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REACH

Authorisation

Applications for Authorisation - a) Scope and procedure

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

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.

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

Yes, it does. 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) 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).

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

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. 

I am a downstream user and the European Commission has not yet decided on the application for authorisation of my supplier of the substance. The sunset date is approaching or is even passed. What should I do?

You can continue using the substance also after the sunset of the substance, provided that a company up your supply chain has applied for authorisation for your use before the latest application date for this substance.

If the Commission has made the decision of granting an authorisation you must notify the use to ECHA three months from the first delivery of the substance. Note that you can notify ECHA about your use only after the Commission's decision. Your notification needs to refer to the specific authorisation number indicated in the label of the product and the safety data sheet you receive from your supplier, which corresponds to your use. Authorisation numbers have the format 'REACH/xx/x/x'. See also https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use and https://newsletter.echa.europa.eu/home/-/newsletter/entry/4_15_downstream-users-notify-echa-if-you-use-an-authorised-substance

Applications for Authorisation - b) Format and content of authorisation application dossiers

What is the format for authorisation applications?

Application for authorisation dossiers shall consist in an IUCLID 5 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 is an application made and submitted simultaneously by a group of applicants (i.e. the submitting applicant and the co-applicants). The submitting applicant shall generate the list of co-applicants participating in the application and indicate the applicant-substance-use combinations. The co-applicants then need to confirm their participation to ECHA before the submitting applicant uploads the application.

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 Data Submission Manual Part 22, 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.

The manual requires us to attach a concordance table to our application. Is there a template?

To further simplify the preparation of applications for authorisation, ECHA no longer requires concordance tables. Any reference to the concordance table in the manuals can therefore be ignored.

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.

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.

Applications for Authorisation - c) Authorisation fees and invoicing

How to calculate the fee for an application for an authorisation?

Several scenarios can be envisaged: A base fee is payable, which covers one applicant and one use. For each additional applicant, an additional fee per applicant applies. In addition, an additional fee applies for each additional use. For example, in the case of an application submitted by four parties with ten uses in total, the relevant fee will be the base fee + three additional applicant fees + nine additional use fees. The level of the base fee and the additional fee per use depends on the size of the companies that are part to the application. It is important to note that, if you are an SME that is party to an application with other parties that are not SMEs, the standard levels of fees set out in Table 1 of Annex VI of the Fees and Charges Regulation will apply. Likewise, the reduced fees for micro companies set out in Table 4 only apply when all parties to the application are micro companies.

However, the level of the additional fee per applicant depends on the applicant's size, regardless of the size of the other parties to the application. For instance, if you are a micro company and you apply for an authorisation with large corporations, the reduced fee per additional applicant that applies to micro companies is still applicable to you.

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

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.

Application for one applicant and more than one substance

It is important to note that 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.

If you submit an application for an authorisation on your own, you will have to pay a base fee, which covers an application for one substance and one use. For each additional substance that is covered by your application, you will have to pay an additional fee per substance. Likewise, for each additional use you want to cover, you will have to pay the additional fee per use. For example, if your application covers two substances - one having two uses and the other having three uses - you will have to pay a base fee + one additional substance fee +  four additional use fees. The level of the base fee, the additional fees per substance, and additional fees per use depend on the size of your company; reduced fees apply if you are a micro, small or medium-sized enterprise.

Application covering more than one applicant and more than one substance

It is important to note that 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.

A base fee is payable, which covers one applicant, one substance, and one use. For each additional applicant, an additional fee per applicant applies. In addition, an additional fee per substance applies for each additional substance and additional fee per use applies for each additional use. For example, in the case of an application submitted by four parties covering three substances and fifteen uses in total, the relevant fee will be the base fee + three additional applicant fees + two additional substance fees + fourteen additional use fees. The level of the base fee and the additional fees per substance and per use depends on the size of the companies that are party to the application. It is important to note that, if you are an SME that is party to an application with other parties that are not SMEs, the standard levels of fees set out in Table 1 of Annex VI of the Fees and Charges Regulation will apply to you. Likewise, the reduced fees for micro companies set out in Table 4 of Annex VI of the Fees and Charges Regulation only apply when all parties to the application are micro companies.

The level of the additional fee per applicant depends on the applicant's size, regardless of the size of the other parties to the application. For instance, if you are a micro company and you apply for an authorisation with large corporations, the reduced fee per additional applicant that applies to micro companies is still applicable to you.

Application covering more than one applicant and only one substance

A base fee is payable, which covers one applicant and one use. For each additional applicant, an additional fee per applicant applies. In addition, an additional fee applies for each additional use. For example, in the case of an application submitted by four parties with ten uses in total, the relevant fee will be the base fee + three additional applicant fees + nine additional use fees. The level of the base fee and the additional fee per use depends on the size of the companies that are part to the application. It is important to note that, if you are an SME that is party to an application with other parties that are not SMEs, the standard levels of fees set out in Table 1 of Annex VI of the Fees and Charges Regulation will apply. Likewise, the reduced fees for micro companies set out in Table 4 only apply when all parties to the application are micro companies.

However, the level of the additional fee per applicant depends on the applicant's size, regardless of the size of the other parties to the application. For instance, if you are a micro company and you apply for an authorisation with large corporations, the reduced fee per additional applicant that applies to micro companies is still applicable to you.

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&As ID=600 to 605. An example where an application might lead to additional workload is the situation where the number of ‘uses applied for' and/or exposure scenarios is greater than one. As far as one "use applied for" shall be covered by at least one exposure scenario, 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: if 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.

Applications for Authorisation - d) Preparing for authorisation application

What is the purpose of the pre-submission information sessions?

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

When and how can I request a pre-submission information sessions?

You can make a request a pre-submission information session either when notifying ECHA of your intention to submit an application for authorisation, or later. You should nevertheless send your request for a pre-submission information session at least 8 months before the planned date for the submission of your application for authorisation. Although you can still notify less than 8 months in advance of the submission of your application, this may have an impact on ECHA's availability to organise a pre-submission information session for your company. Please bear in mind the PSIS should take place at least 2 months after the meeting request and that you probably would like to have sufficient time after the PSIS to potentially further work on your application before submitting it to ECHA.

Requests for pre-submission information sessions are made via a secure web form, available on ECHA's website. For further details see ECHA's Support webpage on pre-submission information sessions (link to: http://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.

Applications for Authorisation - e) Analysis of alternatives and socio-economic analysis

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. This would be helpful in particular to the Committees when proposing to the Commission the duration of the review period. However, ECHA recommends that a targeted socio-economic analysis is also prepared under the adequate control route. 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. 

Applications for Authorisation - f) 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 Data Submission Manual 18: How to report the substance identity in IUCLID 5 for registration under REACH (link to: http://echa.europa.eu/documents/10162/13653/substance_id_report_iuclid_en.pdf).

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 Data Submission Manual Part 22 - How to Prepare and Submit an Application for Authorisation using IUCLID 5 (link to: http://echa.europa.eu/documents/10162/13653/data_submission_manual_22_application_authorisation_en.pdf)

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

Applications for Authorisation - g) 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). 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.

Certain forms of legal entity change which need to be notified in the authorisation process do not need to be notified in other REACH processes, such as registration (see also Q&A 1242).

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 entity 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 legal entity change entails a change in the legal personality of the applicant or authorisation holder and the new legal entity did not have a REACH-IT account before.
  • Notify ECHA via this web form (under "Type of communication” select "Notification of a change of legal entity") including two attachments:
    • Evidence of change, for instance the merger agreement or the agreement of the sale of assets.
    • Filled announcement using the following format1 . 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.

Remember, that if the original entity has other REACH assets (e.g. registrations), the change of legal entity may need to be notified, too. 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.

 

What will happen after I notified ECHA of my change of legal entity regarding an application?
In case of a notification after the submission of the application, but before the issue of the decision by the European Commission, ECHA will acknowledge the receipt of your notification and will assess:
  • Whether the notified change has been properly documented.
  • Whether it induces modifications in the submitted information and any implications for the RAC and SEAC opinions.
ECHA will also update the respective databases and web site as necessary.
What will happen after I notified ECHA of my change of legal entity regarding a granted authorisation?
In case of a notification after the authorisation was granted, firstly ECHA will acknowledge its receipt and confirm the nature of the notified change, as mentioned in Q&A 1244. Then ECHA will assess if the legal entity change should trigger a review of the authorisation based on Art 61(2) REACH and send its assessment to the European Commission, who will decide as appropriate. 
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 action and by when is expected from ECHA and the European Commission following a notification of a change of legal entity regarding an application / authorisation decision?

Where the change concerns a pending application for authorisation, ECHA endeavours to communicate whether the notified change is properly documented and 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) in two weeks. If the change is confirmed to be properly documented, it will be considered to be valid as of the date of the notification.

In that case ECHA will amend its database as regards the concerned 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.

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.

When do I need to inform ECHA about the change of legal entity?
You need to notify this as soon as it has taken place, i.e. when you have documentary evidence that you can send to ECHA. However, in order to reduce uncertainty about its impact, you can also consult ECHA on the specific case in advance, provided you have sufficient information about the foreseen change. For any questions regarding legal entity changes related to authorisation 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) need to be notified to ECHA and how?

Yes.
Please proceed as follows:

  • Create a new REACH-IT account for the new Only Representative. 
  • Then notify ECHA via this web form i) under "Type of communication” please select "Notification of a change of legal entity", ii) mention the affected submission number and uses applied for (of application) or the authorisation number(s) (of granted authorisation), iii) indicate the Company UUID of the new REACH-IT account, and iv) include evidence of the appointment as the Only Representative.

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:

  • 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 this web form. Under "Type of communication” please select "Notification of a change of legal entity", 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.

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: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/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.

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 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.

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

Completeness check

General questions

I submitted a dossier in response to an ECHA decision under compliance check and my dossier failed the technical completeness check (TCC). The deadline given in the TCC letter is later than the deadline for the compliance check. Which deadline should I follow? What are the consequences of a second TCC failure in this case?

You may in this case 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. 

Should also your second submission fail the TCC, the combination of your two submissions in response to the compliance check decision 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.

What are the consequences of a TCC failure close to the 2018 registration deadline? What impact will it have on the registration number of the lead and members of a joint submission?
  • To be legally on the market from 31 May 2018 onwards, any registrant (lead or member) that intends to benefit from the phase-in scheme of this particular registration deadline must have submitted a registration dossier to ECHA by this deadline. A dossier is considered to be submitted if it has been uploaded in REACH-IT and passed the business rules step, as long as it has not been rejected due to incompleteness caused by non-payment of the fee, or second failure of the technical completeness check. Please note the following in relation to a TCC failure close to the registration deadline:
  • A member registrant cannot submit a dossier before the dossier of the lead registrant of that substance has been submitted. As soon as the lead registrant submits a dossier to ECHA (uploads it in REACH-IT and passes the business rules step), member registrants of that joint submission can submit their dossiers.
  • Member registrants cannot receive their registration numbers before the lead dossier is found to be complete. This means that submitted member dossiers are ‘parked’ in the submission pipeline until a decision is taken on the completeness of the lead dossier.
  • If a registration dossier fails the completeness check, ECHA informs the registrant of the missing/incomplete information and grants a deadline by which the registrant has one attempt to complete the information. If the registrant submits all the requested information to ECHA within the deadline, the dossier will receive a registration number and the registration date will be the date of the first submission. If this dossier is the lead registrant dossier, all submitted member dossier for that joint submission will be released from being ‘parked’ and will be processed for completeness.
  • Should also the second submission result in a failure of the completeness check then the combination of the first and second submissions will be rejected and no registration number is issued for that registrant. In case the rejected submission is the lead registrant dossier, a registration number is also not issued for any member registrant of that joint submission. 

The technical completeness check (including manual checks) is in general performed on each dossier within three weeks of its submission date. However, for phase-in substances submitted in the course of the two-month period immediately before the relevant registration deadline, the completeness check may take up to three months after the deadline. Registrants who wish to have the outcome of the completeness check in advance of the 2018 registration deadline may consider these timelines.

Manual checks

I noticed that in IUCLID 6, the field ‘Justification for data waiving’ contains picklist values with different justification options. However, I had prepared my data in IUCLID 5 and provided the justifications in free text. Do I have to modify all the data waiving justifications and use one of the new picklist phrases for the dossier to be considered complete?

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, whenever 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.

Does the manual verification by ECHA staff 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.

Validation assistant

How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?

As a first step, ensure to 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. While the Validation assistant cannot replicate all the checks performed by ECHA (see below), 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 that your submission will not be accepted by ECHA. 

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.

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

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 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; the document is regularly updated with advice based on the experience gained with incoming registrations: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.

We also recommend you to have a look at our webinar on the completeness check process: https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa.

 

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. These warnings will not prevent you from successfully submitting your dossier in REACH-IT; however leaving quality warnings uncorrected may lead to later clarification requests by ECHA.

Cosmetics

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.

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. General Q&As (applicable for more than one Annex XVII entry)

How are the costs of data shared?

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 share the costs of information that they are required to submit to satisfy their registration requirement. Companies cannot be forced to pay for studies that they do not need, nor can they be forced to pay before they actually need them in their respective tonnage band, i.e. before their registration deadline.

Whenever the (potential) registrant requests data earlier, they need to pay when they receive the data. Other elements might be considered as well.

Registrants need to make every effort to reach an agreement on data sharing and its cost in a fair, transparent and non-discriminatory manner.

The Guidance on data sharing provides more details: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Additionally, practical advice for data sharing negotiations is available: http://echa.europa.eu/support/registration/working-together/practical-advice-for-data-sharing-negotiations.

Do I have any data-sharing obligations after I have submitted my registration?

You can have further duties to share data after you have submitted your registration. This can happen when:

  • new potential registrants join the substance information exchange forum (SIEF) as late pre-registrants of a phase-in substance;
  • the potential registrant of a non phase-in substance or a potential registrant of a phase-in substance who did not pre-register is informed of the previous and other potential registrants (and vice versa) by ECHA following an inquiry;
  • after the successful submission of the registration dossier whenever new information becomes available. In such a case, according to Article 22 of REACH, registrants will 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 CSR.
  • as a consequence of the submitted dossier evaluation by ECHA (compliance check or the assessment of a testing proposal) or the 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, and namely in the case of substance evaluation 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. 
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.

How can ECHA assist me if the price for shared data is not justified?

The cost 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.

ECHA has published generic advice on what to take into account during the data-sharing negotiations: http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations.

ECHA will not participate in the discussions between (potential) registrants and has no remit in regulating or assessing the cost of shared data. ECHA therefore 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 details, please refer to the Data sharing pages on ECHA’s website: http://echa.europa.eu/regulations/reach/registration/data-sharing/data-sharing-disputes/data-sharing-disputes-in-practice.

 

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 they concern 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 FAQ 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.

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 substance during its registration at a higher tonnage band, even 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).

B. Data sharing of pre-registered substances

How can communication within a substance information exchange forum (SIEF) be aided?

Communication within a substance information exchange forum (SIEF) is greatly helped if one participant agrees to be a coordinator. The coordinator can propose how to organise  the exchange of information on the substance.

At an early stage, the SIEF 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 SIEF participants.

Detailed information on how to organise the SIEF and improve communication within SIEFs can be found in the Guidance on data sharing [Guidance under review – what to link do now? Also consider linking to homepage for practical info on SIEF formation?]: http://echa.europa.eu/guidance-documents/guidance-on-reach.

How is a pre-substance information exchange forum (pre-SIEF) managed?

REACH-IT provides substance web pages, which support pre-substance information exchange forums (pre-SIEFs).

These pages have two free-text fields for posting information on creating SIEFs.

The first field is for the SIEF Formation Facilitator (SFF) who can use this to post messages on   creating a SIEF and give contact details and information on further communication tools (e.g. dedicated industry websites).

The second field is for all pre-registrants of the substance. All messages are the exclusive responsibility of the authors and ECHA will not verify, approve or disapprove of their contents.

Potential registrants should work towards forming SIEFs as soon as possible, to ensure that there is enough time to organise data sharing and prepare the registration dossiers. The Guidance on data sharing explains how and when a SIEF is formed in more detail: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Who can become a data holder in a substance information exchange forum (SIEF)?

A data holder is any person holding information or data relevant to a phase-in substance and who is willing to share it.

Data holders include:

  • Manufacturers, importers and only representatives of non-EEA manufacturers of phase-in substances in quantities of less than one tonne per year who have     not pre-registered;
  • Downstream users of phase-in substances;
  • Third parties holding information on phase-in substances;

Any party for which ECHA has information submitted under the Plant Protection Products Directive (91/414/EC) or the Biocidal Products Directive (98/8/EC) that meet the conditions established in Article 15 of REACH.

Data holders can sign-up in REACH-IT with a view to becoming a participant in the SIEF for that substance and can provide information to other SIEF members by submitting any or all of the relevant information listed in Article 28(1) to ECHA. More information can be found in  'The SIEF Participants' section of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.

What is the difference between a substance information exchange forum (SIEF) and a consortium?

SIEFs and consortia are two different concepts and must be clearly differentiated.

A SIEF regroups all pre-registrants of the same substance (and other data holders where relevant) and participation is mandatory for actors specified in Article 29 of REACH.

However, REACH does not define the way in a SIEF must cooperate to meet their obligations, nor does it regulate possible forms of cooperation between them for SIEF or other purposes.

There are several possible forms of cooperation that companies can choose to organise their cooperation under REACH. The 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).  

It is often claimed that "consortium" must be formed (or consortium agreements signed) to organise the activities within a SIEF such as data sharing and the joint submission of data. This is not the case. It is participants not mandatory to form or be part of a consortium even if in certain cases (some) registrants may agree about the need to form one.

Consortium formation does not replace a SIEF. Participation in a SIEF is mandatory whilst membership of a consortium is entirely voluntary and may not necessarily regroup all participants of a particular SIEF, but may regroup only some of them or participants of more than one SIEF.

If some or all participants of one or more SIEFs 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 the Community competition rules. In addition, the members of the consortium must cooperate with any SIEF members that are not participants in the consortium or agreement.

Additional information on forms of cooperation can be found in the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Can I leave a substance information exchange forum (SIEF)?

