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Yes. The List of Substances Subject to Authorisation (Annex XIV of the REACH Regulation) includes several substances.
Substances are regularly added to Annex XIV by the European Commission, on the basis of recommendations issued by ECHA. The link to the updated Annex XIV can be found on ECHA's website at: https://echa.europa.eu/authorisation-list.
Further details on the procedure for the inclusion of substances to Annex XIV of the REACH Regulation are available in FAQ ID=127, as well as on ECHA's website at: http://echa.europa.eu/regulations/reach/authorisation.
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.
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 .
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
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.
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.
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.
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
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.
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.
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 full application fee.
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.
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.
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.
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
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.
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
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.
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.
An applicant has the right to contest the decision of the Commission before the General Court.
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.
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.
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.
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:
- How RAC and SEAC intend to evaluate the applications [PDF] [EN]
- Reporting format for the RAC and SEAC opinions [PDF] [EN]
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).
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.
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:
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.
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
a) Do I have to stop using the substance?
b) Do I have to notify my use to ECHA?
a) It depends.
You do not have to stop if the application made up your supply chain has been submitted before the substance’s latest application date. In this case, you can continue using the substance after its sunset date, awaiting for the European Commission’s decision.
You have to stop if the authorisation application has been submitted after the substance’s latest application date. You can restart using the substance only if the European Commission decides to grant an authorisation for your use.
b) Not yet. As long as the European Commission’s decision on the authorisation application covering your use is pending, you cannot notify your use to ECHA. The notification of authorised uses is possible only after an authorisation has been granted. Once the decision to grant an authorisation has been adopted, you then need to submit a downstream user notification of your authorised use (Article 66 of REACH) to ECHA within three months from the first delivery of the substance (see also Q&A 1441).
Yes. If you rely on an authorisation granted to an actor up your supply chain, you must notify your authorised use to ECHA. You must submit your notification within three months from the first delivery of the substance following issuing of the authorisation decision. Your notification needs to refer to the relevant authorisation number(s). Authorisation numbers are indicated on the label of the product and the safety data sheet you receive from your supplier. As they are use-specific, you need to select the specific authorisation number(s) which correspond to your use. Authorisation numbers have the format 'REACH/x/x/x' (see also Q&A 750).
Naturally, you need to comply with the conditions of the authorisation, which should be communicated to you by your supplier in the safety data sheet.
For further information on the downstream user notification for authorised uses (Article 66 of REACH), see:
https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use
ECHA will publish the emissions of non-threshold substances such as environmental endocrine disruptors, PBTs, and vPvBs. It will also publish the release factors related to these emissions to the environment in cases where the applicant has not claimed the volumes used to be confidential. In such cases, ECHA will disclose the emissions as such and redacted information on the release factor (see example).
ECHA encourages applicants to be transparent about the release factors. Indeed, in two thirds of applications received to date (March 2020), applicants have provided this information without claiming the information on the release factor and thus the volume used confidential.
Note that the actual release factors and volumes used are always made available to ECHA’s Committees for Risk Assessment and Socio-economic Analysis when they evaluate the applications and give opinions to the European Commission.
Justification:
Article 64(6) of the REACH Regulation says that the Agency shall determine in accordance with Article 118 and 119 which parts of its opinions should be made publicly available on its website. Article 118(2)(c) provides that disclosure of precise tonnage is normally deemed to undermine the protection of commercial interests of the concerned party.
Under the Aarhus Regulation (Article 6(1)), an overriding public interest in disclosure is deemed to exist where a request is made for information relating to emissions to the environment. ECHA thus considers that emission values are non-confidential from a viewpoint of public interest and right to know.
This policy is consistent with the ECHA’s core values of transparency and efficiency, recognising the overriding public interest in the disclosure of emissions set out in the Aarhus Regulation.
Example:
The volume used of substance is 2 000 kg per year, the release factor is 0.2% and thus the emissions to the environment are 4 kg per year. Unless the applicant has claimed the volume confidential, ECHA will publish this information as part of its opinion.
