under REACH and find the appropriate guidance.

Who is the registrant in case of toll manufacturing of substances?

A toll manufacturer is normally understood to be a company that manufactures a substance (on its own, in a mixture or in an article) in its own technical facilities following the instructions of a third party in exchange for an economic compensation. The substance is generally put on the market by the third party. This construction is, for example, used for an intermediate step in the production process for which sophisticated equipment is needed (distillation, centrifugation etc.). According to the REACH Regulation, manufacturers of substances are required to register the substances they manufacture above one tonne per year. From this point of view the toll manufacturer is a manufacturer and has to register the substance.

This scenario is further discussed in the factsheet Toll manufacturer under the REACH Regulation.
 

Who is the registrant in case of an international company?

International companies sometimes have several daughter companies in the EEA/EU, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant under REACH.

Please see Q&A 27 on who has to register a substance.

Can a Non-EEA manufacturer of a substance register under REACH?

No. The obligation to register a substance applies only to actors established within the EEA. Thus, the registration of substances imported into the EEA on their own, in mixtures or, in certain cases, in articles will have to be done by the importer established in the EEA. This implies that each individual importer needs to register the substance. However, according to Article 8(1) of the REACH Regulation manufacturers of substances, formulators of mixtures or producers of articles established outside the EEA, can nominate an only representative established within the EEA to carry out the required registration. This will relieve the individual EEA importers within the supply chain of that non-EEA manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this only representative. However, the registration obligation may still apply if the EEA-importers import the same substance from other non-EEA manufacturers.
 
More information on the only representative role can be found in Only Representative of non-EU manufacturer and in section 2.1.2.5-'Only representative of a "non-EU manufacturer"' of the Guidance on registration.

For more information, see: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries.

C. Registration, tonnage

Can I register for a tonnage band higher than the actual tonnage of the substance?

Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 2.2.6.3- 'Calculation of the total volume' of the Guidance on registration.

A registration at a higher tonnage band will trigger a higher registration fee in accordance with Regulation (EC) No 340/2008. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band. Practical advice on how to complete a IUCLID dossier is provided in the Manual How to prepare registration and PPORD dossier at: http://echa.europa.eu/manuals.

Does a registration of an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH have to be updated due to a change of tonnage band?
A manufacturer or importer who has registered an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH does in general not have to update this registration in case of a change of tonnage band. However, such a registration would have to be updated due to a change of tonnage band in two cases.
 
Case 1: Where the registration is for a transported isolated intermediate and the 1000 t/a threshold is reached, the registrant must update his registration dossier by submitting the information specified in Annex VII of the REACH Regulation, if not already included in the dossier.
 
Case 2: Where the registrant ceases manufacture and import of the isolated intermediate, he has the duties described in Q&A 54, which include an update of the registration.
How do I calculate the tonnage?

Each registrant has to calculate the yearly tonnage for the registration dossier. The yearly tonnage is calculated as the volume per manufacturer/importer per calendar year.

 

What do I need to do if I find that my volume has exceeded the tonnage band I have registered the substance?

A registrant needs to update their registration without undue delay as soon as the ‘annual or total quantities’ they manufacture or import reach the next tonnage band threshold, as required by Article 22(1)(c). As soon as the annual volume of a substance that has already been registered reaches the next tonnage threshold, the manufacturer or importer has the duty to inform ECHA of the additional data required, following Article 12(2).

D. Registration, dossier creation

ECHA has assigned a list number to my substance. Should I report this in my registration dossier?

The list numbers published by ECHA are not official EC entries. However, we recommend you to assign such an entry to the substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6 or 8) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no appropriate EC entry available, you should not assign any list/EC number to your substance.

E. Registration, completeness check

What are the consequences if my registration fails at the completeness check?

If your registration dossier fails the technical completeness check (TCC) for the first time, you are given a deadline of 4 months during which you have one chance to amend the incompleteness. If you fail to submit the complete dossier by this given deadline, your submission will be rejected.

Rejection of a new registration means that the registration number is not assigned to your substance and any fees paid for this registration will not be refunded or otherwise credited. Consequently, you may only start to manufacture/import the substance or to produce or import an article once you have a complete registration and ECHA has issued you a registration number. If you wish to proceed with your registration you need to make a new initial submission. It will be subject to a new completeness check and registration fee.

Rejection of a registration update means that you maintain your existing registration number but any new information included in that update will not be included in the ECHA’s database. Any fees paid for this registration update will not be refunded or otherwise credited. If the update covered a change of tonnage band, you may not manufacture/import the substance or produce or import an article containing it at the increased tonnage band until ECHA has confirmed that your registration update is complete.

