JUDGMENT OF THE COURT (First Chamber)

23 January 2019 ( *1 )

(Appeal — Regulation (EC) No 1907/2006 (REACH Regulation) — Annex XIV — Establishment of a list of substances subject to authorisation — Inclusion in the list of substances identified for eventual inclusion in Annex XIV — Updating of the entry of the substance bis(2-ethylhexyl)phthalate (DEHP) in the list — Misinterpretation and misapplication of the REACH Regulation and of the principle of legal certainty — Distortion of the facts and evidence — Scope of the review)

In Case C‑419/17 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 11 July 2017,

Deza, a.s., established in Valašské Meziříčí (Czech Republic), represented by P. Dejl, advokát,

appellant,

the other parties to the proceedings being:

European Chemicals Agency (ECHA), represented by W. Broere and N. Herbatschek and by M. Heikkilä, acting as Agents, and by M. Procházka and M. Mašková, advokáti,

defendant at first instance,

Kingdom of Denmark, represented by J. Nymann-Lindegren and M. Wolff, acting as Agents,

Kingdom of the Netherlands,

Kingdom of Sweden, represented by A. Falk, C. Meyer-Seitz, H. Shev and L. Zettergren, acting as Agents,

Kingdom of Norway,

interveners at first instance,

THE COURT (First Chamber),

composed of R. Silva de Lapuerta, Vice-President of the Court, acting as President of the First Chamber, J.–C. Bonichot, A. Arabadjiev, E. Regan and S. Rodin (Rapporteur), Judges,

Advocate General: M. Szpunar,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after hearing the Opinion of the Advocate General at the sitting on 26 June 2018,

gives the following

Judgment

1 By its appeal, Deza a.s. asks the Court to set aside the judgment of the General Court of the European Union of 11 May 2017, Deza v ECHA (T‑115/15, ‘the judgment under appeal’, EU:T:2017:329) by which that Court dismissed the action for annulment of Decision ED/108/2014 of the Executive Director of the European Chemicals Agency (ECHA), of 12 December 2014, updating and supplementing the existing entry of the chemical substance bis(2-ethylhexyl) phthalate (EC No 204-211-0, CAS No 117-81-7) (‘DEHP’) on the list of substances identified (‘the decision at issue’) for eventual inclusion in Annex XIV 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), as amended by Commission Regulation (EU) No 895/2014 of 14 August 2014 (OJ 2014 L 244, p. 6) (‘the REACH Regulation’).

Legal context

2 Article 57 of the REACH Regulation, entitled ‘Substances to be included in Annex XIV’, provides as follows: ‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58: (a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008; (b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008; (c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation (EC) No 1272/2008; (d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation; (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation; (f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.’

3 Article 59 of the REACH Regulation, entitled ‘Identification of substances referred to in Article 57’, provides as follows: ‘1. The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. … … 3. Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 and forward it to [the ECHA] [...] … 7. When comments are made or received, [the ECHA] shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5. 8. If, within 30 days of the referral, the Member State Committee reaches a unanimous agreement on the identification, [the ECHA] shall include the substance in the list referred to in paragraph 1. [The ECHA] may include that substance in its recommendations under Article 58(3). 9. If the Member State Committee fails to reach a unanimous agreement, the Commission shall prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the Member State Committee. A final decision on the identification of the substance shall be taken in accordance with the procedure referred to in Article 133(3). 10. [The ECHA] shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclusion of a substance has been taken.’

Background to the dispute and the decision at issue

4 The appellant, Deza, a limited company incorporated under Czech law, is active in the chemical sector. It produces, markets and uses, inter alia, DEHP.

5 By decision of 28 October 2008, the Executive Director of the ECHA included DEHP in the candidate list of substances, that is to say the list of substances identified for eventual inclusion in Annex XIV to the REACH Regulation.

6 Following the adoption of Commission Regulation (EU) No 143/2011 of 17 February 2011 (OJ 2011 L 44, p. 2), DEHP was included in Annex XIV to the REACH Regulation.

7 On 12 August 2013, the appellant lodged an application for authorisation for the use of DEHP and attached a series of studies and detailed documents, including a chemical safety report, an analysis of alternatives and a socio-economic analysis.

8 On 26 August 2014, the Kingdom of Denmark submitted four dossiers in accordance with Annex XV of that regulation, proposing, first, that DEHP and three other chemical substances, namely Dibutyl phthalate (‘DBP’), Benzyl butyl phthalate (‘BBP’) and Diisobutyl phthalate (‘DIBP’), also be identified as endocrine-disrupting substances for which there is scientific evidence of probable serious effects on human health and the environment and, second, that they be added to the candidate list of substances.

