# C_2014112EN.01003601.xml

| 14.4.2014 | EN | Official Journal of the European Union | C 112/36 |
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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. |
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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; —
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; —
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; —
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. | — | 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; | — | 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; | — | 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; | — | 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. |
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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; | | | | | | | | |
| — | 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; | | | | | | | | |
| — | 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; | | | | | | | | |
| — | 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). | — | 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). |
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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. | — | 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. |
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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). | — | 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). |
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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). | | |

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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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