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REACH

Joint submission of data by multiple registrants

A. Joint submission, general

Do the registrants have to submit all their data jointly?

An overview of what must and what may be jointly submitted for registration based on Article 11 of the REACH Regulation is provided in Section 6.2- 'Overview of the part of the technical dossier that may be jointly submitted for Registration' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Some information of the registration has to be submitted jointly whereas other information needs to be submitted separately. Additionally, there is information the registrant(s) may decide themselves whether to submit jointly or separately, according to the criteria defined in Article 11(3) of REACH.

The following information must be submitted jointly: information on the classification and labelling of the substance, (robust) study summaries and an indication as to which of the submitted information on classification and labelling, study summaries and robust study summaries has been reviewed by an assessor. Under specific conditions, which should be explained in the dossier, a separate submission of these data is allowed (see also Q&A 109).

Additionally, each registrant must submit individually: the identity of the manufacturer or importer, the identity of the substance, information on the manufacture and use(s), exposure information for substances in quantities of 1 to 10 tonnes and an indication of which of the submitted information on manufacture and use has been reviewed by an assessor. The registrants may decide to submit the following information jointly or separately: guidance on safe use of the substance, a Chemical Safety Report (CSR) when required and an indication which of the information submitted for the CSR has been reviewed by an assessor.

What information can be submitted separately?

Member registrants can submit the following information separately, as specified in Article 10(a) (iv), (vi), (vii) or (ix) of REACH:   

  • The classification and labelling;
  • Study summaries of the information derived from the application of Annexes VII to XI;
  • Robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; and
  • Proposal for testing where listed in Annexes IX to X.

Article 11(3) of REACH allows an "opt-out" under specific conditions. Such an "opt out" can only cover some or all of the endpoints submitted by the lead registrant on behalf of all member registrants. However, the member registrants have to remain part of the joint submission regardless of whether information is shared.

Can different classifications of a substance be included in the joint submission dossier?

According to Article 29(2) of the REACH Regulation, one of the main aims of the SIEF is to agree on classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.

Nevertheless if all member registrants agree, the lead registrant may include different classifications of the substance in the joint part of the registration dossier, e.g. if different impurity profiles lead to different classifications.

In this case, member registrants should leave the pertinent section of their member dossier empty to avoid being treated as an opt-out for the classification and labelling of the substance.

If the member registrants cannot agree on the inclusion of all the different classifications of the substance in the joint part of the registration dossier, one or more of the member registrants may decide to provide their substance classification separately (by filling in the respective section in their member dossier). If this is the case, a justification in accordance with Article 11(3) of REACH is required. In addition, in cases where a harmonised C&L for a substance is provided in Annex VI to the CLP Regulation, then that harmonised C&L must be used.

Further information can be found in the manual ‘How to prepare registration and PPORD dossiers

Should all available studies be included to the joint submission dossier?

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.

Can member registrants of a joint submission submit the same generic spectral data or chromatograms?

According to Article 11(1) of the REACH Regulation, the information specified in Article 10(a)(ii), i.e. details on the substance identity including spectral data and chromatograms, have to be submitted separately by each member registrant of a joint submission.

This information is necessary for ECHA to be able to check the sameness of the substance submitted by the different member registrants. Therefore, generic spectral data or chromatograms must not be used. Each member registrant of a joint submission has to provide the specific spectral data and chromatograms for the substance they intend to register.

Can a company resign from its role as lead registrant?

The REACH Regulation does not prevent the change of a lead registrant.

It is up to SIEF participants to agree on who is the lead registrant, who acts with the assent of the other registrants for the same substance. The SIEF/co-registrants can agree to transfer the lead role to another registrant at any point.

Information on how to transfer the lead role in REACH-IT can be found in Q&A 0380.

 

How do I know which joint submission to join?

Multiple registrants of the same substance share two main obligations under the REACH regulation: data sharing and joint submission obligations. Registrants can identify who else has registered their substance and therefore shares common obligations under REACH.

It is the common responsibility of all (potential) registrants, yourself included, to form a single joint submission. ECHA strongly recommends that all registrants use this new page as a tool to ensure compliance with these obligations. For example, no role is displayed next to a registrant that has submitted a registration dossier outside of an existing joint submission. They are required to contact the lead registrant, as they share the same responsibility as the other multiple registrants. Registrants of the same substance are obligated to make every effort and to ensure that they are part of the same joint registration dossier. Existing registrants outside the joint submission are required to negotiate access to the joint submission with their co-registrants – regardless whether they need to share data or not.

For further information see Guidance Chapter "6 Registration: Joint Submission" Please also note the partial exceptions applicable for intermediate registrants.