If the applicant claimed that the volume used should not be disclosed to the public, ECHA would instead publish the volume within a range (e.g. 1 000-5 000 kg), the corresponding release factor also within a range (e.g. 0.1%-0.4 %) and the emission to the environment (4 kg).
No. The REACH Regulation does not provide for the possibility to grant a ‘grace period’ or transitional arrangements. This means that as of the date of the notification of the Commission decision to the authorisation applicant(s) the non-authorised use of the substance will need to be stopped immediately by both the applicant(s) and any downstream users.
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.
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.
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.
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)
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
Yes. Under Article 3(23) of REACH, scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year. Thus, the use of an Annex XIV substance in analysis is exempted from authorisation under Article 56(3) if the substance is used, on its own or in a mixture, in analytical activities such as monitoring and quality control where these activities are carried out under controlled conditions and in a volume not exceeding one tonne per year and per legal entity.
The exemption applies to the use of an Annex XIV substance when it is required as part of an analytical method for the measurement of another substance or property (e.g. used as an extraction solvent or reagent, or to validate the technical specification or performance of a product) and the analysis of the Annex XIV substance itself (e.g. for quality or process control). Where these conditions are met, there is no need to apply for an authorisation for this use or to include this task as a working contributing scenario (i.e. PROC 15) in an application for authorisation.
This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities. However, this exemption does not cover sampling activities (see Q&A 1153).
- Yes, these exemptions cover the incorporation of a substance into the product during the manufacturing process.
- 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.
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.
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.
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.
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.
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.
Yes. The use of an Annex XIV substance when it is required, on its own or in a mixture, as part of an in vitro diagnostic (IVD) method (e.g. in a reagent, calibrator, control material or kit) is considered as scientific research and development and is therefore exempted from authorisation requirements if this activity is carried out under controlled conditions and in a volume not exceeding one tonne per year per legal entity (see Q&A 585).
Annex XIV substances may be required to provide a range of functions during IVD analysis, including: to remove impurities, to prevent undesired reactions that would lead to false positive results, to stabilise or solubilise proteins during analysis, to inactivate viruses prior to analysis.
The exemption covers also IVD medical devices for veterinary and animal health purposes.
It depends. See the more general Q&As 1498 and 1030, as well as Q&A 1442.
For instance, the incorporation of an Annex XIV substance into an IVD medical device which is an article is not exempted under Article 56(3) REACH. Similarly, the use of an Annex XIV substance in upstream life-cycle stages to produce IVD medical devices which are not articles (e.g. reagents, calibrator, control material or kits) and where the Annex XIV substance is not incorporated into the IVD device is not exempted under Article 56(3) REACH. An example of the latter is the use of an Annex XIV substance to lyse cell membranes during the purification of antibodies that are subsequently used in an IVD medical device which is not an article: that use would require an authorisation.
Uses in PPORD are not generically exempted from the authorisation requirement.
However:
- Specific entries in the Authorisation List may include an exemption for uses in PPORD below a specified maximum quantity;
- Activities to develop products and processes may fall under the definition of Scientific Research & Development (SRD) if they are carried out under controlled conditions in a volume less than one tonne per year. In this case, they are exempted from authorisation.
Application for authorisation dossiers shall consist in an IUCLID file, to which a series of specific documents are attached. For the purpose of an application for authorisation, the latest version of IUCLID should be used. Formats for these attachments are provided by ECHA on its website
Authorisation application dossiers shall be submitted electronically via REACH-IT. See (http://echa.europa.eu/applying-for-authorisation)
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.
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.
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
Yes. The applicant's name will normally be made public as part of the Broad information Use during the public consultation on alternatives.
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.
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.
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.
A joint application for authorisation in REACH is made and submitted simultaneously by a group of applicants (i.e. the submitting applicant and the co-applicants). The submitting applicant starts by uploading the IUCLID dossier in REACH-IT. When the dossier has been successfully uploaded, the submitting applicant receives the joint application name and security token, which he will communicate to the co-applicants.
