- June 11, 2023
ECHA Board of Appeal Annuls Certain Information Requirements for Substance Registration
In a recent decision, the Board of Appeal of the European Chemicals Agency (ECHA) ruled on a compliance check of the registration for the substance 4,4''-(9H-fluoren-9-ylidene)bis(2-chloroaniline). The appellant, Cytec Engineered Materials GmbH, the lead registrant of the substance, had raised objections to several information requirements imposed by the draft decision.
After careful consideration, the Board of Appeal made the following determinations:
An in vitro cytogenicity study in mammalian cells or in vitro micronucleus study (Information Requirement 2) was annulled, and the case was remitted to the Agency for further action on that point.
The requirement to provide information on simulation testing for ultimate degradation in surface water (Information Requirement 4) was partially annulled. The Appellant is no longer obligated to provide information on non-extractable residues (NERs) generated in that study. However, they still need to provide information on simulation testing for ultimate degradation in surface water without quantifying NERs.
The Board of Appeal dismissed the Appellant's appeal regarding Information Requirements 1, 3, 5, 6, and 7, upholding the original decision.
This ruling provides clarity on specific information requirements for the substance registration process and highlights the ongoing efforts by the European Chemicals Agency to ensure compliance with regulations for chemical substances.MORE INFO ON: echa.europa.eu