ECHA Board of Appeal: Cytec Engineered Materials GmbH, Germany

Subject matter: A decision taken by the European Chemicals Agency pursuant to Article 41 of the REACH Regulation

Contested Decision: CCH-D-2114573706-39-01/F

Remedy sought by the Appellant:

On 25 October 2021, the Agency adopted the Contested Decision following the compliance check of the registration dossiers for 4,4''-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (EC No 407-560-9; the ‘Substance’).

The Contested Decision requires the Appellant and other registrants of the Substance to submit, depending on the tonnage at which they registered the Substance, information on:

1. In vitro gene mutation study in bacteria (Section 8.4.1. of Annex VII, test method: EU B.13/14 / OECD TG 471);

2. In vitro cytogenicity study in mammalian cells (Section 8.4.2. of Annex VIII; OECD TG 473) or in vitro micronucleus study (Section 8.4.2. of Annex VIII; OECD TG 487);

3. Long-term toxicity testing on fish (Column 2 of Section 9.1.3. of Annex VIII and Section 9.1.6. of Annex IX; OECD TG 210);

4. Simulation testing on ultimate degradation in surface water (Column 2 of Section 9.2. of Annex VIII and Section 9.2.1.2. of Annex IX; test method: EU C.25 / OECD TG 309) at a temperature of 12°C and non extractable residues (‘NER’) must be quantified;

5. Soil simulation testing (Column 2 of Section 9.2. of Annex VIII and Section 9.2.1.3. of Annex IX; test method: EU C.23 / OECD TG 307) at a temperature of 12°C and NERs must be quantified;

6. Sediment simulation testing (Column 2 of Section 9.2. of Annex VIII and Section 9.2.1.4. of Annex IX; test method: EU C.24 / OECD TG 308) at a temperature of 12°C and NERs must be quantified; and

7. Identification of degradation products (Column 2 of Section 9.2. of Annex VIII and Section 9.2.3. of Annex IX; OECD TG 307 and/or 308 and/or 309).