9 The Kingdom of Denmark’s initial proposal was subject to consultation of the interested parties. Several Member States and some non-State entities, including the appellant, submitted comments.

10 In the examination of those dossiers, it transpired that, due to the opposition of several representatives of the Member States, the Kingdom of Denmark’s initial proposal was not going to be approved unanimously. Only the identification of DEHP as an endocrine-disrupting substance that may have serious effects on the environment was not opposed by the members of the Member State Committee.

11 In view of this result, the Kingdom of Denmark divided its original proposal into eight parts as follows: – four parts aimed at identifying the four chemical substances DBP, BBP, DIBP and DEHP as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 57(f) of the REACH Regulation and to supplement, by that new identification, the existing entry of those four substances in the candidate list of substances. – four parts aimed at identifying those four chemical substances as endocrine-disrupting substances that may have serious effects on the environment within the meaning of Article 57(f) of the REACH Regulation and to supplement, by that new identification, the existing entry of those four substances in the candidate list of substances.

12 The Member State Committee did not reach unanimous agreement on the parts of the Kingdom of Denmark’s initial proposal aimed at identifying the substances DEHP, DBP, BBP and DIBP as endocrine-disrupting substances for which there was scientific evidence of probable serious effects on human health.

13 However, that committee did unanimously approve that part of the proposal aimed at identifying DEHP as an endocrine-disrupting substance for which there was scientific evidence of probable serious effects on the environment.

14 On 12 December 2014, the Executive Director of the ECHA adopted the decision at issue, updating and supplementing the existing entry for DEHP in the candidate list of substances and identifying that substance as a substance with endocrine-disrupting properties for which there was scientific evidence of probable serious effects on the environment giving rise to an equivalent level of concern to that of other substances listed in the REACH Regulation.

The action before the General Court and the judgment under appeal

15 By application lodged at the Registry of the General Court on 5 March 2015, Deza brought an action against the contested decision.

16 By the judgment under appeal, the General Court dismissed that action.

Forms of order sought

17 The appellant claims that the Court should: – set aside the judgment under appeal; – annul the contested decision; and – order the ECHA to pay the costs incurred both in the present appeal proceedings and in the proceedings before the General Court.

18 The ECHA contends that the Court should: – dismiss the appeal as unfounded; – order the appellant to pay the costs incurred both in the present appeal proceedings and in the proceedings before the General Court, including those of the interim proceedings.

19 The Kingdom of Denmark and the Kingdom of Sweden support the ECHA’s submissions.

The appeal

The first ground of appeal, alleging an error in law on the part of the General Court in interpreting and applying the REACH Regulation

20 By its first ground of appeal, divided into three parts, Deza maintains that the General Court committed an error in law in holding, in paragraphs 48 to 82, 85 to 98 and 105 to 132 of the judgment under appeal, that the ECHA was entitled to take the decision at issue and that that decision had been adopted after a proper procedure.

First part of the first ground of appeal, alleging that the General Court erred in finding that the ECHA had implied powers to supplement an existing identification of DEHP

– Arguments of the parties

21 The appellant maintains that the ECHA has neither express nor implied powers to supplement an existing identification of DEHP. It claims that the General Court recognised that neither EU law in general nor the REACH Regulation, and more specifically Article 59(8) thereof, expressly attributed such powers to the agency. It submits that the General Court erred in law in considering that it follows from Article 59(8) of the REACH Regulation, relating to the identification procedure for the substances referred to in Article 57 of that regulation, that the ECHA was implicitly empowered to supplement the existing identification of DEHP.

22 The appellant claims in that regard that the General Court disregarded the judgments of the Court of Justice of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), and of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), from which it is apparent that, when a chemical substance was considered as capable of being included on the list of substances subject to authorisation set out in Article 57 of that Regulation, it could no longer also be identified as a substance meeting the criteria set out in point (f) of that article.

23 According to Deza. Article 57(f) of the REACH Regulation concerns the identification substances that cannot be identified on the basis of the criteria set out in Article 57(a) to (e) of that regulation or that have not yet been identified and included in the candidate list of substances on the basis of those criteria. This is not the case for DEHP, which was identified under Article 57(c) of that regulation, six years before the adoption of the decision at issue.

