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 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:

• How to prepare an application for authorisation manual
• SME definition

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) 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 

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

 

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).

This question relates to the implementation of the Commission’s authorisation decision and, as such, is a matter for the national enforcement authorities of the Member States. Please contact your national enforcement authority without delay and ask them how to address the issue.

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).

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.

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.

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.

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. 

 

It depends. The exemption applies, for example, to an Annex XIV substance used together with (but not becoming an integral part of) an article both produced for SRD purposes (e.g. reagent used together with an analytical apparatus). However, the exemption does not apply to an Annex XIV substance which is integrated in (i.e. becoming an integral part of) an article produced for SRD or non-SRD purposes (e.g. mercury in thermometers). Similarly, the exemption does not apply to an Annex XIV substance used to produce an SRD article if the substance is not intentionally incorporated into the SRD article (e.g. used as processing aid or solvent during the manufacturing of the SRD article).

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

However:

1. Specific entries in the Authorisation List may include an exemption for uses in PPORD below a specified maximum quantity;
2. Activities to develop products and processes may fall under the definition of Scientific Research & Development (SRD) if they are carried out under controlled conditions in a volume less than one tonne per year. In this case, they are exempted from authorisation.

For more information, see also ECHA’s “Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)”, available at: https://echa.europa.eu/guidance-documents/guidance-on-reach.

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.

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.

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

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

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

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

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

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

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

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

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

 

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 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.

See also Q&A 752 and 912

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:

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

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.

• How the Committee for Socio-Economic Analysis will evaluate economic feasibility in applications for authorisation [PDF] [EN]

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. 

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 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 chromic acids and their oligomers generated from chromium trioxide covering the further uses or for 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

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:

1. Evidence of change, for instance the merger agreement or the agreement of the sale of assets.
2. Filled announcement using the format indicated below. This describes the change of legal entity and the concerned application(s) or authorisation(s), as well as provides an analysis of the key impacts. It needs to be signed by both the original and the successor legal entity.

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

• Format [DOCX]

 

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

 

Yes, provided that the change does not imply an extension of the scope of the original application (see Q&A 1241).

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.

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.

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.

Yes, until a decision on the review (maintaining, amending or withdrawing the authorisation) is adopted - see also Q&A 0571; 0572; 0573 which relate to the submission windows and the (latest) submission dates. The Q&As are also applicable to Review Reports.

No, the substance cannot be used after the end of the review period. You will have to wait the Commission’s decision before you can continue using the substance.

No. To submit a Review Report, the use has to be the one for which you have an authorisation. But you can submit a new Application for Authorisation.

Yes. As long as your use is within the scope of the authorised use, but more narrowly defined, you can prepare a Review Report for the review of the authorisation. No need to make a new application in this situation. 

Yes you can, as long as each of the new redefined uses are within the scope of the previously authorised use. Please explain this clearly in the explanatory note to be submitted with the review report. In this case an updated version of the Chemical Safety Report, Analysis of Alternatives and – when relevant – a Socio-economic Analysis and a Substitution Plan must be submitted for each use. Splitting the use will have an effect on the fee (i.e., an additional charge will be imposed for the second use). At the same time in some cases this may make your Review Report clearer and more focussed, which helps ECHA’s scientific committees’ evaluation and the Commission’s decision making.

Yes.

Yes. Authorisation holders should use this information too, when preparing the Review Report.

Yes.

No, you do not have to. However, it would be advisable to do so. Moreover, you shall ensure and demonstrate in the review report that the exposure is reduced to as low level as is technically and practically possible. 

You can submit it to ECHA in the same manner as the original application, using the formats available for that purpose on the ECHA’s website. However, you will naturally need to indicate that it is a Review Report and make a link to the original application. You will also need to write an explanatory note which briefly explains what is different in the review report compared to the original application. For details see the Guide “How to apply for authorisation”: https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676

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

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

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

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

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

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

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

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.

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

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

• Show your real intentions to register or update your registration dossier, by providing ECHA with the registration numbers or inquiry numbers and the EC number of the substances you manufacture or import;
• Provide a description of why you need the data and how you intend to use it (e.g. for read-across);
• Submit a declaration that "The robust study summaries provided shall be only used for registration purposes under the REACH Regulation";
• Provide the EC numbers of the substances for which you need the robust study summaries submitted more than 12 years previously
• List the endpoints that you would require information for.

According to REACH, any robust study summaries submitted more than 12 years previously can only be used for the purposes of registration. Furthermore, the provision by ECHA of copies of robust study summaries does not provide ownership rights on this data.

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

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. 

If he needs information involving tests on vertebrate animals, the potential registrant must contact the previous registrants (and/or the other inquirers) identified by ECHA. If he needs information not involving tests on vertebrate animals, the potential registrant may contact these previous registrants (and/or the other inquirers).

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. They must also apply the obligations set out in the Implementing Regulation 2016/9 on joint submission and data sharing. The obligations to make every effort and those set out in the Implementing Regulation apply to any information requested, whether it concerns vertebrate or non-vertebrate animal studies.

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

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.

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

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.

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).

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

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

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

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

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

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

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

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

• the potential registrants tab in the REACH-IT co-registrants page, if included in a successful inquiry notification;
• the registrants tab in the REACH-IT co-registrants page, if included in a successful registration dossier;
• and in the joint submission, if included during creation (lead registrant) or confirmation (member registrant) of the joint submission in REACH-IT.

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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

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

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

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

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

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

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.

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.

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.

• 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.

• 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.

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).

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. 

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.

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

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

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

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

• high tonnages;
• suspected data gaps in the higher-tier human health or environment information requirements;
• high potential for exposure of humans or environment (e.g. widespread uses or uncertain information on uses).

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

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

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

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

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

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

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

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

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

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

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

 

ECHA informs active registrants via REACH-IT, when a compliance check for a substances in their portfolio is launched. This notification is a reminder of the legal obligation to keep the registration dossiers up-to-date, which is particularly important when a compliance check is initiated.

The active registrants receive a generic message to their REACH-IT account without specifying the substance. In order to identify the substance concerned, the registrant is advised to check the substances under assessment on the Dossier Evaluation status webpage using the filter below.

Please note that even if your substances appears under assessment, you may not necessary receive a draft decision, since it is send only to registrants that are concerned by the data gaps identified or it may be registrant specific, if it concerns substance identity information or endpoints that a registrant has opted out. 

Even if you do not receive a draft decision, you can continue to follow the progress of the substance through the Dossier Evaluation status webpage.

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

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

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

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

• If the requested information already exists, you will need to agree on the costs and sharing of the existing data.
• If the requested information needs to be generated, you will need to:
  • agree on the test to be performed, including on the testing material to be used as representative for all registrants;
  • inform ECHA of who will perform the test; and
  • share the costs and new data

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

• Dossier evaluation status
• Public activities coordination tool (PACT)

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

See also ECHA’s Recommendations to registrants.

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

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

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

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

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

See also Q&A 1574.

