delivered on 26 June 2018 (1)

Case C‑419/17 P

(Appeal — 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 — Alleged misinterpretation and misapplication of Regulation (EC) No 1907/2006 and of the principle of legal certainty)

1.By its appeal, Deza a.s. asks the Court of Justice to set aside the judgment of the General Court of the European Union of 11 May 2017, Deza v ECHA, (2) in which the General Court dismissed its action seeking annulment of Decision ED/108/2014 of 12 December 2014 of the European Chemicals Agency (the ECHA) updating and supplementing the existing entry for a chemical substance in the list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 (3) and identifying that substance as a substance having endocrine-disrupting properties within the meaning of Article 57(f) of that regulation (‘the decision at issue’).

2.As requested by the Court of Justice, I will confine this Opinion to an analysis of the first ground of appeal. That ground alleges that the General Court misinterpreted and misapplied the REACH Regulation when it found that the appellant’s plea in law in its action challenging the ECHA’s decision, claiming that the decision had been adopted ultra vires, was unfounded.

3.The first branch of the first ground of appeal relates essentially to the interpretation of Article 57 of the REACH Regulation and will provide the Court with an opportunity to develop its case-law on that article, consisting in particular of the Polynt v ECHA (4) and Hitachi Chemical Europe and Polynt v ECHA (5) judgments. The second and third branches of that ground of appeal concern the procedural aspects of the inclusion of a chemical substance in the candidate list of substances identified for eventual inclusion in Annex XIV to the REACH Regulation (‘the candidate list of substances’), which lists the substances subject to the authorisation procedure.

II. Legal context

4.Title VII of the REACH Regulation contains Articles 55 to 65 of that regulation and governs the authorisation procedure.

5.In accordance with the principles set out in Article 56 of the REACH Regulation, entitled ‘General provisions’, a manufacturer, importer or downstream user must in principle not place a substance on the market for a use or use it him or herself if that substance is included in Annex XIV, save in one of the situations to which that article refers.

6.Article 57 of the REACH Regulation, entitled ‘Substances to be included in Annex XIV’ provides: ‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:… (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;… (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.’

7.Article 59 of the REACH Regulation, entitled ‘Identification of substances referred to in Article 57’, provides: ‘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. … 2. The [European] Commission may ask the [ECHA] to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. … 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]. … … 5. Within 60 days of circulation, the other Member States or the [ECHA] may comment on the identification of the substance in relation to the criteria in Article 57 in the dossier [forwarded] to the [ECHA]. 6. If the [ECHA] does not receive or make any comments, it shall include this substance on the list referred to in paragraph 1. … 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. … 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.’

III. The background to the dispute and the decision at issue

8.The appellant, a limited company incorporated under Czech law, produces, markets and uses the chemical substance bis(2-ethylhexyl)phthalate (DEHP).

9.By a decision of 28 October 2008, the Executive Director of the ECHA included DEHP in the candidate list of substances, on the ground that DEHP had been identified as a substance toxic for reproduction within the meaning of Article 57(c) of the REACH Regulation.

10.By means of Regulation (EU) No 143/2011, (6) the Commission subsequently included DEHP in Annex XIV to the REACH Regulation.

11.On 26 August 2014, the Kingdom of Denmark submitted four dossiers in accordance with Annex XV to that regulation, proposing that DEHP and three other chemical substances should be identified as endocrine-disrupting substances for which there is scientific evidence of probable serious effects on human health and the environment within the meaning of Article 57(f) of the REACH Regulation, and that they should be added to the candidate list of substances (‘the Kingdom of Denmark’s initial proposal’).

12.Interested parties were invited to comment on the Kingdom of Denmark’s initial proposal in accordance with the requirement laid down in Article 59(4) and (5) of the REACH Regulation. It transpired at that stage that, due to the opposition of several members of the Member State Committee, the Kingdom of Denmark’s initial proposal was not going to be approved unanimously.

13.The Kingdom of Denmark then divided its initial proposal into eight parts, that is to say, four parts aimed at identifying the four substances in question as endocrine-disrupting substances that may have serious effects on human health within the meaning of Article 57(f) of the REACH Regulation, and four parts aimed at identifying those four substances as endocrine-disrupting substances that may have serious effects on the environment within the meaning of the same provision.

14.The Kingdom of Denmark subsequently withdrew its proposal in so far as it sought to include the substances other than DEHP in the candidate list on the ground that they were endocrine-disrupting substances that may have serious effects on the environment within the meaning of Article 57(f) of the REACH Regulation.

15.Ultimately, 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.

