Regulatory Developments

ECHA Releases Draft Revised REACH Data Sharing Guidance

July 6, 2011

The European Chemicals Agency (ECHA) has sent to the Partner Expert Group (PEG) a draft of a second version of the guidance on data sharing for phase-in and non-phase-in substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) (Data Sharing Guidance). The first edition of the Data Sharing Guidance was published in 2007. ECHA has revised the entire Data Sharing Guidance document, including correcting mistakes and inconsistencies, proposing to remove sections already covered by technical manuals or falling under the scope of other guidance documents and instead providing links to that information, and other more substantive changes. Specifically with regard to content changes, ECHA states: "The content has been reworked with the aim to restrict the scope to Title III of the REACH Regulation and to add the description of dispute processes." Some of these proposed changes include the following:

  • Pre-Registration Information Reduced: Since the pre-registration process is now complete, ECHA proposes to revise or reduce the information in this section and instead focus on late pre-registration and those actors entitled to late pre-registration.
     
  • Right to Refer/Legitimate Possession: Under REACH Article 10, registrants must "be in legitimate possession of or have permission to refer to the full study report summarised [in a study summary or a robust study summary] for the purpose of registration." ECHA's initial Data Sharing Guidance provided guidance regarding when a company has "legitimate possession of the full study report" and the "right to refer to the full study report." In the proposed revised Data Sharing Guidance, ECHA expands on this discussion, including but not limited to information that may be protected by copyright. ECHA states: "In summary, registrants may be entitled to use the content of a published article in a different form, as long as the appropriate national copyright and/or data protection law(s) have been previously checked and respected. In case of uncertainty, it is recommended to seek legal advice from a national lawyer specialised in the copyright field."
     
  • Data Sharing Disputes: ECHA has proposed an entirely new section devoted to the data sharing dispute processes under REACH Article 30. This section now includes data sharing examples, figures, and a discussion outlining the process under Article 30(2) (dispute regarding new testing requirement), Article 30(3) (dispute before joint registration submitted), and Article 30(3) (dispute after joint registration submitted).
     
  • Inquiry Process: ECHA has significantly modified and updated its guidance with respect to the inquiry process under Articles 26 and 27 for non-phase-in substances and phase-in substances that were not pre-registered. ECHA has added a discussion of the information that must be submitted with an inquiry and the possible outcomes of the process. ECHA states that its "stepwise workflow has been extended and better described in order to provide a comprehensive set of information to those involved in the inquiry process."

Consultation with PEG is the initial step in the consultation process once ECHA identifies a need for updating existing guidance. Other consultations following PEG can be with ECHA's Committees and/or Forum, where relevant; and then a concluding consultation of the European Commission and Member States Competent Authorities via the meeting of the Competent Authorities for REACH and the CLP Regulations (CARACAL). See online.

The revised Data Sharing Guidance is available online.


 
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