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

You should direct all questions to your national authorities.

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

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

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

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

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

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

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

• The scenarios that a (potential) registrant may encounter
• (potential) registrant’s obligation to submit an inquiry dossier
• the type of inquiry to be specified in section 14 of the IUCLID dossier.

 

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

 

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

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

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

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

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.

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

An inquiry dossier should contain: 

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

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

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

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

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

 

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

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

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

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

 

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

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

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

• Contact details: names and addresses of the previous registrants and, if appropriate, other inquirers (potential registrants).
• Studies: a list of submitter’s contact details for each endpoint and the UUIDs of the (robust) study records which have been submitted more than 12 years earlier. This information enables the potential registrant to request the sharing of existing data from the previous registrants.

• Contact details: names and addresses of the previous registrants and, if appropriate, other inquirers (potential registrants).
• Studies: a list of the submitters’ contact details for each endpoint and the UUIDs of the (robust) study summaries which have been submitted more than 12 years earlier. This information enables the potential registrant to request these robust study summaries directly from the previous registrants.

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

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

• a list of submitter’s contact details for each endpoint 
• the UUIDs of the (robust) study summary which have been submitted more than 12 years earlier. 

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

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

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

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

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

• They submit an inquiry to ECHA. Instructions on how to submit an inquiry can be found in the manual ‘How to prepare an inquiry dossier’ at: https://echa.europa.eu/manuals. 
• They contact other registrants of the same substance. The contact information can be found by searching the dissemination page at: https://echa.europa.eu/information-on-chemicals/registered-substances. 

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

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.

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

 

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

Registrants can see different information depending on their status:

• Potential registrants, during the 1 year after successfully submitting their inquiry, can see all registrants. However only the leads are identified.
• Potential registrants, beyond the 1 year of their successful submission and if they have not registered, can only see new potential registrant(s) or registrant(s) that have inquired. They can no longer see the existing registrants that did not inquire.
• Registrants can see the roles of all co-registrants, i.e. whether they are lead or member and can see the potential registrants.

They are not shown in the case where the notifying company did not claim a registration number for the notified substance. For such cases, only the company name and the country are displayed.

The co-registrant page shows only the contact details of those companies who did claim the registration number.

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

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

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

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

For any enquiry, please contact ECHA by using the ECHA Helpdesk contact form.

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

• Lower fees apply to joint submissions as compared to individual submissions. This does not apply in case you decide to opt-out of the joint submission;
• SMEs benefit from a reduced fee in all categories;
• An additional fee is levied for confidentiality.

No fee is required for the registration of substances if you are entitled to a fee waiver. Further information related to the fee waiver can be found under Q&A 1237.

All these provisions are specified in Articles 12(1)(a) and 74 of REACH, taking into account Recital 34 of the regulation. The fee amounts can be found in the REACH Fee Regulation (No. 340/2008, and subsequent amendments).

Further information can be found under Invoicing and Payments..

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

Information related to the chargeable confidentiality claims can be found in the manual “Dissemination and Confidentiality under the REACH Regulation”, chapter 3.5.

ECHA encourages to run the Fee calculator plugin before submitting the IUCLID dossier in REACH-IT. A potential fee mismatch will enable you to identify and correct a mistake in your dossier before the submission.

After your REACH submission has been received by ECHA, you will receive an electronic invoice only, via REACH-IT. This electronic invoice can be downloaded from your REACH-IT account in PDF format.

The timelines for payment of fees levied under the REACH Regulation are specified in the REACH Fee Regulation as subsequently amended by the Commission Implementing Regulation (EC) No 340/2008 and its subsequent amendments (see Q&A 716) and the precise payment due date is set out in ECHA's invoice.

Fees invoiced for initial and update registrations

In the case of fees for registrations submitted, as well as in the case of updates of a registration, the initial payment due date of the fee is set at 14 calendar days from the date on which the invoice was notified to you. 

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline for payment. This second deadline (extended payment due date) is 60 calendar days from the initial payment due date.

If the payment is not made by the extended payment due date, the registration fails the completeness check and will be rejected.

For updates of a registration unrelated to tonnage band changes, the registrant has the possibility to request a further extension of the second deadline for fee payment before its expiry. In practice, this request for extension of the second deadline for payment applies only to:

• Fees levied for new chargeable confidentiality claims included in updates;
• Fees levied as a consequence of a legal entity change.

The request for extension should be submitted before the expiry of the second deadline via the ECHA Helpdesk using the contact form.

If the payment is not made by the deadline of the extension, the update fails the completeness check and will be rejected.

Fees invoiced (PPORD) exemptions and for requests to extend PPORD exemption.

Fees for notification of PPORD exemptions: the initial payment due date of the fee is 7 calendar days from the date on which the invoice was notified to you. Requests to extend a PPORD exemption: the initial payment due date of the fee is set at 30 calendar days from the date on which the invoice was notified to you.

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline. This second deadline (extended payment due date) is 60 calendar days from the initial payment due date.

Where the payment is not made by the expiry of the second deadline, the notification or the request for an extension will be rejected.

Fees invoiced for Legal Entity Change (LEC)

Fees for Legal Entity Change: the initial payment due date of the fee is 14 calendar days from the date on which the invoice was notified to you.

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline. This second deadline (extended payment due date) is 30 calendar days from the initial payment due date.

Where the payment is not made by the expiry of the second deadline, the Legal Entity Change will be rejected.

Fees invoiced for Applications for Authorisation (AfA)

Fees for Application for Authorisation: the initial payment due date of the fee is 14 calendar days from the date on which the invoice was notified to you.

If the payment has not been made within the prescribed period (by the initial payment due date), ECHA will set a second deadline. This second deadline (extended payment due date) is 7 calendar days from the initial payment due date.

Where the payment is not made by the expiry of the second deadline, the Application for Authorisation will be considered as not received by ECHA. In this case the application is not processed further. The only way to proceed is to re-submit the application. 

ECHA does not send confirmations of receipt of payment, but you can check the status of your payment in REACH-IT. Open the submission report and look at the “Submission processing steps” section; the "Financial completeness check" step will be green when your payment has been received and accepted by ECHA.

Please note that it may take several days before ECHA receives the payment depending on the payment method. A SEPA payment is transmitted within three bank business days.

A submission is subject to both a technical and a financial completeness check. Therefore, a fully paid invoice does not necessarily indicate an accepted submission of your REACH dossier.

When an invoice is cancelled (e.g. due to incorrect information on the invoice, such as billing information, company size, etc.), you will receive a credit note for the whole amount and, if needed, a replacement invoice. These electronic documents can be downloaded from your REACH-IT account in PDF format. If you receive two invoices and one credit note, the reference number you should indicate in your bank transfer is the reference number of the latest invoice.

If you pay an invoice for which ECHA later issues a credit note, the paid amount will be credited back to your company by either reallocating the received amount to another open invoice or refunding the amount to you.

Please be informed that ECHA doesn't provide any credit notes in case the invoice was not paid in full and your registration was rejected.