You cannot leave a SIEF. Even if your company ceases its activities with respect to the substance, you still remain a participant of the SIEF.

You are required to share information that you hold in accordance with the data-sharing provisions of REACH. However, you do not have to participate in any submission (or update) made by the members of the SIEF, nor in any additional related costs.

During the pre-SIEF phase, you can de-activate yourself from the pre-SIEF in REACH-IT to show that you are not interested in registering the substance. Even as a non-active participant, you may still be required to share your data.

Do I have to become a member of a substance information exchange forum (SIEF) if I want to register a phase-in substance?

Yes and, in practice, when you pre-registered phase-in substances with either the same name or same chemical identifiers as other potential registrants, REACH-IT automatically placed you in the same pre-SIEF with them. The SIEF is formed when the pre-registrants agree that they are intending to register   the same substance.

If you register a phase-in substance before 1 June 2018 without previously pre-registering it, you will also enter the corresponding SIEF.

If you are a potential registrant of a phase-in substance but have not pre-registered, you must submit an inquiry to ECHA.

Information on SIEF participants and their obligations is given in the Guidance on Data sharing: http://echa.europa.eu/guidance- documents/guidance-on-reach.

What is the role of ECHA in the formation of a substance information exchange forum (SIEF)?

ECHA has no role in forming the substance information exchange forums (SIEFs), neither confirming nor rejecting the creation of a particular SIEF. It is the SIEF participants’ responsibility to precisely define precisely the substance for which a SIEF will be formed.

How do the roles of the substance information exchange forum (SIEF) formation facilitator (SFF) and the lead registrant differ?

The SIEF formation facilitator (SFF) is not formally recognised in the REACH Regulation, while the lead registrant (LR) is specifically foreseen and necessary for joint registrations.

Acting as an SFF is voluntary and not legally binding, i.e. the legal entity volunteering is taking the initiative to contact the others within the pre-SIEF. Potential registrants are not obligated to use a SFF to form a SIEF. They may even bypass the SFF to begin pre-SIEF discussions, if the SFF does not act.

In contrast, the SIEF must select a lead registrant who submits the joint registration before the other registrants in the SIEF can submit their individual (“member”) dossiers for registration.

Additional guidance on the role of the SFF is provided in the Guidance on data sharing http://echa.europa.eu/guidance-documents/guidance-on-reach.

I have received a request from a substance information exchange forum (SIEF) formation facilitator asking me to pay a fee. Do I have to comply with this request?

A SIEF Formation Facilitator (SFF) cannot demand fees for their services unless this has been mutually agreed. An SFF is expected to contact other participants in the pre-SIEF to help the exchange of information and data which is required to form a SIEF. SFFs have no management role beyond facilitating discussions, and they have no legal basis to force other pre-SIEF participants to cooperate with them.

Can ECHA do anything to help substance information exchange forums (SIEFs) share data for different substances?

REACH data-sharing (and joint submission) obligations concern only multiple registrants of the same substance. Therefore, there is no legal mechanism to force different SIEFs to share the data.

Each request for access to studies across different SIEFs will have to be negotiated on a case-by-case basis by the concerned companies.

Further guidance on inter-SIEF rules can be found in Section 3.2.7 - 'Inter-SIEF rules (grouping, read-across)' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.

What can I do if there is a data gap identified within my SIEF and no one is willing to conduct the new test?

If SIEF participants cannot agree who performs the new test (because there is a lack of volunteers or because there is more than one volunteer), they can make a request for ECHA (https://comments.echa.europa.eu/comments_cms/article302.aspx) to designate a registrant to perform the test. On the basis of objective criteria, ECHA will select the registrant who will perform the study.

For the 2018 registration deadline, it can be anticipated that the selection in most cases will be done randomly given the lack of significant differences among the potential registrants.

After the test is performed, all members of the SIEF, who require the study, contribute to its costs with the share corresponding to the number of participating potential registrants.

This procedure applies to situations where SIEF members agree that the test is needed but not if SIEF members disagree on whether the testing is required or justified.

More details are available in section 3.4.1 of the Guidance on Data sharing (https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf).

What should I do if I do not want to reveal my identity to my competitors in a SIEF?

You can nominate a third party representative (TPR) to represent you in the joint submission and in data-sharing activities.

NB: The manufacturer or importer legally remains the pre-registrant or registrant. The TPR must not be confused with the third party holding information (i.e. data holders) nor with an only representative.

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

What if I don’t want to actively participate in the SIEF discussions?

You can show your passive role to your co-registrants in REACH-IT. However, even as a non-active participant to the pre-SIEF, you may still be asked to share data in the SIEF.

The pre-registration and the registration obligation are not affected by the deactivation done in the pre-SIEF in REACH-IT. If you plan to continue manufacturing or importing the substance above one tonne per year after the registration deadline in 2018, you have to register it.

Even if you are passive during the SIEF work, you have the shared responsibility of the data submitted as part of the joint registration. Therefore, you need to understand the data and agree on it with your co-registrants even if you are not actively engaged in compiling it.

More information on deactivating in REACH-IT can be seen in Q&A 347.

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

As you have pre-registered, you have become part of the SIEF for the substance. Other SIEF members may request information for the purposes of registration from you. If you possess such information, you will have to provide it upon request and subject to financial compensation, if applicable.

C. Data-sharing and inquiry

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) as well as access to information regarding the pre-SIEF (namely on other potential registrants who are pre-SIEF members, i.e. who (late) pre-registered but have not yet registered).

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.

Additionally, 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 [add reference to read-across Q&A?], you can contact ECHA to request such data in accordance with Article 25(3). 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.

Why do I need to make an inquiry?

Any potential registrant of a non-phase-in substance or of a phase-in substance which has not been pre-registered has to inquire from ECHA, whether a registration has already been made for the same substance (Article 26 of the REACH Regulation).

A registrant willing to update its dossier has to also previously submit an inquiry (Article 12(2) of the REACH Regulation).

This is to ensure that data are shared by all registrants of the same substance, and that the joint submission obligation can be met.

In accordance with REACH, studies involving vertebrate animals should not be repeated and available studies need to be shared.

The inquiry and its outcome will depend on whether the data concerning a prior registration, if any, has been submitted more or less than 12 years before the date of the inquiry: 

 

Figure 1: Data sharing process following an inquiry

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

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 FAQ 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 (see Q&A 424)

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. However, a request may be made for studies not involving vertebrate animals.

Downstream users

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

Downstream users can use substances, irrespectively of whether they have been (pre-)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. FAQ ID=40 explains the need for substances to be (pre-)registered in order to be placed on the market.

Please note that for the use of substances (whether (pre-)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 at: http://echa.europa.eu/guidance-documents/guidance-on-reach

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 (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
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

 

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 REACH.

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.

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).
 

How can a downstream user know whether the substance they use has been pre-registered?

The list of pre-registered substances has been published on the ECHA website at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances

 

On this page, you can find out if and when a substance you use, as such or in preparations, is intended to be registered.

 

If a substance you use is not on the list, you can express your interest in the substance to the Agency (see Chapter 3 of the Guidance for downstream users - http://guidance.echa.europa.eu).

 

ECHA will then publish the name of the substance on its website. If a potential registrant requests, the Agency will provide them with your contact details.

 

Please note that if your supplier has not pre-registered, you cannot place the substances concerned on the market until they are registered. You may also want to seek another supplier that pre-registered the substance. ECHA is, however, not in a position to provide you with any list of potential registrants that pre-registered your substance.

 

More Q&As on pre-registration can be found at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/Pre-registration

My substance has not been registered yet. Is this a problem?

It could be. There may be a valid reason for not having registered the substance yet – for example, if the substance is a phase-in substance and suppliers are manufacturing/importing it at less than 100 tonnes/year, the registration deadline is not until 2018.

However, if you suspect that your supplier should have registered the substance already, we recommend that you contact them immediately to check. Make sure that substances critical to your business will be registered by the 31 May 2018 deadline and that your uses will be covered. See https://echa.europa.eu/regulations/reach/downstream-users/other-issues-affecting-downstream-users/registration-and-downstream-users.

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.

Downstream users reports

Downstream user report

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.
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.
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 Question 17 below. 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.

Preparations of an IUCLID dossier for downstream user reports

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 at: http://echa.europa.eu/manuals 

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 at: http://echa.europa.eu/manuals.

Submitting the downstream user report

How do I submit a downstream user report?
Two options are 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:
 
A tutorial is available on using the webform.
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 at: http://echa.europa.eu/manuals.
  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 at: http://echa.europa.eu/manuals
  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.
Evaluation

Compliance checks

What is the aim of the strategy for compliance checks (CCH)?

The strategy aims to systematically target dossier elements that are immediately relevant for the safe use of the substance. The chances of non-compliant dossiers being picked up for compliance check are higher. This approach encourages registrants to comply with REACH and to improve their chemical safety assessments. Compliance check approach has been developed in consultation with the Member State competent authorities (MSCAs) and results in an improved quality control of the dossiers.

How does it work in practice?

ECHA and the Member States identify substances/dossiers of concern based on the IT screening and following manual screening. These dossiers are potentially relevant for further regulatory risk management measures and therefore become prioritised for compliance check. Under the CCH, the eight higher tier endpoints are evaluated.  

What happens if my dossier is selected for compliance check?

If the selected endpoints in your dossier are found to be compliant with the standard information requirements, there will be no further administrative action. If the selected endpoints of your dossier are found to be non-compliant, you 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?

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

No. Issuing a compliance check draft decision does not necessarily mean that ECHA has checked the entire dossier. REACH does not limit the number of compliance checks, thus it cannot be excluded that you may receive multiple draft decisions on the same dossier.

Registrants will be able to provide their views on the intended information request. The decision becomes effective only after completion of the decision making procedure involving the Member States.

By when is it possible to submit new data to ECHA so that it will still be taken into consideration for the compliance check evaluation?

The preparation of a draft decision after a compliance check of a dossier follows the timelines set in Articles 50 and 51 of the REACH Regulation.

When the draft decision is sent to the registrant, the registrant has 30 days to comment. The commenting period for the registrant starts from the day of the receipt of the draft decision via REACH-IT. ECHA will take the comments into account and may amend the draft decision accordingly.

Dossier updates submitted after issuing the draft decision are normally no longer taken into account.

ECHA will notify the Member State competent authorities (MSCAs) of the draft decision after consideration of any comments received.
 
The reason for this is that Article 51 of the REACH Regulation sets deadlines for the decision-making which cannot be put on hold once ECHA's draft decision has been referred to the MSCAs. The REACH Regulation provides strict timelines for the MSCA proposals for amendment, the referral to the Member State Committee (MSC), the comments from the registrant on the proposals for amendment and for the agreement-seeking on the draft decision by the MSC. It is therefore of key importance that the factual basis for the decision-making, i.e. the registration dossier subject to the regulatory action does not change during this stage of the decision-making process.

Any updates of the registration that contain information relevant for the endpoints addressed will be taken into account in the phase of following up to the dossier evaluation decisions (Article 42 of the REACH Regulation).
 

What are the target endpoints ECHA is screening in the dossiers?

The ultimate goal is to focus on those endpoints that matter for human health and the environment with special emphasis for those which are related to the Persistent, Bioaccumulative and Toxic (PBT) or Carcinogenic, Mutagenic or Toxic to reproduction (CMR) status of a substance.  

Follow up to dossier evaluation decisions

I cannot provide the information requested in the ECHA decision by the deadline. Is it possible to extend the deadline?

We are not able to alter the deadline of the decision, as it was unanimously agreed by all Member States. We will check whether a dossier update was provided and evaluate the updated registration dossier only when the deadline in the decision has passed. Then we will establish whether the requests in the decision are fulfilled. We advise you to update your registration dossiers by the deadline and, if necessary, include any relevant explanations and proof concerning the status of any pending information requirements, including the expected submission date. You should then update your dossier again as soon as the missing information is available. Member State authorities may take these justifications into account when deciding on possible enforcement actions. Please see Q&A No 1065.

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

We do not have a standard practice for organising teleconferences/meetings with registrants after a decision has been issued. We can, however, clarify how, in practical terms, the decision is executed regarding technical or contextual matters. If you have such enquiries, we ask you to provide them in written form so that we can prepare the best possible answer for you.

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

We are not in a position to discuss the content of the decision as it was unanimously agreed by all Member States. We can, however, clarify how, in practical terms, the decision is executed regarding technical or contextual matters. If you have such enquiries, we ask you to provide them in written form so that we can prepare the best possible answer for you.

Is it possible to adapt the standard information requirements requested in a decision by providing read-across/waiver/weight-of-evidence/alternate tests? Can ECHA let me know whether my proposed adaptation is acceptable (before the deadline expires)?

We cannot elaborate further on alternative approaches, amended testing strategies, or any other scientific aspects of the decision, as we do not have the legal competence to alter a decision unanimously agreed by all Member States. You may adapt the testing requested in a decision according to the specific rules outlined in Annexes VI to X or according to the general rules contained in Annex XI of the REACH Regulation. For any such adaptation to comply with the respective information requirement, it needs to be scientifically justified, referring and conforming to the appropriate rules in the respective annex, and adequate and reliable documentation. We will check whether a dossier update was provided and evaluate the updated registration dossier only when the deadline in the decision has passed, i.e. we do not perform intermediate follow-up evaluations. Once the deadline has passed, we will establish whether the requests in the decision are fulfilled.

What if I do not update my registration dossier by the deadline? What if the information I submitted is not sufficient?
If a dossier update is not received by the deadline, or if we find that the updated information submitted does not fulfil the request in the decision and thereby does not meet the standard information requirements, we inform the Member State competent authorities (MSCAs) and the national enforcement authorities (NEAs) of the respective Member State about the non-compliance with the decision. 
 
The MSCAs and NEAs have to consider and decide on enforcement actions, where appropriate. 
 
In such cases, we submit the respective documents to the relevant MSCA and NEA using a "Statement of non-compliance following a dossier evaluation decision" (SONC). As the registrant, you will receive a copy of the SONC. 
 
Starting from sending such information package to the NEA, the responsibility for handling this case of non-compliance with the REACH Regulation is transferred to the national authorities. 
 
We will support the national authorities in technical or scientific matters, if requested to do so by them. All direct questions that we receive in this situation will be channelled to the national authorities to make sure that they take your communication into account. 
 
Consequently, we will not evaluate any dossier updates unless the respective NEA asks us to do so. Therefore, if you receive a SONC, you should first contact the national authorities and any communication should be directed to them.
 
What if I face technical difficulties during testing?
Facing technical difficulties in testing a substance usually leads to the inability to provide the requested information by the deadline set in the decision. In this case, we advise you to update your registration dossiers by the deadline and, if necessary, include any relevant explanations and proof concerning the status of any pending information requirements, including 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. For these cases, please see Q&A No 1064
General questions

What is REACH and where do I find more information about it?

REACH stands for the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation entered into force on 1 June 2007 to streamline and improve the former legislative framework for chemicals of the European Union (EU). REACH also created the European Chemicals Agency (ECHA) which has a central co-ordination and implementation role in the overall process. ECHA is located in Helsinki, Finland and manages the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the countries in which REACH applies.

The following sources of information about REACH are available:

Who is responsible for the enforcement of REACH?

Member States endorse national provisions defining controls and sanctions for non-compliance with REACH. We recommend you to contact the relevant enforcement authorities in your country for information on the national control procedures in place. You can also contact the customs authorities and the national helpdesk for further information:
https://echa.europa.eu/regulations/enforcement
http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks 

 

Who should I contact if I have a question on REACH?

The first points of contact on REACH are the national REACH helpdesks established in each country of the European Economic Area (EEA). They provide services in their local language(s) and know the national conditions (e.g. national legislation, enforcement authorities, etc.). : http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks

Trade associations, sector groups, chambers of commerce and other organisations, which are particularly familiar with sector-specific terminology, have set up stakeholder helpdesks to provide tailor-made support for their industrial sectors and products; e.g. plastics, minerals, mineral oils, paints.

ECHA provides assistance particularly to those companies that are registering substances and who have questions on e.g. REACH provisions, ECHA's IT systems and the administration of submitted dossiers.

For non-EU companies we have collected REACH information particularly concerning them, available at: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries. If the questions are related to the conditions in a particular country, you may also turn to the corresponding national REACH helpdesk (see the link above) before contacting ECHA.

Import of substances into the EU

To which territories does REACH apply?

REACH is a EU Regulation that directly applies in all Member States of the European Union. REACH is of EEA (European Economic Area) relevance as it has been incorporated into the Agreement on the European Economic Area. This means that REACH also applies in Iceland, Liechtenstein and Norway. Substances imported into the EEA from Switzerland (a non-EU country belonging to the European Free Trade Association but not to the EEA) are treated under REACH in the same way as substances imported from any other non-EEA country. The Member States are best placed to explain how REACH applies to their territories (autonomic areas or overseas territories). We therefore recommend contacting the national REACH helpdesk of the relevant country to clarify specific questions in this regard.

What are the obligations of non-EEA companies?

Manufacturers established outside of the European Economic Area (EEA)/EU do not have direct obligations under REACH, as the EU importer needs to comply with the obligations.  Non-EU companies exporting substances to the EU can (but are not obliged to) appoint an "only representative" to fulfil the obligations of importers. More guidance on only representatives can be found at:
http://www.echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/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 available at:
http://www.echa.europa.eu/guidance-documents/guidance-on-reach

For further information, see also the webpage concerning the non-EU companies: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries

 

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.

What are the obligations of importers of articles?

Under some circumstances, article importers have to register or notify substances in articles to ECHA (see Article 7 of REACH): these obligations are in general the same as for producers of articles. When placing articles on the market in the EEA, importers of articles may also have to communicate information on substances in their articles to their customers. In order to establish whether registration, notification or communication duties apply, any importer of articles is advised to follow first the Guidance in a Nutshell on requirements for substances in articles: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/guidance-in-a-nutshell.

Who is an importer?

An importer is any natural or legal person established within the Community who is responsible for import (Article 3(11) of the REACH Regulation). Import means the physical introduction into the customs territory of the Community (Article 3(10)).

The scope of the customs territory of the Community is defined in the relevant Community legislation on customs that should be consulted for further information. [Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code].

It is important to note, however, that the REACH Regulation and the Customs legislation are independent from each other.

