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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.
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.
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
- 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).
- In the next step, search for your substance name and then create the joint submission by its ‘chemical name’ (see picture).
- 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.
- 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).
- 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.
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.
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
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.
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.
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.
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.
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
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.
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.
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 you have the information required, you can confirm 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
- The member has to communicate their intention to upgrade their tonnage band to the lead registrant.
- 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).
- 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.
In addition to the applicable administrative charges, all members of a joint submission (including the lead registrant) have to contribute to the costs of the data they need. If only one member registrant needs additional studies, they alone will need to pay for the cost of that data.
There is no cost linked to the increase of the joint submission tonnage band, there is 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.
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.
Note that, 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 SIEF members supports 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.
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.
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.
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.
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.
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.