24 According to the appellant, the General Court committed an error of law in recognising that the ECHA had such implied powers, while the existence of an implied power constitutes a derogation from the principle of conferral of powers enshrined in Article 13(2) TEU, which must be interpreted strictly and which assumes that the implied authority recognised is necessary to achieve the objective of the REACH Regulation and, more specifically, to ensure its practical effectiveness. It claims that, by conferring such implied authority on the ECHA, the powers of that agency. as determined by the REACH Regulation, are substantially extended, in breach of the principle of conferral of powers.

25 The appellant also maintains that the General Court, having considered that the ECHA could supplement the existing identification of DEHP, incorrectly applied the doctrine of internal implied powers. It maintains that the General Court stated, in paragraph 52 of the judgment under appeal, that ‘it is true that the words “the [ECHA] shall include that substance on the list” set out in Article 59(8) of [the REACH] regulation prima facie concern the situation in which a dossier drawn up in accordance with Annex XV to that Regulation, which relates to a substance which has not yet been brought to the Member State Committee’s attention, is referred to that committee’. It submits that the General Court incorrectly held, in paragraph 53 of that judgment, that it ‘cannot be inferred … that the Member State Committee is competent only for the identification of substances which have not yet been included in the candidate list’.

26 The appellant maintains that, although that implied power of the agency was necessary to ensure the effectiveness of the REACH Regulation, the Court of Justice, has not, through its case-law, ruled out the identification of the substance under Article 57(f) of that regulation, even though that substance had already been identified previously by virtue of one of points (a) to (e) of Article 57 of that regulation.

27 Furthermore, the appellant submits that it follows from Article 58(8) of the REACH Regulation, which expressly attributes to the Commission, and not to the ECHA, the power to remove substances which no longer meet the criteria of Article 57 of that regulation from Annex XIV, that, if the EU legislature had intended to provide, in that regulation, for a procedure used to supplement or amend a list of substances and confer responsibility for it on an agency such as the ECHA, it would have done so explicitly.

28 The ECHA considers that the appellant’s argument that identification under Article 57(a) to (e) of the REACH Regulation prevents identification under Article 57(f) of that regulation is inadmissible in so far as it was not put forward before the General Court. It submits that none of the arguments put forward are, in any event, well founded.

29 The Kingdom of Denmark and the Kingdom of Sweden maintain that the appellant’s arguments are not well founded.

– Findings of the Court of Justice

30 As regards the case-law of the Court of Justice relied on by the appellant and referred to in paragraph 22 of the present judgment, it must first be noted that the decision at issue was adopted on the basis of Article 59(8) of the REACH Regulation. It must be noted in that regard that Article 59 of the REACH Regulation describes the procedure for identifying substances fulfilling the criteria set out in Article 57 of the REACH Regulation with a view to their inclusion in the candidate list of substances, which serves as a basis for drawing up Annex XIV to that regulation. Once the substance in question is included in Annex XIV, that substance can no longer be used or placed on the market, except where an authorisation for a specific use has been granted under Article 60 of that regulation.

31 The appellant’s proposed interpretation of the judgments of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207) and of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208) is based on a misreading of those judgments. In paragraph 24 of each of those judgments, the Court of Justice considered that Article 57(a) to (c) of the REACH Regulation covers, first of all, substances meeting the criteria for classification in the hazard class carcinogenicity, mutagenicity or reproductive toxicity (‘CMR’) category 1A or 1B, in accordance with sections 3.5 to 3.7 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). Next, Article 57(d) and (e) covers substances which are persistent, bioaccumulative and toxic and those which are very persistent and very bioaccumulative, in accordance with the criteria set out in Annex XIII to the REACH Regulation. Those criteria are based on the assessment of the hazards presented by those substances. Lastly, Article 57(f) of that regulation covers all other substances which do not fulfil any of the foregoing criteria but ‘for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e), and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59’ (judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 24).

32 The Court of Justice has held that Article 57(f) of the REACH Regulation provides for an independent mechanism that makes it possible to identify, as being of very high concern, substances which had not already been designated as such under that provision (judgments of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 25 and of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 25). As the Court of Justice stated in paragraph 29 of each of those judgments, the scope of Article 57(f) expressly encompasses endocrine disruptors, even though that type of effect does not fall within any hazard class listed in that annex.