Please note that according to Article 3(12) of REACH, the import of a substance on its own, in mixtures or in articles manufactured or produced outside the European Union is considered to fulfil the conditions for placing the substance, mixture or article on the Union market.

As stated in Section 1.5.3.3 of the Guidance on Registration, the responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, but this might not be conclusive on its own. This Guidance can be found on the ECHA website at: http://echa.europa.eu/support/guidance.

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

I submitted my inquiry dossier to ECHA. What happens next?

Once you have submitted your inquiry dossier to ECHA, REACH-IT will execute a series of automatic verifications after which we will manually assess your dossier. The assessment can lead to two different outcomes:

  1. If we are able to process your inquiry dossier, you will receive a communication via REACH-IT providing you with an inquiry number as well as details of available (robust) study summaries, as appropriate. You will also receive 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 to use it in your registration dossier. At the end of the Submission Report related to your inquiry dossier (in REACH-IT) there is a button that will allow you to download the i6z file to be used when preparing your registration dossier. 
  2. If we are not able to process your inquiry dossier, due to missing and/or inconsistent substance identification information, you will receive a communication via REACH-IT detailing the changes that you need to make to your inquiry dossier. In this case, you will need to submit a new inquiry dossier.
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 does a Third Party Representative (TPR) function in the inquiry process?

We display on the Co-Registrant page in REACH-IT the contact details of the third party representative (TPR) to registrants and successful inquirers. However, we communicate the result of the inquiry process to the inquirer and not to a designated TPR.

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.

What is the timeframe for processing an inquiry dossier?

The REACH Regulation does not impose any timeframe on ECHA for processing an inquiry dossier. Whilst the internal timeframe is 20 working days, we aim to provide the inquiry result as promptly as possible.

I am a potential registrant of an intermediate. Where can I specify this fact in my inquiry dossier?

Inquiry and registration of intermediates are regarded as two distinct processes. For this reason, it is not necessary to specify in your inquiry dossier the type of registration you plan to submit.

I am a potential registrant of an intermediate. Do I have to submit analytical data as part of my inquiry, even though it is not required for the registration?

Yes. Irrespective of the type of registration, you have to submit analytical data as part of your inquiry. The analytical data has to be sufficient to allow ECHA to verify the identity of your substance. This is to enable ECHA to provide you with the contact details of registrants and successful inquirers of the same substance.

Where can I find further information that would help me prepare my inquiry dossier?

When preparing your inquiry dossier, we recommend that you read the following documents:

 

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, please consult the Data Submission Manual - part 4 (How to Pass Business Rule Verification ("Enforce Rules")), available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-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. 

 

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.

Do I have to wait for the result of my inquiry before submitting my registration?

Yes. 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.

I need to update my registration as a result of a tonnage band increase. Do I need to submit an inquiry?

Yes, but only if you need additional information to update your 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".

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

How can I, as a potential registrant, find the lead registrant of the substance I intend to register?

Go to the Co-Registrants Page, and under the "Registrants" tab, you can see everyone that has already registered your substance.

The lead registrant, if there is one, will be identified in the column "JS role". The lead will also be published on ECHA’s webpage, unless they claimed their identity confidential.

You can also find further tips under the following link: http://echa.europa.eu/support/registration/finding-your-co-registrants/preparing-to-join-an-existing-sief.

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, REACH (as per Article 27(2) and (3)) requires both the potential and previous registrants to make every effort to agree on the sharing of the information and its costs in a fair, transparent and non-discriminatory way. You can find practical advice on data sharing negotiations at: http://echa.europa.eu/support/registration/working-together/practical-advice-for-data-sharing-negotiations

 

In case you fail to reach such an agreement you may, as a last resort, contact ECHA in accordance with Article 27(5) or Article 30(3) of the REACH Regulation. For more details, please find more information at: http://echa.europa.eu/support/registration/working-together/data-sharing-disputes/data-sharing-disputes-in-practice

 

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

No. REACH requires that new testing of a substance involving vertebrate animals can only be carried out as a last resort. Therefore, 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.

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 the REACH Regulation. Instead, you must submit a testing proposal in your registration dossier. We will then evaluate whether the testing proposal is adequate before such a test is performed.

I registered a substance in the past and today I received an ECHA message informing me of a new potential registrant for the same substance. What do I do next?

This communication is for your information only (as per Article 26(3)), so you do not need to take any action. However, in case your information was submitted 12 years prior to the inquiry, and if a potential registrant requests this information from you, REACH requires that you respond in order to enter into negotiation to reach an agreement on the sharing of this information and their associated costs (as per Article 27(2), (3) and (4)). You are required to make every effort to reach a fair, transparent and non-discriminatory agreement on sharing the data and its cost. You may also consider preparing for the potential request for data sharing by ensuring that you comply with the criteria outlined in the Implementing Regulation on joint submission and data sharing. For more information, see the new draft Guidance on data sharing, Chapter "5. Cost sharing".

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 obligation. It is accessible to existing registrants 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.

Registrants can see different information depending on their status:

  • Potential registrants, during the 12 months after successfully submitting their inquiry, can see all registrants. However only the leads are identified.
  • Potential registrants, beyond the 12 months 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.

In case the substance subject to the inquiry process has been pre-registered, inquirers will also be informed about the pre-SIEF members. 

 

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.

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.

In 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 in 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.
Can I appoint a Third Party Representative (TPR) after having registered the substance for which I had previously inquired?

Yes. You can appoint or change your Third Party Representative (TPR) by updating your registration dossier.

I intend to register a non-phase-in substance. How can I find out whether a list number is available for my substance?

Before submitting the registration for a non-phase-in substance, you will need to submit an inquiry (Article 26 of the REACH Regulation). Upon the successful processing of your inquiry, ECHA will provide you with a list number which you will be requested to use when submitting your registration.

Please note that you will also need to submit an inquiry for an EINECS-listed substance which you did not pre-register.

Intermediate

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 registrantmust ensure that the substance is handled under strictly controlled conditions thorughout its lifecycle - also if it undergoes a purification. It must also be ensured that te substance is alwaysmanufactured 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

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.

Joint submission of data by multiple registrants

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’ at: https://echa.europa.eu/manuals

 

Does a joint submission dossier need to include all available studies?

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 available at: http://echa.europa.eu/guidance-documents/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.

 

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: http://echa.europa.eu/guidance-documents/guidance-on-reach.

NONS-Registrants of Previously Notified Substances

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.

 

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).

Notifications of Substances in articles

A. General Q&As (applicable for more than one Annex XVII entry)

Where can I find the Candidate List?

The Candidate List and additional useful information is published on ECHA's website.

You can find the Candidate List at:
http://echa.europa.eu/candidate-list-table
 

What is the Candidate List?

Substances fulfilling one or more of the criteria specified in Article 57 of the REACH Regulation can be identified as "substances of very high concern" (SVHC) and put on the "Candidate List". These SVHC can be:
- substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 A or B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008
- persistent, bioaccumulative and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances (according to the criteria of Annex XIII of the REACH Regulation)
- substances for which there is evidence for similar concern (Article 57(f) of the REACH Regulation), such as endocrine disruptors

Substances are identified as SVHC according to the procedure established by Article 59 of the REACH Regulation.

How is the Candidate List updated?

The Candidate List is updated when substances are identified as Substances of Very High Concern (see above). This is normally done twice per year (in June and December). To allow interested parties to be aware of substances which might be included in the Candidate List, a Registry of Intentions is published on the website of ECHA. As a producer or importer of articles, you are advised to regularly check the Registry of Intentions. This can help you to prepare for possible obligations that could arise when a substance is included in the Candidate List.

What is an article?

Article 3(3) of the REACH Regulation defines an article as "an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition". Chapter 2 of the Guidance on requirements for substances in articles provides information on how to determine if an object fulfils the above definition, including instructions on how to address borderline cases (Appendix).

Is packaging considered part of the article?

Packaging is considered a separate article under REACH. Please refer to section 2.3 of the Guidance on requirements for substance in articles for more information.

Is there any fee for a substance in articles notification?

There is no fee charged for the notification.

I have stopped production/import of the article containing the Candidate List substance. Do I have to notify?

If the production/import ended before the substance was included in the Candidate List or before the notification obligation starts to apply (i.e. 1 June 2011 for substances placed on the Candidate List before 1 December 2010 or 6 months after a substance has been included in the Candidate List) then you do not have to notify. Please note, however, that for the information requirements specified in Article 33 of the REACH Regulation the date of supply of the article is the relevant date, i.e. the obligations also apply to the producers and suppliers of articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Please refer to section 4.3 of the Guidance on requirements for substances in articles for additional information.

Do I have to take into account the tonnage of the substance in articles produced/imported before the substance was put in the Candidate List?

Once a substance enters the Candidate List you have to determine if you have the obligation to notify. One of the inputs needed to determine this is the tonnage of the substance in imported/produced articles per calendar year (or the average of the three previous years if the article has been imported/produced during three years before the start of the notification obligation). In this calculation, you have to include the tonnage in articles imported/produced for the full calendar year, i.e. if applicable, also before the date of the inclusion of the substance in the Candidate List. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.

Do I need to notify Candidate List substances in articles made from recycled material?

The notification obligation also applies to producers or importers of articles containing recycled material.

If you are a producers or importer, you must assess whether the articles you produce or import fall under the criteria of Article 7. It may be difficult to know the exact concentration of a Candidate List substance in, for example, recovered polymers where the concentration varies between each batch.

If your company concludes that the articles contain less than 0.1% of the Candidate List substance, we recommend you to document your basis for this conclusion in case of enforcement.

Can I appoint an only representative (OR) to submit a substance in article notification?

Yes. The only representative has to be a natural or legal person established in the Community to fulfil the obligations of non-EU manufacturers under Title II of REACH (Article 8).

The provision of Article 7(2) on notifying Candidate List substances in articles is part of Title II of the REACH Regulation. Therefore, an OR can be appointed by a producer of an article outside the EU to submit a substance in articles notification.
 

What use will be made of the substance in article notifications? Will they trigger new registration requirements?

The notifications will not trigger a decision to register the substance in articles, as such. However, the notification information can be used in addition to several other sources (e.g. registration information) to support identification of further needs for risk management.

If there are grounds for suspecting that the substance is released from the articles under normal or reasonably foreseeable conditions of use and such a release presents a risk to human health or the environment, you may be required as a producer or importer of articles to submit a registration. These decisions will be taken on a case-by-case basis and are not restricted to Candidate List substances.
 

What are the enforcement activities and the penalties foreseen?

Enforcement of the REACH Regulation, including the obligation to notify Candidate List substances in articles, is in the remit of the authorities of the individual Member States.

You can find the contact details at: http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks.

 

Who should I contact if I have further questions?

You should contact your national REACH helpdesk: http://echa.europa.eu/support/helpdesks/national-helpdesks

If you have questions on technical issues on REACH-IT, the link is available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it and for questions related to IUCLID 6 at: http://iuclid.eu/ or if you are not in the European Economic Area (EEA), you may contact the ECHA Helpdesk: http://echa.europa.eu/support/helpdesks/echa-helpdesk.

If you would like to check your general obligations under the REACH Regulation and how to fulfil them, you should use the Navigator: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.

For general guidance on the provisions of REACH that apply to substances in articles, you should consult the Guidance on requirements for substances in articles available at: http://echa.europa.eu/guidance-documents/guidance-on-reach.

For guidance on how to submit a notification (Article 7(2) of REACH), you should consult:

 

Derogations

Am I exempted from notification?

You are exempted from notifying if:

  • you can exclude exposure of humans and the environment to the Candidate List substance in the articles during normal or reasonably foreseeable conditions of use, including disposal. Chapter 6.3 of the Guidance on requirements for substances in articles provides information on exposure-based exemptions from notifying: http://echa.europa.eu/documents/10162/13632/articles_en.pdf
  • The substance is already registered for that use. Chapter 6.4 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: http://echa.europa.eu/documents/10162/13632/articles_en.pdf

If you conclude that you are exempted from notifying, in line with one of the two cases above, we recommend that you carefully document the basis for and the reasoning behind this conclusion. In this way, you will be prepared for any enforcement activities at national level.

How can I prove that there is no exposure to the Candidate List substance present in my article?

A producer/importer of an article wanting to demonstrate 'exclusion of exposure' has to ensure that the Candidate List substance does not come into contact with humans or the environment during the use and disposal of the article. For more information on exposure-based exemption from notification see chapter 6.3 of the Guidance on requirements for substances in articles (http://echa.europa.eu/documents/10162/13632/articles_en.pdf). Note that in practice it may be more difficult and costly to demonstrate "no exposure" than to make a notification.

How do I find out if the substance is already registered for a particular use? Can I use information that is disseminated on the ECHA website?

A substance has already been registered for a particular use, if two conditions are fulfilled:
- The substance in question has already been registered, and
- The use in question is the same as one of the uses described in an existing registration of this substance.

For more see chapter 6.4 of the Guidance on requirements for substances in articles.

ECHAs dissemination portal (http://echa.europa.eu/information-on-chemicals/registered-substances) contains information on registered uses, taken from section 3.5 of the IUCLID registration dossier and based mostly on the so called use descriptors. However due to the generic architecture of the use descriptors, this description is generally not sufficient to conclude on the sameness of two uses for the purpose of establishing whether an exemption on the basis of Article 7(6) of the REACH Regulation applies. The published information that a substance has been registered for use in the Article Category 'Plastic articles' does not necessarily mean the registration is made to cover all plastic articles. It could mean that use of the substance in production of some specific plastic articles is covered and described in the registration, while other plastic articles are not covered and assessed. The uses of two very different plastic articles may lead to very different exposures to humans and the environment. If the exposure related to the use of your article is not adequately assessed in a registration dossier, it cannot be considered a registered use.

Please note that there are limited possibilities to include information in section 3.5, apart from the use descriptors. Section 3.5 of the IUCLID registration dossier may however contain 'free text' information, which is not based on the use descriptor system. Whether such information is sufficient to conclude on the sameness of use has to be examined on a case by case basis.

Most producers of articles are also downstream users under the REACH Regulation and as such have certain obligations outlined in Title V of the REACH Regulation. Since most substances on the Candidate List are already registered, producers of articles should already have communicated their use to the registrant for the purpose of registrations. Producers of articles will therefore not have to notify in most cases.

Importers of articles may not have access to detailed information on registered uses. If you are not certain that your specific use is already registered you should notify.

I am using a CMR/PBT/vPvB in articles however this substance is not in the Candidate List. Do I need to notify?

Notification requirements apply only to substances already included in the Candidate List and meeting the criteria in Article 7(2) of the REACH Regulation. Therefore, if a substance is not yet in this list there is no need to notify. However, please note that CMR/PBT/vPvB and substances of equivalent concern that fulfil the criteria of Article 57 of the REACH Regulation can be included in the Candidate List. It is advised to keep track of the use of these substances in your articles and to follow the development of the Candidate List via the Registry of Intentions. By signing up for the ECHA e-News (http://echa.europa.eu/news-and-events/news-alerts) you will be alerted every time the Candidate List (http://echa.europa.eu/candidate-list-table) or Registry of Intentions (http://echa.europa.eu/addressing-chemicals-of-concern/registry-of-intentions) is updated with new substances.

How to determine if the notification obligation applies

How do I calculate the concentration of a Candidate List substance in my article?

One of the conditions that triggers your obligation to notify is when the concentration of the Candidate List substance exceeds 0.1% w/w in the article.

You should calculate the concentration of the substance for each article as produced or imported. This threshold applies to each article of an imported object made up of more than one article, which were joined or assembled together.
 

How do I calculate the total amount of the Candidate List substance in my articles?

One of the conditions that triggers the obligation for you to notify is when the total amount of the Candidate List substance present in all articles produced and/or imported exceeds one tonne per actor per year.

The articles concerned should contain more than 0.1% w/w of the substance. If an article contains the substance at a concentration below 0.1% w/w, this article does not have to be included in the tonnage calculation.

The one tonne per year limit applies to the total tonnage produced/imported, in the European Economic Area (EEA) by the same legal entity. The tonnage is not calculated separately for different EU Member States if the legal entity is the same.

If you believe you are close to one of the thresholds but are unsure whether you exceed it or not, we recommend you to notify.

Chapter 4.5 of the Guidance on requirements for substances in articles provides explanations and examples on how to calculate this.

How do I know that a Candidate List substance is present in my article?

The information you need can often be derived from standardised information that is obtained from suppliers of substances/mixtures based in the European Economic Area - EEA (e.g. safety data sheets (SDSs) or, where a SDS is not required, safety information and regulatory requirements (Article 32 of the REACH)).

In the EEA, suppliers of articles containing more than 0.1% of a Candidate List substance must provide available and relevant safety information (Article 33 of the REACH), including, as a minimum, the name of that substance.

Proactive requests in the supply chain are often useful to obtain the necessary information, in particular when the supplier of the article is outside the EEA. As a last resort, chemical analysis of the article could be considered.

For more information, see Chapter 5 of the Guidance on requirements for substances in articles:
http://echa.europa.eu/documents/10162/13632/articles_en.pdf

Do I need to notify and communicate information down the supply chain for certain boron substances included in the Candidate List, which are involved in the production of boron glass articles but not present as such in these articles?

The obligation to notify under Art. 7(2) of REACH and to communicate down the supply chain under Art. 33 of REACH only applies to articles which contain Candidate List substances.

Certain boron substances included in the Candidate List, such as diboron trioxide, boric acid and disodium tetraborate, are involved in processes leading to the production of articles containing “borosilicate glass”. In these processes, the boron substances are usually first chemically transformed into a manufactured glass substance. The glass substance is subsequently processed into articles. In these usual cases, the boron substances are completely transformed and not be present as such in the final glass article. Consequently, there is no obligation to notify under Art. 7(2) of REACH, nor to communicate information down the supply chain under Art. 33 of REACH.

Please note that it remains the responsibility of companies to assess for their specific use of the Candidate List boron substances whether these are completely transformed into glass in the manufacture of “borosilicate glass” and whether the Candidate list substance is present in the boron glass articles.

Information Requirements

Submitting using the webform

The webform contains all the necessary instructions needed to succesfully fill in and submit your notification.