If the update of the registration dossier was submitted to include nanoforms of the substance then the rejection means that, even though you maintain your existing registration number for the non-nanoforms of the substance, the registration does not cover the manufacture or import of the nanoforms of the substance. Registrants that manufacture/import nanoforms of the substance after 1 January 2020 without a registration that covers these nanoforms are in breach of the REACH regulation which may trigger enforcement measures. Therefore, if your registration update to include nanoforms was rejected, you need to, at earliest possible, submit a new registration update in order to fulfil your obligations for nanoforms.

How can I check my dossier for business rules and technical completeness check failures before I submit it to ECHA?

As a first step, prepare your registration/PPORD dataset and dossier according to the advice given in the manual ‘How to prepare registration and PPORD dossiers’ available at: http://echa.europa.eu/manuals. Annexes 1-3 of the manual also give an overview of the business rules and technical completeness check rules that apply to registration and PPORD dossiers. 

Next, use the IUCLID Validation assistant plug-in to help you detect business rules and technical completeness check failures present in your dataset and dossier. To run the Validation assistant, right click on your dataset in the Navigation panel Validate follow the steps in the wizard. The same validation should be performed on the dossier to make sure that no failures have been introduced during dossier creation.

While the Validation assistant cannot replicate all the checks performed by ECHA, it simulates the majority of the verifications done and helps you minimise the chance of failure during submission. It is important to keep in mind, that any failure in the Validation assistant Submission checks tab, that is left uncorrected before submitting your dossier in REACH-IT, will lead to your submission not being accepted by ECHA. 

You can find a video tutorials on the use of the IUCLID Validation assistant in the link below:

https://www.youtube.com/watch?v=zQEncCL8cCE&index=4&list=PLOPGDACSd6qyDkdXwPua1Fjb5bJksY75k

Please note that if the Validation assistant does not indicate any failures, this is not an automatic confirmation of that your dossier is complete. As of 21 June 2016, the technical completeness check includes additional manual verifications of the registration dossier by ECHA staff. These checks cannot be replicated using the Validation assistant plug-in; the related completeness issues cannot be displayed by the tool.

Information on the areas of the additional verifications can be found in the following location; https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.

We also recommend you to have a look at our webinars on the completeness check process: 

https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa

https://echa.europa.eu/-/revised-completeness-check-what-changes-and-how-you-can-prepa-1

 

I submitted a dossier in response to an ECHA decision under compliance check and my dossier failed the technical completeness check (TCC). How should I proceed?

If your dossier is submitted before the compliance check deadline has passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure(s).

If you fail TCC for the second time while submitting the requested update, your submission will be rejected.

If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.

You can inform ECHA about not meeting the compliance check deadline via the contact form: https://echa.europa.eu/contact
 

Do I need to modify the all the data waiving justifications and use in IUCLID 6 ‘Justification for data waiving’ pick list values if I had prepared my data in IUCLID 5 and provided the justifications in free text?

There is no need to change the data waiving justification from free text to an available picklist phrase. A free text justification will be considered equally complete to a picklist value, if it is in line with column 2 of REACH Annexes VII-X, or sections 2-3 of Annex XI.

However, when preparing a dossier in IUCLID 6 from IUCLID 5 data, please review the selection in the field ‘Endpoint’ in particular for IUCLID sections where different information requirements can be addressed (e.g. 4.13, 7.8.1) to ensure that you have clearly indicated that the appropriate requirement is being waived.

What should I do if the Validation assistant reports QLT warnings in the Quality checks tab?

The quality rules warn the user of common inconsistencies and shortcomings in the dossier. These warnings will not prevent you from successfully submitting your dossier in REACH-IT. However, leaving quality warnings uncorrected may lead to future clarification requests by ECHA.

Does the manual verification apply to all submitted registration dossiers?

The manual verification applies to all registration dossiers submitted to ECHA. The manual checks focus on ensuring that registrants who waive or deviate from the standard information requirements provide justifications foreseen by the legislation. Therefore, the extent of the verification depends on whether the dossier contains waiving of standard information or deviations from substance identification conventions, as well as on the specific requirements that apply to the registration type (i.e. lead, member, individual registration) and the registration scope (tonnage band, isolated intermediate).

For further information, please refer to the document ‘Information on manual verification at completeness check’ available at: https://echa.europa.eu/manuals.

I received a task in REACH-IT indicating that my submission failed the technical completeness check. Where can I find further information on the reasons and implications of the failure?

In the task you have a link to the “Submission page” of the submission. Follow this link and go to the “Key documents” section at the bottom of the page. Here you can download the technical completeness check communication which contains all the relevant information regarding the failure, as well as the steps required by you. 

I am unfamiliar with the registration process. What does the completeness check consist of?

