Judgments nº T-283/15 of Tribunal General de la Unión Europea, May 08, 2018

• Resolution Date: May 08, 2018
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-283/15

(REACH - Dossier evaluation - Compliance check of registrations - Check of information submitted and follow-up to dossier evaluation - Statement of non-compliance - Jurisdiction of the General Court - Actions for annulment - Challengeable act - Direct and individual concern - Admissibility - Legal basis - Articles 41, 42 and 126 of Regulation (EC) No 1907/2006) In Case T-283/15,

Esso Raffinage, established in Courbevoie (France), represented by M. Navin-Jones, solicitor,

applicant,

v

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

defendant,

supported by

Federal Republic of Germany, represented by T. Henze, acting as Agent,

by

French Republic, represented by D. Colas and J. Traband, acting as Agents,

and by

Kingdom of the Netherlands, represented by M. de Ree, M. Bulterman and M. Noort, acting as Agents,

interveners,

APPLICATION pursuant to Article 263 TFEU seeking the annulment of the letter from ECHA of 1 April 2015 addressed to the French Ministère de l’ecologie du developement durable, des transports et du logement (Ministry of Ecology, Sustainable Development, Transport and Housing) and entitled ‘Statement of Non-Compliance following a Dossier Evaluation Decision under Regulation (EC) No 1907/2006’.

THE GENERAL COURT (Fifth Chamber),

composed of D. Gratsias, President, A. Dittrich (Rapporteur) and P.G. Xuereb, Judges,

Registrar: C. Heeren, Administrator,

having regard to the written part of the procedure and further to the hearing on 19 September 2017,

gives the following

Judgment

Background to the dispute

1 The applicant, Esso Raffinage, a company established in France, produces and markets a certain substance for which it submitted a registration dossier to the European Chemicals Agency (ECHA) 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; and corrigendum OJ 2007 L 136, p. 3).

2 On 17 November 2010, the applicant submitted an update to its registration dossier for the registered substance for the greater than 1 000 tonnes per annum tonnage band.

3 On 9 July 2010, ECHA initiated a compliance check on the registration dossier for the registered substance pursuant to Article 41(1) of Regulation No 1907/2006.

4 On 28 June 2011, in accordance with Article 50(1) of Regulation No 1907/2006, ECHA notified the applicant of a draft decision prepared according to Article 41(3) of that regulation. The draft decision required the applicant to provide a prenatal developmental toxicity study on one species.

5 After submitting its observations on the draft decision on 28 July 2011, the applicant updated its registration dossier for the substance on 6 September 2011 in order to address the issues of non-compliance found by ECHA.

6 On 14 June 2012, in accordance with Article 51(1) of Regulation No 1907/2006, ECHA notified the draft decision to the Member States’ REACH competent authorities and invited those authorities to submit proposals for amendment under Article 51(2) of that regulation.

7 On 18 July 2012, ECHA notified the applicant of an amended draft decision pursuant to Article 51(5) of Regulation No 1907/2006. Attached to the amended draft decision were proposals for amendment from various Member States. In its proposal, the Kingdom of Denmark recommended that the applicant be required to perform a further study, namely a prenatal developmental toxicity study on a second species. According to that Member State, that second study constituted ‘standard information’, as laid down in section 8.7.2 of Annex X to Regulation No 1907/2006.

8 The applicant did not submit observations regarding that proposal for amendment.

9 On 30 July 2012, the amended draft decision was referred to the Member State Committee pursuant to Article 51(4) of Regulation No 1907/2006.

10 During its 25th meeting, which was held from 19 to 21 September 2012, the Member State Committee reached a unanimous agreement as regards the amended draft decision, including the proposal from the Kingdom of Denmark on the second species prenatal developmental toxicity study. The applicant was present at that meeting. In the course of the open session, the members of the committee and the applicant discussed the requirement for a second species prenatal developmental toxicity study.

11 As is clear from the minutes of the 25th meeting of the Member State Committee, at the open session, the applicant submitted that, because of the limited use of the substance concerned, further testing of that substance was not justified. In particular, a second species prenatal developmental toxicity study was, according to it, not necessary. The members of the Member State Committee told the applicant that its interpretation of Regulation No 1907/2006 was incorrect as regards the need to submit information gained from a second species prenatal developmental toxicity study.