• Company name and billing address indicated by the registrant (the information filled in the tab "Billing company information" in REACH-IT is the one that will appear on the invoice);
• Customer ID number (= Legal entity UUID);
• DUNS number and VAT number (if provided by the registrant during the sign-up, can be modified later on in the company information section);
• Purchase order number (if provided by the registrant when submitting the dossier or when accepting a legal entity change).

If your invoice has not been paid yet, ECHA will be able to cancel it and create a new one with your updated company information. If the invoice has already been paid, ECHA cannot modify the invoice.

ECHA is unable to update any company information in REACH-IT. It is the responsibility of the REACH-IT account owner within the company to make sure that the information is up-to-date.

To receive an invoice with updated company information update your information in REACH-IT. Go to Menu >> Manage Company >> Company information. Here you can modify and update your information by clicking on "Update" at the top right corner of the page. Always remember to save your changes. Additional information on how to update your company information can be found in the ECHA Accounts Manual for Industry Users.

After the company details have been updated, you need to contact the ECHA Helpdesk by using the contact form available on the ECHA website.

Company size information

If the changes in your company information are related to a change in the company size or to an incorrectly declared company size, please refer to the SMEs section on the ECHA website.

You are entitled to the fee waiver if:

1. Your substance is a phase-in substance and considered to be low risk (i.e. does not meet the Annex III criteria of REACH); and
2. You submit a standard registration dossier for 1-10 tonnes per year voluntarily providing the full set of information listed in Annex VII.

The fee waiver does not apply if:

• Your substance is considered to be low risk (i.e. does not meet the Annex III criteria) and you submit a registration dossier for 1-10 tonnes per year with only physicochemical information (listed in section 7 of Annex VII); or
• Your substance is not considered to be low risk (i.e. meets the Annex III criteria) and therefore, you must provide the full Annex VII information; or
• Your substance is a non-phase-in substance.

The above is based on REACH Regulation Articles 12(1)(a) and 74, taking into account Recital 34.

Important notes

In a joint submission, the tonnage band of the other member registrants does not influence the applicability of the fee waiver for your own dossier.

You need to actively claim the fee waiver in IUCLID to benefit from it – the system does not grant it automatically.

More information on the Annex III criteria and their applicability can be found here.

 

When submitting a dossier or accepting a legal entity change, you are able to indicate your own internal purchase order number in the third step of your dossier creation wizard (see screenshot). The indicated purchase order will be linked to the invoice issued for the dossier submission or the legal entity change.

For the submission report or an already issued invoice, it is not possible to add any forgotten purchase order number aor modify it afterwards.

 

As you register online in REACH-IT you should not send any purchase orders by ordinary mail or email to ECHA. Please make sure that your system does not send any purchase orders automatically to ECHA. Your purchase order is only for your internal purposes. ECHA will not confirm your internal purchase order or provide information to or access third party platforms for handling your purchase orders.

Bank transfer is the only accepted payment method. Other types of payment, such as cheque, banker's draft or cash, are not accepted by ECHA.

Payments should be executed in Euros only and it must be ensured that the full amount of the invoice is received by ECHA. Deductions of bank charges, from exchange rate differences or of any other costs will lead to an underpayment of the invoice.

The following bank details are indicated on all invoices issued under the REACH Regulation as from 01.07.2019:

Bank: 		ING Belgium, Avenue Marnix 24, 1000 Brussels, Belgium

IBAN: 		BE93 3631 8789 1767

BIC/SWIFT: 	BBRUBEBB

Please note that separate instructions for the payment of Appeal Fees exist. These are explained in the relevant section of the Board of Appeal on ECHA's webpage.

In the payment instruction, the invoice number should be indicated as the reference number. According to Article 17(1) of the REACH Fee Regulation (EU) No340/2008, in its latest version (see Q&A 716), every payment must indicate the invoice number. Thus, in the free text message/communications or reference field of the payment you should indicate only the payment reference indicated on the invoice. It is comprised of eight digits and you will find it next to ECHA's bank details on the invoice. This is very important, as your payment is automatically processed by REACH-IT. Please instruct your accounts payable/payments department and your bank accordingly.

Where the payment of a fee is not made by the extended payment due date or by the extension of the second deadline, the submission will be rejected or deemed not to be received. In the above mentioned cases, a rejection due to non-payment is not related to the status of the technical completeness check (TCC). Your submission will be rejected regardless of a given prolonged deadline to fulfil information requirements by submitting further information.

Furthermore, if your submission is rejected, the REACH Fee Regulation (EU) No340/2008, in its latest version (see Q&A 716), stipulates that the fees paid in relation to that submission before its rejection shall not be refunded or otherwise credited to you. After you have received the rejection letter, you are able to start your submission process from the beginning.

Since 1 November 2009, a SEPA payment must be transmitted within three banking business days. The bank statement of any given day is available to ECHA only on the next banking business day. Therefore, it normally takes up to five banking business days before ECHA can handle your payment and confirm the invoice as paid in REACH-IT. Please note that the handling time may be longer if your payment cannot be dealt with automatically. By following ECHA's instructions regarding payments you can significantly reduce ECHA's handling time of your payments (see Q&A 721).

On the basis of the daily electronic bank statement, REACH-IT automatically matches your payment with your open invoice if you have indicated the correct payment reference (invoice) number in your payment message and you have paid the correct amount. An additional condition is that you pay each invoice separately as a single payment. One bank transaction per invoice therefore ensures the fast registration of your payment.

ECHA strongly advises you not to pay two or more invoices in the same transaction ("multiple invoice payment"). If you however include more than one invoice in the payment, please make sure that the invoice references are mentioned in full. Otherwise, the payment has to be manually handled by ECHA's accounting department. This may delay the processing of the payment and thus also the overall completeness check of your registration. If, for some reason, you cannot avoid sending multiple invoice payments and you are unable to indicate the full reference numbers in the payment, please make sure to follow the instructions in Q&A 732, which describes the sending of payment advices.

1. Pay one invoice per transaction (single payment);
2. Indicate the correct reference number (eight digit invoice number);
3. Ensure the invoiced amount is paid in full (no charges or exchange rate differences);
4. Instruct your bank to send a SEPA payment with shared cost.

• "Legal entities"
• "Financial identification"

All the information you need for proceeding with the payment is visible in the invoice itself. However, depending on your internal administrative procedures, it is advisable that your accounting/accounts payable department is prepared for the payment of ECHA's invoices.

We therefore recommend that you set up ECHA's bank account information in the accounting system well in advance of the first invoice's due date.

PLEASE NOTE OUR NEW BANK DETAILS SHOWN ON INVOICES AS FROM 01 JULY 2019.

On 01 July 2019 ECHA changed the bank account details shown on its fees and charges invoices. The Agency’s new house bank is ING Belgium NV. ECHA’s new financial identification form (see attachment) covers all the details needed for this new bank account.