The submitting applicant and co-applicants indicate the substance-use combinations they are applying for, scope of their use(s) and provide the information on their role in the supply chain by completing the information in REACH-IT. The submitting applicant finalises the joint application after all co-applicants have completed their parts of the information and confirmed their participation.
Due to the possible complexity and technical issues of joint applications, ECHA recommends to prepare and submit a joint application when (i) all co-applicants of the group apply for all uses in the joint application, and (ii) the co-applicants have agreed on a way to share all the information provided in the application.
In complex cases, it may be preferable for each applicant to submit their own application separately. The applicants can cooperate during the preparation of their applications. For details, see the manual ‘How to prepare an application for authorisation manual’.https://echa.europa.eu/manuals, Application for Authorisation Guidance (Appendix 2) and the presentations "Description of uses for authorisation / Broad Information on Uses" and "Joint versus Individual applications" for additional information.
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.
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.
Via REACH-IT and the secured webforms. However, for organisational and practical issues, emails can be used.
Yes, if they form a group. The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as stated in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, you have to submit a separate application for each substance. See Appendix I of the Guidance on the preparation of an application for authorisation on substance grouping.
When 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.
Several scenarios can be envisaged: A base fee is payable, which covers one substance and one use. An additional fee applies for each additional use and substance. No additional fee for additional applicant(s) is levied, though. However, the levels of the base fee and of the additional fees per use and substance depend on the size of the largest company that is party to the application - .i.e. if in joint applications companies are of a different size, the highest applicable fee will be levied.
For example, in the case of an application submitted by four parties with ten three uses and two substances in total, the relevant fee will be the base fee applicable to the largest applicant + three additional applicant fees + nine two additional use fees applicable to the largest applicant + one additional substance fee applicable to the largest applicant.
The table below shows four examples of calculated fee for applications for a single substance where the (largest) applicant is a large company.
Table: Fees depend on the number of uses, not applicants
Examples | A | B | C | D |
---|---|---|---|---|
Applicants | 1 | 2 | 1 | 2 |
Uses | 1 | 1 | 2 | 2 |
Fee | €54 100 | €54 100 | €102 790 | €102 790 |
The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as defined in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, a separate application must be submitted for each substance.
Further information: ECHA Fee Calculator: a tool provided by ECHA to estimate the possible amount of a fee related to a given application for authorisation.
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.
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.
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 full 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 necessity to impose an additional fee will reflect ECHA's workload associated with processing and evaluating the application. The calculation of the base fee and any applicable additional fees is described in Q&A 600. An application would lead to additional workload if the number of ‘uses applied for' and/or exposure scenarios is greater than one. One "use applied for" shall be covered by at least one exposure scenario. However, the number of uses vs the number of exposure scenarios might not be identical. Thus, in order to reflect the additional workload, ECHA calculates the fee based on the highest number of uses vs. exposure scenarios.
Example 1: Iif you apply for two uses that are covered together in your Chemical Safety Report by one generic exposure scenario, ECHA will calculate the invoice based on two uses.
Example 2: If you apply for two uses which are covered by three different exposure scenarios, ECHA will estimate whether the evaluation of the additional exposure scenario increases ECHA's workload and whether the fee can be based on three uses.
No.
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.
Teleconference based information sessions (TIS) give an opportunity for future applicants to clarify regulatory and procedural aspects of the authorisation application process, and for ECHA to have a better understanding of the practical issues related to Applications for authorisation. ECHA organised earlier “Pre-submission information sessions” (PSIS). TIS are a more focussed, teleconference based way of fulfilling the same purpose as with PSIS.
For further details see ECHA's Support webpage on teleconference based information sessions (link to: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).
You can make a request for a teleconference based information session (TIS) either when notifying ECHA of your intention to submit an application for authorisation, or later. You should nevertheless send your request for a TIS at least eight months before the planned date for the submission of your application for authorisation. Although you can still notify less than eight months in advance of the submission of your application, this may have an impact on ECHA's availability to organise a TIS for your company. Please bear in mind the TIS should take place within one month after the meeting request and that you probably would like to have sufficient time after the TIS to potentially further work on your application before submitting it to ECHA.
