ECHA Board of Appeal dismisses appeal concerning conduct of carcinogenicity study in mice despite existing one in rats
The Board of Appeal of the European Chemicals Agency (ECHA) has dismissed an appeal brought by a defendant, Chemours Netherlands BV, who was required to perform a carcinogenicity study in mice following the evaluation of an active substance (ammonium 2,3,3,3-tetrafluoro-2- heptafluoropropoxy propanoate), when it had already performed one in rats.
According to ECHA’s contested decision, there was a potential risk for workers and the general population to be clarified, as well as a potential risk for the environment and humans through the environment concerning the active substance. The need for a further carcinogenicity study in mice was justified to further evaluate the carcinogenic potential of the substance and to determine if and/or which further action was needed. The appellant challenged the decision and relied on three pleas in law, namely that ECHA had: (i) made an error of assessment; (ii) breached Article 25 of the REACH Regulation; and (iii) breached the principle of proportionality.
The Board of Appeal rejected all pleas and dismissed the appeal. The Board found that ECHA had not committed an error of assessment as there existed a carcinogenicity concern, there was not sufficient available information relating to another similar substance, and by correctly concluding that the requested information would provide information capable of leading to improved risk management measures. It further held that because the appellant did not demonstrate that there are less onerous alternatives available which were capable of clarifying the carcinogenicity concern and that would avoid animal testing, ECHA did not breach Article 25 nor the principle of proportionality.
The decision is available here.