33 In that regard, the Court of Justice set out in paragraphs 24 to 40 of the judgments of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207) and of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), that the identification of a substance under that provision presupposes that two cumulative conditions have been met, namely, first, that it is probable that the substance concerned has serious effects on human health or the environment and, second, that those effects ‘give rise to an equivalent level of concern’ to those of other substances listed in points (a) to (e) of Article 57 of the REACH Regulation. While the Court of Justice considered that the first condition required an analysis of the hazards arising from the intrinsic properties of the substance under consideration, that was not the case for the second condition. Thus, for the purposes of determining whether a substance gives rise to ‘an equivalent level of concern’ within the meaning of Article 57(f) of the REACH Regulation, the Court of Justice considered that it was not necessary to restrict the nature of the concerns that may be taken into consideration solely to hazards arising from the intrinsic properties of the substance concerned.

34 Also, contrary to the appellant’s claim, and as the Advocate General stated in points 50 to 56 of his Opinion, it does not follow from the judgments of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207), and of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208), that Article 57(f) of the REACH Regulation must be interpreted as meaning that a chemical substance, such as DEHP, which has already been included in the candidate list of substances for a dangerous property meeting the criteria set out in Article 57(c) of that regulation, cannot subsequently also be identified under Article 57(f) of that regulation for a different intrinsic property.

35 In paragraphs 24 to 40 of those judgments, the Court of Justice set out the criteria in accordance with which a substance could be identified under one of paragraphs (a) to (f) of Article 57 of the REACH Regulation, without limiting the reasons for which a substance may be included in the list of candidate substances. Accordingly, the General Court was entitled, without erring in law, to consider that it was possible that the intrinsic properties of a substance may come under several of the grounds set out in Article 57(a) to (f) of the REACH Regulation.

36 The appellant’s argument to the effect that the General Court incorrectly applied the doctrine of implied powers cannot succeed. As the Advocate General stated in paragraph 63 of his Opinion, it can be seen from paragraph 54 of the judgment under appeal that, in finding that the ECHA was empowered to adopt the decision at issue, the General Court took the view that the wording of neither Article 57 or Article 59(8) of the REACH Regulation nor the wording of any other provision of that regulation prohibited the ECHA from verifying whether a substance had intrinsic properties other than those which led to the initial inclusion of that substance in the candidate list of substances. Moreover, in paragraph 55 of the judgment under appeal, the General Court indicated that the identification of a substance as fulfilling the conditions of one of the points of Article 57 of Regulation No 1907/2006 other than the one that led to the initial inclusion in the candidate list of substances took, from a technical point of view, the form of a supplement to the existing entry. According to the General Court, it is in this sense that the ECHA’s argument that it has an ‘implied power’ to supplement an existing entry must be understood.

37 In the present case, at the time of the identification of DEHP under Article 57(c) of the REACH Regulation, the information available did not suffice to conclude that the adverse effects of the substance on the environment fulfilled the identification criteria referred to in Article 57(f) of that regulation. As the General Court held in paragraphs 57 and 58 of the judgment under appeal, a chemical substance has different properties which may give rise to risks of a different nature.

38 It must be held in that regard, as the Advocate General stated in paragraphs 76 and 77 of his Opinion, that to deny the ECHA’s power to supplement an existing identification of a chemical substance on the ground that that substance has already been identified, would lead to an incorrect result that is contrary to the objectives of the REACH Regulation. Such an interpretation of that regulation would fix the scientific assessment of that substance at the time of its initial identification and would be contrary to the ECHA’s very task concerning ‘assessment of hazards of substances’, as laid down in that regulation, whereas that assessment, in order to be efficient and effective, must also be capable of being made after the initial identification, in order to be capable of being supplemented by new scientific data.

39 Thus, the General Court was entitled to hold, without erring in law, that the ECHA was empowered to supplement existing entries in the candidate list of substances with new grounds within the meaning of Article 57 of the REACH Regulation.

40 Consequently, the first part of the first ground of appeal must be rejected.

The second part of the first ground of appeal, alleging that the General Court’s assessment concerning the lack of infringement of the procedure for the adoption of the decision at issue is incorrect

– Arguments of the parties

41 The appellant claims that the General Court erred in law in considering that the procedure for adoption of the decision at issue was legal, even though the Kingdom of Denmark, which had submitted a dossier for the purpose of including four chemical substances, including DEHP, on the candidate list of substances, had replaced its initial proposal with a new one in which the proposal concerning the inclusion of DEHP was maintained.

42 The initial proposal, which sought to supplement the REACH Regulation with a new identification of four substances, including DEHP, under Article 57(f) of that regulation, to be submitted to a common vote, was replaced by a new proposal submitted in eight parts seeking the additional identification of chemical substances which was to give rise to a separate vote.

