ECHA Board of Appeal | 19 May 2021 | Italy Zschimmer & Schwarz Italiana SpA

Subject matter

A decision taken by the European Chemicals Agency (the ‘Agency’) pursuant to Article 40 of the REACH Regulation, in accordance with the procedure laid down in Articles 50 and 51 of the REACH Regulation

Contested Decision

TPE-D-2114538916-37-01/F of 20 January 2021

Background to the appealThe Appellant’s registration dossier for  sodium hydrogen N-(1-oxotetradecyl)-L-glutamate  (EC number 253-981-4, CAS number 38517-37-2) included a proposal to perform a pre-natal developmental toxicity study (EU B.31./OECD test guideline (‘TG’) 414), using an analogue substance, instead of a screening study (OECD TG 421/422).

On 20 January 2021, the Agency adopted the Contested Decision rejecting the Appellant’s testing proposal.