In November 2016, the European ChemicalsAgency (“ECHA”) Board of Appeal (“BoA”) published a decision in a case involving a compliance decision on benzaldehyde (“Contested Decision”). Following an appeal from the lead registrant and certain co-registrants of the joint submission, the Executive Director of the ECHA revoked the Contested Decision in its entirety. The Contested Decision required the lead registrant (effectively all co-registrants) to perform further testing, including testing on animals. The lead registrant and certain co-registrants appealed the Contested Decision on various legal and procedural grounds. Most notably, the appeal challenged ECHA’s long established policy of notifying a draft compliance decision only to the owner of the dossier being evaluated (usually the lead registrant) despite such decisions having direct effect on all co-registrants of the joint submission. K&L Gates represented the appellants in this case.
Background ECHA carried out a compliance check on the lead registrant’s dossier pursuant to Article 41(1) of REACH and sent the draft Contested Decision to the lead registrant via REACH-IT. In line with the established procedure, the lead registrant had 30 days to provide comments on the draft Contested Decision. However, due to medical reasons, the lead registrant was unaware of the draft Contested Decision until after the deadline to comment on it had passed. As soon as the lead registrant became aware of the draft Contested Decision it updated its dossier and provided comments to ECHA and the Member State Committee. Some of the other co-registrants also provided comments. ECHA followed its strict policy and in the Contested Decision it did not take into account any updates or comments provided by the parties past the deadline.
Following the consideration of the appeal from the lead registrant and certain co-registrants, the Executive Director of ECHA recognised that the case qualified for special treatment and that ECHA “could have exceptionally provided the [lead registrant] with a further possibility to comment on the draft decision.” As argued by K&L Gates on behalf of the appellants, the whole matter could have been avoided had ECHA notified the draft Contested Decision to all co-registrants of the joint submission and not only to the lead registrant. The case sparks a wider discussion on whether ECHA’s policy of notifying draft compliance decisions only to the lead registrant breaches REACH. This was not tested by the BoA as the Contested Decision was revoked and the appeal was subsequently withdrawn.
Article 50(1) of REACH A compliance decision, while addressed only to the owner (usually the lead registrant) of the dossier under dossier evaluation, has direct effect on the legal rights and obligations of all co-registrants of the joint submission. In particular, this is the case where ECHA requests that further testing be carried out (as REACH requires all co-registrants to share the costs of testing).
Article 50(1) of REACH on registrants’ and downstream users’ rights provides that ECHA should notify any draft decision, including draft compliance decisions to “the registrant(s) or downstream user(s) concerned”. Clearly, the co-registrants of a joint submission would be considered to be the registrants concerned under Article 50(1) of REACH.
Instead of fulfilling its obligation under REACH, ECHA has shifted its notification obligation on to the lead registrant, who is expected, in the case of a joint submission, to notify the co-registrants of the draft compliance decision. ECHA also expects the lead registrant to coordinate the response with the co-registrants and ECHA will only receive coordinated comments from the lead registrant. At the same time, REACH clearly defines the duties and obligations of the lead registrant and these do not include sharing draft compliance decisions with the co-registrants or coordinating comments. This is an area which remains untested before the EU Courts, however, we believe there is scope for challenging ECHA’s current notification procedure.