12 On 6 November 2012, ECHA issued and notified the applicant of a decision based on Article 41(3) of Regulation No 1907/2006 (‘the decision of 6 November 2012’). In the decision of 6 November 2012, ECHA found that the registration dossier did not comply with Regulation No 1907/2006 and gave the applicant until 6 November 2013 to submit information concerning ten separate matters, which included a ‘prenatal developmental toxicity study in rabbits, oral route’ and a ‘Long-term toxicity testing to sediment organisms’.

13 The decision of 6 November 2012 states that ECHA considered that that information was required in order to satisfy the standard information requirements, such as were set out, first, as regards the first study, in point 8.7.2 of Annex X to Regulation No 1907/2006 and, second, as regards the testing on sediment organisms, in point 9.5.1 of Annex X of the same regulation.

14 The applicant did not lodge an action for annulment of the decision of 6 November 2012.

15 By letter of 12 December 2012, the French Ministry of Ecology, Sustainable Development, Transport and Housing (‘the French Ministry of Ecology’), which is the competent authority in France for the registration, evaluation, authorisation and restriction of chemicals, also notified the applicant of the decision of 6 November 2012. In that letter, that ministry pointed out to the applicant that ‘the absence of a response from [the applicant] would constitute a failure to fulfil the obligations under [Regulation No 1907/2006], for which the Environmental Code provides for administrative and criminal penalties’.

16 On 6 November 2013, in response to the decision of 6 November 2012, the applicant chose not to provide all the information requested by ECHA in the decision of 6 November 2012. Instead, as regards the two studies referred to in paragraph 12 above, it added to the registration dossier a 103-page document which, according to it, constituted a ‘weight of evidence’ within the meaning of point 1.2 of Annex XI of Regulation No 1907/2006. According to the applicant, the information provided in that document had not involved any animal testing and had not been brought to ECHA’s attention before the adoption of the decision of 6 November 2012. In particular, the aim of that document was to show that carrying out a second species prenatal developmental toxicity study was unnecessary.

17 On 1 April 2015, ECHA sent a letter to the French Ministry of Ecology, copying the applicant, which was written in English and entitled ‘Statement of non-compliance following a dossier evaluation decision under Regulation (EC) No 1907/2006’ (‘the letter of 1 April 2015’).

18 Attached to that letter was a document, also dated 1 April 2015, entitled ‘Attachment to the statement of non-compliance following a dossier evaluation decision under Regulation (EC) No 1907/2006’. That document set out ECHA’s conclusions and the reasons for considering that the most recent update by the applicant to the registration dossier was not acceptable (the letter of 1 April 2015 and the document attached thereto are hereinafter together referred to as ‘the contested act’).

19 The letter of 1 April 2015 reads as follows:

‘Helsinki, 1 April 2015

[To the] French REACH Competent Authority ...

Communication number ...

Submission number subject to follow up evaluation. ...

Date of submission subject to follow up evaluation: 6 November 2013

Statement of Non-Compliance following a Dossier Evaluation Decision under Regulation (EC) No 1907/2006

Pursuant to Article 41(3) of Regulation No 1907/2006 (REACH Regulation), the European Chemicals Agency (ECHA) has performed a compliance check on the dossier [on the registered substance]. ECHA has taken the decision [of 6 November 2012] attached to this letter in accordance with the procedure laid down in Articles 50 and 51 of the REACH Regulation.

The decision set a deadline for the Registrant to submit the information requested by that decision to ECHA in the form of an updated dossier by 6 November 2013. An update of the dossier was submitted on 6 November 2013, submission number: ...

ECHA has examined the information submitted in the updated dossier. In conclusion, the updated registration dossier does not contain all of the information requested by the ECHA decision. A respective analysis of the reasons for this conclusion is enclosed. Other information in addition to the updated dossier has been submitted in consequence of the decision by the Registrant and is attached.

On this basis ECHA states that:

- The Registrant has not met the obligations following from [the decision of 6 November 2012];

- The...