Judgment — ECLI:EU:T:2018:263
Date: 2018-05-08
Language of the case: English
Court formation: Fifth Chamber
Subject matter: Approximation of laws;Research and technological development;Public health;REACH
Procedure: Action for annulment - successful;Action for annulment - inadmissible
Origin: France

Summary — Judgment of the General Court (Fifth Chamber), 8 May 2018 1. Actions for annulment — Jurisdiction of the EU judicature — Claim seeking that directions be issued to an institution — Not included (Art. 263 TFEU) 2. Actions for annulment — Actionable measures — Meaning — Measures producing binding legal effects — Letter from the European Chemicals Agency (ECHA) addressed to a Member State and finding infringement of Regulation No 1907/2006 on account of non-compliance of the registration dossier for a substance — Included (Art. 263 TFEU; European Parliament and Council Regulation No 1907/2006, Arts 41(4) and 126) 3. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Assessment procedure — Compliance check of registration dossiers — Adoption of a decision requiring the registrant to bring its dossier into compliance — Absence of a response — Consequences (European Parliament and Council Regulation No 1907/2006, Arts 41(3) and 42(1) and Annex XI) 4. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Assessment procedure — Compliance check of registration dossiers — Non-compliance of a dossier — Consequences — Division of competences between the European Chemicals Agency (ECHA) and the Member States (European Parliament and Council Regulation No 1907/2006, Arts 6(1), 41(1) and (3) to (5), 42(1) and (2) and 126) 5. Actions for annulment — Application brought by the natural or legal person to whom the contested measure is addressed — Notion of addressee — Addressee of a copy of that measure — Not included (Art. 263, fourth para., TFEU) 6. Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Letter from the European Chemicals Agency (ECHA) addressed to a Member State and finding infringement of Regulation No 1907/2006 on account of non-compliance of the registration dossier for a substance — Action brought by the undertaking that submitted the registration — Admissibility (Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1907/2006, Arts 41(3) and 42(1)) 7. Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Assessment procedure — Compliance check of registration dossiers — Non-compliance of a dossier — Consequences — Division of competences between the European Chemicals Agency (ECHA) and the Member States — Failure of ECHA to comply with the detailed rules for the exercise of its competence — Not permissible (European Parliament and Council Regulation No 1907/2006, Arts 41(3) and 42(1)) 1. See the text of the decision. (see para. 39) 2. Any measures adopted by the institutions, whatever their form, which are intended to have binding legal effects are regarded as acts open to challenge, within the meaning of Article 263 TFEU. That is the case as regards a letter from the European Chemicals Agency (ECHA) addressed to a Member State and setting out, in imperative and definitive terms, the reasons why ECHA considers that the information submitted by the registrant of a substance, in response to a decision of ECHA that found the registration dossier was not compliant with Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), does not suffice to meet the requirements flowing from that decision; finding infringement of the obligations under Article 41(4) of that regulation; and requesting that the Member State adopt the measures necessary for the enforcement of sanctions in accordance with Article 126 of that regulation. In those circumstances, the effects of the contested act go beyond the mere communication of information to that Member State and constitutes more than a mere technical opinion or detailed factual record of the reasons why the registrant has not satisfied the obligations under Regulation No 1907/2006. The contested act must, therefore, be regarded as producing binding legal effects, both as regards the applicant and as regards the Member State concerned, and as therefore being an act against which an action for annulment may be brought. (see paras 49, 67, 69, 70, 72) 3. In the context of the evaluation, by the European Chemicals Agency (ECHA), of the registration dossiers, pursuant to Article 41(3) of Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), ECHA may prepare a draft decision inviting the registrant(s) to submit any information needed to bring the registration into compliance with the relevant information requirements. Article 42(1) of that regulation provides that ECHA is to examine any information submitted in consequence of a decision taken under Article 41 of the regulation and is to draft any appropriate decisions in accordance with that provision. Having regard to the