16.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 within the meaning of Article 57(f) of the REACH Regulation.

17.By its action, the appellant requested the General Court to annul the decision at issue in so far as it had updated and supplemented the existing entry for DEHP in the candidate list of substances for eventual inclusion in Annex XIV to the REACH Regulation.

18.By its first plea in law, the appellant claimed that the ECHA had acted ultra vires in adopting the contested decision. Specifically, the appellant argued, first, that the REACH Regulation contains no provision empowering the ECHA to supplement an existing entry for a chemical substance in the candidate list of substances, secondly, that the ECHA had infringed the procedural rules laid down in Article 59 of that regulation and, thirdly, that it had circumvented the special procedures for the identification of substances as endocrine disruptors of very high concern within the meaning of Article 57(f) of the REACH Regulation.

19.By the judgment under appeal, the General Court dismissed the action brought against the decision at issue.

20.By document lodged at the Court Registry on 11 July 2017, the appellant brought the present appeal.

21.The appellant asks the Court to set aside the judgment under appeal in its entirety, as well as the decision at issue, and order the ECHA to pay the costs.

22.The ECHA asks the Court to dismiss the appeal and order the appellant to pay the costs.

23.The Kingdom of Denmark and the Kingdom of Sweden support the form of order sought by the ECHA.

24.The appellant’s first ground of appeal is divided into three branches, essentially reiterating the elements of the first plea in law of the action brought against the decision at issue, which are set out in point 18 of this Opinion. Those three branches concern the procedure for identifying chemical substances of very high concern, as established in Article 59 of the REACH Regulation, carried out with a view to the possible inclusion of those substances in Annex XIV to that regulation.

25.I will therefore first make a number of observations on the identification procedure, as established in Article 59 of the REACH Regulation, and will then go on to analyse the three branches of the first ground of appeal.

26.In the system set up by the REACH Regulation, the authorisation procedure is one of the means of regulating chemical substances intended to ensure that substances of very high concern are gradually replaced by suitable alternative substances or technologies, where those alternatives are economically and technically viable. (7)

27.To that end, Article 57(a) to (f) of the REACH Regulation lists a number of intrinsic properties of the chemical substances considered to be substances of very high concern, on the basis of which those substances may be included in Annex XIV to that regulation, entitled ‘List of substances subject to authorisation’. Furthermore, each substance included in Annex XIV to the REACH Regulation can be used or placed on the market in the case where the Commission has granted authorisation, in accordance with Articles 60 to 64 of that regulation, to a person who has applied for authorisation.

28.However, the present case concerns neither a measure by which a substance was included in Annex XIV to the REACH Regulation, nor a decision on an application for authorisation, but rather the entry for a substance in the candidate list of substances. An entry in that list is the preliminary stage for the inclusion of a substance in Annex XIV to the REACH Regulation.

29.The identification of candidate substances has essentially been entrusted to the ECHA, which carries out that task in accordance with the procedure set out in Article 59 of the REACH Regulation.

30.That procedure starts when a Member State or, at the Commission’s request, the ECHA itself, proposes that a substance should be identified as a substance of very high concern for the reasons listed in Article 57(a) to (f) of the REACH Regulation. In such a case, the Member State or the ECHA must prepare a dossier on the substance concerned. That dossier is made available to the Member States, which can submit their comments on the identification of the substance in question. (8)

31.If the ECHA does not receive or make any comments, it is to include the substance on the candidate list of substances. The ECHA otherwise sends the dossier to the Member State Committee. If that committee reaches unanimous agreement on the identification, the ECHA is to include the substance in the candidate list of substances. (9)

32.A substance identified by the ECHA as being a substance of very high concern for the reasons set out in Article 57 of the REACH Regulation and which is consequently included in the candidate list of substances cannot (immediately and automatically) be included in Annex XIV to that regulation. However, the identification of such a substance and its inclusion in the candidate list of substances tends in principle to be the preliminary step to its inclusion in Annex XIV to the REACH Regulation. Inclusion of a substance in the candidate list of substances therefore tends to precede its becoming subject to the obligation to apply for authorisation for the placing on the market or use of that substance.

33.Independently of that interrelation between the inclusion of a substance in the candidate list of substances and its inclusion in Annex XIV to the REACH Regulation, three main legal obligations arise in principle from the fact that a substance has been identified as a substance of very high concern but has not yet been included in that annex. (10)

34.First, under Article 7(2) of the REACH Regulation any producer or importer of articles (products) must notify the ECHA in the case where a substance in the candidate list is present in those articles in a quantity and concentration above the thresholds laid down in Article 7(2).

