Vill du läsa svaren i avsnittet med vanliga frågor på ditt språk? I rullgardinsmenyn ovan kan du ändra språk.
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’ at: https://echa.europa.eu/manuals
Yes. According to Annex VI to the REACH Regulation any physicochemical, toxicological and ecotoxicological information that is available and relevant must be provided in the registration dossier.
In practice, after gathering and assessing all existing information, the registrant has to select the information that is reliable, relevant and adequate.
For key studies, robust study summaries have to be provided; for supporting studies, study summaries are sufficient.
Further guidance on information gathering and evaluation is also provided in chapters R.3 and R.4 of the Guidance on information requirements and chemical safety assessment available at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
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.
Yes, it is possible. It is the common responsibility of multiple registrants/notifiers of the same substance to submit only one joint registration dossier.
A NONS notifier who successfully claims a registration number for a notification under the Dangerous Substances Directive (67/548/EEC) can propose to the existing (potential) registrants that they themselves (i.e. the notifier) become the lead registrant of the joint dossier.
If there was not yet another lead registrant and the notifier’s role has been accepted, they must, firstly, update their registration dossier to fulfil the data requirements for registrations under REACH and, secondly, create a joint submission.
In parallel, the lead registrant needs to communicate with other (potential) registrants both on the choice of data (and the related costs) and on the token (to confirm joint submission membership). Similarly, existing registrants must update their dossiers, after they confirm their membership, as a member dossier of the joint submission.
For more information, see the Guidance on Data Sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
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 with an electronic “handshake”. Q&A 0380 explains what to do step-by-step.
In case there is a disagreement regarding a specific endpoint, potential registrant may opt-out of information according to Article 11(3) (or 19(2) in case of intermediates) if:
- it is disproportionately costly to submit this information jointly; or
- it would lead to the disclosure of information which he considers to be commercially sensitive and may cause substantial detriment; or
- there is disagreement on the selection of this information.
In such cases, you can partially or fully opt-out of the joint submission and include all endpoints you want to opt out of to your member dossier. An opt-out (partial or full) does not allow submitting a registration dossier outside the framework of the joint submission. Even if you fully opt-out, you may still be requested to participate in the cost sharing of the relevant administrative fees associated with the management of the joint submission.
In case of an opt-out, you are required to:
- remain part of the joint submission
- submit your own information to cover the data requirement
- submit a clear and reasoned justification for opting out
- include opt-out information in section 14 of IUCLID 6 dossier
REACH registration dossier of a member registrant
- Sections 2, 4, 5, 6, 7 and 8 of the member dossier should be left empty if the member registrant relies on the information provided in the lead dossier.
- If a member registrant submits a dossier with any of these sections filled in, the submission is regarded as an opt-out (see picture below).
Please note, when a member only opts out of IUCLID section 2 (Classification and Labelling), the opt out status in the joint submission page will be marked as ‘no’. The opt out status is only marked as ‘yes’, when the member opts out of data requirements other than Classification and Labelling.
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 Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’. If fully opting-out you need to answer all four points of template ‘a’. If partially opting-out you need to answer the first three points only.
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 to you 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. Question 3 of template ‘a’ includes a list of elements that can be relevant to this explanation.
- If you are fully opting-out explain why the justification you gave in question 3 covers all the data. You should therefore explain why a partial opt-out was not feasible.
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 Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’. If fully opting-out you need to answer all three points of template 'b'. If partially opting-out you need to answer the first two points only.
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.
- If you are fully opting-out you will need to explain why you couldn’t partially opt-out instead. Your explanation should therefore address why you couldn’t opt-out of only the commercially sensitive 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 Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’. If fully opting-out you need to answer all three points of template 'c'. If partially opting-out you need to answer the first two points only.
Information expected in the justification:
- You need to explain why you disagree on the data selected. Question 1 of template ‘c’ includes a list of elements that can be relevant to this explanation.
- You need to describe what actions you had taken to try and add your data to the lead dossier and why it had not been possible to reach an agreement to add this data.
- If you are fully opting-out you should explain why you could not partially opt-out of only the data you disagree with. Why was it necessary to perform a full opt-out?
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'. To help you provide a valid justification there are templates available in the 'Justification' field. These templates cover opting-out because of 'a': cost, 'b': commercially sensitive information and 'c': data. The template questions are also available in Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’ which is available at: http://echa.europa.eu/manuals.
If you are fully opting-out, you will need to answer all the points of one template. If you are partially opting-out you do not need to answer the last point of the template but should still answer the other points.
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 Questions & Answers - substance identity profile.
Guidance on preparing an opt-out dossier can be found in sections 9.9.2 and 10.2 of the manual ‘How to prepare registration and PPORD dossiers’.
Only the section 2.1 and 4-7 endpoint study record documents that you link to the section 14 endpoint ‘Opt-out information for REACH registration’ will be included in the dossier. Ensure that you have linked all the study record documents that you planned to include in the dossier to this section 14 endpoint before you finalise the dossier creation.
If you have different justifications for the data that you opt-out with, group the linked documents per blocks so that the justification you provide is relevant for the documents in the same block.
Endpoint summaries are not considered as opt-out information but are still required if you are opting-out with endpoint information or are providing your own Chemical Safety Report.
When opting-out, some of the sections that are mandatory for a complete dossier are not automatically pre-selected for inclusion in the IUCLID dossier when you use the joint submission member template. Therefore, when creating your dossier endpoint summary records including section 6 ‘Ecotoxicological information’ and section 7 ‘Toxicological information’ must be selected manually. Guidance on how to include the endpoint summaries in the opt-out dossier can be found in section 10.2 of the manual ‘How to prepare registration and PPORD dossiers’.
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.