Requests for TIS are made via a secure web form, available on ECHA's website. For further details see ECHA's Support webpage on TIS (link to: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).
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
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.
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:
- How to develop the description of uses in the context of Authorisation [PDF] [EN]
- Presentations from seminars on applications for authorisation
- Guidance on information requirements and chemical safety assessment - Exposure Scenario Format
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:
- Guidance on information requirement and CSA
- Characterisation of dose [concentration] - response for human health (Chapter R.8) [PDF] [EN]
- Evaluating applications web page
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.
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.
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.
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.
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.
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:
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.
There is no requirement to submit a socio-economic analysis when submitting an application for authorisation under the adequate control route. However, ECHA recommends that a targeted socio-economic analysis is also prepared under the adequate control route. This would be helpful in particular to the Committees when proposing to the Commission the duration of the review period. Furthermore, if the ECHA Committees do not support the applicant's assessment according to which the risks are adequately controlled, the application can still be evaluated on the provided socio-economic analysis.
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.
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.
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.
Sometimes an applicant may not have been profitable in recent years but still seeks an authorisation for continuing the use of a SVHC. The question thus arises regarding how not obtaining an authorisation would affect the applicant. To answer this question, it should first be noted that changes in applicants’ profits are only one possible element to consider when estimating the benefits of continued use. Impacts on other actors (e.g. within the supply chain, on alternative providers or consumers) may also be important. Other approaches, such as the compliance cost guidance, may also be relevant when assessing the benefits of continued use.
When considering changes to profits as a measure of benefits of continued use, the assumptions about future profits in the baseline scenario need to be justified, regardless of whether the company in question has had negative profits in the past or not. If the company has had negative profits, it is also useful to explain the reasons for this. In particular, the applicant should clarify whether these negative profits link directly to activities that rely on the use of the SVHC. If there is a specific reason why the company has had negative profits in the past, but this is not expected to be the case in the future, then it may make sense to base future projections on, for example, the profits of a typical year or period. The profits considered should be those related to the use applied for (and not e.g. other products of the company not related to the use of the SVHC).
Once the total expected profits over the baseline scenario have been established (with any expected negative profits in specific years reducing the total profits made), an approximative yearly profit can be calculated by dividing the total profits with the number of years applied for. More accurately, the applicant can derive an annuity of expected profits by using the standard annuity formula PMT(rate, nper, pv, [fv], [type]) in Excel.
The Annex XIV entry for HBCDD is a relatively broad entry, which might be considered to describe UVCB substances (with undefined Br positions), as well as multi-constituent substances (containing more than one defined diastereoisomers at concentrations between ≥10% and <80%), and mono-constituent substances (one diastereoisomer ≥80%).
If the application concerns one particular HBCDD substance (either UVCB, or multi- or mono-constituent), then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals).
Should the application concern more than one substances covered by the HBCDD entry (for instance due to different manufacture processes by one manufacturer, or in case of a joint application with applicants manufacturing/importing significantly different HBCDD substances), the application can still be considered as an application for "one Annex XIV substance". Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.
In this latter case, for technical reasons in section 1.1 of the IUCLID application dossier the following information should be filled in: IUPAC name: Hexabromocyclododecane; Type of substance – Composition: other: multiple substances under Annex XIV entry. The actual compositions of the substances applying for can be listed individually as different compositions in section 1.2 by using the repeatable block-function. In the "Brief description" field of each listed composition, please indicate also a remark, e.g. "substance manufactured from manufacturing site A" or "substance manufactured/imported by applicant B".
It is reminded that the REACH Annex XIV substance entry number (for HBCDD this number is "3") shall always be given in section 1.3 of the IUCLID dossier.
General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals)
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
|
2 |
Importer/User of both
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:
Assessment reports in IUCLID (CSR, AoA, SEA):
|
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
|
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:
Assessment reports in IUCLID (CSR, AoA, SEA):
|
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:
Assessment reports in IUCLID (CSR, AoA, SEA):
|
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
These Annex XIV entries are relatively broad entries, covering well-defined substances and UVCB substances, polymers and homologues.