35.Secondly, under Article 31(1)(c) of the REACH Regulation, the supplier of a substance or preparation must provide the recipient with a safety data sheet where a substance is included in the candidate list of substances for reasons other than those under Article 31(1)(a) and (b) of that regulation. The obligation under Article 31(1)(c) of the REACH Regulation seems to me to relate above all to substances identified as being of very high concern for the reasons set out in Article 57(f) of that regulation, because the reasons to which Article 31(1)(a) and (b) of the regulation refers correspond, in principle, to those set out in Article 57(a) to (e) of that regulation.

36.Thirdly, Article 33(1) and (2) of the REACH Regulation states that any supplier of an article containing a candidate substance in a concentration above the threshold specified in that article must provide the recipient of the article, and a consumer purchasing from that recipient who so requests, with sufficient information, available to the supplier, to allow safe use of that article, including, as a minimum, the name of that substance.

37.By the first branch of the first ground of its appeal, the appellant contends that, contrary to the position of the General Court set out in paragraphs 48 to 82 of the judgment under appeal, the ECHA was not empowered to identify DEHP as an endocrine disruptor of very high concern under Article 57(f) of the REACH Regulation, in so far as that substance had already been identified as a substance toxic for reproduction within the meaning of Article 57(c) of that regulation.

38.In support of that first branch the appellant puts forward three separate arguments, which may be summarised as follows. First, in its case-law on Article 57 of the REACH Regulation, the Court of Justice rules out any power on the part of the ECHA to supplement an entry in the candidate list of substances for a chemical substance already identified as being of very high concern. Secondly, the requirements established in the case-law on implied internal powers are not satisfied in this case, and the General Court therefore erred in finding that the ECHA had such powers. Thirdly, an interpretation of the wording and scheme of the provisions of the REACH Regulation confirms the appellant’s thesis.

(a) Positions of the parties

39.In the first branch of the first ground of appeal, the appellant invokes the case-law on Article 57 of the REACH Regulation, inferring therefrom that the Court has excluded any power on the part of the ECHA to supplement an existing entry for a chemical substance in the candidate list of substances. The appellant refers on this point to the judgments in Polynt v ECHA (11) and Hitachi Chemical Europe and Polynt v ECHA. (12) According to the appellant, it follows from those judgments that Article 57(f) of the REACH Regulation concerns 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.

40.In its response the ECHA contends, first, that the appellant’s argument that identification under Article 57(a) to (e) of the REACH Regulation precludes a substance from being identified under Article 57(f) of that regulation was not put forward before the General Court and can, for that reason, be found to be inadmissible.

41.Secondly, the ECHA submits that that argument — to the extent to which it is admissible — is unfounded.

42.The Kingdom of Denmark and the Kingdom of Sweden submit that the ECHA is empowered to supplement an already existing entry in the candidate list of substances.

(b) Admissibility

43.In respect of the ECHA’s plea of inadmissibility, the appellant did indeed not address the interrelation between Article 57(a) to (e) and Article 57(f) of the REACH Regulation before the General Court. Consequently, the appellant also did not plead that the interrelation in question precludes an already existing entry in the candidate list of substances from being supplemented. Nor, furthermore, did the appellant invoke the Court of Justice’s case-law on Article 57 of the REACH Regulation before the General Court.

44.However, it is worth noting that the appellant states, in support of the first branch of its first ground of appeal, that two categories of substance can be covered by Article 57(f) of the REACH Regulation, that is to say, substances which cannot be identified on the basis of the criteria set out in Article 57(a) to (e) of that regulation, and those which have not yet been identified and included in the candidate list of substances on the basis of those criteria.

45.To my mind, the appellant is not seeking by means of that argument to show that the fact that a chemical substance has been placed on the candidate list of substances for the reasons in Article 57(a) to (e) of the REACH Regulation means that the substance in question does not meet the criteria set out in Article 57(f) of that regulation. Were that the case, that argument would concern a material aspect of the system for regulating chemical substances and would amount to a new argument. It seems to me, however, that the argument in question is claiming that the ECHA’s powers to include a chemical substance in the candidate list are exhausted once that substance has first been identified as being of very high concern. It is, therefore, the same line of argument as that advanced before the General Court.

46.Admittedly, the appellant did not invoke the Court of Justice’s case-law on Article 57 of the REACH Regulation before the General Court. However, it is from that case-law that it draws the conclusions consistent with the line of argument which it set out in support of the first plea in law of its application, to the effect that the ECHA did not have power to ‘include’ DEHP in the candidate list of substances a second time.

