Case C‑471/18 P

Federal Republic of Germany

v

Esso Raffinage

European Chemicals Agency

 Judgment of the Court (Third Chamber), 21 January 2021

(Appeal – Registration, evaluation and authorisation of chemicals – Regulation (EC) No 1907/2006 (REACH) – Articles 5 and 6 – General obligation to register substances – Articles 41 and 42 – Evaluation of registration dossiers and compliance check of information submitted by registrants – Declaration of non-compliance – Actionable measure – Interest in bringing proceedings – Locus standi – Respective competences of the European Chemicals Agency (ECHA) and national authorities – Obligation on ECHA to check the compliance of additional information submitted by registrants at its request – ECHA’s power to take an appropriate decision – Article 1 – Objective of promoting human health and the environment – Articles 13 and 25 – Use of animal testing – Promotion of alternative methods)

1.        Action for annulment – Actionable measures – Meaning – Letter from the European Chemicals Agency (ECHA) containing a declaration of non-compliance following a registration dossier evaluation decision – Included

(Art. 263 TFEU; European Parliament and Council Regulation No 1907/2006, Arts 41 and 42)

(see paragraphs 63-65)

2.        Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Compliance check of registration dossiers – Non-compliance of a dossier – Conclusions – Power of the European Chemicals Agency (ECHA) to take an appropriate decision – Allocation of competences between ECHA and the Member States

(European Parliament and Council Regulation No 1907/2006, Arts 41(3) and 42(1))

(see paragraphs 82, 83, 86, 88, 90)

3.        Action for annulment – Natural or legal persons – Interest in bringing proceedings – Need for a vested and present interest – Assessment at the time when the action was brought – Action capable of securing a benefit for the applicant – Burden of proof

(Art. 263 TFEU)

(see paragraph 101)

4.        Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Evaluation procedure – Decision of the European Chemicals Agency (ECHA) requesting further information in the context of a substance evaluation – Possibility for every registrant to submit adaptations to the standard information – Obligation on every registrant to generate information obtained by means other than animal testing whenever possible

(European Parliament and Council Regulation No 1907/2006, Art 41(1)(a) and (b), 41(3) and 42(1))

(see paragraphs 126-129, 132)

Résumé

Esso Raffinage (‘Esso’) submitted to the European Chemicals Agency (ECHA) an application for registration of a substance it manufactures.

By decision of 6 November 2021, ECHA requested that Esso provide it with additional information before the expiry of one year. In reply, Esso provided ECHA with information other than that requested, but which it considered to be alternative to that information.

On 1 April 2015, ECHA sent to the ministère de l’Écologie, du Développement durable, des Transports et du Logement (Ministry of Ecology, Sustainable Development, Transport and Housing, France) a letter headed ‘Statement of non-compliance following a dossier evaluation decision under Regulation (EC) No 1907/2006’ (‘the letter at issue’). In that letter, ECHA stated that Esso had not met its obligations. (1)

The General Court upheld Esso’s action, after declaring it admissible, and annulled the letter at issue. The Court, to which an appeal was brought by the Federal Republic of Germany, has dismissed the appeal, clarifying the scope of ECHA’s power to take decisions following a compliance check of information contained in substance registration dossiers.

Findings of the Court

In the first place, the Court reviews the General Court’s findings relating to the admissibility of Esso’s action, in particular as regards whether the letter at issue is open to challenge. In that regard, the Court points out, first of all, that, in order to determine whether an act is intended to produce binding legal effects, account may be taken of objective criteria, such as the content of the act in question, the context in which it was adopted and the powers of the body which adopted it, and of a subjective criterion relating to the intention that led the institution, body, office or agency of the Union which drafted the contested act to adopt it. However, that subjective criterion can play only a complementary role as compared with the objective criteria referred to above and, therefore, cannot be given greater weight than those objective criteria, nor can it affect the assessment of the effects of the resulting contested act.

Next, the Court states that, by providing that ECHA may adopt ‘any appropriate decisions’, (2) the EU legislature has conferred on ECHA the power to draw legally binding conclusions from the evaluation of the information submitted by a registrant who has previously been notified of a decision asking it to bring its registration dossier into compliance with the requirements of the REACH Regulation. (3) ECHA is therefore able to decide whether the information in question complies with those requirements and whether the registrant has complied with the corresponding obligations. Those obligations include not only the obligation to comply with the decision requiring the submission of that information, but ultimately also include the obligation on manufacturers and importers of substances in quantities of one tonne or more per year (4) to comply with all the requirements applicable to the registration of those substances. In that regard, the Court points out that the EU legislature established the substance registration and evaluation system in order to allow ECHA to determine that industry is meeting its obligations, subject to penalties if those obligations are not met. In that context, it is for the Member States to establish a system of penalties applicable to the undertakings concerned and to take the measures necessary to ensure that they are implemented, (5) in the event that ECHA finds that those undertakings have infringed the obligations arising from the REACH Regulation. (6) The Court concludes that the General Court was therefore right to find that it is ECHA and not, as the Federal Republic of Germany submits in its appeal, the Member States, which has the power to adopt a decision declaring that those obligations have been infringed, such as that contained in the letter at issue.

Finally, the Court notes that that analysis of the allocation of competences between ECHA and the Member States is supported by the objectives of the REACH Regulation, which introduces an integrated system for monitoring chemical substances that are manufactured, imported or placed on the market in the Union, with the aim of ensuring a high level of protection of human health and the environment. One of the essential elements of that system is the establishment of ECHA, a central and independent entity responsible for, first, receiving applications for registration of those substances and updates to those applications, next, checking that they are complete and rejecting them if they are incomplete and, lastly, checking the compliance of the information they contain with the relevant requirements, if necessary after they are completed. (7)

In the second place, the Court examines the General Court’s findings relating to ECHA’s exercise of its decision-making powers. In that regard, the Court states, first of all, that the obligation on ECHA to evaluate substance registration dossiers that are submitted to it and to check the compliance of the information contained therein relates, if a registrant has submitted ‘adaptations to the standard information requirements’, to the question whether those adaptations and their justifications comply with the rules governing them. Every registrant has the possibility to submit, with their registration dossier, alternative information to the ‘standard information’ required, referred to as ‘adaptations’, subject to compliance with the requirements governing such adaptations. Next, the Court notes that the possibility for registrants to have recourse to such ‘adaptations’ at subsequent stages of the procedure for the registration and evaluation of substances, in particular where ECHA has adopted a decision requesting that a registration dossier be supplemented by a study involving animal testing, arises from the relevant general provisions of the REACH Regulation and from the guiding principle of limiting animal testing which those general provisions reflect. In particular, the REACH Regulation requires the use of information obtained by means other than animal testing ‘wherever possible’ and that such testing be undertaken ‘only as a last resort’. Finally, the Court finds that ECHA must examine those adaptations and rule on their compliance in accordance with the procedural and decision-making arrangements laid down by the REACH Regulation, which it did not do in the present case, as the General Court was correct to find.

1      Those obligations arise from the decision of 6 November 2012 and from Article 5 and Article 41(4) 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 and corrigendum OJ 2007 L 136, p. 3) (‘the REACH Regulation’).

2      Article 42(1) of the REACH Regulation.

3      Decision taken under Article 41(3) of the REACH Regulation.

4      Article 5 and Article 6(1) of the REACH Regulation.

5      Articles 125 and 126 of the REACH Regulation, read in the light of recitals 121 and 122 of that regulation.

6      Article 51 of the REACH Regulation.

7      Articles 6, 20, 22, 41 and 42 and recitals 19, 20 and 44 of the REACH Regulation.