The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA, (i.e. initial submissions and updates). The completeness check consists of two parallel verifications: (i) the technical completeness check, in which ECHA verifies that all the required elements have been provided in the registration dossier; and (ii) the financial completeness check, in which ECHA verifies that the registration fee has been paid, if applicable to that submission.

If during the technical completeness check the registration dossier you submitted is found incomplete, ECHA will issue a deadline by which you have only one attempt to submit the complete information. If you do not provide the requested information by the set deadline in the form of an update dossier, the submission will be rejected. In such a case, any registration fee you had paid in relation with this submission will not be refunded or otherwise credited.

You can find more information about the registration process on "From sbmission to decision" .

We also recommend you to have a look at our webinar on the technical completeness check process.

The Validation assistant reports a completeness check failure related to that the technical function of the substance requires article service life to be reported. However, the uses of my substance do not result in inclusion in or onto an article. What should I do?

IUCLID 6 v.4.14.1 includes the new Validation assistant rule TCC_0305_08 which checks that a service life is provided in case a specific technical function has been indicated for the substance. The rule is based on the list of technical functions and their definition in ECHA Guidance R.12.

Contrary to its indication as a completeness check rule by the Validation assistant, this rule should be interpreted as a quality warning. The rule will not cause a completeness check failure when the dossier is submitted in REACH-IT. The rule type will be corrected from a completeness check rule to a quality rule in the October 2020 IUCLID release.

As for all quality rules reported by the Validation assistant, when TCC_0305_08 is triggered, it is recommendable to review the corresponding information reported in IUCLID:

  • If you realise that your substance is indeed included in or onto articles, you should report the corresponding service life records in IUCLID section 3.5.6.
  • If you confirm that service life in articles is not relevant for your substance, and that the reporting of the technical functions is accurate, you do not need to modify the use description of the substance despite the indication by the Validation assistant. You may find the Q&A 1669 helpful to further clarify when a technical function is expected to lead to a service life in/on articles. 

When reporting the technical function, please bear in mind the following:

  • Reporting the technical functions of the substance should be limited to what the substance itself (technically) actually does in a mixture and/or in a material/article and should not refer to the function of the final mixture or article.
  • The technical function of the substance should only be reported for the particular life cycle stage and use where this function is delivered. Where a substance is present in a use without particular function, the option ‘no technical function’ should be selected.
  • The technical functions reported should only include those that the registrant is aware of (including those emphasised in marketing) or has been made aware of by its customers.
  • Where the actual substance function cannot be described by one of the technical functions in ECHA Guidance R.12, the function should be described using the picklist option ‘other:’ and adding a brief explanation of this function.

Note that all other completeness check rules related to article service life will lead to a completeness check failure when the dossier is submitted in REACH-IT. The exception applies only to TCC_0305_08.

F. Registration, information on chemicals

Are registration numbers assigned to active substances in biocidal products which are considered as registered under REACH?
No, registration numbers are not assigned to active substances in biocidal products. Registration numbers are assigned exclusively for substances:
- where complete registration dossiers were submitted to ECHA by the registrant according to Article 20 of REACH;
- which were notified under Directive 67/548/EEC and the registration number was claimed by the notifier according to Article 24 of REACH.
How can I check if my supplier has a valid registration?

As you are responsible for using registered substances only, it is your interest to contractually ensure that your supplier guarantees the validity of their registration. Your first option is thus to ask directly your supplier.

If the supplier has not claimed the information as confidential you can search via the registrant name or the registration number from the Registered substances page.
https://echa.europa.eu/information-on-chemicals/registered-substances
 
 

Brief Profile
The full list of public active and inactive registrants/suppliers can be found in the Brief profile.
 
 

Fact sheet
The full list of public active and inactive registrants/suppliers/registration numbers can be found in the Fact sheet.

How can I check what information from my registration dossier will be published on the ECHA website?

The IUCLID Dissemination preview plug-in simulates which information from a registration dossier will be made public on the ECHA website at: http://echa.europa.eu/information-on-chemicals/registered-substances, according to Article 119 of the REACH Regulation.

To use the tool, click on the button on the upper corner of your dossier → Dissemination preview. 

How is the total tonnage band calculated for registered substances published on the ECHA website?

The total tonnage band displayed in the registered substances page is aggregated data calculated from all dossiers in a joint/individual submission. Tonnage data is considered only from full registrations where the tonnage band is not claimed confidential. Tonnage data is extracted from the last year reported in section 3.2 of the IUCLID dossier and is the sum of manufactured + imported tonnage - tonnage directly exported – tonnage immediately used as intermediate.