How can I provide substance identity information when notifying a substance in article?

This information should be provided in the IUCLID file. As a minimum it includes the substance name and/or EC and CAS numbers.

To improve the submission process, ECHA publishes pre-filled substance datasets with substance identity information in the Candidate List.

Substance identity information is also available in the "supporting documentation column" of the same webpage. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
http://echa.europa.eu/manuals

The Candidate List can be found at: http://echa.europa.eu/candidate-list-table 
 

How can I provide information on classification and labelling when notifying a substance in articles?

This information should be provided in the IUCLID file. To improve the submission process, ECHA publishes pre-filled substance datasets with classification information in the Candidate List.
Classification information is also available in the "supporting documentation column" of the same webpage. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
http://echa.europa.eu/support/dossier-submission-tools/reach-it

The Candidate List can be found at: http://echa.europa.eu/candidate-list-table

How can I describe the use of the Candidate List substance in my article?

This information should be provided in the IUCLID file (section 3.5), by using the descriptor "Technical function of the substance". Chapter 5.9 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) provides guidance on how to fill these IUCLID section.

How can I describe the use of my article?

This information should be provided in the IUCLID file. There you should give:
- a brief description of the article and its use(s) in free text under "Further description of article" (section 3.5 of IUCLID).
- a brief description of the use of the article during its service life using the use descriptor system (section 3.5 of IUCLID). For articles the relevant descriptors are the following:
> Article category (AC) related to subsequent service life
> Environmental release category (ERC)
> Process category (PROC) for articles used by workers
> Technical function of the substanceExposure related description of article (section 3.5 of IUCLID)
- Indicate if the article is used by consumers and/or workers.

Similar articles with similar uses can be grouped under the same use description. Chapter 5.9 of the Data Submission Manual provide guidance on how to fill these IUCLID sections.

How can I provide the tonnage range?

This information should be provided in the IUCLID file. There you should give: As a minimum requirement, the tonnage range is to be provided in the IUCLID Dossier Header. In section 3.2 of IUCLID, producers and importers of articles can indicate the tonnage of the Candidate List substance contained in the produced/imported articles. In section 3.5 you have the possibility to provide more detailed information (tonnage of substance per use) if you so wish. Chapter 5.7 of the Data Submission Manual provides guidance on how to fill these IUCLID section, including which years to base the calculation on.

When do I have to submit information on my production site?

Is it possible to include several sites in the same notification?Only producers of articles who manufacture their articles in the European Economic Area (EEA) will have to enter their production sites. Article importers do not need to fill in this information. Please refer to Chapter 5.8 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) for additional information. If a company has several sites producing articles, it can list all the sites in one notification. Different notifications should not be made for different sites if the sites belong to the same legal entity. 

What are the pre-filled substance datasets?

To facilitate the submission of notifications ECHA has made available pre-filled substance datasets in IUCLID format (i6z files) for substances on the Candidate List. These datasets contain information on substance identification, composition and classification and labelling. Each substance has its own pre-filled dataset, which can be downloaded from the Candidate List webpage. Chapters 3 and 4 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) provide information on how to download and use the datasets.

How can I find the registration number?

The registration number only needs to be included in the notification dossier if the substance has already been registered and the registration number is available to the notifier. If the article is imported from outside the EU, this field does not need to be filled. Producers of articles, incorporating the Candidate List substance into the article themselves, should normally have access to the registration number via the Safety Data Sheet (SDS) for the substance. In this case, the article producer is likely to be exempt from the notification obligation however he should verify that his use is indeed covered by the registration.

Submitting via REACH-IT

If available, the registration number should be provided in the IUCLID file (section 1.3). Chapter 5.5 of the Data Submission Manual provides guidance on how to enter this information in IUCLID.

Which is the "per year" definition for notification purposes?

Article 3(30) of the REACH Regulation specifies that "per year" means "per calendar year", i.e. 1st January – 31st December. However, for the purpose of the tonnage calculation, if the article has been manufactured or imported for at least three consecutive years the average volume of the preceding three years is recommended to be used. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.

At which stage of the manufacturing process do I have to notify?

Notification is required from producers or importers of articles, therefore you have to notify only when the object manufactured/imported is an article. Please refer to Chapter 2 of the Guidance on requirements for substances in articles for additional information on the distinction between a substance/mixture and an article.

Submission of the notification dossier

How can I submit a notification using the webform?

The webform is an easy-to-use tool accessible from the ECHA website for notifying substances in articles. All instructions and information requirements to carry out the notification are provided at every step. Submitting the notification using the webform is recommended to all users, especially those who are not familiar with IUCLID.

The webform simplifies the notification process as there is no need to download a pre-filled substance dataset, use IUCLID or follow the data submission manual (these are necessary only when submitting via REACH-IT).

Be aware, however, that if you notify your substance in articles with the webform, none of the information submitted can be claimed confidential.

How can I submit a notification via REACH-IT?

This method is recommended for notifiers who are already users of IUCLID and who want to maintain their report records in the REACH-IT system. It is also recommended to those who want to report a different substance identification, composition, or classification and labelling information or to those who wish to indicate part of the information included in the notification as confidential (in addition to information which is always treated as confidential, see Article 118 of REACH).

The notification is made using the IUCLID 6, which can be downloaded free of charge from the IUCLID web page (link to: http://iuclid.eu/) and submitted to ECHA via REACH-IT. The Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) provides detailed and illustrative assistance to successfully carry out the notification.

To facilitate the submission of the information required to complete a notification, ECHA has created pre-filled substance datasets in IUCLID 6 format for substances on the Candidate List. These datasets contain information on substance identification, composition and classification and labelling. Each Candidate List substance has its own pre-filled dataset, which can be downloaded from the Candidate List webpage (http://echa.europa.eu/candidate-list-table).

Once you have created your Substance in Articles notification dossier, it is recommended to use the Technical Completeness Check (TCC) tool. This IUCLID 6 plugin will detect any missing information in your dossier before exporting it and submitting it to ECHA through REACH-IT. You can download the latest version of the TCC plugin from the IUCLID 6 web page (http://iuclid.eu/).

What is the deadline for notification?

A notification of a substance in articles shall be made at the latest 6 months after the substance has been included on the Candidate List. The obligation started to apply from 1 June 2011.

What are the implications if one fails to submit a notification in time? Can it be done later?

If you have the obligation to notify a substance in your articles and the deadline has already passed you are encouraged to notify immediately. You might face national enforcement sanctions if you fail to meet the deadline. Although ECHA accepts notifications after the legal deadline, this does not prevent your national enforcement authorities to impose sanctions on you.

What if I start to import the substance after it has been included in the Candidate List?

If the import of the substance starts after the notification deadline has expired (i.e. 6 months after the inclusion in the Candidate List), notifications must be made without undue delay as soon as the conditions related to the notification obligation are met, i.e. as soon as the 1 tonne per year threshold has been exceeded.

How many articles can I submit in one notification for the same substance?

One notification should be submitted for all the articles produced or imported containing the same substance by/to one legal entity. You are however requested to indicate the uses for each different type of article in your notification.

Is it possible to submit a single notification for different substances or different importers/manufacturers?

No, it is necessary to submit a separate notification for each substance and for each importer/manufacturer.

Do I have to update my notification?

In order to be able to demonstrate compliance with your obligations, you are recommended to update your notification if the information included in the notification changes. Examples of important changes could be: change in tonnage range, production/import of different articles (with e.g. different use) containing the same substance etc.

How can I update my notification of substances in articles using the webform?

You cannot update a notification that was submitted with the webform. Instead, a new notification will need to be created from scratch and submitted to ECHA.

If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality.

How can I update my notification of substances in articles using REACH-IT and IUCLID?

If you submitted your notification of substances in articles using a IUCLID dossier, you can update your IUCLID dataset and submit the dossier update via REACH-IT.

If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality.

For more information, see Chapter 8 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it).

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-EEA companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance. 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.

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 entity you need to:

  • create a new account to represent the new legal entity, reflecting their size;
  • follow the instructions in ‘Change of OR' from Industry User Manual 17;
  • 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'.

You may need to pay a fee to complete the process.

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.

Pre-registration

Changes to pre-registration after 1st December 2008

Is it possible to modify the data entered during a pre-registration?

A pre-registration can be modified with the exception of the Substance ID and the UUID assigned to that pre-registration. You can manually modify contact information (both internal and third party representative), similar substances, tonnage/deadline and the information in the remark field of the pre-SIEF.

Further information on how to delete, deactivate or modify a pre-registration are explained in detail in Q&A 346.

Is it possible to transfer a pre-registration from an importer to an only representative?

No, it is not possible to transfer pre-registrations from importers to an only representative.

Further information on the general principle of legal entity change can be found in Chapter 1.5.3.1 of the Guidance on Registration at: https://echa.europa.eu/guidance-documents

Duties following from pre-registration

What are the duties following from pre-registration?

For each substance you have pre-registered, a pre-SIEF page is set up in REACH-IT. In the pre-SIEF page, you will find the contact information of the other companies that have pre-registered with the same substance identifier (e.g. EC number).

You need to contact each other to see who will be the lead registrant and if your substances are the same.

In the SIEF, you will share the data you have on your substance with your co-registrants, share costs and prepare the joint registration.

The aim of a SIEF is to avoid duplicating the testing of substances and to agree on their classification and labelling. In a SIEF, companies must share animal testing studies to keep these tests to an absolute minimum. They may also share other data relevant for REACH. It is an opportunity to generate and obtain the registration information required by the REACH Regulation in a cost-effective manner.

I have a valid pre-registration. Am I allowed to cease manufacture or import at the end of the extended registration deadline?

According to Article 28 of the REACH Regulation, a pre-registrant can benefit from the extended registration deadlines specified in Article 23. Pre-registration does not establish any obligation to maintain the manufacturing process or import of a substance. You should bear in mind, however, that other SIEF members may ask you to provide them with information required for the purposes of registration and, if you are in possession of such information, you will have to supply it.

Is the submission number proof that my substance has phase-in status?

No, it is not. Neither the receipt of the submission number nor the receipt of the pre-registration number constitutes evidence that your substance has phase-in status.

To determine whether your substance is a phase-in or a non-phase-in substance, refer to Section 1.7.1 of the Guidance on registration, available at: http://echa.europa.eu/support/guidance.

The pre-registration of a phase-in substance without an EC number does not require the potential registrant to submit documentary evidence showing the phase-in status of a substance within the meaning of Article 3(20) of the REACH Regulation in the pre-registration (see Article 28(1) of the REACH Regulation).

Nevertheless, pre-registrants have to confirm in the pre-registration that they are willing to claim phase-in status for their substance. Manufacturers/importers need to keep this information at the disposal of the enforcement authorities of the Member States at any time.

How can I use the pre-registration number?

The pre-registration number is a confirmation that the pre-registration has been received by ECHA. It is up to each pre-registrant to decide how to use this information.

Do I need to indicate the pre-registration number on safety data sheets (SDSs)?

In general, the REACH Regulation does not govern the use of the pre-registration number. As Member States are responsible for enforcing REACH, individual Member States may have national requirements concerning the communication of the pre-registration number.

However, the registration number (when eventually assigned) has to be indicated on the safety data sheet, as laid down in point 1.1 of Annex II to the REACH Regulation. More information on registration numbers can be found in Section 7.4 of the Guidance on registration, available on ECHA’s website: http://echa.europa.eu/support/guidance

How will the pre-registration data be used?

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 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 Section 1.7.1.1 – Phase-in substances of the Guidance on

registration at: http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.
Which are the different registration deadlines?

Article 23 of the REACH Regulation provides for a scheme with different registration deadlines for so-called ’phase-in substances’, depending on the tonnage band and hazards of the substance.

The respective deadlines to submit a registration dossier to ECHA are as follows:

  • 30 November 2010 for CMR (Classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, in accordance with Directive 67/548/EEC.) ≥ 1 tonnes/year, R 50-53 (Classified as very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment (R50-53) in accordance with Directive 67/548/EEC.) ≥ 100 tonnes/year and other substances ≥ 1 000 tonnes/year; or
  • 31 May 2013 for other substances ≥ 100 tonnes/year; or
  • 31 May 2018 for other substances ≥ 1 tonne/year.
How do I calculate the tonnage to determine the respective registration deadline?

The actual amount of manufacture and/or import, the forecasted tonnages and how hazardous the substance is, defines the relevant registration deadline. The envisaged yearly quantity has to be calculated per calendar year.

Detailed guidance and practical examples are provided in the Guidance on Registration (Section 1.6.2 – Calculation of volume to be registered and Article 3 (30) of the REACH Regulation): http://echa.europa.eu/support/guidance

What are pre-registration and late pre-registration numbers?

Every successfully (late) pre-registered phase-in substance received a (late) pre-registration number. This reference number is unique to every company and pre-registered substance.

The structure of the (late) pre-registration number:
<TYPE>-<BASE-NUMBER>-<CHECKSUM>-<INDEX-NUMBER>

Examples:
05 - 1234567890 - 49 - 0000
17 - 1234567890 - 49 - 0000

Where:

  • 05 is the pre-registration type (submitted before 01/12/2008)
  • 17 is the late pre-registration type (submitted between 01/12/2008 and 31/05/2017)
  • 1234567890 is the random unique 10-digit number
  • 49 is the calculated checksum (changeable 2-digit number)
  • 0000 is the index number

(Late) pre-registration numbers have the same format as other reference numbers automatically assigned by REACH-IT.

Can I, as a downstream user, check the pre-registration number online and see if my supplier pre-registered?

No, there is no functionality in REACH-IT that would accommodate and distribute this information as it could be considered confidential business information. Downstream users are advised to make appropriate contractual arrangements with their suppliers to ensure that they comply with REACH and have a valid pre-registration.

If you are in doubt and need verification, please contact your local enforcement authority for more information. 

Does a downstream user have pre-registration obligations?

A downstream user who is not manufacturing or importing substances is not required by the REACH Regulation to pre-register a phase-in substance. However, a downstream user of a substance that does not appear on the list of pre-registered substances published by ECHA, may notify ECHA of their interest in the substance, their contact details and the details of their current supplier. ECHA can then provide contact details of the downstream user to a potential registrant.

The ECHA website provides public information and documents from REACH processes such as the list of pre-registered substances or downstream users’ notifications as they become available at: https://echa.europa.eu/information-on-chemicals.

More information on the obligations of downstream users is available in 22 EU languages in the Guidance for Downstream users. Please change the language in the top right corner at: https://echa.europa.eu/guidance-documents.

Can a downstream user participate in a SIEF and 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. https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf

What should I do if nobody in the pre-SIEF replies to my emails?

A pre-SIEF might have many participants, but it is possible that most of them are undecided about registration or have decided not to register. The status ‘Inactive’ in the pre-SIEF indicates that the company will not register, but not all companies use it.

If companies do not reply to your emails, you might want to try contacting them in another way (if their email address is outdated). You might limit this to companies you are familiar with and who you think might be registering.

It will also be helpful to download the pdf file of pre-registrants at regular intervals to see if any changes to contact details have been made. Please note that communications might be filtered out as spam.

If further communication attempts remain unanswered, document the attempts made and prepare to register your substance alone. Communicate your progress by email to the others in the pre-SIEF. Think about becoming the SIEF Formation Facilitator (SFF) so you can indicate in the pre-SIEF how others can contact you.

If your substance is a complex substance, consider the possibility that other manufacturers/importers of the substance used other identifiers for the substance and are in a different pre-SIEF. Look in the list of pre-registered substances for pre-SIEFs you could potentially merge with.

How do you merge a pre-SIEF?

To merge pre-SIEFs, you will need to do the following:

  • Contact the other pre-SIEF;
  • Establish which pre-registrant should be the lead registrant of the joint submission;
  • The lead registrant should create a joint submission in REACH-IT for the substance;
  • The lead registrant should use the pre-registration number to create the joint submission only if the identity of the substance as specified in the pre-registration specifically and correctly identifies the substance to be registered;
  • Every member of the joint submission should use the same chemical identifiers used by the lead registrant to create the joint submission in REACH-IT;
  • Members of a joint submission, as any other registrant, should individually provide the information on the identity and compositions of their own substance. This information should correspond to their substance as manufactured. Members of a joint submission should therefore not provide generic compositions or duplicates of compositions provided by other registrants, as appropriate.
How do you split a pre-SIEF?

To split a pre-SIEF, you will need to do the following for each substance covered by the pre-SIEF:

  • Establish, among those pre-registrants having the same substance, which pre-registrant should be the lead registrant of the joint submission.
  • The lead registrant should create a joint submission in REACH-IT for that substance;
  • The lead registrant should ensure as far as possible that a distinction can be made between the identity of the substance as defined in the joint submission and the other substances also covered by the pre-SIEF. For this purpose, the lead registrant may need to enter manually the correct and specific identity of the substance rather than use the pre-registration number;
  • Every member of the joint submission should use the same chemical identifiers used by the lead registrant to create the joint submission in REACH-IT;
  • Members of a joint submission, as any other registrant, should individually provide the information on the identity and compositions of their own substance. This information should correspond to their substance as manufactured. Members of a joint submission should therefore not provide generic compositions or duplicates of compositions provided by other registrants, as appropriate.
Is it still possible to benefit from the specific provisions for phase-in substances?

No. The deadline to benefit from the specific provisions for phase-in substances was 31 May 2017.

If you are a first-time manufacturer or importer of a substance, you will need to submit an inquiry to ECHA. You can find further information on the inquiry process under Q&A 444.

REACH Registration

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 FAQ 12.

In order to identify your obligations, please use the Navigator tool:
http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations

This tool is designed to help companies in determining their obligations under REACH and find the appropriate guidance on how to fulfil them.

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' available under the following link:
http://echa.europa.eu/documents/10162/13634/factsheet_toll_manufacturer_en.pdf

In case of an international company, who is the registrant?

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 FAQ ID=27 on who has to register a substance.