If you use an external accounting company, please ensure that all required information about ECHA and REACH is passed on, in order to ensure the smooth handling of ECHA's invoices. It is also advisable that you ensure beforehand that there are no misunderstandings related to ECHA's status as an EU body which is exempt from any national tax or any value added tax. Please refer to Q&A 725 and Q&A 726.

Please make sure that the persons handling the payments of ECHA's invoices are aware that the payment should be made at the full amount so that any possible bank charges are not deducted from the payment.

Please inform your accounting department that if the invoice is paid after the extended due date, the REACH dossier submission will be rejected and the paid fee will not be refunded.

Please ensure that ECHA’s invoice number is stated in the payment instruction (see Q&A 721).

 

ECHA’s New Financial Identification Form (PDF)

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.

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.

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’

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.

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.

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.

 

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.

To delete a joint submission search for your joint submission in REACH-IT and use the ‘Delete joint submission’ functionality.

You can only delete the joint submission if:

• There are no members in the joint submission (active or inactive)
• There are no submissions linked to it (failed or passed)

If the above options do not apply, ECHA can delete the joint submission upon your request. In order to do so, please contact ECHA using the contact form.

Please take into account that once the deletion has taken place, ECHA will not be able to revert the action.

The joint submission is created by the lead registrant using the pre-registration number, inquiry number or the registration number.

When none of these identifiers are available, or the pre-registration number refers to a submission that does not correctly define the substance identity, you should proceed as follows: Select Menu >> joint submission >> Create new.

Read carefully the information provided on the right side of the page. If you are certain that you do not have any reference number, click on the link ‘substance identity manually’ and follow the wizard.

When forming a joint submission, you are required to first agree on the substance’s chemical name with all of your co-registrants. Therefore, we recommend that you first read ECHA's "Guidance for identification and naming of substance under REACH and CLP" chapter 4.3. UVCB substances. Also consult our Sector-specific support for substance identification, on certain UVCB substance types (e.g. oleochemicals, essential oils, metals, etc.).

The chemical name of the UVCB substance must be reported in the ‘IUPAC name’ field of the reference substance in section 1.1. of your IUCLID dossier. This applies even if the naming conventions for UVCB substances do not follow the IUPAC nomenclature.

The spelling of the chemical name is important, the name needs to be identical both in your joint submission in REACH-IT and in IUCLID dossier section 1.1 ‘Identification’. This is important in order to pass the business rules check. The name should not contain spelling errors or additional spaces between words or characters.

Creating a joint submission

1. Start your registration by creating a new joint submission. Use the ‘insert the substance identity manually’ link, found in the checklist of joint submission creation wizard (see picture).
   
   
    
2. In the next step, search for your substance name and then create the joint submission by its ‘chemical name’ (see picture).
   
   
    
3. Select ‘other name’ or ‘IUPAC name’ depending on the naming convention of your substance as the ‘chemical name type’ and insert the derived name of your UVCB substance into the field and click continue (see picture). This will be the name of your substance in REACH-IT.
   
   
   
    
4. REACH-IT might suggest other already pre-registered or registered constituents with similar names; please ensure that you select ‘your constituent’ at the bottom of the page and click ‘continue’ (see picture).
   
   
   
    
5. The name has now been added to the section ‘selected constituents’ (see picture). Click ‘continue’ and confirm you substance identity and continue with the joint submission creation wizard.
   
   
   
    

Prepare and submit your dossier as part of the joint submission you created.

Remember to report all the identified constituents of your UVCB substance in IUCLID dossier section 1.2 ‘composition’. For further information on composition requirements for UVCB substances consult our guidance “How to prepare registration and PPORD dossiers.” on page 32. Also, fill in the ‘Description’ in section 1.2 including the identity of the starting materials and a description of the production process used to manufacture the substance. For Manufacturing process description see Q&A 1199.

Once you have submitted your dossier

A numerical identifier will be issued to your substance once it has passed the business rules check. Export the EC number from the joint submission page and use it in the reference substance in any future updates. Members submitting after the lead has passed the business rules check should export the issued EC number from the joint submission page and use the numerical identifier and the correct IUPAC name in section 1.1 of the IUCLID dossier. Instructions on how to download and export the EC number can be found in Q&A 1258.

 

Joint submissions have a status of either active or closed. Registrations can only be submitted to an active joint submission. Upon creation, the joint submission will automatically have the status active. Within the joint submission, a deadline to submit a lead dossier that at least passes the business rules verification step is clearly displayed. If no submission takes place until the given deadline, the joint submission’s status will turn to closed.

Closed joint submissions will remain in the system, but no submissions can be made into them. A closed joint submission will not block the creation of another joint submission for the same substance and same scope (full or intermediate). Therefore, once a joint submission’s status has been changed to closed, any (potential) registrant can create a new joint submission for the same substance.

Closed joint submissions cannot be turned back to active. If the joint submission is still needed, the lead registrant can create a new joint submission, using the same substance identifiers. However, a new name will be required, as joint submission names cannot be recycled.

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.

If the current lead registrant does not want to continue in their role as lead, it is up to the SIEF members to choose a new member, who will take over the lead role. In order to transfer the role, the following shall be observed:

• The current and the future lead registrant need to agree on the handover. Then, the following actions must be performed within the Joint Submission in REACH-IT:
  • The current lead registrant will need to assign the lead role to the future lead registrant using the ‘Assign New Lead’ button. The future lead registrant, should already be a member of the joint submission.

    

  • Then, the future lead registrant should accept the assignment by clicking ‘Confirm Lead’ button and subsequently become the lead registrant in the Joint Submission.

    

• The new lead registrant needs to submit a lead dossier containing all the information to be provided on behalf of the joint submission. If the new lead registrant has previously submitted a registration dossier for this substance, the lead dossier should be submitted as a spontaneous update.

The initial lead registrant is still technically considered as the lead registrant of the joint submission until all above mentioned technical steps are carried out.

For the time being, any active registration that is part of a joint submission can be updated without any limitations, as long as you are not changing the type of your registration. For intermediate joint submissions, changing your registration to both intermediate and full or only full is only possible, if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission.

However, we highly encourage you to start negotiating with the other joint submission on merging into one, as in the future it will be unavoidable. For further information see Q&A 1170.

To increase the Joint Submission tonnage band, the Lead Registrant needs to submit a spontaneous update. Please note, that the increase of tonnage band of the Joint Submission may require additional data to be provided in the Lead Dossier.

In Dossier Creation Wizard

Step 1

The tonnage band indicated in submission type (IUCLID 6 template) represents the tonnage band of the Joint Submission. Please pick the same submission type as was used from the last successful submission at a higher tonnage band.
 

 

Step 2

The administrative information of the dossier represents the data of the Lead Registrant. The tonnage band indicated in this step represents the tonnage band of the Lead Registrant’s own registration.

Keep in mind that the lead registrant can have his tonnage band different from the tonnage band of the Joint Submission, while the information required for the lead dossier is based on the highest tonnage band of any Joint Submission member. If the Lead Registrant increases his own registration’s tonnage band, a new invoice will be triggered.