47.To my mind, therefore, the appellant’s argument — which the ECHA challenges — set out in the first branch of the first ground of appeal is admissible.

(c) Substance

48.By way of reminder, the appellant submits, in the first branch of the first ground of appeal, that the Court of Justice’s case-law on Article 57 of the REACH Regulation precludes any power on the part of the ECHA to supplement an existing identification of DEHP.

49.I do not share that view, however.

50.It is true that, in paragraph 35 of the judgment in FCD and FMB, (13) the Court held that the substances of very high concern are those listed in either Article 57(a) to (e) of the REACH Regulation due to their intrinsic properties, or in Article 57(f) of that regulation, which includes ‘all other substances’ 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) of Article 57 of the REACH Regulation.

51.In that vein, in the judgments to which the appellant refers explicitly in support of its appeal, specifically in paragraph 24 of the judgments in Polynt v ECHA (14) and in Hitachi Chemical Europe and Polynt v ECHA, (15) the Court briefly called to mind the wording of Article 57(a) to (e) of the REACH Regulation and went on to state, in relation to Article 57(f) of that regulation, that it ‘covers all other substances which do not fulfil any of the foregoing criteria’. Then, in paragraph 25 of those judgments, the Court clarified that ‘Article 57 provides, at point (f), for an independent mechanism that makes it possible to identify, as being of very high concern, substances which have not already been designated as such under that provision’.

52.However, contrary to the interpretation put forward by the appellant, the passages to which the preceding point of this Opinion refers, according to which Article 57(f) of the REACH Regulation relates to substances of very high concern ‘which have not already been designated as such under that provision’, are not, in my view, speaking in terms of the ECHA, which, in this particular case, did not previously identify a substance concerned as being a substance of very high concern for the reasons set out in Article 57(a) to (e) of the REACH Regulation.

53.It seems to me that those passages relate rather to the perspective of the EU legislature, which supplemented the list of reasons for which a substance can be included in the candidate list of substances with residual reasons, not provided for in Article 57(a) to (e) of the REACH Regulation, but which are not exclusive. Identification of a substance as being a substance of very high concern for the reasons set out in Article 57(f) of the REACH Regulation therefore does not mean that it cannot be identified as a substance of very high concern for the reasons set out in the preceding points of that article, that is to say, Article 57(a) to (e) of that regulation.

54.An in-depth reading of the case-law on Article 57 of the REACH Regulation corroborates that interpretation. It emerges from a number of passages in Polynt v ECHA (16) and Hitachi Chemical Europe and Polynt v ECHA, (17) likewise adduced by the appellant and referred to in point 51 of this Opinion, that Article 57(f) of the REACH Regulation covers all the other substances ‘which do not fulfil any of the foregoing criteria’. (18) Furthermore, in particular in paragraph 29 of the judgments in Polynt v ECHA (19) and Hitachi Chemical Europe and Polynt v ECHA, (20) the Court analysed Article 57 of the REACH Regulation and explained what the EU legislature intended by structuring that article as it did.

55.For the same reasons, the passages in which the Court stated that Article 57(f) of the REACH Regulation covers ‘all [the] other substances’ should be understood to concern, not the other substances as such, but the other reasons for which a substance may be included in the candidate list of substances.

56.In the light of the foregoing, I am of the view that the interpretation of the case-law on Article 57 of the REACH Regulation that the appellant advances in the first branch of the first ground of appeal cannot succeed.

(a) Positions of the parties

57.The doctrine of implied internal powers cannot, according to the appellant, be construed broadly. The appellant thus disputes the findings of the General Court, in paragraph 70 of the judgment under appeal, that it was necessary to find that the ECHA had implied powers, in particular in order to achieve the objective of the REACH Regulation. According to the appellant, no implied powers can be inferred from that objective because, if that were so, the rules for delimiting the ECHA’s powers would essentially be the provisions delimiting the objectives of that regulation.

58.In line with that argument, the appellant submits that it is also not necessary to find that the ECHA has implied powers either in order to achieve the objective of the REACH Regulation or to ensure that it has practical effect, since the ECHA can opt for another way of regulating the matter, in particular the restrictions provided for under Title VIII of that regulation.

59.The ECHA contends that the appellant has misinterpreted the General Court’s reasoning. According to the ECHA, the General Court merely interpreted Article 59(8) of the REACH Regulation as meaning that it expressly empowers the ECHA to include in the candidate list of substances a substance which is already in that list by reason of a different intrinsic property under Article 57 of the REACH Regulation.