Which substances have to be registered?
Registration is required for all substances:
- as defined in Article 3(1) of REACH;
- manufactured in or imported into the EU in quantities of 1 tonne or more per registrant per year;
- unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 9, 15 or 24 of the REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
If you want to know whether you have to register a substance you should first consult section 2.2- 'What to register?' of the Guidance on registration. There you will also find information on substances exempted from registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition, the Navigator tool can help to clarify the registration obligations for your specific substance: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.
Do I have to register alloys?
The REACH Regulation refers to alloys as "special mixtures" (Recital (31), Annex I (0.11.), as amended by Regulation (EC) No 1272/2008). Therefore, an alloy is to be treated in the same way as other mixtures under REACH, which means that the alloy as such is not subject to registration but the alloying elements (e.g. metals), irrespectively of the production process of the alloy are. However, components which are not important for the properties of the alloy should be considered as impurities (i.e. they are part of a substance in the mixture) and therefore need not be registered separately. Please note that intermetallic compounds are often wrongly regarded as alloys, although they have a well defined stoichiometry. Such substances are listed in EINECS (e.g. "aluminium, compound with iron (1:1)", "iron, compound with titanium (2:1)", etc.) and cannot be regarded as mixtures, therefore these intermetallic compounds have to be registered as such. This means that e.g. separate (pre-)registrations of the substances Al and Fe do not cover the substances "aluminium, compound with iron (1:1)" or "aluminium, compound with iron (1:3)". For each intermetallic compound with a different metal ratio a separate (pre-)registration is required.
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
 

Do I have to register a substance occurring in nature if I have to apply a process to extract this substance?
Substances occurring in nature are exempted from the duty to register in accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as they are not chemically modified, not classified as dangerous in accordance with Directive 67/548/EEC, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 3(39) of the REACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered.
The processes mentioned in Article 3(39) of REACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 3(39) of REACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, point 8 of REACH.
Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 3(39) of REACH, the lavender oil can be regarded as a substance that occurs in nature.
On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature.
In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 3(39) of REACH is applicable or not.
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.
Have PORD exemptions under Directive 67/548/EEC been transferred into REACH?

National Process Orientated Research and Development (PORD) exemptions for the notification of substances under Directive 67/548/EEC are no longer valid under REACH since 1 June 2008, because there are no such notifications under REACH. Therefore, to benefit from the registration exemption, manufacturers or importers of substances or producers of articles wishing to continue their PORD activities need to submit a PPORD notification (REACH, Article 9). For guidance on how to prepare and submit a PPORD notification in practice, please consult the Data Submission Manual 1, available at:

http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-manuals

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.

Will a registration under the REACH Regulation be required for substances that are manufactured within the EEA but exported 100% outside of the EEA?
Yes. Article 6 of the REACH Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported outside of the EEA. Therefore, substances manufactured in the EEA above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the REACH Regulation and which are subsequently exported to non-EEA countries must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in the EEA.
Do I have to register chemically surface treated substances?
The surface treatment of a substance is a "two dimensional" modification of macroscopic particles. A "two dimensional" modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance.By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified.
Therefore a chemically surface treated substance cannot be regarded as a mixture nor be defined by the criteria of the Guidance for identification and naming of substances under REACH: http://echa.europa.eu/guidance-documents/guidance-on-reach.
With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance.Taking this decision up under REACH means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under REACH, but the following requirements should be fulfilled:
1. Registration of the basis substance (macroscopic particle)
2. Registration of the surface treating substance
3. Description of the use "surface treatment" in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
4. Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios.
Do I have to register substances used in medicinal products?2
According to Article 2(5)(a) of the REACH Regulation substances used in medicinal products for human or veterinary use within the scope of the relevant EU legislation are exempted from the Registration Title of the REACH Regulation (Title II). More explanation is provided for in Section 2.2.3.2- 'Medicinal products' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation are also exempt from the Titles on Downstream Users, Evaluation and Authorisation (Titles V, VI and VII of the Regulation).
Importantly, substances are exempted from these Titles only to the extent that they are used in medicinal products in accordance with Regulation 726/2004, Directive 2001/82 and Directive 2001/83. Quantities of the same substance used for other purposes are not exempted.
The exemption covers the manufacture (in the EU) of substances in medicinal products that are exported; and the manufacture (in the EU) of active substances within the scope of EU legislation on medicinal products that are exported. The exemption also applies to imports of substances in medicinal products and imports of active substances within the scope of the EU rules on medicinal products.
Intermediates that are not present in the medicinal product (as defined in Regulation 726/2004, Directive 2001/82 and Directive 2001/83) are not exempted from 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?

The answer to this question depends on your role at the time when the registration obligation applies.

REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). It does not on downstream users, distributors or suppliers of substances. Therefore, the registration obligation does not apply to you if you have:

  • manufactured or imported pre-registered substances before the registration deadline; and
  • ceased such activities and simply acted as a supplier after that.

If you have not ceased your activities before the relevant registration deadline, you must submit a registration dossier for all quantities of the substance manufactured or imported before and after the respective registration deadline.

In any case, any actor down the supply chain who is not subject to the registration obligation may continue to use and/or supply quantities of the substance that you have supplied to them before the registration deadline.

Is a metal hydroxide manufactured from the metal oxide covered by the exemption from registration in Annex V, point 6 of the REACH Regulation?
According to Annex V, point 6 of the REACH Regulation hydrates of a substance or hydrated ions, formed by association of a substance with water are exempted from registration, provided that the substance (i.e. the anhydrous form) has been registered by its manufacturer or importer.
 
Hydrates of a substance are characterised by the fact that water molecules are linked by molecular interactions, in particular by hydrogen bonds, to other molecules or ions of the substance. For the purposes of Annex V, hydrates and water free forms (anhydrous) of compounds shall be regarded as the same substance (e.g. CuSO4.5H2O and CuSO4).
 
In contrast, a metal hydroxide (e.g. Ca(OH)2) and a metal oxide (e.g. CaO) cannot be regarded as the same substance as both substances have different structures, regardless of the manufacturing process. The formation of the hydroxide involves forming new covalent bonds, which is different from forming a hydrate which only involves weak intermolecular bonds. Therefore a metal hydroxide manufactured from the metal oxide is not covered by the exemption from registration in Annex V, point 6.
Are substances that are banned under Regulation (EC) No. 2037/2000 (on substances that deplete the ozone layer) subject to (pre-) registration?

Yes. Substances are not exempted from (pre-)registration on the grounds that they are within the scope of Regulation (EC) No. 2037/2000 on substances that deplete the ozone layer. FAQ ID=30 explains which substances have to be (pre-)registered.

Is a registrant required to update their registration dossier with a new analysis dataset each time the substance is imported from a new non-EU manufacturer?
There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-EU source. However, according to Article 22(1)(b) of REACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances available on the ECHA website.
There are three possible outcomes of this assessment:
 
1. Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance.
 
2. Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in C&L) with the new composition of the substance.
When do I have to register my substance?
Various aspects need to be taken into account when considering the registration deadlines. These include tonnage, dangerous properties, and whether it is a phase in or a non-phase in substance. Information on these aspects is provided in Chapter 2.3- 'When to register?' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
 
The REACH Regulation creates a special transition regime for phase-in substances (Section 2.3.1.1- 'Phase-in substances' of the Guidance on registration). In order to benefit from the extended registration deadlines for phase-in substances (Section 2.3.2- 'Deadlines for Registration' of the Guidance on registration, these substances must be pre-registered (see also FAQ ID=23). Depending on its intrinsic properties and its tonnage, a pre-registered substance needs to be registered before 1 December 2010, 1 June 2013 or 1 June 2018.
 
Non-phase-in substances and phase-in substances which have not been pre-registered must be registered before manufacture or import can continue. In this case the registrant may have to wait for 3 weeks before continuing manufacture or import (Article 21 of the REACH Regulation). Prior to registration of such substances, the manufacturer or importer has a duty to make an inquiry to ECHA regarding any previous registration for that substance.
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, unless stated otherwise. For phase-in substances that have been imported or manufactured for at the least three consecutive years, quantities are calculated on the basis of the average production or import volumes for the three preceding calendar years (Article 3 (30) of the REACH Regulation). Detailed guidance and practical examples are provided in Section 2.2.6 'Calculation of the volume to be registered' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach

 

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 http://echa.europa.eu/guidance-documents/guidance-on-reach.

This section clarifies that companies are free to register a substance for the intended tonnage band. 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 registrations and PPORDS at: http://echa.europa.eu/manuals.

How do I register my substances and do I need IUCLID?

All registrations shall be submitted to ECHA. This shall be done using the REACH-IT Portal. For more information please visit the REACH-IT section of the ECHA website: http://echa.europa.eu/support/dossier-submission-tools/reach-it.

According to Article 111 of the REACH Regulation, registration dossiers have to be submitted in the format of IUCLID (International Uniform Chemical Information Database). IUCLID is a software tool for companies to store data on chemicals and prepare registration dossiers. Registrants are not obliged to use the IUCLID software, but they must submit their registration in the IUCLID format.

The IUCLID software is downloadable free of charge from the IUCLID website http://iuclid6.echa.europa.eu/home.

How much is the registration fee?

The registration fee for a substance depends on the tonnage of registration, size of the company and the type of submission. Additionally:

  •  Lower fees and charges apply to joint submissions as compared to separate submissions. This does not  apply in case you 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 in a quantity between 1 and 10 tonnes per year when a registration containing all the information in Annex VII, which is the basic set of information requirements for substances manufactured or imported at or above 1 tonne.
All these provisions are specified in Article 74 of REACH. The fees are developed in the Commission Fee Regulation (No. 340/2008). Further information can be found in the REACH-IT FAQs on "Invoicing":
http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach-it/invoicing.

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: http://echa.europa.eu/guidance-documents/guidance-on-reach.
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.
Can a third party representative register?

No, under REACH, a third party representative cannot register. A third party representative 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 third party representative only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations.

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.
What are the duties of registrants that cease manufacture and import?
If a registration for a substance has been submitted, the obligations to update the registration (Article 22) and to keep information (Article 36) apply. This means that a registrant ceasing manufacture and import of this substance has to inform the Agency about the new total tonnage manufactured and imported (in this case zero t/a). Furthermore this registrant has to keep available all the information he required to carry out his duties under REACH for a period of at least 10 years after he last manufactured, imported, supplied or used the substance (as such or in a mixture). In this regard, the period of at least 10 years does not start if the registrant, who ceased manufacture and import, still supplies or uses the substance.
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.
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 FAQ ID=54, which include an update of the registration.
I plan to manufacture/import a phase-in substance for the first time either less than 12 months before the relevant registration deadline or after it. When do I have to register this substance in each case?
The "no data, no market" principle set out in Article 5 of the REACH Regulation applies to all substances that are manufactured or imported in quantities of 1 t/a or more where they have not been registered or pre-registered. This means that a company planning to start manufacture or import of 1 t/a or more of a phase-in substance after the relevant registration deadline given in Article 23 of REACH needs to have validly registered the substance before starting this activity.
 
According to Article 28(6) of REACH a first-time manufacturer or importer of a substance may submit a late pre-registration within 6 months of the date of first manufacture or import in quantities of 1 t/a or more of that substance and no later than 12 months before the relevant registration deadline given in Article 23 of REACH. Therefore, a company planning to start manufacture or import of 1 t/a or more of a phase-in substance less than 12 months before the relevant registration deadline also needs to have validly registered the substance before starting this activity.
 
In both cases, prior to registration the company planning to start manufacture or import has to submit an inquiry according to Article 26 of REACH. Further information can be found in section 4.4- 'Substances subject to the inquiry process' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach
 
After the submission of the registration dossier it may take up to three weeks before ECHA informs the registrant whether his registration is complete or not. Manufacture or import of a substance cannot start before the end of this period and can only start once ECHA has informed the registrant that the registration is complete and a registration number has been assigned.
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 you may realise that your registration dossier has to be corrected or modified for reasons other than those triggering the need for an update of the registration according to Article 22 of the REACH Regulation. 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, which however does not affect the assessment of the substance made) and noticed this only after you submitted the dossier to ECHA. In this case you should make 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.
 
If the mistake leads to a failure in the business rule verification, then instead of a spontaneous update submission an initial submission has to be made, as if it was the first dossier submission. Part 4 of the REACH-IT Data Submission Manual describes how to pass the business rule verification.
Is there any obligation according to Article 21 of REACH to interrupt the manufacture or import of the substance during the technical completeness check (TCC)?
In case the manufacture or import is only to be started, e.g. in case of a non phase-in substance, the waiting period must be respected.
 
On the other hand, there is no requirement to interrupt manufacture or import of phase-in substances during the TCC. However, when the initial submission of a phase-in substance was incomplete, ECHA will give the registrant a deadline to complete the dossier. Until the end of this deadline, the registrant is allowed to continue his activities. If he does not update the dossier, the registrant must cease manufacture or import by this deadline at the latest. If he updates his dossier, the registrant can continue the manufacture or import of the substance until he receives the decision by ECHA on the outcome of the completeness check. If he receives a decision rejecting his registration, he must cease manufacture or import of the substance.
Are registration numbers assigned to active substances in biocidal products? Does ECHA disseminate any information on those substances?
REACH does not provide for the assignation of registration numbers to active substances in biocidal products. It is reminded that 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.
 
Regarding the information on active substances in biocidal products, this is held by the European Commission, and certain information is publicly available via its website at http://ec.europa.eu/environment/biocides.
 
ECHA has access to the information necessary for data sharing purposes.
If a registrant decides to change its Third Party Representative (TPR) does it need to update the registration and is there a fee for this?

If a registrant changes its TPR, the new TPR will have to create a REACH-IT account (provided he does not yet have a REACH-IT account).

In case of a change of TPR, the following steps shall be taken by the registrant in order to update the details of its TPR:

To update a TPR in a pre-registration or 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.

I am a potential registrant of a non-phase-in substance or phase-in substances that has not been pre-registered. I am already in contact with the Lead Registrant (LR). Do I still need to send an inquiry to ECHA?

Yes. You have to submit an inquiry to ECHA although you have established a contact with the lead registrant (LR) and therefore have access to the respective and most up to date data package.

The obligation to submit an inquiry serves to avoid unnecessary testing and in particular to reduce testing on vertebrate animals. In addition, it provides the potential registrants the advantage that ECHA has verified the identity of the substance foreseen for registration and puts them in contact with the correct previous registrants and inquirers. By contrast, it is up to the members of a SIEF themselves to verify that they register the same substance.

Further guidance can be found in the Questions and Answers documents on inquiry and substance identification available in the following web page:
http://echa.europa.eu/regulations/reach/substance-registration/inquiry

Who can benefit from the phase-in scheme?

Manufacturers and importers who have manufactured a substance in any of the current Member States of the EU at least once after 31 May 1992 (15 years before the entry into force of REACH) and never placed it on the EU market can benefit from the phase-in scheme. This benefit also applies if you were a manufacturer before the entry into force of REACH and became an importer after it.

For all other manufacturers and first time importers who did not manufacture the substance in the EU, the substance is considered as a non-phase-in substance.
 

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.
A phase-in substance was registered and manufactured on an ongoing basis in the tonnage range 1-10 t/a. What does the registrant need to do, if they reach a higher tonnage threshold?

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 (regardless of its phase-in status before registration) reaches the next tonnage threshold, the manufacturer or importer has the duty to immediately inform ECHA of the additional data required, following Article 12(2).

Further information is available at: http://echa.europa.eu/support/registration/your-registration-obligations/do-i-reach-the-one-tonne-a-year-threshold

What should I do if there is no SIEF Formation Facilitator (SFF) in my pre-SIEF?

The SFF role was created to initiate and conduct discussions after pre-registration, and to facilitate the exchange of information and data required to form the SIEF. However, the SFF role is not formally recognised under REACH and potential registrants have no legal obligation to use an SFF to form a SIEF. If no pre-SIEF member has taken the initiative to take on the role of SFF or the SFF is inactive, you should contact the other pre-SIEF members to know more about the status of your SIEF.

The pre-SIEF is the first step for recognising potential registrants of the same substance and help you to start discussions on substance identity and substance sameness. SIEFs are expected to start communicating and organising themselves outside the REACH-IT environment. ECHA recommends that potential registrants contact their relevant trade associations to receive further advice on how to evolve from pre-SIEFs to SIEFs.

Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?

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.

These chemical species are identified as substances of very high concern (SVHC) and included in the Candidate List1 as two separate 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 obligation to register, it may be justifiable in some specific situations described in the table below, to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide. Hence, in these specific cases, chromic acids and their oligomers present in an aqueous solution of chromium trioxide can be covered by a registration dossier for chromium trioxide.

Important note: The presented approach is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. It derives from very specific aspects of the Chromium VI aqueous chemistry; 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 approach can thus not be applied by analogy to any other substance.

Manufacturers and importers of chromium trioxide and chromic acids and their oligomers have to consider the following situations:

 

Actor / Scenario Legal requirement Explanation
Manufacturer or importer of chromium trioxide who generates chromic acids and their oligomers in water One registration according to Article 10 for chromium trioxide

The generation of chromic acids and their oligomers by adding chromium trioxide to water and their further use have to be included in the registration dossier and have to be considered for the chemical safety assessment (CSA) and the chemical safety report (CSR).

In case a downstream user (DU) generates chromic acids and their oligomers from chromium trioxide, this use has to be communicated up the supply chain and has to be included in the registration dossier.

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

One registration according to Article 10 for chromium trioxide The registrant has to register chromium trioxide and chromic acids and their oligomers in one dossier for chromium trioxide. It has to become clear from the registration dossier that chromic acids and their oligomers are also imported. Therefore, at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to chromium trioxide; the second composition refers to the composition of chromic acids and their oligomers. A remark has to be entered to clarify the approach.  The tonnage to be reported is the aggregated tonnage of both chromium trioxide and chromic acids and their oligomers. The tonnage has to be reported on the basis of equivalent chromium trioxide tonnage. 
Importer of chromic acids and their oligomers generated in water from chromium trioxide Registration according to Article 10
either for chromic acids and their oligomers generated from chromium trioxide
or for chromium trioxide

In case the importer decides to register chromic acids and their oligomers in a dossier for chromium trioxide, it has to become clear from the registration dossier that what is actual imported are chromic acids and their oligomers.