If the application concerns one particular substance within the scope of one of these entries, then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation.
If the application concerns more than one substance covered by the applicable entry (i.e., either entry 42 or entry 43 in the authorisation list), the application will still be considered as an application for "one Annex XIV substance" for that specific entry. Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.
In this latter case, for technical reasons section 1.1 of the IUCLID application dossier should contain the following information:
- IUPAC name: the name of the entry as it appears in the Authorisation List (“4-Nonylphenol, branched and linear” or “4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated” accordingly);
- Type of substance – Composition: “other:” “multiple substances under Annex XIV entry”.
In this case, in section 1.2 the available information about the actual compositions of the substances applying for can be provided, listed as different compositions by using the repeatable block-function.
It is reminded that in all cases the REACH Annex XIV substance entry number (for these entries the number is "42" and “43” accordingly) shall be given in section 1.3 of the IUCLID dossier.
General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation.
It is noted that in the case the application concerns both entries (42 and 43) a single multi-substance dossier will need to be submitted. In this case, ECHA will charge a fee for two substances and the IUCLID dossier shall accordingly contain two substance datasets, according to the instructions provided in the manual.
Yes, given the method of manufacture of this type of substance. The commercially manufactured nonylphenol ethoxylates predominantly consist of C9 alkyl substituents in position 4 (para-) of the phenol ring. Therefore a substance defined as nonylphenol ethoxylated is covered by the entry 43 for ‘4-Nonylphenol, branched and linear, ethoxylated’.
A change of legal entity is a change of the legal person who is the applicant of an authorisation or an authorisation holder. This change can take place, for instance, as the result of a merger, a split or an asset sale (sale of a production site or business). See Q&A 1242. Also purely administrative changes such as a change of corporate name or address and a change of Only Representative (OR) of a non-EU company need to be notified. See Q&A 1253.
Yes.
Please submit the notification as follows:
- Go to REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.
- Then notify ECHA via email: legal-entity-changes-authorisation@echa.europa.eu. Please mention the affected submission number (of application) or authorisation number (of granted authorisation), and confirm that you have updated the name in REACH-IT.
In this manner ECHA can quickly process the change. ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.
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.
Please follow the next steps:
- If relevant, create a new REACH-IT account for the successor legal entity. This is relevant when the new legal entity did not have a REACH-IT account before.
- Log into the REACH-IT account of the original legal entity and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions. For the submission, include two attachments:
- Evidence of change, for instance the merger agreement or the agreement of the sale of assets.
- Filled announcement using the format indicated below. This describes the change of legal entity and the concerned application(s) or authorisation(s), as well as provides an analysis of the key impacts. It needs to be signed by both the original and the successor legal entity.
See also Q&A 1247.
Remember, that if the original entity has other REACH assets (e.g. registrations), the change of legal entity may need to be notified, too, via the same functionality in REACH-IT. See ECHA’s Practical Guide and technical instructions provided in the REACH-IT tool.
- Format [DOCX]
Currently no fee needs to be paid for this notification for the purposes of authorisation.
If the change concerns a pending application for authorisation, ECHA will communicate whether the notified change corresponds to the requirements described in Q&A 1241 and is properly documented. Furthermore, it will give its view on whether the change is minor (i.e. purely administrative changes and changes that would not have material implications on the content of the application or the terms of the RAC and SEAC opinions) or major (i.e. all other cases). ECHA endeavours to process notifications in two weeks. If the change is confirmed, ECHA will provide to the original legal entity a token. The original legal entity will need to communicate the token to the successor legal entity, who will need to accept the legal entity change in REACH-IT. The change is considered valid as of the date of the notification.
In this case ECHA will amend its database concerning the change of the legal entity. If the change is major, the RAC and the SEAC might need additional time to assess the implications of the change during the opinion-making process. If ECHA has already adopted an opinion, it will send its assessment to the European Commission so that it can take this into account when deciding on the authorisation.
In cases concerning granted authorisations, ECHA will send its assessment on the nature of the change to the European Commission, including its assessment on whether a review of the authorisation should be triggered on the basis of Article 61(2) of REACH.