For dossiers that contain full and intermediate registrations, the tonnage data extracted will be the sum of the reported manufactured plus imported tonnage fields, minus the tonnage immediately used as intermediates. Tonnage data will be summed for all dossiers in a joint/individual submission, and will be displayed as:

  • A tonnage band range, i.e., 100 000 – 1 000 000 tonnes, if no dossier contains a confidentiality claim on tonnage band;
  • Open tonnage band, i.e., 1 000+ tonnes, when at least one dossier contains a confidentiality claim on tonnage band;
  • "Tonnage data confidential", when all dossiers aggregated have claimed their tonnage band as confidential, REACH Articles 119(2)(b); and
  • "Intermediate use only", when only intermediate registration dossiers are present in the joint submission.

For more information, see Dissemination manual, section 2.6.11.

Why is there no information on commercially available products on the ECHA pages?

REACH applies to chemical substances and therefore only information about chemicals are disseminated on the ECHA webpage. It does not contain information about chemical preparations, formed by mixing different chemical substances, nor about articles containing chemicals.

In other words, you can find information about methanol or butane, but not for example about a shampoo, cleaning products or pencils.

Under the Waste Framework Directive (EU 2018/851), ECHA will make available information that suppliers submit info on articles that contain substances of very high concern.
 

Is the information on chemicals accurate?

Most of the data disseminated on the ECHA website is retrieved from dossiers submitted by industry. Due to the quantity of information and the number of chemicals, substance Infocards and Brief Profiles are automatically generated based on the information available. The quality and correctness of the information submitted remains entirely the responsibility of the data submitter. ECHA is working with our stakeholders to continually try to improve overall data quality.

Information submitted by industry may or may not have been verified by ECHA. Under the evaluation processes, 20% of submitted dossiers are to be checked.

Information in ECHA’s regulatory processes is all verified by the relevant experts before publication; this includes lists like the Candidate list of SVHCs, the Authorisation list, and Restriction list.

When can an adaptation of the information requirements under REACH be exercised by a Registrant, in case the substance is used in cosmetic products in the EEA?

In general, testing for human health endpoints can be adapted (‘waived'), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure.

Two main scenarios are foreseen where cosmetics-based waiving could be applied. 

  • In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;  
  • In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).  

In all circumstances, you shall provide a reasoned justification for requesting the waiver.

In the case of an only representative, what name will appear on the dissemination page: the non-EU company or the only representative?

The table below defines which legal entity will be disseminated on ECHA’s webpage depending on information provided in sections 1.1 and 1.7 of your IUCLID dossier.

 

 

 

 

Further information can be found in the manual Dissemination and confidentiality under the REACH Regulation at: http://echa.europa.eu/manuals

I made a request of confidentiality under art. 119(2) of REACH Regulation. Will ECHA send an official confirmation on the acceptance/rejection of my claim?

Yes. ECHA sends a communication of confirmation/rejection of a confidentiality claim via REACH-IT, at the end of the assessment procedure. While processing the confidentiality claim, the information requested confidential is not disseminated on the ECHA website.

After the assessment procedure, the confidentiality claims considered valid will remain so. However, the rejected confidentiality claims will be disseminated on the ECHA website.

For further information on the assessment procedure please read the manual Dissemination and Confidentiality under REACH Regulation, section 3.8. Assessment of the Confidentiality Request by ECHA.

How do I know whether or not a substance has been registered?

The first place is the lead registrant list, which shows the substances for which the registration process has been initiated and those to which a registration number has already been assigned.

Another option is the list of registered substances on ECHA’s website.
You can see the names of registrants by viewing the information on ECHA’s website. The company names appear at the bottom of the ‘General Information’ section. In some cases, the list may not include your specific supplier, because:
• your supplier is not the one manufacturing or importing the substance; or
• the registrant has successfully claimed the name as confidential or
• the registrant is an importer covered by a representative of the non-EU exporter.

The most reliable information should come from your supplier. You should be aware, however, that information can travel slowly along long supply chains.

G. Registration, scope

What falls under the definition of PPORD (Product and Process Oriented Research and Development)?
According to Article 3 (22) of the REACH Regulation PPORD is defined as "any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance".Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
In order to promote innovation, Article 9 of the REACH Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the ECHA. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD): http://echa.europa.eu/guidance-documents/guidance-on-reach.
Requirements for substances in articles

Do I have to register substances in articles?

The registration requirement for substances in articles (as required by Article 7 (1) of REACH) applies only if all the following conditions are met: 

  • the substance is intended to be released during normal and reasonable foreseeable conditions of use; and 
  • the total amount of the substance present in the article exceeds one tonne per producer or importer per year; and 
  • the substance has not yet been registered for that specific use. Pre-registrations, however, do not relieve you from the obligation to register.

