Judgments nº T-125/17 of Tribunal General de la Unión Europea, September 20, 2019

• Resolution Date: September 20, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-125/17

(REACH - Evaluation of substances - Triclosan - ECHA decision requesting further information - Article 51(6) of Regulation (EC) No 1907/2006 - Action brought before the Board of Appeal - Task of the Board of Appeal - Adversarial nature of the procedure - Scope of the review - Intensity of the review - Powers of the Board of Appeal - Article 93(3) of Regulation No 1907/2006 - First sentence of Article 47(1) of Regulation No 1907/2006 - Relevant information - Proportionality - Article 25 of Regulation No 1907/2006 - Annex XIII to Regulation No 1907/2006 - Data obtained under relevant circumstances - Persistence - Neurotoxicity - Reproductive toxicity - Article 12(1) of Regulation (EC) No 771/2008 - Delay in the submission of a scientific opinion)

In Case T-125/17,

BASF Grenzach GmbH, established in Grenzach-Wyhlen (Germany), represented initially by K. Nordlander and M. Abenhaïm, lawyers, and subsequently by K. Nordlander and K. Le Croy, Solicitor,

applicant,

v

European Chemicals Agency (ECHA), represented initially by M. Heikkilä, W. Broere and T. Röcke, and subsequently by M. Heikkilä, W Broere and C. Jacquet, acting as Agents,

defendant,

supported by

Kingdom of Denmark, represented initially by C. Thorning and M. Wolff, and subsequently by M. Wolff, J. Nymann-Lindegren and P. Ngo, acting as Agents,

by

Federal Republic of Germany, represented initially by T. Henze and D. Klebs, and subsequently by D. Klebs, acting as Agents,

and by

Kingdom of the Netherlands, represented by M. Bulterman and C. Schillemans, acting as Agents,

interveners,

ACTION under Article 263 TFEU for the partial annulment of Decision A-018-2014 of the Board of Appeal of the ECHA of 19 December 2016 in so far as it partially dismissed the applicant’s appeal against the ECHA decision of 19 September 2014 to request further information about the substance Triclosan (CAS 3380-34-5) and in which it fixed the deadline for presenting that information as 26 December 2018,

THE GENERAL COURT (Fifth Chamber, Extended Composition),

composed of D. Gratsias, President, I. Labucka, S. Papasavvas, A. Dittrich (Rapporteur) and I. Ulloa Rubio, Judges,

Registrar: N. Schall, Administrator,

having regard to the written part of the procedure and further to the hearing on 12 December 2018,

gives the following

Judgment

1. Background to the dispute and the contested decision

   1 Triclosan (CAS 3380-34-5) is a broad-spectrum antibacterial that is approved for use as a preservative in certain types of cosmetic products. It is registered solely for cosmetic use under 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, corrigendum OJ 2007 L 136, p. 3).

   2 The applicant, BASF Grenzach GmbH, manufacturer of Triclosan, is the sole registrant of that substance within the meaning of Article 3(7) of Regulation No 1907/2006.

   3 In 2012, Triclosan was included in the Community rolling action plan for evaluation within the meaning of Article 44 of Regulation No 1907/2006 due to grounds for concern relating to its persistent, bioaccumulative and toxic properties as well as its potential for endocrine disruption.

   4 In accordance with Article 45 of Regulation No 1907/2006, the competent authority of the Kingdom of the Netherlands was appointed to carry out the evaluation of Triclosan, in cooperation with the competent authority of the Kingdom of Denmark. Together, pursuant to Article 46(1) of Regulation No 1907/2006, those authorities prepared a draft decision for the applicant, in which requests for further information about Triclosan were made.

   5 On 20 March 2013, pursuant to Article 50(1) of Regulation No 1907/2006, the draft decision was notified to the applicant.

   6 On 23 April 2013, the applicant provided its comments on the draft decision.

   7 The competent authority of the Kingdom of the Netherlands took account of the applicant’s comments and revised the draft decision, in accordance with Article 50(1) of Regulation No 1907/2006.

