2.

Second plea in law, alleging a breach of proportionality principle, read in conjunction with Article 13 TFUE, Article 25(1) REACH, Article 47 REACH and the General Court’s consistent case law concerning judicial review and burden of proof. — As regards the rat test, the applicant puts forward that both ECHA and the Board of Appeal recognized the differences between the thyroid systems of, respectively, rats and humans, but relied essentially on data from studies on rats to posit potential effects on human thyroxine (while existing studies on humans showed the absence of such effects). In so doing, the applicant claims, the Triclosan Decision (i) fails to take account of all the relevant information available, (ii) is contradictory, (iii) relies on inconsistent evidence, and, for these reasons it is vitiated by a manifest error in assessment of the necessity of the rat test, in so far as it addresses an alleged human developmental neurotoxicity concern. With respect to the sexual reproductive toxicity endpoints in the rat study, so the applicant goes further, both ECHA and the Board of Appeal also failed to take account of all the relevant information available and relied on inconsistent evidence. According to the applicant, in so doing, ECHA and the Board of Appeal committed a manifest error in assessment of the necessity of the rat test for any reproductive toxicity endpoints. According to the applicant, the rat test is also manifestly inappropriate because the test results cannot possibly help ECHA clarify the alleged endocrine disruption concerns on humans. Finally, the applicant puts forward that the Triclosan Decision is illegal in that the Board of Appeal upheld the rat test without verifying whether all the requirements of the proportionality principle were satisfied; in particular, the Board of Appeal failed to review whether less restrictive means were available to clarify the alleged endocrine disruption concerns of Triclosan. — As regards the fish test, the applicant claims that (i) the Board of Appeal failed to actually exercise its discretion and determine whether, based on the scientific evidence available, there existed a ‘potential risk’ that could justify requiring further testing; (ii) ECHA and Board of Appeal (both) failed to demonstrate that, based on the available scientific evidence, there existed a potential risk of endocrine disruption justifying further testing on fish; and (iii) ECHA and the Board of Appeal (both) reversed the burden of proof and breached Article 25(1) REACH, by requiring the applicant to demonstrate the absence of such risk. — As regards the persistence test, the applicant puts forward that, in requiring the applicant to carry out the persistence test in both freshwater and marine water in order to allegedly clarify a potential risk of persistence of Triclosan in the environment, ECHA and the Board of Appeal failed to pay due regard both to the weight-of-evidence concerning the persistence of Triclosan, and the requirement to consider environmentally relevant conditions as set forth under Annex XIII. The applicant further claims that, by requiring the applicant to carry out the persistence test in pelagic water (i.e., clear water without sediment), ECHA and the Board of Appeal also failed to respect the clear directive in Annex XIII REACH to consider the evidence that reflects environmentally ‘relevant’ conditions. Moreover, so the applicant claims, having decided that the derogation simulation test need to reflect environmentally relevant conditions, both ECHA and the Board of Appeal then failed to exercise the appropriate expert judgment to identify the appropriate test conditions.