Therefore at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to the generic substance "chromium trioxide"; its purity and composition should be indicated as 100 %. The second composition shall refer to the actual composition of chromic acids and their oligomers which are imported. A remark has to be entered to clarify the approach.  
Manufacturer or importer of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water
or
Importer who is unaware of the manufacturing methods of the chromic acids and their oligomers
Registration according to Article 10 for chromic acids and their oligomers 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. 

 

Please, also see Q&A=805 (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?)

How do I register if I am located outside the EEA?
What are some examples of manufacturing?

Under REACH, manufacturing means producing or extracting substances in their natural state. It is a case-by-case decision to establish the extent to which the different steps in producing the substance are covered by the definition ‘manufacturing'.

Example
A company that purchases registered substances from within the EU and then formulates these into mixtures (e.g. paints) would be regarded as a downstream user under REACH.

In layman's terms, this company might be considered to be a manufacturer of paints. However, within the context of REACH, the company would not be a manufacturer of a substance and so would have no registration obligations for these substances. For further information see the Guidance on registration (http://echa.europa.eu/documents/10162/13632/registration_en.pdf). Examples on manufacturing on intermediates available in the Guidance on intermediates and Practical Guide 16.

How do I determine who is responsible for importing ?

You should register if you are the legal entity established in the EU who is responsible for importing.

The responsibility for importing depends on many factors such as:

  • Who orders?
  • Who pays?
  • Who is dealing with the customs formalities?
    However, this might not be conclusive on its own.

Example
A sales agency established in the EU that acts as an intermediary, i.e. they transmit orders from buyers to non-EU suppliers (and are paid for this service). However, they take no responsibility for the goods or the payment of the goods and do not own the goods at any stage. In this case, the sales agency is not considered to be an importer for the purposes of REACH. The sales agency is not responsible for the physical introduction of the goods.

In many instances, this will be the ultimate receiver of the goods (the consignee) who is the legal entity responsible for importing the goods.

For further information and examples see chapter 2.1.2.4 "Who is responsible for registration in case of import?" in the Guidance on registration:

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 chapter 2.1.2.5 "Only representative of a non-EU manufacturer" in the Guidance on registration:

How do I document the re-import of a registered substance?

Substances which have been registered, exported and then re-imported are exempted from registration under certain conditions.

To benefit from this exemption, you need to document that the following conditions are fulfilled:

  1. The substance must have been registered before it was exported from the EU.
  2. The substance already registered and exported must be the same, as the substance being re-imported.
  3. The substance must not only be the same but it must actually proceed from the same supply chain in which the substance was registered.
  4. The re-importer must have been provided with information on the exported substance as required by REACH (e.g. safety data sheet).

For further information, see chapter 2.2.3.6 "Re-imported substance" in the Guidance on registration:

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 chapter 2.2.2.2 "Substances under customs supervision" in the Guidance on registration:

What are some examples of articles containing substances intended to be released?

Substances may be intended to be released from articles to provide "added value". Scented children's toys, for example, are articles made with the intent of releasing substances. The release is an additional quality of the toy and is therefore intended because it gives added value, namely a pleasant smell.

As a counter-example, consider the case of a printer cartridge or a wet cleaning wipe. In these cases, the substances can be physically separated from the article. Therefore, they cannot be considered as substances in an article, but rather as substances in a container.

The consequence is that the supplier of cartridges is considered as a supplier of substances and the general registration obligations therefore apply.

For further information see the Guidance on requirements for substances in articles:

How do I find out if the substance in my article has been registered for a use?

In most cases, if you want to find out for which uses a substance has been registered, you will have to ask other actors up your supply chain.

For this purpose, you need to describe the function of the substance in the article, the process by which the substance is included in the article and into which type of article. This description should be in line with the use descriptor system.

Safety data sheets (SDSs) can be helpful as they contain information on uses of the substance or mixture as far as they are known by the supplier. If the SDS also includes a registration number, it may be possible, depending on the accuracy of the use descriptions in the SDS, to conclude that a particular use of this substance has already been registered. However, if you have doubts, you should seek confirmation from the actual registrant up the supply chain.

Alternatively, you could identify and ask manufacturers or importers of that substance from any supply chain for the uses they have registered this substance for, or whether they have registered it for a particular use.

A good way to identify manufacturers and importers of a substance is to launch a corresponding request within the substance information exchange forum (SIEF) for this substance, provided that you have pre-registered the substance or joined the SIEF as a data holder.

For further information see the Guidance on requirements for substances in articles:

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:

What do I need to do if I find my volume has exceeded 100 tonnes per year?

Each year, you need to calculate your yearly tonnage as the average over the three preceding years.

Example

If you have yearly volumes of 60 tonnes in 2013, 90 tonnes in 2014, 140 tonnes in 2015 and 200 tonnes in 2016. The three-year average tonnage in 2016 is 97 tonnes per year, but the three-year average in 2017 is 143 tonnes.

In this case, you would need to register the substance as soon as possible as the registration deadline for substances over 100 tonnes per year has passed on 31 May 2013. The registration requirements should be based on the 2017 tonnage calculated as the average over 2014-2016, i.e. 143 tonnes.

As the yearly tonnage is based on a three-year average it should be easier for companies to anticipate any increase of yearly tonnage.

For further information see the Guidance on registration:

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:

Which substances are covered by Annex V?
Annex V of REACH lists thirteen broad categories of substances for which registration is deemed inappropriate or unnecessary. The registration exemption applies to the substances as such, provided however that they meet the conditions for the exemption which are given in the particular category of Annex V.
 
If you need more detailed information on any category of substances, you can find this in the Guidance for Annex V, which gives explanations and background information for applying the different exemptions and clarifies when an exemption can be applied and when not.
 
Which substances are exempted from registration in the interest of defence?

In specific cases, REACH allows individual Member States to exempt certain substances from the application of REACH, in the interests of defence.

More information on national exemptions in the interest of defence in individual Member States is available on the European Defence Agency website:

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:

Which substances used in food or feedingstuffs are exempted from registration?

When a substance is used in food for humans or feedingstuffs for animals in accordance with the Food Safety Regulation ((EC) No 178/2002), the substance does not have to be registered.

This includes the use of the substance:

  • as a food additive in foodstuffs (Council Directive 89/107/ECC);
  • as a flavouring in foodstuffs (Council Directive 88/388/ECC and Commission Decision 1999/217/EC);
  • as an additive in feedingstuffs (Regulation (EC) No 1831/2003);
  • in animal nutrition (Council Directive 82/471/EEC).

Amounts of the same substance used for other uses than food and feedingstuffs are not exempted from registration. Only the amounts of the substance used in food and feedingstuffs are exempted from the registration obligation under REACH.

For further information, see chapter 2.2.3.1 of the Guidance on registration:

Which substances used in medicinal products are exempted from registration?

When a substance is used in a medicinal product within the scope of either:

  • The Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ((EC) No 726/2004); or
  • The Directive on the Community code relating to veterinary medicinal Products (2001/82/EC); or
  • The Directive on the Community code for medicinal products for human use (2001/83/EC); the substance does not have to be registered under REACH for that use.

The exemption does not distinguish between active or non-active ingredients as it applies to any substance ‘used in medicinal products'. Excipients used in medicinal products are therefore also exempted from registration.

Amounts of the same substance used for other uses than pharmaceuticals are not exempted. Only the amounts of the substance used in medicinal products are exempted from the registration obligation.

For further information, see chapter 2.2.3.2 of the Guidance on registration:

Which substances used in biocidal products are regarded as registered?

Active substances manufactured or imported for use in biocidal products are regarded as registered for the use in that biocidal product in the following situations:

  • The active substance has been approved in accordance with Regulation (EU) No 528/2012 ("BPR"), or
  • The active substance is under assessment in the review programme of existing active substances established under Article 16(2) of Directive 98/8/EC and continued under Article 89 BPR.

The list of approved active substances is available from the ECHA website:

To check which active substances are in the review programme, please see Annex II, part I to Commission Delegated Regulation (EU) No 1062/2014, also available from the ECHA website:

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance

An exemption from REACH registration also applies in the following cases:

  • The active substance is manufactured/imported for use in a biocidal product which has a simplified authorisation (Article 27 BPR)
  • The active substance is manufactured/imported for use in a biocidal product which has a provisional authorisation (Article 55 BPR)
  • The active substance is manufactured/imported for use exclusively in a biocidal product which is the subject of experiments or tests for the purposes of scientific or product and process-orientated research and development (Article 56 BPR).

If you manufacture or import a substance for biocidal and non-biocidal uses, you need to register it for the quantities of the substance used in non-biocidal products.

Which substances used in plant protection products are regarded as registered?

Active substances manufactured or imported for use in plant protection products, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, are regarded as registered under REACH (for that use) if the active substance is approved and included in Commission Implementing Regulation (EU) No 540/2011 (list of approved active substances), or where the application for approval of the active substance is deemed admissible in accordance with Article 9 of Regulation (EC) No 1107/2009.

Amounts of the same active substance used for other uses than in plant protection products are not regarded as being registered even if they are approved. Also, other substances such as co-formulants, synergists, safeners and adjuvants are not regarded as being registered.

The Commission maintains an electronic list of the approved (and non-approved) active substances which is available at the following link:

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

When should a recovered substance be registered?

A recovered substance should be registered as soon as it is no longer considered waste (when it reaches the end of waste criteria).

For further information on the end of waste criteria, see the following page:

How do I document that a recovered substance is already registered?

To benefit from this exemption, you need to document that the following conditions apply:

  1. The same substance must have been registered.
  2. The substance must be the same.
  3. The company that did the recovery must have the information required by REACH available (e.g. safety data sheet).

For further information, see chapter 2.2.3.5 ‘Recovered substance already registered' in the Guidance on registration:

Which substances are covered by Annex IV?
Annex IV of REACH lists a number of substances for which sufficient information is available to consider them as causing minimum risk to human health and the environment.
 
These substances are typically of natural origin and the list of exempted substances includes, for example, water and nitrogen. Substances included in Annex IV are exempted from the registration provisions.
 
The registration exemption applies to the substance as such, not to a particular use.
 
For more information see Annex IV of the REACH Regulation:
 
I pre-registered a substance which was not listed in the EINECS. In the list of pre-registered substances published by ECHA, a "list number" has been assigned to my substance. Should I report this list number 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 phase-in 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.

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 section 9 of the Guidance on Data-sharing (https://echa.europa.eu/guidance-documents/guidance-on-reach).

Requirements for substances in articles

Applications for Authorisation - a) Scope and procedure

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.). 
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.

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 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 SVHC) exceeds one tonne per producer or importer per year; and
  4. the substance has not yet been registered for that specific use.

However, you do not need to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal.

You must notify SVHCs in articles at the latest six months after the SVHC has been included on the Candidate List for authorisation (Article 7(7)).

Information on a substance on the Candidate List contained in articles must be sent by the supplier of the articles to the recipients as soon as possible after the substance is included in that list (Article 33). 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 were not released. Scented children's toys, for example, are articles with intended release of substances, because fragrance substances contained in the toys are released in order to fulfil an accessory function, namely to scent. Consequently, substances that are released because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, are generally not intended releases, 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 or functionality 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 2.4- '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. 1 June 2011 for substances placed on the Candidate List before 1 December 2010 or 6 months after a substance has been included in the Candidate List) 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 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.

What happens if an article producer’s supplier did not pre-register?

Registration of substances in articles is obligatory for article producers or importers only if the substances are intended to be released from the articles and are present in quantities of one tonne or more per year. If an article supplier finds out after 1 December 2008 that they have registration obligations for a substance intended to be released from the articles they have been producing or importing already, they cannot submit a pre-registration anymore and they have to limit their production/import to one tonne or less per year until:

  • Theyhave made a registration and received a registration number; or
  • Someone else registers their use of the substance.

More Q&As on pre-registration can be found at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/Pre-registration

 

Restrictions

A. General Q&As (applicable for more than one Annex XVII entry)

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, (http://ec.europa.eu/enterprise/sectors/toys/files/tsd-guidance/tsd_rev_1-6_explanatory_guidance_document_en.pdf) 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 appendices 1 to 6 to REACH, need to refer to entries 28, 29 or 30 of Annex XVII. If another specific restriction exists for these substances, this needs to be mentioned as well in the SDS.

Moreover, Article 31(9) of the REACH Regulation requires suppliers to update the SDS without delay once a restriction has been imposed. In Section 16 (other information), a clear indication of where changes to the previous version have been made needs to be included, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes.

What is regarded as scientific research and development, which is exempted for restrictions? For example, does research by students at universities fall under this?
Article 3(23) of the REACH Regulation defines scientific research and development as “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year”.
To further clarify the exemption (within Article 67(1) of the REACH Regulation, manufacture, placing on the market or use of a substance in scientific research and development (SRD) is exempted for restrictions), note that under the authorisation process the following Q&As (concerning the exemption in Article 56 for the use of Annex XIV substances in scientific research and development) has been provided. The same approach can be broadly considered as applicable to restrictions.
  • Q&A 1153 states that sampling for further analysis is not exempted and thus not regarded as scientific research and development. However, “activities considered to form part of the use of the sample in performing analytical activities” fall within the exemption. 
  • Q&A 1030 explains that the uses of a substance upstream preceding an exempted end-use in scientific research and development are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to certain conditions. 
  • Q&A 585 explains that the exemption from authorisation also applies to the use of a substance in analytical activities such as monitoring and quality control under certain conditions. This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities, but does not cover sampling activities.
Scientific experimentation, analysis or chemical research in universities and secondary schools, conducted by students, may fall within the exemption, if they are carried out under controlled conditions, in a volume less than one tonne per year. In other words, if the volume of a substance used in scientific experimentation, analysis or chemical research is less than one tonne per year and it is used under controlled conditions, restrictions do not apply to that use. 
Which restrictions under REACH concern textiles and leather articles?

Many entries in the Restriction List (Annex XVII) cover articles. Such entries are, for instance, entries 50 - 52, 61 and 63. These may address types of textiles and leather articles, even if these are not explicitly mentioned.
The following entries in the Restriction List (Annex XVII) are specific to textiles: 
Entry 4 ((2,3 dibromopropyl) phosphate, CAS No 126-72-7);
Entry 7 (Tris(aziridinyl)phosphinoxide, CAS No 545-55-1; EC No 208-892-5) and 
Entry 8 (Polybromobiphenyls; Polybrominated biphenyls (PBB), CAS No 59536-65-1).
These entries state that these substances “Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.” 
The following entries in the Restriction List (Annex XVII) restrict substances in relation to textiles and/or leather articles:
Entry 18, restriction on mercury compounds in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;
Entry 20 (paragraph 6), restriction on dioctyltin (DOT) compounds in textile articles intended to come into contact with the skin;
Entry 23 (paragraph 6), restriction on cadmium and its compounds in textiles and clothing; 
Entry 43, restriction on azocolourants and azodyes in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity (indicative list is provided);
Entry 46 (paragraph 3) restriction on nonylphenol and nonylphenol ethoxylates in textiles and leather processing (with some exceptions);
Entry 46a, restriction on nonylphenol ethoxylates in textile articles which can reasonably be expected to be washed in water during their normal lifecycle, and
Entry 47 (paragraphs 5-7), restriction on chromium VI compounds in leather articles coming into contact with the skin.

Which restrictions under REACH concern electrical and electronic equipment?
Many entries in the Restriction List (Annex XVII) cover specific articles or all articles without explicitly referring to electrical and electronic equipment. These are, for example, entries 18a, 20, 23-26, 50-52. They may apply to electrical and electronic equipment, even if these are not explicitly mentioned (or derogated) in the entry.
The following entries of the Restriction List (Annex XVII) specifically include a derogation for electrical and electronic equipment: 
Entry 45 (paragraph 3) provides a derogation from the restriction on diphenylether, octabromo derivative (C12H2Br8O) for electrical and electronic equipment within the scope of Directive 2002/95/EC, which has been replaced by Directive 2011/65/EU (on the restriction of the use of certain hazardous substances in electrical and electronic equipment),  and
Entry 63 (paragraph 8) excludes articles within the scope of Directive 2011/65/EU from the restriction on lead and its compounds in articles supplied to the general public.
Which restrictions under REACH concern paints or paint strippers?
Many entries in the Restriction List (Annex XVII) cover substances and mixtures in general, without specifying product types. They may thus also apply to paints/paint strippers, even if these are not explicitly mentioned in the entry.
In addition, the following entries in the Restriction List (Annex XVII) explicitly restrict the placing on the market of paints and/or paint strippers: 
Entry 16, restriction on certain lead carbonates in substances or mixtures intended for use as paint;
Entry 17, restriction on certain lead sulphates in substances or mixtures intended for use as paint;
Entry 20, restriction of organostannic compounds acting as biocide in free association paint;
Entry 20 (paragraph 5), restriction on dibutyltin (DBT) compounds in paints and coatings; 
Entry 23 (paragraph 2), restriction on cadmium and its compounds in paints with codes [3208] and [3209] and in painted articles; 
Entries 28-30 (paragraph 1), restriction on CMRs as substances, as constituents of other substances or in mixtures (including paints), for supply to the general public; (paragraph 2) derogation for artists’ paints covered by Regulation (EC) No 1272/2008;
Entry 48, restriction on toluene (CAS No 108-88-3; EC No 203-625-9) in spray paints intended for supply to the general public; 
Entry 54, restriction on (2-(2-methoxyethoxy)ethanol (DEGME) (CAS No 111-77-3; EC No 203-906-6) for supply to the general public, as a constituent of paints and paint strippers;
Entry 55, restriction on 2-(2-butoxyethoxy)ethanol (DEGBE) (CAS No 112-34-5; EC No 203-961-6) for supply to the general public, as a constituent of paints and paint strippers and in spray paints and
Entry 59, restriction on dichloromethane in paint strippers under certain conditions.
Entry 03 of Annex XVII to REACH - Oil lamps

Which type of oil lamps are considered as decorative within the context of Entry 3 of Annex XVII?
An indicative description of "decorative oil lamps" is provided by the European Standard EN 14059 (which specifies requirements and test methods for decorative oil lamps) (section 3.6): 
Oil lamp for decorative purposes is an oil lamp for interior or exterior use (e.g. in garden torches) appealing by its design and or the light atmosphere it creates. 
 