fact that the check carried out by ECHA following a first decision requiring the registrant to bring the dossier into compliance, is merely the continuation of the same, single procedure, it must be held that, if the registrant completely fails to provide the information requested, no new assessment of the compliance of the dossier and therefore no new decision within the meaning of Article 42(1) of Regulation No 1907/2006 is required. On the other hand, where, in response to the decision requiring the registration dossier to be rendered compliant, the registrant avails itself of the possibility, laid down in Annex XI of Regulation No 1907/2006, of adapting the standard testing regime and the submissions in that regard are not manifestly unreasonable, having regard to the requirements of that annex, and do not therefore amount to an abuse of procedure, ECHA is to assess those adaptations. ECHA evaluates whether those adaptations comply with the conditions laid down in Annex XI of Regulation No 1907/2006 irrespective of whether the adaptations in question rest on substantial and new facts that were not known at the time when the first decision requiring the dossier to be brought into compliance was taken under Article 41(3) of the regulation. (see paras 55, 57, 62, 63) 4. It is clear from Articles 6(1), 41(1) and (3) to (5), 42(1) and (2) and 126 of Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), that the European Chemicals Agency (ECHA) alone is competent to initiate the compliance check of a registration dossier. That check may lead to the adoption of a number of decisions. If ECHA considers that the dossier under examination does not comply with the requirements as regards information relating to it, it is required to initiate the procedure laid down in Article 41(3) of Regulation No 1907/2006. In that regard, the reference that provision makes to Article 51 of Regulation No 1907/2001, as to the adoption of the decision formalising the requirement of bringing the registration dossier into compliance, means that that decision is taken by ECHA where the Member States reach a unanimous agreement on the draft, and by the Commission where the Member States do not reach such an agreement. Whoever is the author of that decision, it is, under the present version of Regulation No 1907/2006, once again for ECHA, in the context of the competence attributed expressly to it by Article 42(1) of the regulation, to examine all information submitted in accordance with it and to prepare, where necessary, any appropriate new decision. Consequently, it follows that Article 126 of Regulation No 1907/2006, read in conjunction with Article 42(1) of the same regulation, means, in such a context, that it is for Member States to impose appropriate sanctions on registrants who have been held, in accordance with the latter provision, to have infringed their obligations. In that respect that, even if a registrant may always bring its dossier into compliance after the adoption of a decision finding that it did not comply, pursuant to Article 42(1) of Regulation No 1907/2006, the role of the Member States, under Article 126 of the same regulation, is to assess whether it is necessary, having regard to the facts of each case, to impose sanctions that are effective, proportionate and dissuasive for the period during which the registrant was in breach of its obligations under Article 41(4) of Regulation No 1907/2006. (see paras 60, 61) 5. See the text of the decision. (see paras 88, 89) 6. See the text of the decision. (see paras 91, 92, 95-97) 7. It is clear from the allocation of competences regarding the evaluation of registration dossiers that the European Chemicals Agency (ECHA) is to carry out that evaluation in accordance with the detailed rules laid down in Articles 41 and 42 of Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Those rules must be complied with by ECHA in the exercise of its competences, and ECHA may not act independently of that legal framework by having recourse to an instrument other than the decision laid down by Articles 41 and 42 of Regulation No 1907/2006. In that respect, having regard to its content, a letter from ECHA addressed to a Member State and finding that a registration dossier is non-compliant constitutes an act that is equivalent to a decision that ECHA was required to prepare pursuant to Article 42(1) of Regulation No 1907/2006, and which should have been adopted in accordance with of Article 41(3) of that regulation. Having regard to the fact that, first, Article 41(3) of Regulation No 1907/2006 provides for the adoption of a decision in accordance with the procedure laid down in Article 51 of that regulation and, secondly, that procedure was not followed, it must be held that ECHA carried out its tasks without complying with the detailed rules relating to them. (see paras 108, 109)