The timelines for the assessment about any implications for the RAC and SEAC opinions or for the authorisation decision (potential trigger of a review of the authorisation) depend on the stage in the process at which the notification was made.
ECHA or the Commission may request for clarifications or additional information concerning your notification.
An applicant for authorisation or an authorisation holder should inform ECHA about any legal entity change as soon as it has taken place (i.e. when they have the documentary evidence) using the ‘Legal entity change’ functionality in REACH IT. To reduce uncertainty you can also consult ECHA on the specific case in advance, provided you have sufficient information about the foreseen change. For any questions, please contact ECHA at legal-entity-changes-authorisation@echa.europa.eu.
Yes.
Please proceed as follows:
- Create a new REACH-IT account for the new Only Representative.
- Log into the REACH-IT account of the original Only Representative and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions.
ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.
Yes.
Please submit the notification as follows:
- Log into REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.
ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.
The Review Report updates the Application for Authorisation (AfA), and it must be sent to ECHA. The fee is the same as the one for an AfA. The Review Report will follow the same process as for an AfA. The greater the relevant technical and other progress during the review period, the greater the need to update the information. The information elements are the same. In other words, a Review Report should include an updated version of the assessment reports submitted in the original application (Chemical Safety Report, Analysis of Alternatives and – when relevant – an updated Socio-economic Analysis and an updated Substitution Plan). The use description may also need to be updated e.g. to reflect a more narrow scope.
See Section 6 of the Practical Guide “How to apply for an authorisation” at https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676.
All the Q&As related to Applications for Authorisation are also valid for Review Reports mutatis mutandis.
You will need to first establish if the increase in the tonnage for the authorised use of the Annex XIV substance would result in an increase in exposure levels to workers and/or emissions to the environment compared to the levels set out in the CSR referred to in the authorisation decision. This CSR forms part of the conditions under which the authorisation was granted to you and served as a basis for the European Commission’s conclusion that the conditions for granting the authorisation were fulfilled.
If you conclude that the exposure levels are likely to increase, you should submit a review report earlier than what was stipulated in the authorisation decision, especially if the increase in exposure leads to higher health and environmental impacts than when the use of the Annex XIV substance was authorised.
You can update your downstream user notification of authorised uses via the relevant reference number page.
Step 1: In REACH-IT, search for the relevant “reference number”
Step 2: Enter an identifier and choose “Downstream user notification of authorised uses” as a dossier type. Click on “Search”
Step 3: The relevant result will be displayed under “Results” page. Click on the reference number.
Step 4: On the reference number page, click on “Create and submit online an update”
Step 5: To continue to the online dossier creation, click on “Yes I want to prepare an online dossier”
Step 6: You are redirected to the online dossier creation. Add any relevant information.
Step 7: In “Update details”, add a reason for updating your downstream user notification of authorised uses.
Carefully review all the information before submitting your dossier.
You can cease all notified uses from the reference number page. Below are the steps on how to cease manufacture in REACH-IT.
Step 1: In REACH-IT, search for the relevant “reference number”.
Step 2: Enter an identifier and choose “Downstream user notification of authorised uses” as a dossier type. Click on “Search”.
Step 3: All downstream user notifications of authorised uses will be displayed. Click on the reference number for the
substance for which you wish to notify you are ceasing the use.
Step 4: On the reference number page, click on “Cease all notified uses”.
Step 5: Choose a justification for ceasing the use, and click on “Confirm the cease use”.
Step 6: The cease use has been successfully recorded. The reference number status is set as “Inactive”.
You should update your downstream user notification of authorised uses to attach your measurements. Please refer to Q&A 1794 to update your downstream user notification of authorised uses.
Once you have launched the submission wizard, click on ‘Edit Authorised uses’ as shown in the screenshot below:
Upload your document (e.g. filled in template provided by ECHA or by the authorisation holder, laboratory analysis etc.) in the ‘File attachment’ section. Read the text in red and take note of the deadline for providing the relevant attachment.