Judgments nº T-135/13 of The General Court, April 30, 2015

• Resolution Date: April 30, 2015
• Issuing Organization: The General Court
• Decision Number: T-135/13

(REACH - Identification of certain respiratory sensitisers as substances of very high concern - Equivalent level of concern - Action for annulment - Whether directly concerned - Admissibility - Rights of the defence - Proportionality)

In Case T-135/13,

Hitachi Chemical Europe GmbH, established in Düsseldorf (Germany),

Polynt SpA, established in Scanzorosciate (Italy),

Sitre Srl, established in Milan (Italy),

represented by C. Mereu and K. Van Maldegem, lawyers,

applicants,

supported by

REACh ChemAdvice GmbH, established in Kelkheim (Germany), represented by C. Mereu and K. Van Maldegem,

and by

New Japan Chemical, established in Osaka (Japan), represented by C. Mereu and K. Van Maldegem,

interveners,

v

European Chemicals Agency (ECHA), represented by M. Heikkilä, W. Broere and T. Zbihlej, acting as Agents,

defendant,

supported by

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

and by

European Commission, represented by K. Mifsud-Bonnici and K. Talabér-Ritz, acting as Agents,

interveners,

APPLICATION for annulment in part of Decision ED/169/2012 of the ECHA of 18 December 2012 concerning the inclusion of substances of very high concern in the list of candidate substances, in accordance with Article 59 of 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), in so far as it concerns hexahydromethylphthalic anhydride (EC No 247-094-1), hexahydro-4-methylphthalic anhydride (EC No 243-072-0), hexahydro-1-methylphthalic anhydride (EC No 256-356-4) and hexahydro-3-methylphthalic anhydride (EC No 260-566-1),

THE GENERAL COURT (Fifth Chamber),

composed of A. Dittrich (Rapporteur), President, J. Schwarcz and V. Tomljenović, Judges,

Registrar: L. Grzegorczyk, Administrator,

having regard to the written procedure and further to the hearing on 20 November 2014,

gives the following

Judgment

Background to the dispute

1 The first applicant, Hitachi Chemical Europe GmbH, and the second applicant, Polynt SpA, manufacture and import hexahydromethylphthalic anhydride (EC No 247-094-1), hexahydro-4-methylphthalic anhydride (EC No 243-072-0), hexahydro-1-methylphthalic anhydride (EC No 256-356-4) and hexahydro-3-methylphthalic anhydride (EC No 260-566-1) (together, ‘MHHPA’) for industrial use as intermediates or monomers in the chemical synthesis of chemicals and polymers, as well as for the manufacture of articles, as co-monomers or intermediates, in the manufacture of polymer resins.

2 The third applicant, Sitre Srl, uses MHHPA as a hardener for epoxy resins as intermediate or co-monomer in the manufacturing of epoxy-based electrical insulators for transformers for medium-voltage power distribution.

3 MHHPA is a cyclic acid anhydride. It has been listed in Table 3.1 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). By that listing, MHHPA has inter alia been classified among the category 1 respiratory sensitisers, which may cause allergy or asthma symptoms or breathing difficulties if inhaled.

4 On 6 August 2012, the Kingdom of the Netherlands sent to the European Chemicals Agency (ECHA) a dossier that it had prepared concerning the identification of MHHPA as a substance of very high concern in accordance with the procedure laid down in Article 59 of 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), subsequently amended inter alia by Regulation No 1272/2008. In that dossier, the Kingdom of the Netherlands proposed that MHHPA be identified as a substance for which there was scientific evidence of probable serious effects on human health or the environment which gave rise to a level of concern equivalent to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006, in accordance with Article 57(f) of that regulation.

5 On 3 September 2012, the ECHA requested interested parties to submit their comments on the dossier prepared concerning MHHPA. Within the framework of that consultation procedure, the first and second applicants submitted comments through a trade association of which they were members.