If the substance has already been registered for your specific use, then you do not need to register. This registration can be done in your supply chain or any other supply chain. Chapter 3.3.1 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use.

In order to determine what is an article in this context, especially regarding border line cases between containers and articles, you can consult the Guidance on requirements for substances in articles

Under what conditions and when do I have to notify to ECHA substances of very high concern in articles?

Substances that meet the criteria outlined in Article 57 of the REACH Regulation are commonly referred to as substances of very high concern (SVHCs). You must notify SVHCs present in articles (Article 7(2)) if the following conditions are met:

  1. the substance has been included in the Candidate List of SVHCs for authorisation; and
  2. the substance is present in articles above a concentration of 0.1% weight by weight (w/w); and
  3. the total amount of the substance in those articles (i.e. those containing more than 0.1% (w/w) of the Candidate List substance) exceeds one tonne per producer or importer per year; and
  4. exemptions do not apply.

Two specific exemptions can apply to the notification of substance in articles:

(a) exemption based on exclusion of exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal (Article 7(3)) and

(b) exemption for substances already registered for that use (Article 7(6)).

You must notify Candidate List substances in articles at the latest six months after the SVHC has been included on the Candidate List for authorisation (Article 7(7)).

The Candidate List will be updated continuously when substances that meet the criteria of Article 57 are identified.

You can find further information at: http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.

The Candidate List can be found at: http://echa.europa.eu/candidate-list-table.

As Article 7(6) of REACH states "Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use" does it refer to the same supply chain or to different supply chains?
Provided that the substance has been registered by any manufacturer/importer for that specific use, paragraphs 1 to 5 of Article 7 of the REACH Regulation shall not apply. This means that it is not relevant whether the registration was done within the same supply chain or within another supply chain.
Can I already rely on the provisions of Article 7(6) of REACH when a substance in an article has been pre-registered?
No, because Article 7(6) of the REACH Regulation only applies if the substance has already been registered for that use.
What is an intended release of a substance from articles?

A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance was not released. A scented children's toy, for example, is an article with intended release of substances, because fragrance substances contained in the toy are released in order to fulfil an accessory function, namely to scent. Consequently, the release of a substance because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, is generally not considered as an intended release, as the release as such does not provide a function in itself.

An intended release of a substance from an article has furthermore to occur under normal or reasonably foreseeable conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article's life cycle is not an intended release. Similarly, a release in an accident or due to any form of misuse which is not in accordance with the use instructions of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.

May steel semi-finished products such as slabs, blooms and billets be considered as articles?
The transition point of steel and steel semi-finished products from substances/mixtures to articles during processing is to be determined by comparing the importance of physical and chemical characteristics for achieving the object's function. If it can be unambiguously concluded that the shape/surface/design are more relevant for the function than the chemical composition, the object that it is assessed is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture. To determine whether or not steel semi-finished products constitute an article one can use the indicative questions given in Section 2.3 - 'Deciding whether an object is an article or not' of the Guidance on requirements for substances in articles http://echa.europa.eu/guidance-documents/guidance-on-reach
 
ECHA also advises industry to consult sector-specific guidance documents provided by business associations. However, it is up to the individual companies to examine their specific situation and determine whether their product may be considered as an article.
Is there any notification fee for the submission of a notification of Substances of Very High Concern (SVHC) in articles per Article 7 (2) of REACH?
There is no fee charged for the notification of SVHC in articles.
I have stopped production/import of the article containing a Substance of Very High Concern (SVHC). Do I have to notify?

If the production/import ended before the SVHC was included in the Candidate List or before the notification obligation starts to apply (i.e. 6 months after a substance has been included in the Candidate List or 1 June 2011 for substances placed on the Candidate List before 1 December 2010) then you do not have to notify. However, you may still have obligation, under Article 33 of REACH, to provide the recipient of the article, or the consumer upon request, with sufficient information to allow safe use of the article, including, as a minimum, the name of that substance. 

Do I have to consider the tonnage produced/imported before the Substance of Very High Concern (SVHC) was put on the Candidate List for the calculation of the tonnage in accordance with Article 7 (2) of REACH?
For articles which have been produced/imported for at least three consecutive years, the tonnage to be reported must correspond to the average tonnage of the substance in the article produced/imported during these three full years. If the substance in the article has only been produced or imported for two full years, the average of these two full years must be notified. However, if the substance in the article has been produced or imported only since the previous calendar year, the tonnage will be calculated based on the previous calendar year only and no averaging will be made.
 
For instance, substances that had been placed on the Candidate List before 1 December 2010 must have been notified by the producer or importer of the article by 1 June 2011. The producer or importer should have provided the average tonnage of the three or two preceding years, or the tonnage of 2010, depending on for how many consecutive years they had imported or produced the article. 
 
