Board of Appeal decision on a joint submission dispute in case of a ‘complete opt-out’
The Board of Appeal has issued its decision in case A-011-2017, concerning the joint registration for charcoal. The case was found to be inadmissible.
Helsinki, 28 March 2018 – The Board of Appeal has issued its decision in Case A-011-2017, concerning the joint registration for the substance charcoal. By the decision under appeal ECHA granted a registrant ‘access to the joint submission’ and issued a ‘token’ to enable this to happen. The registrant in question wished to join the joint registration for charcoal whilst relying on a ‘complete opt-out’ from all information in the lead registrant’s dossier. The lead registrant challenged the ECHA decision before the Board of Appeal.
The Board of Appeal examined the requirements of the principle of ‘one substance, one registration’ (OSOR) and the role of ECHA in implementing this principle when a registrant relies on a ‘complete opt-out’. It found that, if a registrant decides to rely on a ‘complete opt-out’ and informs ECHA and the lead registrant accordingly, the registrant cannot be prevented from making its separate submission part of the joint registration. Based on Article 11 of the REACH Regulation, supported by Article 3(3) of the Commission Implementing Regulation on data-sharing, ECHA must give such a registrant access to the joint registration. ECHA is not first required to examine whether the registrant has made ‘every effort’ to agree on the terms to obtain the ‘token’ from the lead registrant.
The Board of Appeal highlighted that complete opt-outs are a narrow exception to the rule that data must be shared. A complete opt-out requires heightened scrutiny by ECHA. In particular, the REACH Regulation requires ECHA to perform a thorough completeness check of opt-out dossiers, and prioritise them for a compliance check. ECHA should also inform the enforcement authorities of the Member States of any breaches it detects with regard to, for example, the duplication of tests on vertebrate animals.
By this examination, the Board of Appeal concluded that the decision to ‘grant access to the joint submission’ to a registrant who relies on a complete opt-out is taken under Article 11 of the REACH Regulation. As Article 11 does not fall under the competence of the Board of Appeal, the case was found to be inadmissible.