Entry 16-17 of Annex XVII to REACH-lead compounds in paints

What is the definition of paints in the context of entries 16 and 17 of Annex XVII? In particular, are children's paint sets, and also other stationery-type paints such as artist paints and do-it-yourself (DIY) decorations for t-shirts also covered?

The REACH Regulation does not provide a specific definition for paints.
According to a general meaning, paint is a mixture, usually of a liquid with a solid pigment. Furthermore, Commission Decision 2009/544/EC (establishing the ecological criteria for the EU Ecolabel to indoor paints and varnishes) provides  the following definition: 'Paint' means a pigmented coating material, in liquid or in paste or powder form, which when applied to a substrate, forms an opaque film having protective, decorative or specific technical properties.
The abovementioned definitions provide an indication of what could be generally considered as a paint in the context of entries 16-17 of Annex XVII (to REACH) provisions.

It should be noted that the restrictions in entries 16-17 of Annex XVII only allow Member States to permit the use of paints containing the restricted substances for the restoration and maintenance of works of art and historic buildings and their interiors. Thus children's paint sets and other stationery-type paints such as artist paints and do-it-yourself (DIY) decorations for t-shirts must not contain the restricted substances.

Concerning children's paint sets, these may also be covered by the Toys Directive (Directive 2009/48/EC on the safety of Toys), which lays down limits for the presence of lead in toys.

Entry 18(a) of Annex XVII to REACH - Mercury

Are the repairing and maintenance activities covered by the restriction in Entry 18(a) of Annex XVII?
Fever thermometers and other measuring devices for sale to the general public in use in the European Union before the 3 April 2009: The prohibition concerns the placing on the market of fever thermometers and other measuring devices for sale to the general public after the 3 April 2009.
Pursuant to paragraph 2, thermometers as well as other measuring devices for sale to the general public in use in the European Union before the 3 April 2009 are exempted from the prohibition. These instruments containing mercury which were in use in the European Union before the 3 April 2009 can be placed on the second hand market except in the territories of Member States which decided to regulate theses existing instruments. Repairing and maintenance activities for these existing instruments are excluded from the scope of the restriction. Nevertheless, in the case of repairing and maintenance activities performed on these devices, new measuring devices containing mercury shall not be used as this would be considered making available new measuring devices to the general public.
How should derogation in entry 18(a) of Annex XVII related to Antique Barometers be interpreted?
Under 18(a) antiques measuring devices are defined as more than 50 years old on 3 October 2007.
Under paragraph 3 antique measuring devices are exempted from the restriction. Repairing and maintenance activities for these antique measuring devices are also exempted for the restriction.
The intention of the legislator in granting an exemption for antique measuring devices is that their trade should continue (Directive 2007/51/EC, Recital No 4) due to their cultural and/or historical value. Therefore these instruments should continue to be serviced in order to keep their cultural and/or historical value.
Antique measuring devices such as barometers containing two columns of mercury which one consists of a thermometer are considered falling within the derogation of paragraph 3 and therefore they should continue to be serviced. The columns can be repaired or replaced if these activities are part of the maintenance and repair services and preserve the cultural and/or historical value of the instrument.
Professionals may buy measuring devices containing mercury if they are destined for the repair and maintenance activities of antique measuring devices.
Is there any definition for measuring devices in the context of entry 18(a) of Annex XVII?

The REACH Regulation does not provide a definition of measuring devices (often referred to as measuring instruments). However, in the context of entry 18(a), it has to be noted that:

  1. The restriction provision in paragraph 1 of entry 18(a) covers those measuring devices that are intended for sale to the general public and provides an indicative list of these (thermometers, manometers, barometers, sphygmomanometers etc.)
  2. Furthermore paragraphs 5 and 7 provide exhaustive lists of mercury-containing measuring devices intended for industrial and professional uses which have not been allowed to be placed on the market after 10 April 2014 (barometers; hygrometers; manometers; sphygmomanometers; strain gauges to be used with plethysmographs; tensiometers; thermometers and other non-electrical thermometric application; mercury pycnometers; mercury metering devices for determination of the softening point; mercury triple point cells other than those used for the calibration of platinum resistance thermometers).

For the purposes of Directive 2004/22/EC on measuring instruments, ‘measuring instrument' means any device or system with a measurement function that is covered by Articles 1 and 3. According to the European Standardisation organisation-CEN, "measuring instruments allow for testing the accuracy and calibration of measuring devices (e.g. water meters, gas meters, electricity meters, etc.)". (http://www.cencenelec.eu/standards/sectors/mid/pages/default.aspx)

The abovementioned definitions provide an indication of what could generally be considered as a measuring device in the context of entry 18(a) of Annex XVII to REACH provisions.

Entry 19 of Annex XVII to REACH - Arsenic Compounds

Are imports of CCA treated wood from outside the European Union banned under Entry 19 of Annex XVII?
Under Entry 19 of Annex XVII to REACH, CCA type C cannot be used to treat wood in the EU due to the fact that it has not been authorised under Directive 98/8/EC. A request for authorisation could, however, be made in the future in line with the requirements of Directive 98/8/EC.
Concerning wood newly treated with CCA type C and imported from third countries:
· paragraph 4 a) authorises only the treatment of wood with CCA type C if this biocidal product is authorised under Directive 98/8/EC.
· under paragraph 4 b) it is stated that "Wood treated with CCA solutions in accordance with point a) may …."
This implies that all wood that is placed on the market in the EU must conform to the requirements of paragraph 4 a).
Therefore wood newly treated with CCA type C may only be placed on the EU market if this biocidal product used for treatment is authorised under Directive 98/8/EC.
Whilst the Directive does not impose general obligations on wood treatment installations outside the EU, this requirement is valid for any manufacturer, distributor, or importer placing wood on the EU market whether this wood is manufactured in the EU or manufactured outside
the EU and imported. Obviously the requirement does not apply to wood treatment installations outside the EU producing wood for marketing outside the EU.
In summary since 30 June 2007, it is prohibited to place on the market and to import wood newly treated with CCA type C, until such time as a biocidal product containing this active substance is authorised in line with all the requirements of Directive 98/8/EC.
Under Entry 19, paragraph 4b) of Annex XVII there is a list of applications for which wood treated with CCA type C can be used. May treated wood be used for other applications, such as railway sleepers other than underground railway sleepers?

Paragraph 4b) of Annex XVII to REACH concerning arsenic compounds provides for a list of applications for which wood treated with CCA may be used. This is not a list of examples of possible uses but an exhaustive list of authorised applications. It flows both from the actual wording of those provisions and from their objective that the derogation provided for in paragraph 4 must necessarily be subject to a strict interpretation, as confirmed by the Court of Justice (case C-358/11, pp. 40-43).

Consequently, wood treated with CCA cannot be used for other applications than the ones listed in paragraph 4 b). Wood treated with CCA can, therefore, not be used for railway sleepers installed above ground.

Entry 20 of the Annex XVII to REACH - Organostannic compounds

What types of organotin compounds are covered by entry 20 of Annex XVII of REACH "organostannic compounds"?

Organostannic compounds covered by entry 20 in Annex XVII to REACH, must contain a carbon-tin bond. Substances like tin salts or organotin compounds, for which tin is bound to an atom other than carbon (for example hexanoic acid, 2-ethyl-, tin(2+) salt (CAS-No. 301-10-0)) are not covered by entry 20 in Annex XVII to REACH.

What is the meaning of the expression "already in use" in the context of the entry 20 of Annex XVII to REACH?
Paragraphs 4(b), 5(b) and 6(b) of entry 20 of Annex XVII to REACH, state that articles (and mixtures in the case of article 5(b)) not complying with point (a) of the paragraph shall not be placed on the market after [a certain date] ‘except for articles that were already in use in the Union before that date'". 
 
The phrase ‘already in use' means in the possession of the end-user. Therefore, the derogations apply only to articles which reached end-users before the dates referred to in paragraphs 4(b), 5(b) and 6(b) of the entry. Those (second-hand) articles may continue to be traded after the dates on which the respective bans came into force. All articles still held by distributors, or in the storage facilities of importers or manufacturers on the dates when the bans came into force, should have been withdrawn from the distribution chain.
(a) Do toys fall within the scope of the dioctyltin (DOT) compounds restrictions of entry 20 (paragraph 6)? (b) Can toys benefit from the derogations for organotins in entry 20 of the Restriction List (Annex XVII)? (c) Would a paint coating on a toy that contains dibutyltin (DBT) as a biocide and not as a catalyst fall within the derogation?

(a) Yes, they do. Entry 20 in the Restriction List (Annex XVII) to REACH imposes DOT compounds restrictions for childcare articles, which are not toys. The REACH Regulation does not contain a definition of toys. The definition of toys in Directive 2009/48/EC on the Safety of Toys is illustrative in determining what should be considered as a “toy” in the context of this restriction (see Q&A 0982).

However, paragraph 6(a) of entry 20 restricts DOT compounds in textile toys as in any other textile article intended to come into contact with the skin. Furthermore, organic tin (including DOT) in toys is restricted by paragraph 13 of Part III (Chemical Properties) of Annex II to Directive 2009/48/EC on the safety of toys, which specifies maximum migration limits.

(b) and (c)

In addition to derogation in paragraph 5(d), the other derogations currently applicable to TBT, DBT and DOT compounds in articles relate to the continued placing on the market of articles that were already in use in the EU before the 1 July 2010 for TBT (paragraph 4(b), before the 1 January 2012 (paragraph 5(b)) for DBT and before the 1 January 2012 for DOT (paragraph 6(b)).

Does the restriction in entry 20 (organostannic compounds) of Annex XVII to REACH apply to packaging?

Yes. Packaging can be considered as an article (or a product composed of different articles) in its own right. More information can be found in the ECHA guidance on requirements for substances in articles available at https://echa.europa.eu/guidance-documents/guidance-on-reach (in particular in chapter 2). 

Therefore, with regard to entry 20, packaging should comply with the restrictions for tri-substituted (TBT, TPT) and dibutyltin (DBT) compounds. The restriction of dioctyltin compounds (DOT) which applies only to certain listed articles for the general public, applies to textile packaging.

Entry 23 of Annex XVII to REACH - Cadmium and its compounds

According to paragraph 10 of entry 23 of Annex XVII to REACH cadmium shall not be used or placed on the market if the concentration is equal to or greater than 0,01% by weight of the metal in metal parts of jewellery. Does this concentration threshold apply to each metal component of an item of jewellery or to the jewellery item as a whole?

With reference to paragraph 10 of the Annex to Commission Regulation (EU) 494/2011 amending entry 23 of Annex XVII of the REACH Regulation (cadmium) the concentration threshold of cadmium applies in each metal part of jewellery. The wording used by the legislator, i.e. "metal parts of the jewellery and imitation jewellery" implies that each metal part is relevant; therefore in order to determine if the restriction applies the calculation of the concentration in this case is to be done for each metal part. Therefore, if there are several metal layers as coatings on the surface of an inner (metallic) part of the jewellery these should be regarded as integral part of the metal part and the concentration limit of 0,01% is calculated for this whole metal part. In case the inner part is not metal, but the coating is made of metal layers, this coating is regarded as one metal part. If the jewellery article contains several metal parts, each of them should comply with the concentration limit.

Is it allowed to continue the sale/placing on the market of jewelry articles containing more than 0.01% of Cadmium, manufactured and already placed on the market (e.g. sold by the manufacturer to the distributor) before the 10 December 2011 following the entry into force of the new restriction according to Entry 23 of Annex XVII, paragraphs 10 and 11?

The prohibition of the placing on the market of jewellery and imitation jewellery articles containing cadmium includes sales from the manufacturers to distributors and from distributors to retailers, as well as imports. However, Commission Regulation (EU) 494/2011 contains derogation for articles that were placed on the market before 10 December 2011 (for the date see corrigendum published in OJ L 136/105). This means that jewellery and imitation jewellery articles placed on the market for the first time before 10 December 2011 do not need to comply with the prohibition thus they can be sold following entry into force of the new restriction for example to a retailer or on the second-hand market.

Which uses of brazing fillers containing cadmium can be regarded as uses for safety reasons (derogation in paragraph 9 of entry 23 of Annex XVII to REACH)?

Paragraph 8 of entry 23 of Annex XVII to the REACH Regulation states that cadmium and its compounds shall not be used in brazing fillers in a concentration equal to or greater than 0,01 % by weight. In addition, brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight. The paragraph also states that brazing shall mean a joining technique using alloys and undertaken at a temperature above 450°C. In accordance with the following paragraph 9, by way of derogation paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications nor to brazing fillers used for safety reasons.

The safety aspect in relation to this derogation is if the use of cadmium containing brazing filler may prevent accidents causing human suffering or environmental pollution.

For the enforcement purposes examples of applications are given. It can be considered that the derogation on uses of cadmium containing brazing fillers for safety reasons in paragraph 9 of entry 23 covers the current uses, such as:

  1. Brazing fillers used in turbine wheels in power plant technology in temperature below 650°C.

    Turbine wheels in power plant technology are parts of speed drivers for gas compressors and boiler feed pumps, where rotational speed is approximately from 1000 revolutions per minute (rpm) up to 20 000 rpm. Cadmium containing brazing fillers are needed as they can be used below 650 °C without decreasing the strength of the parent material (base metal).  Cadmium-free brazing fillers require higher temperatures which causes the weakening of the parent material.  Weakening of the parent material could lead to the breakdown of the turbine wheel. Due to high rotational speed the parts and pieces of shrapnel may cause injuries to workers and others in the vicinity of the wheel.  The breakdown of the turbine wheel may result also in a complete shutdown of the power plant, the compressor station of a gas pipeline, or of a refinery.
     
  2. Brazing fillers used in pipes and tubes where acetylene is transferred in high pressure (1.5 – 17 bar).

    Cadmium containing brazing fillers are needed in the joining process for pipes and tubes, where acetylene is transferred in order to avoid formation of explosive substances.  Acetylene forms explosive substances with copper and silver as well as other materials (e.g. formation of copper acetylide and silver acetylide).  Cadmium reduces the overall percentage of copper and silver in the brazing fillers to the level where formation of explosive substances does not exist. Another reason to use cadmium in brazing fillers for this application is that cadmium facilitates the capillary action and solder penetration ensuring a good quality joint with high integrity for pipes and tubes where acetylene is transferred in high pressure (1.5-17 bar). Release of acetylene from pipes and tubes may as well cause serious risk, as acetylene is extremely flammable gas and explosive with and without contact with air.

Other applications that would like to benefit from the derogation need to show the similar kind of safety aspects as described above.

Such considerations should take into account the availability on the market of cadmium-free brazing fillers which can address the safety aspects of the specific application of the brazing fillers in an equivalent manner.

See also ECHA´s report "The use of brazing fillers containing cadmium for safety reasons" [PDF].

Which types of articles coloured with mixtures containing cadmium can be regarded as using cadmium for safety reasons (derogation in paragraph 3 of entry 23 of Annex XVII to REACH)?

Paragraph 1 of entry 23 of Annex XVII to the REACH Regulation provides a restriction on cadmium and its compounds in mixtures and articles produced from certain synthetic organic materials (plastic materials) and paragraph 2 provides a restriction on cadmium and its compounds in paints (Tariff codes 3208 and 3209). The following paragraph 3 states that by way of derogation the restrictions in paragraphs 1 and 2 do not apply to articles coloured with mixtures containing cadmium for safety reasons.

There are two safety aspects in relation to this derogation. The first relates to the use of a specific colour or pigment with certain properties which is necessary to prevent accidents. The second relates to the use of a specific colour or pigment with certain properties in safety equipment.

For the enforcement purposes example of applications are given. Based on above, it can be considered that the derogation in paragraph 3 of entry 23 covers current applications of articles such as:

  1. Coloured wire insulation and cable jackets used in aircraft electrical and control systems for the purpose of fire detection and extinguishing systems, flight control systems or during flight tests.

    The wire and cable connections are often used in in a high temperature application (greater than 150ºC ambient temperature). Cadmium pigments are used to keep the colour from changing or fading over time in the high temperature. Changing established colour conventions could introduce a significant risk of maintenance errors, which may lead to a risk of passengers.
     
  2. Outdoor safety equipment, such as:
    • parts of rescue boats for ships (e.g. safety belts, water pockets of life rafts, canopies) and
    • parts of safety equipment for outdoor applications (e.g. seats, reels and diverse technical parts).
    Outdoor safety applications are applications used typically in outdoor activities in areas where visible colours are needed for rescue or orienteering purposes in case of emergency situations. Cadmium pigments provide highly visible colour contrast with its surroundings (e.g. in rescue situations) and where durability of the colour for the ambient environment (e.g. weather resistance, light fastness, heat resistance and chroma) is needed.

The other applications that would like to benefit from the derogation need to show the similar kind of safety aspects than described above.

Such considerations should take into account the availability on the market of alternative substances which can address the safety aspects of the specific application in an equivalent manner.

See also ECHA´s report "The use of cadmium and its compounds in articles coloured for safety reasons" [PDF].

What parts of plastic coated copper beads (CCB) used in jewellery should comply with the cadmium restriction entry 23?

Entry 23 (paragraph 10 (i)) of Annex XVII to the REACH Regulation states that cadmium and its compounds must not be used or placed on the market if the concentration of cadmium is equal to or greater than 0,01 % by weight of the metal in metal beads and other metal components for jewellery making (see Q&A, 158). In addition, it should be noted that articles produced from plastic material referred to in paragraph 1 of the entry must not be placed on the market if the concentration of cadmium is equal to or greater than 0.01 % by weight of the plastic material.

Thus, in the case of plastic coated metal beads (CCB beads), both the plastic material and the metallic part of the bead need to comply with entry 23 (cadmium restriction).

Please also note that if the article is painted, then paragraph 2 will also apply to this article.

