ECHA Board of Appeal: Celanese Production Germany GmbH & Co. KG | Compliance check

Subject matter : A decision taken by the European Chemicals Agency pursuant to Article 42(1) of the REACH Regulation

Contested Decision : CCH-D-2114538555-43-01/F

Background to the case and remedy sought by the Appellant : On 14 July 2017 the Agency adopted an initial compliance check decision pursuant to Article 41 of the REACH Regulation. In this decision, the Agency held that there are data-gaps in the Appellant’s registration dossier for the substance  butyl glycollate (EC No 230-991-7). By that decision, the Agency consequently required the Appellant to submit a pre-natal developmental toxicity study in a second species and an extended one-generation reproductive toxiticy study (Sections 8.7.2. and 8.7.3. of Annex X to the REACH Regulation) or, alternatively, a valid adaptation.