43 The appellant submits that that change to the Danish proposal enabled the adoption of the decision at issue. It maintains that the Member State Committee did not reach unanimous agreement on the basis of the initial proposal. It submits in that regard that, by virtue of the settled case-law of the Court of Justice, a procedural irregularity leads to annulment of all or part of a decision only if it is established that the content of that decision could have differed if that irregularity had not occurred. The appellant claims that the adoption procedure in question is contrary to the REACH Regulation and the case-law of the Court of Justice, and the General Court erred in law in considering that that was not so.

44 The ECHA and the Kingdom of Denmark claim that the second part of that ground of appeal is not well founded.

– Findings of the Court of Justice

45 It must be noted, first of all that, as the General Court stated in paragraph 85 of the judgment under appeal, the purpose of the identification procedure for the substances referred to in Article 57 of the REACH Regulation, established in Article 59 of that regulation, was to ensure that Member States and interested parties to that procedure could be heard before the drafting of a decision to include a substance in the candidate list of substances. Furthermore, as the General Court correctly observed in paragraph 86 of that judgment, Article 59 of the REACH Regulation does not specify the manner in which several proposals for identifying a substance as a substance of very high concern within the meaning of Article 57 of that regulation should be presented.

46 Likewise, as the General Court rightly held in paragraph 86 of the judgment under appeal, the REACH Regulation contained no provision preventing a Member State from amending or withdrawing in the course of the procedure one or more proposals for inclusion concerning substances which it regarded as meeting the criteria set out in Article 57 of that regulation.

47 Furthermore, those two articles do not set out any obligation to group proposals into one and the same document when those proposals are submitted from the same source at the same time.

48 In the present case, as the General Court stated in paragraph 88 of the judgment under appeal, the Kingdom of Denmark merely divided its initial proposal into eight separate parts. This dividing-up was followed by a partial withdrawal of the proposals relating to DBP, BBP and DIBP in so far as these proposals concerned serious effects on the environment, while the proposal relating to DEHP was maintained.

49 As regards the part of the proposal relating to DEHP, it must be noted that the General Court held, in paragraph 89 of the judgment under appeal, that the appellant had not demonstrated how the substantive content of the Kingdom of Denmark’s initial proposal differed from that of the proposal which was voted on at the meeting of the Member State Committee held from 8 to 11 December 2014.

50 Finally, the General Court held, in paragraphs 93 and 94 of the judgment under appeal, that the unanimous agreement of the Member State Committee on DEHP was not vitiated by irregularity because it relied solely on ‘serious effects on the environment’, whereas the original identification proposal and the dossier submitted in accordance with Annex XV were grounded on ‘serious effects on human health and the environment’ of that substance. It follows from the wording of Article 57(f) of that regulation that the properties referred to in that provision are those which may have serious effects either on human health or on the environment, those being alternative criteria.

51 The second part of the first ground of appeal must therefore be rejected.

The third part of the first ground of appeal, alleging that the General Court erred in law in failing to recognise that the ECHA misused its powers

– Arguments of the parties

52 The appellant claims that the decision at issue and the procedure carried out by the ECHA before the adoption of that decision do not comply with the legally compulsory procedure provided for by the European Parliament and the Council of the European Union and that, consequently, the General Court erred in law in rejecting the line of argument developed by the appellant in that regard before it.

53 Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ (OJ 2013 L 354, p. 171) provides that ‘the European Union will develop harmonised hazard-based criteria for the identification of endocrine disruptors, [...] in all relevant Union legislation’. The appellant maintains that it follows from that decision that the criteria for harmonised application drawn up by the EU for identifying endocrine-disrupting substances must be implemented having regard for all EU legislation, including the REACH Regulation. It is for the Commission to adopt those criteria. The appellant maintains in that regard that, under Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), the Commission was to adopt measures specifying scientific criteria for the determination of endocrine-disrupting properties by 13 December 2013 at the latest. Likewise, the Commission was required to submit by 14 December 2013 at the latest draft measures concerning specific scientific criteria for the determination of endocrine-disrupting substances.

54 The appellant also maintains that the Commission was empowered to determine criteria for the purposes of identifying dangerous substances but did not exercise that power. The ECHA was nonetheless, in such a situation, not empowered to determine those criteria itself. Thus, according to the appellant, the identification of DEHP under Article 57(c) of the REACH Regulation by virtue of the agency’s own ad hoc criteria is unlawful.

