# C_2019172EN.01004101.xml

| 20.5.2019 | EN | Official Journal of the European Union | C 172/41 |
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20.5.2019

EN

Official Journal of the European Union

C 172/41

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Action brought on 25 March 2019 — 3V Sigma/ECHA

(Case T-176/19)

(2019/C 172/55)

Language of the case: English

Parties

Applicant: 3V Sigma SpA (Milan, Italy) (represented by: C. Bryant and S. Hainsworth, Solicitors, and C. Krampitz, lawyer)

Defendant: European Chemicals Agency

Form of order sought

The applicant claims that the Court should:

| — | declare the application admissible; |
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declare the application admissible;

| — | annul the decision of the defendant’s board of appeal of 15 January 2019 regarding the substance evaluation of bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4- diyldiimino}dibenzoate insofar as it (i) dismissed the applicant’s administrative appeal against the original decision and (ii) decided that the applicant must provide information on the OECD TG 308 study by 22 October 2020; and |
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annul the decision of the defendant’s board of appeal of 15 January 2019 regarding the substance evaluation of bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4- diyldiimino}dibenzoate insofar as it (i) dismissed the applicant’s administrative appeal against the original decision and (ii) decided that the applicant must provide information on the OECD TG 308 study by 22 October 2020; and

| — | order defendant to pay the costs. |
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order defendant to pay the costs.

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 that an error in law and a manifest error of assessment were committed in considering that the OECD TG 308 study is necessary.
  The applicant submits that the defendant’s board of appeal would have erred in law and would have made a manifest error of assessment in failing to distinguish, on one hand, the conditions under which tests must be carried out in order to establish the existence or, otherwise, transformation and/or degradation products of a substance and, on the other hand, the conditions under which an assessment of the persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties of any such transformation and/or degradation product must be carried out. As a result, the applicant submits that the defendant’s board of appeal would have erroneously concluded that the OECD TG 308 study requested from the applicant was necessary. |
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1.

First plea in law, alleging that an error in law and a manifest error of assessment were committed in considering that the OECD TG 308 study is necessary.

The applicant submits that the defendant’s board of appeal would have erred in law and would have made a manifest error of assessment in failing to distinguish, on one hand, the conditions under which tests must be carried out in order to establish the existence or, otherwise, transformation and/or degradation products of a substance and, on the other hand, the conditions under which an assessment of the persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties of any such transformation and/or degradation product must be carried out. As a result, the applicant submits that the defendant’s board of appeal would have erroneously concluded that the OECD TG 308 study requested from the applicant was necessary.

| 2. | Second plea in law, alleging that the defendant’s board of appeal erred in law and made a manifest error of assessment in determining that the designated testing temperatures are appropriate.
  The applicant submits that the defendant’s board of appeal would have erred in law and would have made a manifest error of assessment in concluding that the designated testing temperature for the OECD TG 308 study, namely 20 oC, was appropriate. The defendant’s board of appeal would have failed to take into account the fact that performing the study at higher temperature would have a material impact on the concentrations of any transformation and/or degradation products formed and, consequently, on which, if any of them, would then be subject to a persistent, bioaccumulative and toxic/very persistent and very bioaccumulative assessment, thus critically undermining the appropriateness of the study. |
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2.

Second plea in law, alleging that the defendant’s board of appeal erred in law and made a manifest error of assessment in determining that the designated testing temperatures are appropriate.

The applicant submits that the defendant’s board of appeal would have erred in law and would have made a manifest error of assessment in concluding that the designated testing temperature for the OECD TG 308 study, namely 20 oC, was appropriate. The defendant’s board of appeal would have failed to take into account the fact that performing the study at higher temperature would have a material impact on the concentrations of any transformation and/or degradation products formed and, consequently, on which, if any of them, would then be subject to a persistent, bioaccumulative and toxic/very persistent and very bioaccumulative assessment, thus critically undermining the appropriateness of the study.

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