# C_2017112EN.01004801.xml

| 10.4.2017 | EN | Official Journal of the European Union | C 112/48 |
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Action brought on 28 February 2017 — BASF Grenzach v ECHA

(Case T-125/17)

(2017/C 112/67)

Language of the case: English

Parties

Applicant: BASF Grenzach GmbH (Grenzach-Wyhlen, Germany) (represented by: K. Nordlander and M. Abenhaïm, lawyers)

Defendant: European Chemicals Agency

Form of order sought

The applicant claims that the Court should:

| — | declare the application for annulment admissible; |
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| — | annul the decision of the Board of Appeal of the European Chemicals Agency (ECHA) of 19 December 2016 concerning the substance evaluation of Triclosan pursuant to Article 46(1) of Regulation (EC) No. 1907/2006( 1 ) (case No A-018-2014) (‘the Triclosan Decision’), in so far as the Board of Appeal dismissed the applicant’s administrative appeal, confirmed the rat test, the fish test and the persistence test previously requested by ECHA, and decided that the remaining information was to be provided by 28 December 2018; |
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| — | order ECHA to pay the applicant’s costs for these proceedings. |
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Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

| 1. | First plea in law, alleging a breach of essential procedural requirements
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The applicant puts forward that by confining its role to a limited legality review instead of conducting a full administrative review of the Triclosan Decision, the Board of Appeal breached an essential procedural requirement. According to the applicant, the Board of Appeal also breached two essential procedural requirements in disregarding — without addressing their merits — numerous key arguments and pieces of scientific evidence which the applicant had brought forward. In so doing, so the applicant claims, the Board of Appeal not only failed to exercise its power of administrative review, but also breached the applicant’s right of defense. | — | The applicant puts forward that by confining its role to a limited legality review instead of conducting a full administrative review of the Triclosan Decision, the Board of Appeal breached an essential procedural requirement. According to the applicant, the Board of Appeal also breached two essential procedural requirements in disregarding — without addressing their merits — numerous key arguments and pieces of scientific evidence which the applicant had brought forward. In so doing, so the applicant claims, the Board of Appeal not only failed to exercise its power of administrative review, but also breached the applicant’s right of defense. |
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| — | The applicant puts forward that by confining its role to a limited legality review instead of conducting a full administrative review of the Triclosan Decision, the Board of Appeal breached an essential procedural requirement. According to the applicant, the Board of Appeal also breached two essential procedural requirements in disregarding — without addressing their merits — numerous key arguments and pieces of scientific evidence which the applicant had brought forward. In so doing, so the applicant claims, the Board of Appeal not only failed to exercise its power of administrative review, but also breached the applicant’s right of defense. | | |

| 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.
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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. | — | 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. |
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| — | 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. | | | | | | |

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( 1 )  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006, L 396, p. 1)

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