B. Joint submission, creation/deletion

Deleting a joint submission

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.

Creating a joint submission by manually selecting the substance identity

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.
create submission

Creating a joint submission for a UVCB substance without numerical identifiers (EC/CAS)

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.

 

What is a joint submission status? Can I change my closed joint submission to active?

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.

C. Joint submission management, lead registrant

How can the lead registrant role in REACH-IT be transferred to another member of the joint submission?

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.

      assign new lead

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

      assign new lead

  • 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.
Can a joint registration be updated even though another joint submission for the same substance exists?

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.

How can the lead registrant increase the Joint Submission’s tonnage band?

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.

How can the lead registrant decrease the Joint Submission’s tonnage band?

Step 1

Before decreasing the Joint Submission tonnage band, the Lead Registrant needs to make sure that all members of the Joint Submission have the tonnage band equal or below the decreased (new) Joint Submission’s tonnage band.

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

Step 2

The Lead Registrant submits an updated dossier using the same submission type standard registration or intermediate registration that was used for the last successful submission, but at a decreased tonnage band.

If the Lead Registrant’s tonnage band is above the new Joint Submission’s tonnage band, the Lead Registrant has to update its own registration's tonnage band (administrative information) to be equal or lower than the decreaed tonnage band.



Mark the dossier as an update, add the last successful submission number and chose ‘change of joint submission 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.

Can the tonnage band of the lead registrant be below the Joint Submission tonnage band?

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.

 

How can the lead registrant change the registration type of the Joint Submission?

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.

How can a lead registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current intermediate registration dossier?

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.

D. Joint submission management, member registrant

How can a member registrant confirm their membership in a Joint Submission in REACH-IT before they submit their registration dossier?

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.
joint submission

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.

How can a member registrant change from an individual to a joint submission?

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"
What are the ‘one substance, one registration' (OSOR) rules?

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
Can a registrant update their individual dossier without creating/joining a joint submission, even though multiple registrants exist?

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.

A registrant submitted an individual registration and ECHA requested that they update their dossier. Can the individual registrant perform the update without creating/joining a 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.
How can I find other joint submissions in REACH-IT?

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.

Joint submission

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. 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: 

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

How can a member registrant increase their registration tonnage band above the tonnage band of the joint submission?
  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.

How can a member registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current dossier?

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.

My lead registrant is no longer active, because it ceased manufacture, the company was closed, or its registration was revoked. What should I do?

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.

E. Joint submission, opt-out

How can a potential registrant opt out of a Joint Submission?
a) Reasons for opting out
In case there is a disagreement regarding a specific endpoint, you 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 is considered to be commercially sensitive and may cause substantial detriment; or
there is disagreement on the selection of this information.
In such cases, a member registrant can submit a partial or full opt-out of the joint submission and include all endpoints the co-registrant wants to opt out for.
 
b) Duties of a member registrant who opts out of the joint submission
A registrant that submits an opt-out (partial or full) must remain a member of the submission and participate in data-sharing negotiations. Even a member who fully opts out of the joint submission may be requested to share administrative costs 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 dossier.
 
c) Preparation of a member registrant’s dossier:
If a member registrant relies on the information provided by the lead registrant, he should not fill in any data to sections 2.1, 4, 5, 6, 7 and 8 of the member 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):
 

opt out

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 preparing an opt-out dossier can be found in sections 8.9.2 and 9.2 of the manual How to prepare registration and PPORD dossiers.
 
d) Opt-out status of member registrants in REACH-IT:
The opt-out status is marked no, if the member registrant did not opt out, or has only opted out of section 2.1 (Classification & Labelling and PBT assessment).
The opt-out status is marked yes, if the member registrant opted-out of any other sections (i.e. 4, 5, 6, 7).
 
Under what circumstances can a registrant submit partially or fully separate data from other members of the joint submission?

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.

I want to justify opting-out due to disproportionate cost. What information should I provide?

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.
I want to justify opting-out due to commercially sensitive information that could cause substantial commercial detriment. What information should I provide?

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.
I want to justify opting-out due to disagreement on the Annex VII-X data submitted. What information should I provide?
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 on the ‘Insert existing templates’ icon). 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 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.
I want to opt-out for classification and labelling information. Do I need to provide a justification?

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.

When opting-out of a joint submission, how can the endpoint summaries be added to the dossier?

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.

I want to justify opting-out due to a disagreement on the classification and labelling information. What information should I provide?
When opting-out classification and labelling 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 a template (d) ‘Disagreement on the classification and labelling information’ is 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:
 
  • 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.