Board of Appeal publishes two decisions related to the rejection of adaptations

ECHA/NI/16/37

The decisions of the Board of Appeal in cases A-014-2014 and A-003-2015 both concern ECHA decisions following compliance checks rejecting adaptations (or waiving) for the pre-natal developmental toxicity (PNDT) endpoint.

Helsinki, 4 August 2016 – In both decisions, ECHA rejected the adaptation proposed as the conditions that need to be met for an adaptation under the third indent of column 2 of section 8.7 of Annex IX (to the REACH Regulation) had not been met.

The appellants in both cases claimed that the conditions had been met and that the approach taken by them in their adaptation proposals was consistent with the advice given by ECHA in a webinar. The appellants also claimed in both cases that they had, in any event, satisfied the information requirement for the PNDT endpoint through the use of a weight of evidence adaptation.

The Board of Appeal rejected the appeals on the basis, amongst others, that there had been no error of assessment on the part of ECHA in finding that the PNDT endpoint had not been satisfied by an adaptation.

The Board of Appeal also found that ECHA had acted consistently with the advice in its webinar giving advice on adaptation possibilities for the PNDT endpoint. Importantly, the Board of Appeal stressed that it was not the role of ECHA to develop, justify or improve an adaptation on behalf of a registrant.