   8 On 6 March 2014, in accordance with Article 52(1) of Regulation No 1907/2006, the revised draft decision and the applicant’s comments were notified to the competent authorities of the other Member States and to the European Chemicals Agency (ECHA).

   9 Four competent authorities of those other Member States and the ECHA submitted proposals for amendment, pursuant to Article 51(2) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

   10 After having reviewed those proposals, the competent authority of the Kingdom of the Netherlands amended the draft decision, pursuant to the first sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

   11 On 22 April 2014, the amended draft decision was referred to the Member State Committee, pursuant to the second sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

   12 The applicant provided comments on those proposals for amendment, which were taken into account by the Member State Committee (Article 51(5) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation).

   13 On 12 June 2014, pursuant to Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, the Member State Committee reached a unanimous agreement on the amended draft decision.

   14 On 19 September 2014, the ECHA adopted Decision SEV-D-2114285478-33-01/F on the evaluation of Triclosan (‘the ECHA decision’) on the basis of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. By that decision, it requested the applicant to produce in particular the following information:

   - simulation testing of Triclosan on ultimate degradation in fresh surface water (lake or river) and sea water, performed as a pelagic test, that is to say in water only, without addition of suspended solids, at an environmentally relevant temperature of at most 12 degrees centigrade, in accordance with EU test method C.25 and Organisation for Economic Cooperation and Development (OECD) test guidelines 309 for the Testing of Chemicals (‘the persistence test’);

   - an enhanced developmental neurotoxicity study, in accordance with OECD test guidelines 426 for the Testing of Chemicals, with relevant elements of the extended one-generation reproductive toxicity study, in accordance with OECD test guidelines 433 for the Testing of Chemicals, which involved testing on rats (‘the enhanced neurotoxicity rat study’);

   - a fish sexual development test, in accordance with OECD test guidelines 234 for the Testing of Chemicals, on zebrafish or Japanese medaka (‘the fish test’).

   15 By its decision, the ECHA also asked the applicant to provide the information available on the effects of Triclosan on the cardiovascular system of certain laboratory animals and humans as well as further information on the ‘wide dispersive indoor use of reactive substances in open systems’ emission scenario.

   16 The ECHA decision fixed 26 September 2016 as the deadline for providing the information requested.

   17 On 17 December 2014, the applicant brought an action against the ECHA decision before the Board of Appeal of that agency, pursuant to Article 51(8) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, and with Article 91(1) of that regulation.

   18 In accordance with Article 91(2) of Regulation No 1907/2006, the action against the ECHA decision had suspensory effect.

   19 On 2 April 2015, the ECHA lodged the defence before the Board of Appeal.

   20 On 6 October 2015, PETA International Science Consortium Ltd was granted leave to intervene before the Board of Appeal in support of the form of order sought by the applicant.

   21 On 12 January 2016, PETA International Science Consortium lodged its statement in intervention before the Board of Appeal. On 22 February 2016, the ECHA and the applicant submitted their observations on that statement. The applicant enclosed an expert opinion as an annex to its observations.

   22 A hearing before the Board of Appeal was held on 9 June 2016. At that hearing, the ECHA submitted three studies by which it sought to refute the expert opinion submitted by the applicant as part of its observations on the statement in intervention. That board allowed the parties to submit their observations on that opinion and on the three studies submitted by the ECHA after the hearing.

   23 On 19 December 2016, the Board of Appeal adopted Decision A-018-2014 (‘the contested decision’). By that decision, it annulled the ECHA decision in so far as the latter had obliged the applicant to provide information about the effects of Triclosan on the cardiovascular system (see paragraph 15 above) and dismissed the action as to the remainder. In addition, it fixed 26 December 2018 as the deadline for the submission of the information referred to in paragraph 14 above.

2. Procedure before the Court and forms of order sought

   24 By application lodged at the Registry of the Court on 28 February 2017, the applicant brought this action.

   25 By a separate document lodged at the Court Registry on the same day, the applicant brought an application for interim measures, by which it claimed, in essence, that the President of the General Court should order the immediate suspension of the implementation of the contested decision, pending a...