Judgments nº T-805/17 of Tribunal General de la Unión Europea, October 03, 2019

• Resolution Date: October 03, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-805/17

(REACH - Article 11 of Regulation (EC) No 1907/2006 - Article 3(3) of Implementing Regulation (EU) 2016/9 - Requirement for joint submission of data - Joint submission with possibility of a complete opt-out - Administrative practice of ECHA requiring an agreement on the terms for making a joint submission with the lead registrant for a registered substance - Failure to reach an agreement - Dispute resolution mechanism applied by analogy - Decision granting access to a joint submission - Legal basis -Broad discretion of ECHA - Manifest error of assessment - Obligation to state reasons - Legal certainty)

In Case T-805/17,

BASF SE, established in Ludwigshafen-am-Rhein (Germany), represented by R. Cana, D. Abrahams, E. Mullier and H. Widemann, lawyers,

applicant,

v

European Chemicals Agency (ECHA), represented by M. Heikkilä, C. Jacquet and T. Basmatzi, acting as Agents,

defendant,

ACTION under Article 263 TFEU for the annulment of Decision DSH-30-3-0122-2017 of ECHA of 2 October 2017 granting Sustainability Support Services (Europe) AB access to the joint submission lodged by BASF, as lead registrant for the substance disodium 4,4'-bis[(4-anilino-6-morpholino-1, 3, 5-triazin-2-yl)amino]stilbene-2,2'-disulphonate, EC No 240-245-2 and CAS No 16090-02-1,

THE GENERAL COURT (Sixth Chamber),

composed of S. Papasavvas, acting as President, D. Spielmann and O. Spineanu-Matei (Rapporteur), Judges,

Registrar: E. Coulon,

gives the following

Judgment

Legal framework

1 The present case has been brought in the context of the procedure for the joint submission of data for registered substances established by Article 11 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, corrigendum OJ 2007 L 136, p. 3; ‘the Reach Regulation’).

2 In accordance with Article 5 of the REACH Regulation, all substances manufactured or placed on the market in the European Union must be registered.

3 Under Articles 6 and 7 of the REACH Regulation, submissions for registration are submitted to the European Chemicals Agency (ECHA).

4 According to Article 10 of the REACH Regulation, each registration comprises a technical dossier and, when required, a chemical safety report. The same provision defines the categories of information that the technical dossier and report in question must contain.

5 For the purposes of observance of the ‘one substance, one registration’ principle in the REACH Regulation, Article 11 of that regulation provides that all potential registrants of the same substance are to submit information jointly to ECHA (‘the joint submission obligation’).

6 The second subparagraph of Article 11(1) of the REACH Regulation requires, in particular, certain information and any relevant indication covered by the joint submission obligation to be submitted by a single registrant, called the ‘lead registrant’, with the agreement of the other assenting registrant(s). Each registrant must then separately submit the information relating, in particular, to the identity of the substance, identified uses and exposure.

7 A registrant may, however, pursuant to Article 11(3) of the REACH Regulation, choose to submit information separately that the lead registrant could submit (‘complete opt-out’), in three cases, namely: (i) it would be disproportionately costly for him to submit this information jointly; (ii) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or, (iii) he disagrees with the lead registrant with respect to the selection of this information. In any of those cases, the registrant is to submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or an explanation as to the nature of the disagreement, as the case may be.

8 From a technical point of view, in order to submit the data in question, ECHA put in place an IT system known as REACH-IT. In order to be eligible for access, registrants must have access to an alphanumeric code (‘the security token’).

9 Prior to the entry into force of Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data-sharing in accordance with the REACH Regulation (OJ 2016 L 3, p. 41; ‘the implementing regulation’), the security token was supplied by ECHA. Where the registrants were not able to agree on the terms for registering a substance when making a joint submission, the REACH-IT system enabled them to register that substance separately. Moreover, in the event that they wished to submit all relevant information separately, which option is open to them under a complete opt-out, ECHA requested them to submit a separate registration instead of joining an existing joint submission.

10 Following the entry into force of the implementing regulation, ECHA made technical amendments to the REACH-IT system, so as to ensure that it is no longer technically possible for a registrant to submit a separate file when a registration already exists for the same substance. Registrants must henceforth be party to the same registration in which they may submit information jointly or separately. Those amendments became effective on 21 June 2016.

11 The amendments to the REACH-IT system therefore had the effect of granting a privileged position to the first registrant of a substance, acting in its capacity as lead registrant, in relation to the subsequent registrants of the same substance. A registrant who intended to submit all the information required separately, in accordance with Article 11(3) of the REACH Regulation (‘the registrant seeking a complete opt-out’), was required to obtain the security token of the lead registrant in order to be able to join in the registration of the substance in the REACH-IT system and thus submit its own information in the context of the sole registration of that substance (‘the previous administrative practice of ECHA’).

12 For situations in which the registrants did not reach a decision on the conditions for the grant of the security token, ECHA decided to resort, by analogy, to the dispute resolution mechanism which it had put in place in order to adopt decisions under Article 27(6) and Article 30(3) of the REACH Regulation on the sharing of data. In procedural terms, those provisions provide for a remedy before the Board of Appeal of ECHA. In order to decide whether such a mechanism should be applied by analogy to disputes relating to joint submissions, ECHA relied on Article 11 of that regulation, as implemented by Article 3(3) of the implementing regulation.

13 Thus, ECHA proposes a dispute resolution mechanism between a registrant seeking a complete opt-out and the lead registrant in respect of the conditions under which the lead registrant must provide the former with a security token (‘the dispute resolution mechanism’). Under that mechanism, ECHA is to examine the efforts made by the companies concerned and, if it takes the view that the registrant seeking a complete opt-out has done all he could in order to reach an agreement with the lead registrant, it is to provide it with a security token. Therefore, a registrant can still seek a complete opt-out while being party to the sole registration of the substance concerned.

Background to the dispute and the contested decision

14 The applicant, BASF SE, is the lead registrant for the substance disodium 4,4'-bis[(4-anilino-6-morpholino-1, 3, 5-triazin-2-yl)amino]stilbene-2,2'-disulphonate with EC number 240- 245-2 and CAS number 16090-02-1 (‘disodium’ or ‘the substance’).

15 The applicant is part of the group of producers of optical brighteners used in the pulp and paper industry.

16 Disodium is one of 14 stilbene optical brighteners which were registered by joint submission in accordance with the REACH Regulation under the ‘category approach’ by the producers forming part of the group referred to in paragraph 15 above.

17 On 18 January 2017, all the registrants of the substance received communications from ECHA. In those communications, ECHA requested them to make a single joint submission for the substance and referred to the legal consequences which the continued infringement of the joint submission obligation would have entailed after the expiry of the time limit laid down by the implementing regulation, one of which was the annulment of the individual registrations (‘the communications of 18 January 2017’).

18 The communications of 18 January 2017 referred, inter alia, to the individual registration of the substance by Sustainability Support Services (Europe) AB (‘SSS’) and indicated that, by virtue of the ‘one substance, one registration’ principle, registrants were to be subject to a joint submission for the substance by 25 July 2017 at the latest.

19 On 26 January 2017, referring to the communications of 18 January 2017, the applicant, as the lead registrant of the substance, contacted SSS and requested it to join the joint submission for the substance and to contribute to the costs associated therewith.

20 In the exchanges which took place between the applicant and SSS following the communications of 18 January 2017, the latter informed the applicant...