Reach opt-out conditions

Registrants are allowed to opt out from the joint submission under specific conditions.

The right to opt out does not apply to the data sharing obligations, or to opting out of membership of the SIEF. Any exercise of the opt out must be fully justified in each case as prescribed by the REACH text.

the criteria to opt-out of joint submission?

  1. Disproportionately costly to submit the information jointly.
  2. Disclosure of relevant information (Protection of confidential business information).
  3. Disagree with Lead Registrant:
  • test data is not appropriate to his product‟s specific application.
  • Data proposed for the joint registration is of an unsatisfactory standard, and does not wish to compromise his reputation by being associated with what he sees as inferior material.
  • A registrant might consider the data proposed for use in the joint registration to be of an unnecessarily high standard.

To take into account:

  • The REACH Regulation does not define “disproportionate” costs, registrants relying on this ground to opt out should provide sufficient explanations in their registration dossiers.
  • The case must be based on the commercial loss which would be sustained if such CBI were disclosed by joint registration.
  • Dossiers submited under the opting out provisions will be prioritised by ECHA during the compliance checking.

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