Federal Republic of Germany v Esso Raffinage.
Date: 2021-01-21
63


It follows from the settled case-law of the Court that an action for annulment may be brought, on the basis of the first paragraph of Article 263 TFEU, against any provision or measure adopted by the institutions, bodies, offices or agencies of the Union, whatever form it may take, which is intended to produce binding legal effects capable of affecting the interests of a natural or legal person by bringing about a distinct change in their legal position (judgments of 11 November 1981, IBM v Commission, 60/81, EU:C:1981:264, paragraph 9; of 12 September 2006, Reynolds Tobacco and Others v Commission, C‑131/03 P, EU:C:2006:541, paragraph 54; and of 31 January 2019, International Management Group v Commission, C‑183/17 P and C‑184/17 P, EU:C:2019:78, paragraph 51).
64


Furthermore, in order to determine, in a given case, whether the contested act is intended to produce binding legal effects, it is necessary to examine the substance of the act and to assess its effects in the light of objective criteria, such as the content of the act in question, taking into account, as appropriate, the context in which it was adopted and the powers of the Union institution, body, office or agency which adopted it (judgments of 13 February 2014, Hungary v Commission, C‑31/13 P, EU:C:2014:70, paragraph 55; and of 9 July 2020, Czech Republic v Commission, C‑575/18 P, EU:C:2020:530, paragraph 47). Those powers should not be understood in the abstract, but should be regarded as factors that inform the specific analysis of the content of the act in question, which is central and indispensable (see, to that effect, judgment of 25 October 2017, Romania v Commission, C‑599/15 P, EU:C:2017:801, paragraphs 49, 51 to 52 and 55).
65


Lastly, while it is clear from the Court’s case-law that it is also possible to take into consideration 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 (see, to that effect, judgments of 17 July 2008, Athinaïki Techniki v Commission, C‑521/06 P, EU:C:2008:422, paragraph 42; and of 26 January 2010, Internationaler Hilfsfonds v Commission, C‑362/08 P, EU:C:2010:40, paragraph 52), it follows from the preceding paragraph that that subjective criterion can play only a complementary role as compared with the objective criteria referred to in that paragraph 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.
81


Therefore, in accordance with the settled case-law of the Court, in interpreting the provision in question, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgments of 7 June 2005, VEMW and Others, C‑17/03, EU:C:2005:362, paragraph 41; and of 4 February 2016, C & J Clark International and Puma, C‑659/13 and C‑34/14, EU:C:2016:74, paragraph 124), as informed, where necessary, by the preparatory work for those rules (see, by analogy, judgments of 9 December 2019, Nederlands Uitgeversverbond and Groep Algemene Uitgevers, C‑263/18, EU:C:2019:1111, paragraph 56; and of 11 March 2020, Baltic Cable, C‑454/18, EU:C:2020:189, paragraph 48).
83


Where such a measure follows a decision requiring a registrant to bring the information in its registration dossier into compliance with the requirements of the REACH Regulation, as set out in paragraph 76 above, that measure is intended to determine, first of all, whether the information submitted complies with the requirements in question and, consequently, whether the registrant has complied with the corresponding obligations. As held by the General Court, those obligations are not limited to 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 to comply with all the requirements applicable to the registration of those substances under Article 5 and Article 6(1) of that regulation. As the Court has previously held, the EU legislature introduced the registration and evaluation system laid down by that regulation in order to allow ECHA to determine that industry is meeting its obligations (see, to that effect, judgments of 10 September 2015, FCD and FMB, C‑106/14, EU:C:2015:576, paragraph 32; and of 17 March 2016, Canadian Oil Company Sweden and Rantén, C‑472/14, EU:C:2016:171, paragraph 25), chief among them being the obligation set out in Article 5, the infringement of which renders the economic operators concerned liable to penalties, in accordance with Article 126 of that regulation (see, to that effect, judgment of 27 April 2017, Pinckernelle, C‑535/15, EU:C:2017:315, paragraph 46).
88


Finally, as regards the objectives pursued by the REACH Regulation, to which the General Court did not refer in that judgment, the Court has previously pointed out that they include, as follows from Article 1(1) of that regulation, that of ensuring a high level of protection of human health and the environment by means of an integrated system for monitoring manufactured chemical substances, imported or placed on the market in the Union, based on the registration, evaluation and authorisation of those substances and possible restrictions on their use (judgments of 10 September 2015, FCD and FMB, C‑106/14, EU:C:2015:576, paragraphs 31 and 32; of 17 March 2016, Canadian Oil Company Sweden and Rantén, C‑472/14, EU:C:2016:171, paragraphs 24 and 25; and of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 20).
98


In those circumstances, it should be pointed out that, first, in so far as the Federal Republic of Germany seeks to argue that the General Court should have classified the letter at issue as an act confirming the decision of 6 November 2012, it follows from the Court’s case-law that a measure is to be regarded as such when it contains no new factual or legal elements as compared with the earlier measure (judgment of 31 January 2019, International Management Group v Commission, C‑183/17 P and C‑184/17 P, EU:C:2019:78, paragraph 67 and the case-law cited).
103


It also follows from the Court’s case-law that the existence of an interest in bringing proceedings presupposes that annulment of the contested act must be capable of procuring an advantage for the natural or legal person who brought the action (see, to that effect, judgments of 17 September 2009, Commission v Koninklijke FrieslandCampina, C‑519/07 P, EU:C:2009:556, paragraph 63; and of 31 January 2019, Islamic Republic of Iran Shipping Lines and Others v Council, C‑225/17 P, EU:C:2019:82, paragraph 30).
107


As regards the question whether the General Court erred in law in holding that the letter at issue was of direct concern to Esso, within the meaning of the first part of the fourth paragraph of Article 263 TFEU, it is settled case-law that the requirement that a Union measure be of direct concern to the natural or legal person challenging it requires the fulfilment of two cumulative criteria, namely that the measure must, first, directly affect the legal situation of the individual and, secondly, leave no discretion to the addressees of that measure who are entrusted with the task of implementing it, such implementation being purely automatic and resulting solely from EU rules alone without the application of other intermediate rules (judgments of 5 May 1998, Dreyfus v Commission, C‑386/96 P, EU:C:1998:193, paragraph 43, and of 3 December 2019, Iccrea Banca, C‑414/18, EU:C:2019:1036, paragraph 66).
134


That provision reveals that the use of alternative methods to animal testing is one of the means favoured by the REACH Regulation for evaluating the toxicity of substances in humans (see, to that effect, judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 108) and that such use contributes, on that basis, to the attainment of the objective of protecting human health and the environment which underlies the entire registration and evaluation procedure established by that regulation (see, to that effect, judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraphs 45 to 47).
143


For their part, the national authorities have, in accordance with Articles 125 and 126 of the REACH Regulation, the duty to ensure that that decision is enforced and complied with and, to that end, inter alia, to carry out checks and impose effective, proportionate and dissuasive penalties (see, to that effect, judgment of 27 April 2017, Pinckernelle, C‑535/15, EU:C:2017:315, paragraph 46).