6 Subsequently, the ECHA referred the dossier to its Member State Committee, as referred to in Article 76(1)(e) of Regulation No 1907/2006, which, on 13 December 2012, reached a unanimous agreement on the identification of MHHPA as a substance of very high concern meeting the criteria set out in Article 57(f) of Regulation No 1907/2006.

7 By its Decision ED/169/2012 of 18 December 2012 on the inclusion of substances of very high concern in the candidate list (‘the contested decision’), the ECHA identified MHHPA as a substance meeting the criteria referred to in Article 57(f) of Regulation No 1907/2006, in accordance with Article 59 of that regulation.

Procedure and forms of order sought

8 By application lodged at the Court Registry on 28 February 2013, the applicants brought the present action for partial annulment of the contested decision, in so far as it concerned MHHPA.

9 By letter registered at the Court Registry on 14 June 2013, the European Commission applied for leave to intervene in support of the form of order sought by the ECHA. After hearing the main parties, that application was granted by order of 9 September 2013.

10 By document lodged at the Court Registry on 27 June 2013, the Kingdom of the Netherlands applied for leave to intervene in support of the form of order sought by the ECHA. After hearing the main parties, that application was granted by order of 9 September 2013. Since the application by the Kingdom of the Netherlands for leave to intervene was made after the expiry of the period prescribed in Article 115(1) of the Rules of Procedure of the General Court, it was decided that the Kingdom of the Netherlands could submit its observations only during the oral procedure, in accordance with Article 116(6) of those Rules of Procedure.

11 By documents lodged at the Court Registry on 21 and 24 June 2013, respectively, REACh ChemAdvice GmbH and New Japan Chemical applied for leave to intervene in support of the form of order sought by the applicants. After hearing the main parties, those applications were granted by orders of 10 December 2013 in Hitachi Chemical Europe and Others v ECHA (T-135/13, EU:T:2013:716 and EU:T:2013:734).

12 The Commission lodged its statement in intervention on 28 October 2013. By documents lodged at the Court Registry on 10 December 2013 and 6 January 2014, respectively, the ECHA and the applicants submitted their observations on that statement.

13 REACh ChemAdvice and New Japan Chemical lodged their statements in intervention on 30 January 2014. By documents lodged at the Court Registry on 17 and 18 March 2014, respectively, the ECHA and the applicants submitted their observations on those statements.

14 On hearing the report of the Judge-Rapporteur, the Court (Fifth Chamber) decided to open the oral procedure.

15 By order of 15 October 2014, after hearing the parties, the present case and the case Polynt and Sitre v ECHA, with the reference T-134/13, were joined for the purposes of the oral procedure, in accordance with Article 50 of the Rules of Procedure.

16 In the context of measures of organisation of procedure provided for in Article 64 of the Rules of Procedure, the Court requested the ECHA to provide a document. The ECHA did so within period prescribed. In addition, in the context of those measures, the Court requested that the parties deal with certain questions in particular, in their oral arguments.

17 By letter of 31 October 2014, the applicants lodged their observations on the report for the hearing.

18 The parties presented oral argument and answered the questions put to them by the Court at the hearing on 20 November 2014.

19 The applicants claim that the Court should:

- declare the action admissible and well founded;

- annul the contested decision in part in so far as it concerns MHHPA and its monomers;

- order the ECHA to pay the costs.

20 The ECHA contends that the Court should:

- declare the action inadmissible or, at least, unfounded;

- order the applicants to pay the costs.

21 REACh ChemAdvice and New Japan Chemical claim that the Court should:

- declare the action admissible and well founded;

- annul the contested decision in part in so far as it concerns MHHPA and its monomers.

22 The Kingdom of the Netherlands and the Commission contend that the Court should declare the action inadmissible or, at least, unfounded, and order the applicants to pay the costs.

Law

23 Without formally raising a plea of inadmissibility, the ECHA, supported by the Kingdom of the Netherlands and the Commission, disputes the admissibility of the action. Therefore, before the substance of the case is examined, the questions raised by the ECHA concerning the admissibility of the action must be answered.

1. Admissibility

   24 The ECHA, supported by the Kingdom of the...