- ECHA
- Assistenza
- Controllo della completezza tecnica
- Manual verification
- Justification for opting-out
Justification for opting-out
Registration is based on the ‘one substance, one registration’ principle. This means that manufacturers and importers of the same substance have to submit their registration jointly.
However, as a registrant, you can opt-out from jointly submitting information and submit some data separately, if:
- it would be disproportionately costly for you 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
- you disagree with the lead registrant on the selection of information.
ECHA verifies the following information during the completeness check if a registration dossier contains information marked as opted-out:
- There is a justification in line with Articles 11(3) or 19(2) of the REACH Regulation.
- All the information submitted as opted-out is complete.
- When the opted-out information is submitted to fulfil information requirements at a higher tonnage than those covered by the joint submission, all the relevant information requirements are addressed.
- When the opt-out is submitted using a token provided by ECHA, and you cannot rely on any of the information jointly submitted by the lead registrant, all the information required under REACH Articles 10 and 12 (or Articles 17 or 18) is included in the opt-out dossier and that information is complete.
If you have questions related to technical completeness check, use ECHA’s contact form:
- ECHA’s contact form
- In the contact form, select ‘Registration’ under Topic.
Provide the following details related to your question in the ‘Question’ field: - Indicate clearly that your question concerns the technical completeness check.
- If you are still preparing your dossier and need help to understand how to fill in a particular IUCLID section, provide as many details as possible on your situation and approach to fulfil the information requirement.
- If you have already submitted your dossier and need help to understand the completeness check outcome, include the submission number assigned to your submission by ECHA.
- In the contact form, select ‘Registration’ under Topic.
For questions related to the Validation assistant, there is a separate instruction available:
Route: .live1