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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.