Mark the dossier as an update, add the last successful submission number and chose ‘change of tonnage band’ from the drop-down menu as justification for the spontaneous update.

Step 1

Before decreasing the Joint Submission tonnage band, the Lead Registrant needs to make sure that all members of the Joint Submission, except for the Lead himself, have the tonnage band equal or below the decreased (new) JS’s tonnage band. Members can update their own tonnage band by submitting a spontaneous update.

The tonnage band of Intermediate registrations do not affect the tonnage band of the full joint submission, therefore, a member with an intermediate registration can have a higher tonnage band than the decreased Joint Submission.

Step 2

The Lead Registrant has to contact ECHA via the contact form and request that ECHA performs the decrease of the Joint Submission tonnage band.

If a consultant is representing the Lead Registrant, a signed request by the Lead Registrant needs to be submitted.

Step 3

After ECHA has decreased the Joint Submission tonnage band, the Lead Registrant has to submit a spontaneous update using the same submission type (IUCLID template) that was used for the last successful submission, but at a decreased tonnage band.

In the same update, the Lead Registrant has to update its own registration’s tonnage band (administrative information) to be equal or lower than the decreased tonnage band.

Mark the dossier as an update, add the last successful submission number and chose ‘change of tonnage band’ from the drop-down menu as justification for the spontaneous update.

Please note: If a final decision from ECHA was sent to the Joint Submission members, they will need to comply with such decision even after the tonnage band decrease.

Yes. If the lead registrant wants to lower his tonnage band below the tonnage band of the Joint Submission, the Lead needs to submit a spontaneous update.

In Dossier Creation Wizard

Step 1.

The tonnage band indicated in submission type (IUCLID template) represents the tonnage band of the Joint Submission and should remain the same as used during the last successful submission.

Step 2.

The administrative information of the dossier represents the data of the Lead Registrant. The tonnage band indicated in this step represents the tonnage band of the Lead Registrant’s own registration, which can be equal or lower than the tonnage band of the Joint Submission, indicated in submission type.

 

If there is full agreement among the members of a Joint Submission and there is no Joint Submission of the different type, the lead registrant can send a formal request to ECHA so that ECHA can apply the necessary changes.

N.B. A Joint Submission type can change from full to intermediate only if there are no full members present.

Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.

Before changing your registration, please consider the following flowchart:

Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.

Data sharing negotiations.

In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.

For further information on how to transfer the lead role to the member of a joint submission see Q&A 380.

The lead registrant of a joint submission will provide you with a combination of joint submission name and security token outside of the REACH-IT environment (e.g. by email, phone). To confirm your membership, log in to REACH-IT and use the ‘Join existing Joint Submission’ functionality and follow the wizard.

Member registrants will also need to indicate their membership to a joint submission by adding the joint submission name during the submission of their registration dossier in REACH-IT.

Member registrants are able to indicate their membership to a joint submission in section 1.5 of IUCLID 6 registration dossier. This information can be used for your own administrative purposes, but will not be verified against the information derived from REACH-IT.

Member registrants cannot submit their dossiers until the lead dossier has been accepted for processing by ECHA. The status of the lead dossier can be checked in the joint submission in REACH-IT.

An individual registrant who wants to become part of a joint submission needs to submit a spontaneous update and indicate that their registration is part of a joint submission. Before submitting, they have to confirm membership of the joint submission, in this case the lead registrant needs to provide the joint submission name and the security token.

Once the information required is obtained, they can confirm the membership by signing in to REACH-IT >> Select Menu >> Joint Submission >> Join existing and enter the joint submission name and security token and follow the wizard.

When updating the dossier in IUCLID pay attention to the following:

• Enter the registration number in section 1.3 of your substance dataset
• Create the registration dossier by right-clicking the substance and selecting "create dossier" and follow the wizard
• Choose the template "REACH Registration member of a joint submission –general case/ - intermediate" depending on your submission.
• Indicate the reason for update as "Change from individual to joint submission"

If you are an individual registrant and no other company has registered the same substance, you will not face any constraints when updating your registration. If there are other registrants for the same substance, you will have to fulfil certain criteria to be able to update. Below you can find the scenarios of your case:

• A joint submission exists for the same substance and same registration type and your registration is outside of this: You cannot update your dossier, until you join the joint submission.
• A joint submission exists for the same substance and same registration type and your registration is part of it: You can update your registration without any limitation, as long as you are not changing the type of your registration. For intermediate joint submissions, changing your registration to both intermediate and full or only full is only possible if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission.
• No joint submissions exist for the same substance and for the same registration type (full or intermediate), but other individual registrations have been submitted: You can update your registration without any limitation, as long as you are not changing the type of your registration or until a joint submission is created. For intermediate registrations, changing your registration to both intermediate and full or only full is only possible if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission

As long as your registration fulfils the criteria listed below, you are allowed to update it, even if there are other individual registrations in the system:

• There are only individual registrants and no joint submission exists in REACH-IT.
• You are not changing your registration type with your update. For intermediate registrations, changing your registration to both intermediate and full or only full is only possible if there is no other full and intermediate registrant (either as part of a joint submission or as individual registrant).

If any potential or existing registrant creates and submits a joint registration, this joint registration will block all the individual registrants of the same substance and same registration type from being able to update their dossiers, until they join the joint submission.

• If there is a joint submission for the same substance you will need join the joint submission in order to submit the update.
• If there is no joint submission, but there are individual registrants for the same substance, you should create a joint submission and take up the role as lead registrant before submitting the update.
• If there is no joint submission and you are the only individual registrant, you can update your registration without creating the joint submission.
• None of the above applies, if the update requested is linked to a technical completeness check (TCC) failure. In this case you should submit an update as individual registrant.

1. The member has to communicate their intention to upgrade their tonnage band to the lead registrant.
2. The lead registrant submits a dossier update using the IUCLID template corresponding to the higher tonnage band (submission type). The dossier will include all data required for the higher tonnage band. When creating the dossier, in the dossier header, the lead registrant should indicate their own tonnage band, which will in this case be lower than the used template (administrative information).
3. Once the lead has successfully submitted the lead dossier, the member can submit their updated member dossier indicating the new, higher tonnage band in the dossier header (administrative information) and pay the corresponding fee.

Fees
There is no cost linked to the increase of the joint submission tonnage band, fees are levied only for the increase of the tonnage band of a registration. Therefore, as long as the lead registrant only increases the tonnage band of the joint submission, but not their own registration, they will not incur any additional fee. On the other hand, when the member registrant submits their updated dossier at an increased tonnage band, they will receive a new invoice.
Member registrants of a joint submission (including the lead registrant) contribute only to the cost of the data they need and the applicable administrative charges. If only one member registrant needs additional studies, they alone will need to pay for the cost of that data. Should later on another registrant require the new, higher tonnage band, then the costs of the data / studies performed need to be shared amongst the registrants who require those.

