ECHA Board of Appeal decision on case "Albemarle Europe SPRL, Belgium"

Contested Decision : Decision of 13 January 2021 on a compliance check of the registration for the substance N,N''-ethylenebis(3,4,5,6-tetrabromophthalimide), adopted by the European Chemicals Agency under Article 41 of the REACH Regulation

The Contested Decision was notified to the Appellant under annotation number CCH-D-2114539007-53-01/F

Background to the dispute

1. This appeal concerns a compliance check of the registration for the substance N,N'- ethylenebis(3,4,5,6-tetrabromophthalimide) (the Substance).1

2. The Appellant’s registration dossier contained adaptations to omit the simulation testing required under Section 9.2.1. of Annex IX to the REACH Regulation.2 Those adaptations were based mainly on the Appellant’s conclusion that the Substance is poorly soluble in water and in organic solvents. In relation to the requirement to provide information on the identification of degradation products under Section 9.2.3. of Annex IX, the Appellant sought to rely on adaptations under Section 2 of Annex XI and Column 2 of Section 9.2. of Annex IX.

3. On 21 March 2017, a substance evaluation process for the Substance was started. On 1 June 2018, a draft substance evaluation decision was notified to the Appellant. That draft substance evaluation decision requested the Appellant to provide information on a simulation study in sediment in accordance with OECD3 test guideline (TG) 308, to be conducted at temperatures of 20°C and 12°C, with the aim of investigating both the persistence and the biodegradation of the Substance and identifying its degradation products.