Thus, there are situations, where volumes of the substance predating the inclusion in the candidate list are considered in the tonnage calculation for the notification of a substance in an article.
 
Where production/import of the article starts in the current year, you are advised to notify as soon as the 1 tonne threshold is exceeded. In that case please indicate an expected tonnage range for the whole year.
Do article producers and importers notify only once according to Article 7 (2) of REACH, or should the notifications be updated?
While registrations of substances in articles must be updated with relevant new information, there is no legal requirement to update a "notification of substances in articles" dossier. However, ECHA recommends that notifiers update their notification dossier whenever there is a change in the information that was notified. Furthermore, it is also in the interest of the notifier to maintain an updated dossier, because based on the notification, ECHA may take a decision according to Article 7 (5) of REACH to require producers or importers of articles to submit a registration.
How can producers or importers of articles find information on whether an SVHC has already been registered for use in a particular article and whether the exemption in Article 7(6) of REACH thus applies?
The possibilities that companies have to verify whether a substance has been registered for a particular use are clarified in the Guidance on requirements for substances in articles. It should be noted that the sameness of both the substance identity and the use must be ensured. The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
 
Sources of such information are e.g. the safety data sheets, supply chain communication and trade associations. The ECHA website also provides information from registration dossiers. The amount of available information will often be larger for EU-producers of articles than for importers of articles. Thus it may often be easier - particularly for importers of articles - to notify an SVHC in an article than to document that the substance has already been registered for the particular use in the specific article.
Is a permanent magnet a substance/mixture or an article under REACH?

A permanent magnet should be considered as a substance or a mixture (and not an article) under REACH. This is because its shape, surface or design are less relevant for its function than its chemical composition. As a substance or a mixture, a permanent magnet is subject to the applicable provisions of the REACH and CLP regulations (e.g. it needs to be appropriately packaged and labelled).

Permanent magnets are used in different sizes and forms. They should create a (strong) permanent magnetic field and be stable to perform their main function of attracting or repelling other magnetic objects through a magnetic force (e.g. in cupboards to keep a door closed). They should also have high magnetic coercivity (i.e. they should be difficult to demagnetise).  

The materials to be used to produce permanent magnets should either be either materials with permanent magnetic fields or materials with a susceptibility to be magnetised by applying an external magnetic field. The latter should also retain the imprinted magnetic pattern (high magnetic coercivity). 

The magnetism is one example of a physical property that results from the chemistry of the materials an object is made of, given in the Guidance on requirements for substances in articles (subchapter 2.2). The Guidance also states that such material characteristics or properties are not to be confused with the shape, surface and design of an object.

The stability (magnetic coercivity) and the strength of the created permanent magnetic field appear to be the most important properties of a permanent magnet. Therefore, the magnetic properties of the permanent magnet, which are strongly related to its chemical composition, determine its function.

Are ammunition cartridges designed to launch a projectile (e.g. a bullet) considered as ‘articles' under REACH?
Yes, ammunition cartridges that are designed to launch a bullet are considered to be articles with an integral substance/mixture (the propellant) because the shape, surface and design of such ammunition cartridges determine their function to a greater degree than does its chemical composition.
It should be noted that this answer is limited to ammunition cartridges that are designed to launch a projectile (i.e. a bullet). It does not necessarily apply to ammunition where the function of the object is the deliberate release of a mixture (i.e. flares, gas grenades, etc.). 
 
This Q&A was first published on ECHA website on 04/08/2016.
When do I have to communicate information on Candidate List substances in articles down the supply chain and to consumers? What information do I need to communicate?

If you are a supplier of an article containing a substance, you have to provide to the recipient of the article (Article 33(1)) or to a consumer (Article 33(2)) relevant safety information, available to you, when both the following conditions are met:

  • The substance is included in the Candidate List for authorisation, and
  • The substance is present in the article produced and/or imported above a concentration of 0.1% (w/w).

The information is to be provided to the recipient of the article, i.e. industrial or professional users and distributors, when the article is supplied for the first time after the inclusion of the substance into the Candidate List and to the consumer upon request by that consumer, within 45 calendar days of that request and free of charge.

The communication of information at the request of a consumer is independent of whether the article was purchased by that particular consumer.

The information you should communicate must be sufficient to allow safe use of the article, considering all life cycle stages of the article including disposal. Section 3.4.1 of the Guidance on requirements for substances in articles describes in detail which information should be communicated.

If no particular information is necessary to allow safe use of the article containing a Candidate List substance, e.g. when exposure can be excluded at all life cycle stages of the article including disposal, as a minimum the name of the substance in question has to be communicated to the recipients of the article or to consumers.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Do the articles assembled or joined together in a complex object remain articles?

