Case T-673/13: Action brought on 9 December 2013 — European Coalition to End Animal Experiments v ECHA
Date: 2013-12-09
Institutions: General Court
Subjects: administrative formalities, chemical product, product safety, scientific report, toxic substance








C_2014112EN.01003601.xml










14.4.2014   


EN


Official Journal of the European Union


C 112/36





Action brought on 9 December 2013 — European Coalition to End Animal Experiments v ECHA
(Case T-673/13)
2014/C 112/48
Language of the case: English

Parties


Applicant: European Coalition to End Animal Experiments (London, United Kingdom) (represented by: D. Thomas, Solicitor)

Defendant: European Chemicals Agency (ECHA)

Form of order sought

The applicant claims that the Court should:






—


Annul the decision of the Board of Appeal of the European Chemicals Agency of 10 October 2013 in Case A-004-2012 relating to section 8.7.2 of Annex X of the Regulation (EC) No 1907/2006 (1) (developmental toxicity studies in a second species), insofar as it relates to a second species pre-natal developmental study;










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Remit the case to ECHA, with a direction that it consider where there is a need to conduct a pre-natal developmental study on the registrant’s substance, based on the outcome of the first study and all other relevant available data.





Pleas in law and main arguments

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






1.


First plea in law, alleging that the Board of Appeal was wrong to say that the cumulative principle in the REACH testing annexes meant that a second species was the default requirement at Annex X to Regulation (EC) No 1907/2006 tonnage. In support of this plea the applicant claims that:






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The Board of Appeal’s reasoning represents a non sequitur. Testing requirements do not necessarily increase as one moves to a higher tonnage annex: the cumulative principle is often not relevant for particular endpoints, and is not for developmental toxicity;










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Column 1 of section 8.7.2 of Annex X, by its explicit terms, requires a study in ‘one species’, not two — the same as column 1 of section 8.7.2 of Annex IX;










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The Board of Appeal’s reasoning ignores the clear words of column 2 of section 8.7.2 of Annex IX, which provides that whether a second species study is required at Annex IX or Annex X tonnage depends on the outcome of the first species study and all other relevant available data: it is not automatic;










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The Board of Appeal’s conclusion makes no sense in policy terms: it ascribes to the REACH legislators an intention that, at a lower Annex level (Annex IX), the need for a second species study is dependent on scientific evaluation, whereas at a higher Annex level (Annex X), science is irrelevant.














2.


Second plea in law, alleging that the Board of Appeal was wrong to say that the legislators had brought forward an Annex X requirement — a second species developmental toxicity study as a default requirement — to Annex IX. In support of this plea the applicant claims that:






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The reasoning is based on a false premise: column 1 of section 8.7.2 of Annex X does not impose a second species study as a default requirement (see the first plea), and it follows that there is no such requirement to bring forward to Annex IX (even supposing that that were otherwise the correct approach).














3.


Third plea in law, alleging that the Board of Appeal was wrong to soy that the requirement in column 2 of section 8.7.2 of Annex IX (for evaluation of the need for a second species study) does not carry across to Annex X. In support of this plea the applicant claims that:






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By its explicit terms, this is precisely what column 2 of section 8.7.2 of Annex IX does say, by the words ‘or the next’. The approach for the two annexes is identical.














4.


Fourth plea in law, alleging that the Board of Appeal was wrong to say that only adaptation under column 2 of section 8.7 of Annex X or Annex XI can obviate the need for a second species study at Annex X tonnage. In support of this plea the applicant claims that:






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Adaptation, whether under column 2 or Annex XI, only becomes relevant if there is first a testing requirement under column 1. With column 1 of section 8.7.2 of Annex X, there is no requirement for a second species developmental toxicity study until and unless evaluation of the first species study and other available evidence points to the need for a second species study (see above).










(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)