Opt-out
In case the data that is required for the higher tonnage band is only available for the specific member registrant, who wishes to update their dossier, they can decide not to share it with the lead registrant, but instead include it in their own dossier and submit an opt-out for the higher tonnage band.
By submitting an opt-out dossier you will not be entitled to the reduced joint submission fees. Furthermore, any registrant who in the future wishes to update their registration to this higher tonnage band would have to include the data in their dossier separately. For this reason, ECHA recommends that the lead registrant’s dossier contains all information, regardless of their tonnage band. Alternatively, and only if the majority of co-registrants support it, the member registrant can take over the lead role of the joint submission.

Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.

Before changing the member registration, please consider the following flowchart:

Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.

Data sharing negotiations

In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.

You should appoint a new lead registrant together with the other registrants of the substance as soon as possible. Of course, you can offer to become the lead registrant.

A lead registrant is a legal requirement under Article 11 REACH. Moreover, there are important practical reasons why you should have a lead registrant. As such, you have an own interest in ensuring that there is a lead registrant to your registration.

For example, a lead registrant is needed to give potential registrants access to the joint submission and to confirm that they may refer to the information in the lead dossier. A lead registrant is also a natural first contact point for data sharing negotiations, and thus facilitates all registrants’ compliance with their data sharing obligations.  In addition, a lead registrant is needed to update the information that was jointly submitted for a substance. Without a lead registrant, each registrant must update its registration individually with new information about the substance.

After the lead registrant has disappeared, the remaining registrants need to discuss among each other to appoint a new lead registrant as soon as possible. Once you have agreed on a new lead registrant, you should contact ECHA via the contact form, and request the transfer of the lead registrant role.

If you know that your lead registrant for a substance will disappear, you and the other registrants are encouraged to appoint a new lead registrant before the disappearance. Like that you ensure that there is no time without a lead registrant. This is easier to do in practice, because the old lead registrant can hand over the lead registrant role within REACH-IT. Q&A 0380 explains what to do step-by-step.

Registrants must always submit their information within the framework of a joint submission. However, registrants can submit some information separately, if: 

• it would be disproportionately costly for them to submit some information jointly, or
• submitting the information jointly would lead to the disclosure of commercially sensitive information that would likely cause substantial commercial detriment, or
• they disagree with the lead registrant on the selection of information.

Registrants who fall under any of the above circumstances can submit some or all data on their own: these are respectively called partial and full opt-out. Technical implementation of the opt-out is described in Q&A 396.

A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7. 

Information expected in the justification:

• Cost of accessing the jointly submitted data. You should have received this information from the lead registrant. If you have not been able to obtain this information from the lead registrant you should explain the actions you took to try and obtain this information and the lead registrant’s response.
• Cost of completing and submitting your opt-out dossier. Bear in mind your own possible internal costs related to preparing the dossier. You should not provide a figure of zero for this answer.
• Explain why submitting this data jointly would be disproportionately costly. See below some examples for the basis of your explanation:
• Your registration type being different from the joint registration.
• Your registration tonnage band and the associated data requirements being different, e.g., Annex VII requirement fulfilled with an Annex VIII study.
• Type of data, e.g., data publicly available, own data available, other data available at lower cost (e.g. QSAR).
• Cost breakdown quality and clarity.
• Explain the measures taken to agree on the cost of accessing the jointly submitted data.

A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7. 

Information expected in the justification:

• You need to specify precisely which information is commercially sensitive.
• You need to explain why you believe submitting this information jointly would cause substantial commercial detriment. You explanation should show your reasoning for believing substantial commercial detriment would be caused.

• You need to explain why you disagree on the data selected. Question 1 of template ‘c’ includes a list of elements that can be relevant to this explanation.
• You need to describe what actions you had taken to try and add your data to the lead dossier and why it had not been possible to reach an agreement to add this data.

The opt-out justification requirement also applies when opting-out only for classification and labelling (C&L) information. A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided. This justification must be included in the 'Justification' field of the endpoint 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. For further information on how to provide a valid justification see Q&A 1722.

Before opting-out for C&L information, you should bear in mind that this information can be jointly submitted in the lead registration dossier even if it differs from the C&L of the other registrants in the joint submission. In this case, the lead registration dossier should have a separate C&L record in section 2.1 with a link to a relevant ‘boundary composition of the substance’ in section 1.2. If you decide to opt-out for the C&L information, you should therefore explain in your justification why an agreement to include the information in the lead registration dossier could not be reached. For further information on how to report the boundary composition you can consult the Q&As on Substance identity profile.

Endpoint summaries are not considered as opt-out information but are still required if you are opting-out with endpoint information or are providing your own Chemical Safety Report.

When opting-out, some of the sections that are mandatory for a complete dossier are not automatically pre-selected for inclusion in the IUCLID dossier when you use the joint submission member template. Therefore, when creating your dossier endpoint summary records including section 6 ‘Ecotoxicological information’ and section 7 ‘Toxicological information’ must be selected manually. Guidance on how to include the endpoint summaries in the opt-out dossier can be found in the manual ‘How to prepare registration and PPORD dossiers’, section 9.2 How to include endpoint summaries in an opt-out dossier.

• The reason for the disagreement with the lead registrant on the classification and labelling information. See below some examples for the basis of your argumentation:
• Quality (reliability, adequacy) of data used in deriving the classification
• Difference in interpretation of data for classification
• Difference in concentrations of constituents / impurities / additives influencing classification
• Difference in (nano)forms of the substance influencing classification
• An explanation of the differences in the classification and labelling information that you wish to submit separately compared to the jointly submitted information. For each different classification, provide a reference to the data underlying the classification. This reference may be to information submitted in your own dossier as a (robust) study summary, or alternatively, references to publicly available literature may be provided.
• An explanation of the actions you have taken to include your classification and labelling in the Lead dossier and your reasoning as to why it was not possible to include this information.

The company size can be updated in REACH-IT via the ‘Company size’ functionality from the main menu and selecting the ‘Update company size’ functionality. 

This will open a wizard that will guide you through the process of updating the company size. Read carefully the instructions and have the documentary evidence at hand to substantiate the companies involved in the ownership structure.

Note: By declaring that your company is an SME, you become eligible to an SME fee reduction. ECHA routinely verifies the SME status of legal entities who self-identify as SMEs. We recommend that you keep your company size information up-to-date in your REACH-IT account.

The final decision on what documentation is considered adequate evidence of a ‘sale of assets’ is determined on a ‘case by case' basis in accordance with the relevant national principles of private and corporate law of the Member State where the entity is established. For this reason ECHA Practical Guide 8 – How to report changes in identity of legal entities limits itself to the general example of the asset sales agreement and does not provide further information in this regard.

The relevant documents should be presented to the national enforcement authorities upon request. Ultimately, the REACH duty holders bear responsibility for the submission of adequate documentary evidence. To ensure that it complies with the national legal order they may seek legal advice from in-house or private practice lawyers, for example.

