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REACH

Evaluation

Compliance checks

I have a dossier containing information requirements which I have opted out from and I have received a (draft) decision. What are my obligations to bring my dossier into compliance?

As of January 2019, ECHA sends its (draft) decision to all non-compliant registrants of the joint submission. If you have opted out for one or more information requirements (Article 11(3) of REACH) and your information is found to be non-compliant, you also receive a separate (draft) decision.

 

You and the other recipients of ECHA’s decision will need to coordinate at least the following:

  • If the requested information already exists, you will need to agree on the costs and sharing of the existing data.
  • If the requested information needs to be generated, you will need to:
    i  agree on the test to be performed, including on the testing material to be used as representative for all registrants;
    ii  inform ECHA of who will perform the test; and
    iii  share the costs and new data.

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