55 According to the appellant, the General Court wrongly considered that the ECHA had not misused its powers by drawing up its own identification criteria, while certain rules of EU law do not confer such a power on that agency.

56 The ECHA, the Kingdom of Denmark and the Kingdom of Sweden reject the appellant’s arguments.

– Findings of the Court of Justice

57 As regards Decision No 1386/2013, as the Advocate General observed in points 100 and 101 of his Opinion, the General Court did not err in law in considering, in essence, in paragraphs 120 and 121 of the judgment under appeal, that it sets out a programme, which is clearly apparent from the words used in the second sentence of the third paragraph of point 50 of the annex to that decision, that is to say the European Union ‘will develop’ harmonised criteria.

58 As regards Regulation No 528/2012, the General Court correctly stated, in paragraph 109 of the judgment under appeal, that, as is apparent from Article 2(3)(j) thereof, Regulation No 528/2012 applied without prejudice to the REACH Regulation. Accordingly, in common with Decision No 1386/2013, Regulation No 528/2012 is not intended to cast doubt on the applicability of the criteria for identifying endocrine disruptors, set out in Article 57 of the REACH Regulation and applied by the ECHA in the procedure under Article 59 of that regulation.

59 The same is true with regard to point 3.6.5 of Annex II to Regulation No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1). As the Advocate General pointed out in point 103 of his Opinion, the General Court rightly held, in paragraphs 117 and 118 of the judgment under appeal, that it followed from that provision that it was permissible to ascertain whether a substance had endocrine-disrupting and potentially adverse effects, not only ‘on the basis of the assessment of [EU] or internationally agreed test guidelines’, but also on the basis of ‘other available data and information, including a review of the scientific literature reviewed by the [European Food Safety Authority]’.

60 Finally, the General Court did not err in law in finding that the Commission’s roadmap of 2014 was not legally binding.

61 In the absence of a harmonised definition, the REACH Regulation authorises the ECHA to continue to manage an integrated system for monitoring chemical substances, including registration, evaluation and authorisation, together with possible restrictions on their use (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 20) which must include, for the sake of effectiveness and efficiency, endocrine disruptors.

62 It follows from the foregoing that the third part of the first ground of appeal must be rejected and, consequently, the first ground of appeal must be rejected in its entirety.

The second ground of appeal, alleging that the General Court misinterpreted and misapplied the principle of legal certainty

Arguments of the parties

63 By its second ground of appeal, the appellant claims that the General Court erred in law in holding, in paragraphs 135 to 153 of the judgment under appeal, that the decision at issue was not contrary to the principle of legal certainty even though it led to an unclear, imprecise and unpredictable legal situation for the appellant.

64 The appellant maintains that the current identification of DEHP in Annex XIV of the REACH Regulation under Article 57(c) of that regulation, supplemented by a new identification under Article 57(f) of that regulation is problematic. The appellant asks, in that regard, whether new time limits are to be set for the filing of the application for authorisation of DEHP identified under Article 57(f) of the REACH Regulation, the time limit for filing such an application under the legislation in force having expired on 21 August 2013. It questions the ‘fate’ of the current application for authorisation that it submitted for DEHP under Article 57(c) of the REACH Regulation and the impact concerning the use of DEHP in medical devices, which are not covered in general by that regulation, even though such use does not require, according to the current wording, authorisation within the meaning of Title VII of that regulation.

65 The General Court itself expressly acknowledged, in paragraph 146 of the judgment under appeal, that, while Annex XIV of the REACH Regulation was supplemented by a new identification of DEHP under Article 57(f) of that regulation, ‘the application for authorisation [of that substance identified in accordance with Article 57(c) of that regulation submitted by the appellant must] be amended to take account of that development’ and ‘[the appellant must] take account of that amendment to Annex XIV’ to the REACH Regulation. However, the General Court does not indicate how that ‘amendment’ should be made, or refer to a specific provision of the REACH Regulation or other text governing that matter.

66 The ECHA disputes the appellant’s arguments.

Findings of the Court of Justice

67 It must be noted that the General Court examined, in points 133 to 153 of the judgment under appeal, whether the decision at issue failed to comply with the principles of foreseeability, legal certainty and protection of legitimate expectations.

68 The General Court, having recalled that the principles of legal certainty and protection of legitimate expectations constituted general principles of EU law, confirmed that the decision at issue fulfilled the requirements arising from those principles.

