Judgments nº T-610/17 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-610/17

(REACH - Substances subject to authorisation - Inclusion of 1-bromoproprane (nPB) in Annex XIV to Regulation No 1907/2006 - Volumes - Registration dossier - Data - Substance grouping - Principle of sound administration - Right to conduct business and pursue a trade freely - Obligation to state reasons - Legitimate expectations - Proportionality - Equal treatment)

In Case T-610/17,

ICL-IP Terneuzen, BV, established in Terneuzen (Netherlands),

ICL Europe Coöperatief UA, established in Amsterdam (Netherlands),

represented by R. Cana, E. Mullier and H. Widemann, lawyers,

applicants,

v

European Commission, represented by M. Huttunen, R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,

defendant,

supported by

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

intervener,

APPLICATION under Article 263 TFEU for annulment in part of Commission Regulation (EU) 2017/999 of 13 June 2017 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ 2017 L 150, p. 7), in so far as it includes 1-bromopropane (nPB) in that annex.

THE GENERAL COURT (Fifth Chamber),

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

Registrar: S. Bukšek Tomac, Administrator,

having regard to the written part of the procedure and further to the hearing on 14 February 2019,

gives the following

Judgment

1. Background to the dispute and the contested regulation

   1 1-bromopropane (n-propylbromide; ‘nPB’) is a liquid brominated substance. It is used as a solvent in vapour degreasing. It is also used as an intermediate in the manufacture of other substances. It has been classified as a toxic substance for reproduction (category 1B) in 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).

   2 One of the applicants, ICL-TP Terneuzen, BV, is the lead registrant of nPB. It manufactures and uses nPB within the meaning 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).

   3 The other applicant, ICL Europe Coöperatief UA, places nPB on the market for use as a solvent in vapour degreasing and surface cleaning applications and uses it within the meaning of Regulation No 1907/2006.

   4 On 11 October 2002, ICL-IP Terneuzen submitted a registration dossier for nPB, for a tonnage band of 1 000 to 10 000 tonnes per annum. It subsequently invited all the members of the substance information exchange forum to become members of a joint submission for the substance.

   5 On 3 September 2012, the European Chemicals Agency (ECHA) published on its website a dossier proposing the identification of nPB as a substance of very high concern on the basis of Article 57(c) of Regulation No 1907/2006.

   6 On 18 October 2012, the applicants submitted comments on the proposed identification of nPB as a substance of very high concern. In their comments, the applicants emphasised in particular that nPB was mainly used as an intermediate, and therefore excluded from authorisation, and that its non-intermediate uses were either strictly controlled or subject to strict occupational exposure levels.

   7 By Decision ED/169/2012 of the Executive Director of ECHA of 18 December 2012, nPB was included on the candidate list, in application of Article 59(8) of Regulation No 1907/2006.

   8 On 1 September 2014, in the context of the sixth prioritisation exercise, ECHA published on its website a draft recommendation for the inclusion of substances, including nPB, in Annex XIV to Regulation No 1907/2006 (‘Annex XIV’) and invited interested parties to submit their comments by 1 December 2014. The 22 substances covered by that draft recommendation, including nPB, were selected on the basis of the provisional results of that prioritisation exercise, which were published on ECHA’s website on the same date.

   9 On 1 December 2014, the applicants submitted comments on that draft recommendation on behalf of the other registrants. In their comments, the applicants emphasised in particular that around 70% of nPB was used for intermediate purposes and was thus exempt from the application of Title VII of Regulation No 1907/2006.

   10 On 1 July 2015, ECHA adopted a recommendation for the inclusion of substances in Annex XIV, in which it recommended the inclusion of nPB in Annex XIV without any exempted uses or categories of uses (‘the ECHA recommendation’). On the same date, ECHA published its updated, final results and documents in support of its conclusions, including a reference document relating to nPB. It is apparent from that document that nPB received a total prioritisation score of 20/45 for the criteria set out in Article 58(3)(a) to (c) of Regulation No 1907/2006. That score is made up of the score of 1/15, awarded for inherent properties, 12/15 for volumes, and 7/15 for wide dispersive use. In its final conclusion on nPB, ECHA stated that although other substances on the candidate list assessed in that recommendation round were awarded a higher priority score on the basis of the criteria set out in Article 58(3)(a) to (c) of Regulation No 1907/2006, the inclusion of nPB in Annex XIV was recommended because of considerations connected with the grouping of that substance and trichloroethylene, a substance already included in that annex.

   11 On 10 August 2015, the applicants sent a first letter to the European Commission. In that letter, they claimed that the ECHA recommendation was procedurally and legally flawed.

   12 On 18 September 2015, the Commission replied to the applicants.

   13 On 4 February 2016, the applicants sent a second letter to the Commission. In that letter, they put forward additional elements to demonstrate that the inclusion of nPB in Annex XIV on the basis of the ECHA recommendation would be legally flawed and requested a meeting with representatives of the Commission.

   14 On 3 October 2016, the applicants sent a third letter to the Commission. In that letter, they informed the Commission that the volumes of nPB used in vapour degreasing and surface cleaning applications had declined further owing to the fact that the only other registrant of that non-intermediate use had suspended its registration, leaving ICL-IP Terneuzen as the only supplier of the non-intermediate use of nPB within the scope of the authorisation and that new data had been gathered on the substance in question and had allowed safe levels for nPB use to be established. The applicants asked the Commission to examine that additional information as a matter of urgency and requested that a meeting be held in any event before the forthcoming meeting of the regulation committee.

   15 On 15 November 2016, the Commission informed the applicants by letter that, owing to an oversight, their letter of 4 February 2016 had not been answered. It added that it had asked ECHA to analyse the data sent by the applicants and agreed to their request for a meeting, inviting them to contact its secretariat in order to find a suitable date for a meeting in November.

   16 On 7 and 8 December 2016, during the regulation committee meeting, the draft Commission Regulation amending Annex XIV to include the recommended substances, including nPB, was discussed.

   17 On 7 December 2016, the applicants contacted the Commission by email to arrange the meeting referred to in paragraph 15. In their communication, they asked whether the regulation committee meeting on 7 and 8 December 2016 concerning the inclusion of nPB in Annex XIV would still take place.

   18 On 8 December 2016, the regulation committee gave a favourable opinion on the ECHA recommendation.

   19 On 23 December 2016, the Commission replied to the applicants’ email of 7 December 2016. In its reply, it stated in particular that that email had arrived too late for a meeting with the applicants to be arranged, as the regulation committee meeting had taken place on the same date.

   20 On 13 June 2017, on the basis of the favourable opinion of the regulation committee and the ECHA recommendation, the Commission adopted Regulation (EU) 2017/999 of 13 June 2017 amending Annex XIV (OJ 2017 L 150, p. 7; ‘the contested regulation’). The contested regulation included nPB in Annex XIV in entry 32, without providing for any exemption for certain uses or categories of uses, and fixed the expiry date concerning that substance as 4 July 2020. As is apparent from recital 1 of that regulation, the Commission considered that nPB met the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation No 1272/2008 and therefore met the criteria for inclusion in Annex XIV set out in Article 57(c) of Regulation No 1907/2006. In recital 13 of the contested regulation, it stated that nPB had been identified and included in the list of candidate substances under Article 59 of Regulation No 1907/2006, which had been prioritised for inclusion in Annex XIV by ECHA in its recommendation and that, notwithstanding the information provided by the interested parties, it was appropriate to include nPB in that annex.

2. Procedure before the General Court and forms of order sought by the parties

   21 By application lodged at the Court Registry on 6 September 2017, the applicants brought the present...