More information on changes in identity of legal entities can be found in the aforementioned Practical Guide 8 – available at http://echa.europa.eu/practical-guides

Transferred items (i.e. registrations/notifications)

If a registration/notification for a substance is transferred from the legal initiator to the legal successor, who already has a valid registration/notification for the same substance, the status of the transferred registration/notification will be marked ‘Annulled’, because a legal entity can only have one registration for the same substance.

Tonnage band update

For transferred registrations when the originating legal entity has registered the same substance as the legal successor and the tonnage of the originating legal entity is higher than the registered substance of the legal successor, the system will keep track of the legal successor's right to a higher tonnage band. The legal successor will need to submit a spontaneous update to indicate the higher tonnage band. No fee applies for this update.

Transfer of joint submission roles linked to Registrations

Where the initiating legal entity has submitted registrations as part of a joint submission, the joint submission role (e.g. Member or Lead registrant) are transferred together with the registrations to the legal successor. If no registrations were submitted, the roles are not transferred. The legal successor need to confirm their membership to the joint submission. 

Invoicing

The Agency will issue an invoice for the legal entity change pursuant to Commission Regulation (EC) No 340/2008 Article 5 (Fee regulation) if the item list contains one or more payable items.

• Items that trigger a fee during a legal entity change are: Registrations, Registration of on-site isolated intermediate, Registration of transported isolated intermediate.
• Items that do not trigger a fee during a legal entity change are: Pre-registrations, Product and Process Oriented Research and Development (PPORD) notifications, Classification and Labelling (C&L) notifications, Inquiry notifications.

Where an invoice is needed (i.e. the legal entity change includes at least one payable item), only one invoice will be issued per legal entity change. Invoices are issued to the legal successor. The company size of the legal successor after the change of legal personality will determine the fee. Pursuant to Commission Regulation (EC) No 340/2008 Annex III Table 3, a reduced fee will be invoiced to SMEs. After the invoice is paid in full, the transfer of items will take place and the legal entity change be completed in REACH-IT. If the invoice is not paid within the extended due date the legal entity change is deleted from the system and items will not be transferred. Information about the fee regulation can be found here.

For more information, see the guide How to report changes in identity under REACH and CLP.

When a legal entity change (LEC) takes place, a new submission number is created to keep track of the asset transfer. These submission numbers are assigned for administrative purposes and are not linked to a dossier.

1. Go to REACH-IT Menu >  select ‘Reference numbers’

 

2. Select the reference number linked to the dossier you wish to download

 

3. Scroll to the middle/bottom of the page, and open the tab ‘Reference number history’

 

4. Select the last successful submission number (initial submission or submission update in the Event column) that took place before the legal entity change.

 

5. Click on request IUCLID file

Yes, according to Article 12 of the Fee Regulation (EC) No 340/2008 and the references therein to the definitions concerning micro, small and medium-sized enterprises as set out in the Annex to the European Commission Recommendation 2003/361/EC, both EEA and non-EEA companies are to be considered for the classification of partner and linked enterprises during the determination of the SME status of a company. Moreover, the non-EEA company is the very entity under consideration, in case when a submission is made by an Only Representative, as specified in Article 12 of the Fee Regulation.

Under REACH, registrants and applicants can benefit from reduced fees established for micro, small and medium enterprises (SMEs).

Companies declare their SME size at the time of dossier submission, based on which ECHA issues an invoice. At a later stage, ECHA carries out an ex-post assessment, to verify the correctness of the company size. The SME verification process is important to ensure that only genuine SMEs benefit from the reduced fees and that correct fees are collected.

Before declaring the SME status in REACH-IT, companies should be familiar with the rules set by the Commission Recommendation 2003/361/EC on SME definition.

Companies should upload documentary evidence to their REACH-IT account to support SME status claims. This is only required for those submissions, which are related to SME fee reductions.

The documentary evidence should include:

• Information about the ownership structure (upstream, downstream) at the time of the submission.
• The financial statements (consolidated, if available) together with accompanying notes for the two latest accounting periods before the time of the submission.
• Official certificate/information confirming the average number of employees for each of the two latest accounting periods before the time of submission.

The documents listed above shall be provided for all partner and linked enterprises, as defined by Article 3 of the aforementioned Commission Recommendation.

In case of Only Representatives, the assessment on whether the SME reduction applies is done by reference to the headcount, turnover and balance sheet information of the non-EU company represented and its linked and partner enterprises.

All documents uploaded to REACH-IT are treated confidentially by ECHA and used exclusively for size verification purposes. For transparency and traceability reasons, documents cannot be deleted. It is, however, possible to add supplementary documentation to your REACH-IT account at a later stage. The documentation is not assessed immediately, but only once the size verification process has been initiated.

The list of documentary evidence accepted by ECHA can be found in SME verification -page.

Instructions on how to upload documents and other useful information about REACH-IT can be found at Discover REACH-IT -guide.

More information on company’s size assessment and links to the relevant legislation can be found at SME fees under REACH and CLP -page

If the original version of any document is not in one of the official languages of the European Union, a certified translation should be provided.

Legal basis for certified translations is Article 13(3) of the amended Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Please see it at: 

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:079:0007:0018:EN:PDF

A certified translation is the one which is accompanied by a signed statement that the translator is competent in the source and target languages (a sworn translator) and that the translation is an exact and accurate translation of the source document. The certified translator should have a certificate or a stamp that identifies the services provider and his qualification.

The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. Ceasing to manufacture or import of substances have no consequence on that obligation.

If after registering a substance, you have decided to stop manufacturing or importing it, you should still pay the applicable registration fee in full in case ECHA found that you were not eligible for the claimed SME fee reductions. Once the registration fee is paid and, therefore, your registration can be considered complete, you can indicate in REACH-IT that you have ceased the production or import of a substance. If at a later stage you decide to restart manufacturing or importing it, you would only need to report it again in REACH-IT and the registration would still be valid. Otherwise, you would need to submit a new registration and pay a new registration fee.

In case the balance to the correct registration fee is not paid, such registration will be de-activated in ECHA’s database and the rejection of the registration will be communicated to you by a decision.

The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. The termination of the OR agreement has no consequence on that obligation.

Since your represented company benefited from reduced SME fee at the time of registration, therefore you, as the appointed OR at that time, are still liable to demonstrate the eligibility for the SME fee reduction obtained, once ECHA initiates the verification of your represented company size. The failure to provide complete documentation would result in ECHA finding your represented enterprise as non-eligible for the claimed SME fee reductions. In such case, the OR would be liable for the difference between the fee already paid and the correct registration fee, as well as the applicable administrative charge.

The REACH Regulation states that the tonnage band is calculated per registrant per substance, including non-nanoforms and nanoforms. Thus, the registration obligation depends on the total yearly tonnage of the substance that you manufacture or import, including both non-nanoforms and nanoforms. If the overall volume of the substance is above 1 tonne per year, nanoforms within that total volume also need to be registered, even if they represent a volume of less than 1 tonne per year.