In the Guidance on requirements for substances in articles, the term “complex object” refers to any object made up of more than one article. In complex objects, several articles can be joined or assembled together in various manners. For example, they can be mechanically assembled (e.g. pair of (metallic) scissors, foldback clips) or joined using substance(s)/mixture(s) (e,g. block of sticky notes, glued chip in a bank card, unpainted bicycle frame formed by welding together multiple steel tubes). The more articles it is made of, the more complex an object becomes.

Articles that are assembled or joined together in a complex object remain articles, as long as they keep a special shape, surface or design, which is more decisive for their function than their chemical composition, or as long as they do not become waste (as defined in the Waste Framework Directive - Directive 2008/98). An importer or a supplier of a complex object (e.g. foldback clip) is importer or supplier of the various articles the complex object is made from, and must therefore comply with the applicable communication and notification obligations for each one of them (e.g. the bent strip of steel and the two metallic wire handles of the foldback clip). Whether the complex object is an article depends on whether it fulfils the criteria of the definition of an article. 

How do I determine the concentration of a Candidate List substance in an article?

The determination of the concentration of a Candidate List substance, to check whether it is above the 0.1% w/w threshold or not, is essential to check whether communication and notification obligations apply.

Table 5 in the Guidance on requirements for substances in articles illustrates and explains in detail several scenarios on how to determine the concentration of a Candidate List substance (weight by weight (w/w)) in an article or in articles incorporated in a complex object (any object made up of more than one article). In summary:

  • Scenario I. Article made from a Candidate List substance as such or in a mixture: the concentration is calculated over the total weight of the article (e.g. plastic chair produced by injection moulding)
  • Scenario II.  Candidate List substance as such or in a mixture used for joining two or more articles (complex object): the concentration of the Candidate List substance is calculated over the total weight of the complex object (e.g. unpainted bicycle frame formed by welding together multiple steel tubes, using a mixture containing the substance)
  • Scenario III. Candidate List substance in coatings (e.g. paint, lacquer, varnish, functional coating) -  III. A) Fully coated article; III. B) Partially coated article; III. C) Coated complex object: the concentration of the Candidate List substance in the (fully/partially) coated article is calculated over the total weight of the coated article or of the complex object
  • Scenario IV.  Very complex objects (e.g. sofa, bicycle, mobile phone, car and aircraft): the calculation rules set out for scenarios I to III above apply for each article or simpler complex object.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Restrictions

A. General Q&As

Does the importer of a mixture have any obligations concerning potential impurities present in the mixture, where the impurity is a substance listed in Annex XVII?

The obligations of the importer of the mixture depend on the interpretation of each specific entry in Annex XVII to REACH for the substance concerned, taking account of the wording, the context and the purpose of the restriction in question.

For instance, if a substance were completely banned, then it could not be placed on the market, not even as an impurity in a substance in an imported mixture. On the other hand, some Annex XVII entries specify limits above which a substance cannot be placed on the market. This limit may not be exceeded, no matter what is the source of the substance in the mixture. However, this can only be determined on a case-by-case basis depending on the substance, the restriction and the concentration of the substance as an impurity in the imported mixture.

It should be noted that the impurity may be permissible at any concentration if the use of the imported mixture is not covered in the ‘conditions of restriction' listed in Annex XVII for the substance.

When a specific Annex XVII entry (e.g. entry 56 MDI) specifies the requirement for the package to contain protective gloves in order for the mixture to be placed on the market, is it possible to attach the protective gloves to the package, if it cannot contain them?

In special cases where, due to the size or shape of the packaging, it is technically not possible to include the protective gloves inside the packaging, it is considered to be sufficient that the gloves are fixed tightly to the packaging in a manner that they cannot be unintentionally removed during handling and transport. The gloves must not obstruct the label and the removal of the gloves must not destroy the label. In addition, both the packaging containing the mixture and the protective gloves must be placed on the market as a single unit, which explicitly signals to the consumer that the mixture may only be used with the protective gloves .

What is the definition of "toys", in the context of restrictions in Annex XVII to REACH?
A number of Annex XVII entries (Entries 5, 31, 43, 50 , 51 and 52) specifically refer to toys. The REACH Regulation does not  define "toys". Toys are defined by Directive 2009/48/EC (hereinafter referred to as the Toys Safety Directive-TSD).
 