69 It thus noted, in paragraphs 135 and 137 of the judgment under appeal, that it followed from the case-law of the Court of Justice that the principle of legal certainty required, particularly, that rules of law be clear, precise and foreseeable in their effects, in particular where they may have adverse effects on individuals and undertakings and that, as regards the principle of the protection of legitimate expectations, the Court of Justice held that a person may not plead a breach of that principle unless the administration has given him precise assurances (see, to that effect, judgment of 20 December 2017, Global Starnet, C‑322/16, EU:C:2017:985, paragraph 46 and the case-law cited).

70 Accordingly, any trader to whom an institution has given justified hopes may rely on the principle of the protection of legitimate expectations. In whatever form it is given, information which is precise, unconditional and consistent and comes from authorised and reliable sources constitutes assurances capable of giving rise to such hopes (judgment of 14 March 2013, Agrargenossenschaft Neuzelle, C‑545/11, EU:C:2013:169, paragraphs 24 and 25 and the case-law cited).

71 By contrast, if a prudent and alert economic operator can foresee the adoption of an EU measure likely to affect his interests, he cannot plead the principle of protection of legitimate expectations if that measure is adopted (judgment of 14 March 2013, Agrargenossenschaft Neuzelle, C‑545/11, EU:C:2013:169, paragraph 26).

72 The General Court considered whether, in accordance with the requirements of the principle of legal certainty, the decision at issue clearly set out its legal basis and its legal effects. It found that that decision referred clearly to Article 59(8) of the REACH Regulation as the legal basis for its adoption. It also rightly found that the appellant was capable of being unambiguously aware of the scope of that decision, since it was clearly apparent from it that it was intended to supplement the existing entry relating to DEHP on the candidate list of substances under Article 57(f) of the REACH Regulation.

73 Moreover, it does not follow from the judgment under appeal that the General Court itself created a situation of legal uncertainty. Following that judgment, the classification of DEHP was confirmed and that substance will continue to be assessed in accordance with the REACH Regulation.

74 Thus, the General Court was right to consider that the appellant had not put forward any evidence capable of demonstrating that an institution or agency of the European Union had directly provided it with specific assurances. The General Court was therefore entitled to consider that the decision at issue did not fail to comply with the principles of legal certainty and protection of legitimate expectations.

75 In those circumstances, the second ground of appeal must be rejected as unfounded.

The third ground of appeal, alleging that the General Court failed to have regard to the extent of its power of review and that evidence was distorted

Arguments of the parties

76 By its third ground of appeal, the appellant claims that the General Court, in paragraphs 163 to 202 of the judgment under appeal, examined the decision at issue without having regard to the requirements concerning the extent of its power to review decisions of the institutions or bodies of the European Union and furthermore distorted the facts and evidence adduced before it.

77 According to the appellant, even though the broad discretion on the part of the EU institutions, in particular concerning the examination of highly complex technical and scientific evidence, is subject to limited judicial review, that judicial review requires the EU institutions that have adopted the act in question to be able to show before the Court of Justice that in adopting the act ‘they actually exercised their discretion’, which presupposes the taking into consideration of all the relevant factors and circumstances of the situation the act was intended to regulate.

78 The appellant also considers that the General Court distorted the evidence by considering that the studies on which the dossier drawn up in accordance with Annex XV to the REACH Regulation concerning DEHP (‘the supporting document’) was based merely constituted part of the entirety of the evidence examined by the Member State Committee. It claims that none of the scientific studies carried out on fish after 2008 indicate that DEHP has adverse effects on human health and the environment, which, also in the view of the General Court, is a condition for the identification of that substance under Article 57(f) of the REACH Regulation.

79 In addition, the appellant maintains that the supporting document is based on scientific studies carried out on rats which focused on the effects of DEHP not on the environment, but on human health in the event of direct exposure to DEHP, even though it concerned ‘demonstration’ of the effect of that substance on the environment. The appellant claims that such a procedure is scientifically incorrect. The General Court wrongly failed to take that circumstance into account in the judgment under appeal.

80 The ECHA contends in response that the third ground of appeal is not well founded and that the evidence was examined correctly.

Findings of the Court of Justice

81 The General Court examined the evidence and scientific studies that served as the basis for the decision at issue in paragraphs 157 to 202 of the judgment under appeal, in the context of a lengthy and detailed examination which fulfilled the requirements of effective judicial review.

82 After recalling the case-law principles governing the rigour of the judicial review concerning the assessment of highly complex technical and scientific factual evidence, it referred to all the scientific studies on fish and rats which formed part of the supporting document.