Similarly, the overall quantity of the substance, cumulating the quantity of both non-nanoforms and nanoforms, determines the applicable information requirements. The information requirements of the total volume apply to the non-nanoform and each of the nanoforms of the substance, even if their individual volumes represent a lower tonnage band.

For more information see the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification, section 2.1 Registration obligations.

Yes, nanoforms manufactured as a dispersion must be registered.

Yes, a polymer can also meet the definition of a nanoform.

The obligation to submit information on nanoforms as set out in REACH Annexes VI to X only applies to substances subject to registration. Polymers are exempt from registration. Nevertheless, any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain, if the conditions set out in Article 6(3) of REACH are met.

For specific cases we recommend contacting our helpdesk for a more detailed reply.

Before being introduced into the polymer during the polymerisation phase, the nanoform has to be manufactured or imported. If you manufacture or import in a quantity above 1 tonne per year the substance of which nanoform is introduced in the polymer, you must register the nanoform, even if it is then used in the manufacturing of a polymer.

However, if you buy a nanoform from a supplier in the EU, you do not have to register it, but the manufacturer or importer in the supply chain must do so. In the latter case, you have to ensure that your use of the nanoform is covered by the registration of the manufacturer/importer. 

Finally, if you import the polymer you must submit a registration for the nanoform if it has not already been registered by an actor up the supply chain and if the conditions set out in Article 6(3) of REACH are met (see Q&A 1674).

If you buy a nanoform in the EU and use it without modification, you do not have to register it. However, the manufacturer or importer in your supply chain must have registered it. As a downstream user, you must ensure that your use of the nanoform is covered by its registration or prepare a chemical safety report yourself.

The obligation to register nanoform(s) of a substance applies to all nanoforms meeting the definition set out in REACH, as soon as the substance is imported/manufactured in quantities of 1 tonne or more/year/registrant. This obligation applies irrespective of whether the nanoform was intentionally produced. Each manufacturer/importer is responsible for characterising its substance, and thereby identifying if the substance contains forms that qualify as nanoforms. For each form that qualifies as a nanoform, the manufacturer/importer must characterise the nanoform and report the characterisers in the registration dossier. In addition, they must ensure that a corresponding hazard dataset is submitted.

The answer depends on the location of the supplier of the substance. The registration obligation applies to manufacturers and importers of substances in the EU. If the substance is supplied by the manufacturer or importer and they are established in the EU, that manufacturer or importer must register the nanoform. If the supplier of the substance is based outside of the EU and the substance is imported by the EU ‘distributor’, this distributor actually qualifies as an importer under REACH. In this case, the EU distributor must register the substance, including its nanoforms.

Each registrant is responsible for registering the nanoforms that they themselves manufacture or import. The information required by Annex VI, including the characterisation of nanoforms or sets of nanoforms, must be submitted separately by each registrant. 

The information required by Annexes VII-X can be submitted jointly in the lead registrant dossier on behalf of the member registrants. Alternatively, this information can be submitted separately by each registrant via the opt-out mechanism.

If a co-registrant claims not to produce nanoforms but does not provide any proof to support their claim, the other registrants of the substance should proceed with the registration of their nanoforms following the REACH requirements.   

Registrants that manufacture/import nanoforms of the substance after 1 January 2020 without a registration that covers these nanoforms are in breach with their duties under the REACH regulation, which may lead to enforcement measures by national enforcement authorities.

If none of the characterisation parameters of the nanoform(s)/set(s) of nanoforms reported in the existing registration dossier change, there is no need to update the dossier with regard to the identity of the nanoforms covered.

Note that even if none of the numerical characterisation parameters change, if the change in the production line concerns the surface-treatment process, the description of the surface-treatment process in the registration dossier may still need to be updated.

The revision of the European Commission’s nanomaterials definition does not impact the current definition of a nanoform used in REACH. REACH Annex VI contains a definition for a nanoform and this definition must be applied to determine the requirements applicable under REACH.

A batch-to-batch variability results from the variation of process parameters inherent to a manufacturing process that is defined by a series of parameters (e.g. starting materials, solvents, temperature, order of manufacturing steps, etc.).

If the variation in a parameter is only due to batch-to-batch variability, then these are still considered as being the same nanoform. However, if there are deliberate changes to the process parameters, then these are different nanoforms.

1. The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set
2. The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly. This justification is substantiated by supporting data on the nanoforms in the set.

The REACH Regulation defines a substance as “a chemical element and its compounds”. A substance becomes a different substance when there is a modification of the chemical element or the compounds that compose it. Following from this, the modification of the form of a substance, including its modification into a nanoform, does not make it a different substance under REACH. 

REACH also specifies that the surface treatment of a nanoform does not lead to the creation of a new substance, but a new nanoform of the substance concerned. Each nanoform must be specifically characterised and reported in the registration dossier.

Registrants are free to choose the analytical techniques as long as the data requirement is fulfilled. For questions concerning a specific nanoform, please submit the question using our contact form.

For the purposes of determining whether you have a nanomaterial according to the REACH definition, and of reporting of particle size for fulfilling the information requirements of REACH Annex VI, you should report the physical size, not an aerodynamic size.

There is no definition for the term “granular form" in REACH. However, this can be interpreted to mean "particles".   

All nanoforms, by definition, will have at least 50% of their particles by number below 100 nm, and all nanoforms will be "granular" when available as a dry powder. However, some nanoforms are available only in suspensions, or are incorporated into a matrix throughout their entire lifecycle. In this case, there may be no exposure to the dry powder, or the granular form in general.   

1. The justification must address separately each characteriser listed in section 2.4 of Annex VI. To this end, it must follow the structure of the text template available in the IUCLID section 1.2 field 'Justification for reporting set of similar nanoforms' and address all applicable points in it.
2. The justification must be substantiated by scientific evidence addressing the physicochemical, environmental fate, ecotoxicity and toxicity properties of nanoforms that are within the boundaries of the set of nanoforms. For each characteriser, the justification must summarise the supporting data.  
3. Each scientific evidence summarised in the justification must be submitted in the form of a (robust) study summary  
   In all the above cases, the findings from these studies and the characterisers of the nanoforms used in the studies must be summarised in accordance with the points listed. 
   • The (robust) study summary can be provided by attaching it in the section 1.2 field ‘Attached information’;
   • When the (robust) study summary is reported elsewhere in the IUCLID dossier, e.g. in IUCLID section 4-7, a reference to it can also be made by linking it via the section 1.2 field ‘Cross-reference’; 
   • Alternatively, references to publicly available literature may be provided instead of a robust study summary.
4. For each characteriser, the justification must explain how the scientific evidence demonstrates that all the nanoforms in the set can be assessed jointly. This explanation must clearly show that the nanoforms used to generate the supporting data are representative of all the nanoforms included in the boundaries of the set.
5. The justification must always be provided in full in the field 'Justification for reporting set of similar nanoforms' or in the field ‘Attached information’. The justification cannot refer to explanations provided elsewhere in the dossier.