Board of Appeal annuls ECHA decision on BASF’s testing proposal

The European Chemical Agency’s (ECHA) Board of Appeal has annulled a decision previously made by the ECHA in regards to German company BASF Personal Care and Nutrition.

In 2015, BASF submitted a registration dossier to the ECHA for its reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and stearic acid substance, which is a fatty acid derivate used as an ingredient in cosmetic products.

A testing proposal was also submitted for a prenatal developmental toxicity (PNDT) study on analogue substance L-glutamic acid, N-coco acyl derivs disodium salts, requesting a read-across approach instead of a test.

The company expressed concern that testing the ingredient on vertebrate animals would cause it to incur a marketing ban.

However, ECHA rejected the read-across proposal on the grounds that it did not fulfil the requirement of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH), the EU’s chemicals regulation programme.

BASF claimed that the agency wrongly rejected the proposed read-across and alleged a breach of the duty to state reasons.

Following several hearings, the Board of Appeal concluded that the ECHA had breached the duty to state reasons and that the decision was to be remitted to a competent body of the agency for further action.