Article 2(1) of the TSD states: "This directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys)".
Annex I to the TSD contains a more detailed list of products that are not considered as toys within the meaning of the Directive. Article 3 of the TSD defines certain types of toys such as "functional toy", "aquatic toy", "chemical toy" and "activity toy". Furthermore, Article 2(2) of the TSD explicitly mentions that the TSD shall not apply to the following toys: (a) playground equipment intended for public use; (b) automatic playing machines, whether coin operated or not, intended for public use; (c) toy vehicles equipped with combustion engines; (d) toy steam engines; and (e) slings and catapults. It is considered that if the TSD definition of "toys" is used in Annex XVII to REACH, these exemptions will automatically form part of that definition.
 
The European Commission services have prepared an explanatory guidance document on the TSD, providing clarifications about its scope and definitions of certain categories of toys. Overall, the definition of toys in the TSD should be used to determine what we mean by "toys" for the purposes of restrictions in Annex XVII to REACH. Concerning toys exempted from the scope of the TSD (Article 2(2) of the TSD) these should also normally not be considered as "toys" for the purpose of the relevant REACH restrictions. In certain cases, it may be necessary to describe a class of toys to be covered by a restriction by reference to specific properties of the item.                                   
What is the definition of "childcare articles", in the context of restrictions in Annex XVII to REACH?
A definition of "childcare articles" was inserted by the 22nd amendment of Council Directive 76/769/EEC, (which was repealed by REACH, Annex XVII) via the Directive 2005/84/EC of the European Parliament and of the Council. Directive 76/769/EEC was amended so that the following definition for childcare articles was added in its Article 1(3)c: "childcare article" means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. Hence the intention of the legislator was to use this definition for the purpose of all the restriction provisions and thereby this to be applicable for the entire Directive 76/769/EEC. Therefore, the same definition appears in entries 51 and 52 of Annex XVII, providing an indication of what should be generally considered as a "childcare article" in the context of all Annex XVII (to REACH) provisions. 
 
What is the meaning of the expression "placing/placed on the market for the first time" in the context of entries 3(7), 31(2)(b), 58(1) and 59(1)(b) of Annex XVII to REACH?
Article 3(12) of REACH defines "placing on the market" as supplying or making available, whether in return for payment or free of charge, to a third party. Import is deemed to be placing on the market.
 
Placing on the market for the first time limits the scope of the restriction to the first natural or legal person who supplies or makes available substances, mixtures or articles on the market in the EU. The first placing on the market in the EU will either be by the manufacturer or the importer of the substance, mixture or article concerned.
 
In some cases a restriction entry in Annex XVII refers to specific Directives/Regulations when describing the inclusion or exception of some substances or product categories from the entry. If this Directive/Regulation is repealed or modified, is the new/amended legislation applicable to the restriction?
In general, the answer is yes. However, it should be assessed on a case-by-case basis whether the new legal act replaces the repealed one for the purpose of the REACH restriction, taking into account, for example, the objective of the reference. 
The new legal act may explicitly state that references to the repealed act must be construed as references to the new legal act (e.g., Article 139 of REACH).
For example:
  • Entry 19 (paragraph 4) exempts certain uses of arsenic compounds for wood preservation if they are authorised in accordance with Directive 98/8/EC. This Directive was replaced by Regulation (EU) 528/2012, which explicitly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 96).
  • Entry 45 (paragraph 3) exempts electrical and electronic equipment within the scope of Directive 2002/95/EC from the restriction of diphenylether, octabromo, derivative. This Directive was replaced by Directive 2011/65/EU, which explicitly states that references to the repealed Directive must be interpreted as reference to the new directive (Article 26).
  • Entry 50 (paragraph 3) defines tyres covered by the PAH restriction as tyres for vehicles covered by three directives, including Directive 2002/24/EC. This Directive was replaced by Regulation (EU) 168/2013, which expressly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 81).
As regards the amendment of an act referred to in a restriction, references in acts of Union law are usually ‘dynamic’, so that the reference is taken to be to the latest version of the act referred to. However, less commonly, a reference may expressly refer to an act as it stands on a specific date; this is known as a ‘static’ reference.
What information on restrictions is needed on the safety data sheet and when does the safety data sheet need to be updated due to restrictions?

Article 31(6) of the REACH Regulation provides that the safety data sheet (SDS) shall contain a Section 15 entitled ‘regulatory information’. Annex II to REACH provides requirements for the compilation of the SDS. Section 15(1) specifically mentions that, if the substance or mixture covered by the SDS is the subject of specific provisions in relation to the protection of human health or the environment at Union level (e.g. restrictions under Title VIII), these provisions must be mentioned, unless this information is already mentioned in other parts of the SDS. Thus, all restriction entries applicable to the specific substance or mixture covered by the SDS need to be indicated therein. As an example, SDSs including carcinogenic, mutagenic or toxic to reproduction substances (as such or in a mixture) listed in append