Do paragraphs 5 and 6 of entry 23 (cadmium and its compounds) cover unplated metal parts?
No. They cover only plated metal parts. Paragraphs 5 and 6 of entry 23 prohibit the use of cadmium for “cadmium plating” (defined as a deposit or coating on a metallic surface with metallic cadmium) metallic articles used in specified sectors/applications. The placing on the market of cadmium-plated articles used in those sectors/applications and of articles manufactured in some of those sectors/applications is also prohibited. The latter reference to “articles manufactured” must be taken to mean articles that have been cadmium plated, since paragraphs 5 and 6 relate only to “cadmium plating”. Accordingly, Paragraphs 5 and 6 do not cover articles with metal parts containing cadmium unless these parts are plated with cadmium. 
Note that metallic articles containing cadmium may be covered under other EU legislation. For example, (1) electrical and electronic equipment falls under Directive 2011/65/EU on the Restriction of the use of certain Hazardous Substances and must comply as well with the maximum concentration limits for cadmium set in that Directive and (2) toys are covered under Directive 2009/48/EC on the Safety of Toys.
Is ink covered by entry 23 of Annex XVII to REACH, concerning cadmium and its compounds?
No. Ink is not included in the TARIC codes [3208] [3209] which define the scope of paragraph 2 of entry 23. 
Entry 27 of Annex XVII to REACH - Nickel and its compounds

Are mobile telephones covered by the restriction set in Entry 27 of Annex XVII on nickel?

Entry 27 of Annex XVII to REACH states that nickel may not be used "in articles intended to come into direct and prolonged contact with the skin, if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5 Jg/cm²/week". The aim of this restriction to protect consumers against nickel allergy which may be caused by prolonged contact of the skin with nickel-releasing articles that come into direct and prolonged contact with the skin such as jewellery, buttons, tighteners, zips and rivets in items of clothing. It has emerged that some mobile telephones contain nickel in surface material and that consumers are at risk of developing eczema through skin contact with the mobile telephone. As mobile telephones are clearly intended to come into direct contact with the skin, and as they are used on a daily basis often for prolonged periods of time, it is considered that mobile telephones fulfil the condition of "direct and prolonged contact with the skin". Therefore mobile telephones are covered by the restriction and should comply with the conditions set in Entry 27 of Annex XVII to REACH.

How to clarify the "prolonged contact with the skin" in relation to the nickel restriction entry 27?

Prolonged contact with the skin is defined as contact with the skin to articles containing nickel of potentially more than

  • 10 minutes on three or more occasions within two weeks, or
  • 30 minutes on one or more occasions within two weeks.

The skin contact time of 10 minutes applies when there are three or more occasions of skin contacts within a two-week time period. The skin contact time of 30 minutes applies when there is at least one occasion within a two-week time period.

Details

 

 

Entry 28 to 30 of Annex XVII to REACH - CMR substances

Are substances classified as CMRs, and included in Annex VI to CLP but not yet included in the Appendices 1-6 of Annex XVII to REACH, covered by the restrictions in entries 28-30 of Annex XVII to REACH?
No, only substances listed in the relevant Appendices (1 - 6) of Annex XVII are covered by the restrictions in entries 28 - 30.
 
When substances are classified for the first time as CMR and included in an ATP of the CLP Regulation, the European Commission prepares a draft amendment to include these substances in the Appendices of REACH Annex XVII. The amendment then has to be adopted in accordance with Article 68(2) of REACH, before the new substances are covered by entries 28-30.
Entry 31 of Annex XVII to REACH - Creosotes in wood

What is the meaning of the expression "second hand market for re-use" in paragraph 2(c) of entry 31 of Annex XVII to REACH?
Paragraph 1 of entry 31 prohibits the placing on the market of wood treated with the substances listed in points (a) to (i) of column 1 of the entry, whether as substances on their own or as mixtures. Paragraph 2(c) of entry 31 states that "….the prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31 (a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use….."
 
This derogation therefore concerns wood that had already been treated with the substance listed in points (a) to (i) of column 1 of entry 31 before 31 December 2002. The intention of the derogation is to allow second-hand wood treated before 31 December 2002 with the substances covered by this entry to be traded by the end-user and subsequent users. This type of derogation is often included in restriction entries to avoid enforcement difficulties.
It should be noted that the conditions in paragraph 3 apply to second-hand wood benefiting from the derogation in paragraph 2(c). Thus, it cannot be used e.g. inside buildings, in toys, in playground etc.
Entry 40 of Annex XVII to REACH - Flammable substances in aerosol generators for entertainment and decorative purposes

Entry 40 of Annex XVII prohibits the use of flammable, highly flammable or extremely flammable substances in "aerosol generators placed on the market for the general public for entertainment and decorative purposes". Are aerosol generators containing coloured hairsprays and glitter for the body and sold to the general public restricted under this entry?
 Entry 40 provides an indicative list of examples of products that are covered by the restriction. These examples are all products to be used for the decoration of venues for festivities/parties and for use during parties. None of these examples are cosmetic products within the meaning of Regulation (EC) No 1223/2009 on cosmetic products.
Article 67(2) of REACH excludes cosmetic products as defined by Directive 76/768/EEC (now Regulation (EC) No 1223/2009) from the scope of restrictions when they target risks to human health within the scope of that legislation. This restriction on aerosol dispensers is entirely linked to the human health of consumers, which are fully addressed by Regulation (EC) No 1223/2009. 
Therefore, the restriction in Entry 40 of Annex XVII to REACH, prohibiting the use of flammable, highly flammable or extremely flammable substances in "aerosol generators placed on the market for the general public for entertainment and decorative purposes", does not cover aerosol dispensers which are cosmetic products. Coloured hair sprays and body glitter fall within the definition of cosmetic products in Regulation (EC) No 1223/2009 as they are intended "to be placed in contact with an external part of the human body" with a view to "changing its appearance". They have a similar use to more classical cosmetic products, such as normal hair sprays and should not be considered as having an entertainment or decorative purpose within the meaning of the entry.
Are there any definitions for aerosols, aerosol dispensers, in the context of Entry 40?

The REACH Regulation does not define aerosols or aerosol dispensers.
According to the ordinary meaning of the word, an aerosol is considered to be "a substance enclosed under pressure and released as a fine spray by means of a propellant gas". (Oxford advanced dictionary definition). The term may in certain contexts be used for a mixture enclosed under pressure and released as a fine spray by means of a propellant gas, or the dispenser or package used to change the ingredient inside the container into a spray by the use of a propellant gas. The European Aerosol Federation uses the term "aerosol" for both the suspension and the dispenser/package.

Furthermore, it should be noted that according to Article 2.3.1 of the CLP Regulation (for "Classification, Labelling and Packaging"), the term "aerosol dispenser" means: any non-reusable container made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state.

The CLP definition is very similar to the definition provided in Article 2 of the Aerosol Dispensers Directive (ADD) (75/324/EEC).
The above definitions provide an indication of what could be generally considered as ‘aerosols/aerosol dispensers' in the context of Entry 40 of Annex XVII. Note that aerosol generators should be regarded as aerosol dispensers, as the original restriction discusses aerosol generators.

What is the meaning of products for entertainment and decorative purposes in the context of entry 40 of Annex XVII? Are aerosol dispensers containing coloured hairsprays and glitter for the body and sold to the general public restricted under this entry?

Entry 40 prohibits the use of flammable, highly flammable or extremely flammable substances in "aerosol dispensers where these aerosol dispensers are intended for supply to the general public for entertainment and decorative purposes". Paragraph 1 provides an indicative list of examples of products that are covered by the restriction. These examples are all products to be used to decorate, for instance, venues for festivities (e.g. Christmas, weddings, and carnivals) or parties (e.g. birthday parties and fancy-dress parties) and for entertainment use, for instance, during festivities and parties. None of the examples listed in the entry are cosmetic products within the meaning of Regulation (EC) No 1223/2009 on cosmetic products.

Coloured hair sprays and body glitter would fall within the definition of cosmetic products in Regulation (EC) No 1223/2009, as they are intended "to be placed in contact with an external part of the human body" with a view to "changing its appearance" and therefore have a similar use to more classical cosmetic products, such as normal hair sprays. Coloured hair sprays and body glitter should not be considered as having an entertainment or decorative purpose, and therefore they are not covered by entry 40 of Annex XVII to REACH.

Entry 43 of Annex XVII to REACH - Azocolorants and Azodyes

Are optical brightening agents (OBAs) azodyes within the meaning of the Entry 43 to Annex XVII?

Through a literature search and consultation with experts in this area it was not found any structural connection between optical brighteners (or better called fluorescent dyes) and azodyes since either the NH bonds in the fluorescent dyes are connected to heterocyclic NC structures and therefore cannot form any of the 22 banned arylamines or they do not contain any azo bonds where reductive cleavage could take place to generate any of the aromatic amines covered by the azodyes ban. Therefore at the present time, this information confirms that the restriction in Entry 43 to Annex XVII does not cover optical brightening agents (OBAs). Should the chemical structure of optical brightening agents be different from the definition as reported above, this answer may change accordingly.

The restriction indicated in entry 43(3) applies only to the placing on the EU market of substances or mixtures containing the azodyes listed in Appendix 9 at a concentration exceeding 0.1% by weight, and to the use of such substances/mixtures within the EU. Does the restriction therefore not apply to imported articles which have been dyed with the azodyes listed in Appendix 9?

Entry 43(3) of Annex XVII restricts the placing on the market of substances and mixtures containing over 0.1% of the azodyes listed in Appendix 9, when they are intended for colouring textile and leather articles, and also the actual use of the substance or mixture for that purpose. Therefore, the presence of these substances in imported articles is not restricted.

However, pursuant to paragraphs 1 and 2 of the restriction, if an azodye in Appendix 9 releases one or more of the aromatic amines listed in Appendix 8 in a concentration above 30 mg/kg (0,003 % by weight, it cannot be used in textile and leather articles which may come into direct and prolonged contact with human skin or the oral cavity (such as those listed in paragraph 1). Those textile and leather articles cannot be placed on the market unless they comply with that concentration limit.

Is the list of restricted items in entry 43 of Annex XVII to REACH concerning azocolourants and azodyes exhaustive?
No. The use of the words “such as” makes clear that the list of items mentioned in paragraph 1 of entry 43 of Annex XVII to REACH is a non-exhaustive list of examples of items covered by this restriction (clothing, footwear, textile toys etc.). 
Do sofas and chairs (e.g. garden chairs/sun loungers’ type) fall under the scope of the restriction entry 43 of Annex XVII to REACH?
Yes. Garden furniture made of textile or leather is covered by entry 43 as people who use them can be in light clothing (even in bathing suits or bare) and “direct and prolonged contact with human skin” is very likely. There is even a direct reference to chair covers in the list of examples of articles covered by the restriction. 
Entry 46 of Annex XVII to REACH - Nonylphenol.

Does the entry 46 of Annex XVII cover traces in cosmetic products?
Regulation 1223/2009 on cosmetic products, that repealed Directive 76/768/EEC, introduces a ban on the marketing of cosmetic products containing nonylphenol (CAS: 25154-52-3) and 4-nonylphenol, branched (CAS: 84852-15-3). Pursuant to Article 17 of the cosmetics Regulation, the presence of traces in cosmetic products is allowed, provided that such presence is technically unavoidable in good manufacturing practice and that the product does not cause damage to human health.  
Entry 46 of Annex XVII to REACH bans the placing on the market of nonylphenol and nonylphenol ethoxylates as a substance or in mixtures in a number of applications including cosmetic products, when the concentration is higher than 0.1% by weight. The objective of entry 46 is the protection of the environment. Therefore Article 67 (2) of REACH does not apply. Entry 46 covers traces in cosmetic products to the extent that their presence presents a risk to the environment. The application of entry 46 of Annex XVII to REACH is complementary to, and does not conflict with, Regulation (EC) No 1223/2009. 
 
Does the entry 46 of Annex XVII cover all nonylphenols?

Yes. The intention of the legislator was to cover all isomers, linear and branched, of nonylphenol and their ethoxylates and therefore all of them are covered by the restriction.

The restriction on nonylphenol and nonylphenol ethoxylates was based on the risks identified in the risk assessment report prepared by the United Kingdom under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. The risk assessment report states that "It is understood that nonylphenol (CAS Number: 25154-52-3) as originally defined by CAS (Chemical Abstract Service) covered all nonylphenols. However, subsequent revisions redefined it to cover only straight chain nonylphenol, other isomers having different CAS numbers. Given the method of manufacture of nonylphenols, very little if any straight chain nonylphenol is produced. That which is produced is only likely to be present at very low levels in commercial mixtures. The commercially produced nonylphenols are predominantly 4-nonylphenol with a varied and undefined degree of branching in the alkyl group. This assessment covers commercially produced material (predominantly 4-nonylphenol, branched). This material will also contain smaller amounts of other isomers and impurities, and falls under the CAS Number 84852-15-3."

Therefore Council Directive 76/769/EEC, as amended by Directive 2003/53/EC, did not specify any CAS or EC numbers for nonylphenol. In the revision of the REACH restriction by Regulation 552/2009/EC, which made several technical changes, the CAS and EC numbers were added. This will be corrected by a technical amendment to reflect the intention of the legislator.

What are personal care products in entry 46?

Paragraphs (1) to (9) of entry 46 list the ‘purposes' to which the restriction applies. Following paragraph (7) "cosmetic products" is paragraph (8) "other personal care products". It therefore seems that cosmetics are to be considered as a subcategory of personal care products.

REACH does not define "cosmetic products". According to Regulation (EC) No 1223/2009 on cosmetic products,  "cosmetic product" means "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance protecting them, keeping them in good condition or correcting body odours."

Based on the above, it can be interpreted that "other personal care products" within the meaning of entry 46 include, but are not limited to, any product meeting the conditions indicated in the above definition for substances and mixtures and other products used for personal hygiene, such as toilet papers, some female hygiene products, nappies, cotton pads, etc. This interpretation can be broadly considered as a perception of the average consumer for this product category. 

Entry 48 of Annex XVII to REACH - Toluene

For adhesive tapes, does the concentration limit for toluene of 0.1% in adhesives as specified in Entry 48 of Annex XVII apply to the whole mass of the tape or just to the mass of the adhesive layer on the tape?

Entry 48 prohibits the placing on the market for supply to the general public of toluene as a substance or in mixtures, in a concentration equal to or greater than 0.1% by weight, where the substance or the mixture is used in adhesives and spray paints. Adhesive tapes consist of a layer of adhesive coated on a flexible substrate. As the restriction concerns the concentration of toluene in adhesives, the concentration of toluene must be calculated with reference to the amount of adhesive on the tape, and not with reference to the total weight of the adhesive and substrate.

Entry 50 of Annex XVII to REACH - PAH in extender oils and tyres

What is an interpretation of the "major operational change" concerning the requirement to control the calibration of the PAH/PCA ratio after each "major operational change" under Entry 50 to Annex XVII?

As stated in Recital 8 of the Directive 2005/69/EC (OJ L323, 9.12.2005, p.51), there are at present no harmonized test methods for measuring PAHs in the extender oils, or for measuring PAHs in tyres that contain such oils. Until suitable harmonized methods are available, the only named method that is permitted for measuring the PAH content of extender oils is the IP346 analysis method. This method is permitted providing that certain additional conditions are met. These additional conditions are necessary because the IP346 method does not measure the PAH content directly. In fact IP346 measures the total content of polycyclic aromatic compounds (PCA) rather than the PAH content. The PCAs are a group of substances to which PAHs belong, but in which PAHs are present in only very small amounts. The legal limit for PAHs in extender oils, which is 1 part per million (ppm) of BaP and 10ppm total PAH content, is considered to be met if the total PCA content is <3%. In other words, the PCA content of 3% is taken as a proxy measurement for a PAH content of 10ppm. The proxy measurements will be valid only if the ratio between the PAH and PCA content in the extender oil is known and does not change over time. The additional conditions therefore require an initial calibration of the technique (measurement of the PAH/PCA ratio) and recalibration at intervals of six months, or after "major operational change", in order to ensure that the measurements remain valid over time. The term "major operational change" should therefore be taken to mean any change in materials or processes that could invalidate the results of the proxy measurement. The principle cause of invalid results would be a change in the PAH/PCA ratio in the extender oil. However, it should be remembered that not only is IP346 a proxy method for measuring PAH, but that the quantity that it does measure, namely PCA content, is meaaured in a rather indirect way, namely by a change in the refractive index of a solution, and that PCAs are not the only substances that affect the refractive index of a solution. The potential for obtaining invalid results is therefore quite high and the method should therefore be used with considerable caution. It would therefore be advisable to recalibrate in case of doubt. The provision to control the calibration of the PAH/PCA ratio every six months is to safeguard the validity of the IP346 results against unintentional or unknown changes. This would apply for the case where the manufacturing process and materials used remain the same, and where there is no reason be expect a change in the PAH/PCA ratio. However, it is possible to imagine, for example, that a tyre manufacturer receives a reformulated extender oil from his supplier without being made aware of the change that has been made, and the results from the IP346 could be invalidated as a consequence. A six month recalibration interval was considered sufficient to cover such occurrences. Conclusion: The provision to control the calibration of the PAH/PCA ratio after each "major operational change" is to safeguard the validity of the IP346 results. A major operational change is therefore a deliberate change to materials or processes that might be expected to significantly influence the PAH/PCA ratio, or otherwise affect the validity of the measurement. Examples of such a change would be where the source of supply for the extender oil is changed, or where the method of using the oil is changed. Judgment of whether a particular change is sufficiently important to trigger the need for recalibration will necessarily be made case-by-case and will require expert opinion.

Does the restrictions provided in Entry 50 concerning on PAHs in tyres cover mobile machinery?
Entry 50 to Annex XVII as enacted by Commission Regulation 552/2009 restricts the use of PAH in tyres for "vehicles covered by Directive 2007/46/EC establishing a framework for the approval of motor vehicles and their trailers".
Article 2 of Directive 2007/46 defines its scope. Paragraph 1 lists the vehicles designed for use on roads.
Article 2 of Directive 2007/46, Paragraph 3 lists the following vehicles:
a) vehicles designed and constructed for use principally on construction sites or in quarries, port or airport facilities;
b) vehicles designed and constructed for use by the armed services, civil defence, fire services and forces responsible for maintaining public order;
c) mobile machinery.
Article 2 of Directive 2007/46, paragraph 4 lists the following vehicles:
a) vehicles intended exclusively for racing on roads;
b) prototypes of vehicles used on the road under the responsibility of a manufacturer to perform a specific test programme provided they have been specifically.
In addition the definition of "motor vehicle" in point 11 of Article 3 requires that the vehicles covered should have a maximum de