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Q What information can be submitted separately?
A

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.

Modified Date: 20/03/2019
Topic: REACH
Scope: Joint submission of data by multiple registrants
Chapter: Joint submission general
ID: 0109
Version: 1.1
This answer has been agreed with national helpdesks.

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