83 The General Court inter alia referred, expressly, to the findings of numerous studies on fish concerning disruption of their endocrine system following exposure to DEHP.

84 In paragraph 166 of the judgment under appeal, the General Court nevertheless noted that ‘point 5.1.6 of the supporting document indicates that, on an overall assessment of a part of the studies used, it is highly probable that the estrogenic pattern of behaviour of DEHP has adverse effects on the sexual and reproductive phenotypic features of male and female fish. This fact, together with the effects of DEHP as observed in the studies on rats referred to in Chapter 4 of the supporting document, suffice for a conclusion that DEHP may have adverse effects on the environment’.

85 It appears from the dossier before the Court of Justice that the studies on rats intend to establish the effects of DEHP on human health and not on the environment.

86 It follows that the General Court distorted the evidence by referring to the studies on rats which concerned the effects of DEHP on human health in the event of direct exposure to DEHP in order to infer that that substance had effects on the environment.

87 However, it is settled case-law of the Court of Justice that, if the grounds of a decision of the General Court contain an infringement of EU law but its operative part is shown to be well founded on other legal grounds, such an infringement is not one that should cause that decision to be set aside, and a substitution of grounds must be made (judgment of 26 January 2017, Mamoli Robinetteria v Commission, C‑619/13 P, EU:C:2017:50, paragraph 107 and the case-law cited).

88 Although the General Court, in paragraph 166 of the judgment under appeal, referred in error to the studies on rats, it also referred in that paragraph to the studies on fish which demonstrate the effects of DEHP on the environment. Thus the General Court’s assessment concerning the significant number of studies on fish and the effect of DEHP on their endocrine system sufficed to justify its rejection of the plea in law alleging that the scientific evidence was insufficient.

89 In view of those considerations, the third ground of appeal must be rejected as ineffective.

The fourth ground of appeal, alleging that the General Court infringed the appellant’s fundamental rights

Arguments of the parties

90 The appellant claims that the General Court infringed the fundamental rights and principles enshrined in the European Convention on Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘ECHR’) and in the Charter of Fundamental Rights of the European Union (‘the Charter’). Having incorrectly interpreted and applied EU law, the General Court also infringed the rights of the appellant and the principles enshrined in the ECHR and the Charter, in particular the right to a fair hearing laid down in Article 6 of the ECHR and Article 47 of the Charter, the right to enjoyment of its property, in accordance with Article 1 of Additional Protocol No 1 to the ECHR and Article 17 of the Charter, and the principle of legal certainty.

91 The ECHA disputes the appellant’s arguments.

Findings of the Court of Justice

92 It must first be held that that ground of appeal is manifestly devoid of reasoning and precision in so far as it includes a mere abstract statement of the legal rules allegedly infringed by the General Court and lacks any line of argument.

93 It follows from Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) and Article 169(2) of the Rules of Procedure of the Court of Justice that an appeal must indicate precisely the contested elements of the judgment which the appellant seeks to have set aside and also the legal arguments specifically advanced in support of the appeal (judgment of 4 July 2000, Bergaderm and Goupil v Commission, C‑352/98 P, EU:C:2000:361, paragraph 34).

94 Moreover, it is settled case-law that elements of the appeal that contain no argument specifically identifying the error of law allegedly vitiating the judgment under appeal do not fulfil that requirement and must be rejected as manifestly inadmissible (order of 24 November 2016, Petraitis v Commission, C‑137/16 P, not published, EU:C:2016:904, paragraph 17).

95 It follows from all of the foregoing that the fourth ground of appeal must be rejected as inadmissible and, consequently, the appeal must be dismissed in its entirety.

Costs

96 Under Article 184(2) of the Rules of Procedure of the Court, where the appeal is unfounded, the Court is to make a decision as to the costs. Under Article 138(1) of those Rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

97 Article 140(1) of those Rules provides that the Member States which have intervened in the proceedings are to bear their own costs.

98 Since the ECHA has applied for costs, and Deza has been unsuccessful, the latter must be ordered to pay the costs.

99 The Kingdom of Denmark and the Kingdom of Sweden must bear their own costs.

On those grounds, the Court (First Chamber) hereby:

1. Dismisses the appeal;

2. Orders Deza, a.s. to bear its own costs and to pay those incurred by the European Chemicals Agency (ECHA);

3. Orders the Kingdom of Denmark and the Kingdom of Sweden to bear their own costs.

[Signatures]

( *1 ) Language of the case: Czech.