(b) Assessment

60.In respect of the appellant’s argument that the General Court applied the doctrine of implied internal powers incorrectly, I share the ECHA’s view that, in the judgment under appeal, the General Court found that the ECHA did have power to adopt the decision at issue, but did not base its finding on the doctrine of implied internal powers.

61.As the General Court stated in paragraph 44 of the judgment under appeal, it was the appellant that had argued that, contrary to the ECHA’s contention, the latter’s powers to supplement an existing entry for a chemical substance in the candidate list of substances could not be derived from the doctrine of ‘implied powers’.

62.The General Court did indeed state, in paragraph 52 of the judgment under appeal, that the words ‘the [ECHA] shall include that substance on the [candidate] 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.

63.However, it follows from paragraph 54 of the judgment under appeal that, in finding that the ECHA had power to adopt the decision at issue, the General Court took the view that neither the wording of Article 57 or Article 59(8) of the REACH Regulation nor that of any other provision of that regulation prohibits the ECHA from verifying whether a substance has intrinsic properties other than those which led to the initial inclusion of that substance in the candidate list of substances. Furthermore, in paragraph 55 of the judgment under appeal, the General Court stated that, from a technical point of view, the identification of a substance as fulfilling the criteria in one of the points of Article 57 of the REACH Regulation other than the one that led to the initial inclusion in the candidate list of substances takes 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.

64.For the reasons set out below, the appellant’s argument that the doctrine of implied internal powers was misapplied cannot succeed, because the General Court did not rely on that doctrine in the judgment under appeal. Furthermore, the General Court based its reasoning in that respect on a schematic and teleological interpretation of the provisions of the REACH Regulation, which is the subject matter of my analysis of the last argument raised by the appellant in the first branch of its first ground of appeal.

3. The linguistic and schematic interpretation of the provisions of the REACH Regulation

(a) Positions of the parties

65.According to the appellant, a linguistic and schematic interpretation of the provisions of the REACH Regulation corroborates its position.

66.In that respect the appellant relies, first of all, on the wording of Article 59(8) of the REACH Regulation, according to which the ECHA ‘shall include’ the substance identified by the Member State Committee under Article 57 of that regulation in the candidate list of substances. Specifically, it argues that the words ‘shall include’ indicate that this refers to substances not yet included in the candidate list of substances. The appellant therefore asserts that, if the substance concerned is already included in that list, it cannot be included in it a second time.

67.Furthermore, in the appellant’s view, the reading of Article 59(10) of the REACH Regulation, which refers to a decision on ‘inclusion of a substance’, bears out that interpretation.

68.Lastly, the appellant submits that it follows from Article 58(8) of the REACH Regulation, which expressly provides that only the Commission has the power to remove substances which no longer meet the criteria under Article 57 of that regulation from Annex XIV to that regulation, that the legislature did not intend to give that power to an agency such as the ECHA, and would otherwise have expressly so provided.

(b) Assessment

69.According to the ECHA, neither the wording of Article 57 nor that of Article 59(8) of the REACH Regulation prohibits it from verifying whether a substance has intrinsic properties other than those which led to its initial inclusion in the candidate list of substances.

70.This is essentially the view that the Kingdom of Denmark and the Kingdom of Sweden have also put forward.

71.I am not persuaded by the appellant’s thesis that the reading of Article 59(8) of the REACH Regulation suggests that the ECHA only has power to make one single inclusion of a substance in the candidate list of substances. To my mind, the appellant’s conclusions regarding use of the words ‘shall include’ in Article 59(8) of the REACH Regulation are misplaced. The same can be said of its analysis of Article 59(10) of that regulation.

72.It is true that, as I have indicated in points 33 to 36 of this Opinion, three obligations arise from the inclusion of a chemical substance in the candidate list of substances, that is to say, the obligation to notify the ECHA of articles containing the substances in the candidate list of substances, the obligation to provide the recipient with a safety data sheet, and the obligation to inform recipients and consumers how to use those articles safely. There is nevertheless reason to find that a second ‘inclusion’ of the same substance in the candidate list of substances need not necessarily change the extent of those obligations. That approach, to my mind, could advocate in favour of the interpretation of the provisions of the REACH Regulation advanced by the appellant in its first ground of appeal.

73.Nevertheless, I would note that the inclusion of a substance in the candidate list of substances is merely an initial phase of the authorisation procedure and can potentially lead to a substance previously identified by the ECHA as a substance of very high concern being included in Annex XIV to the REACH Regulation.

74.It seems obvious to me that a chemical substance may be identified as being of very high concern and included in Annex XIV to that regulation for several of the reasons set out in Article 57 of the REACH Regulation. That view is borne out by the wording of Article 58(1)(b) of the REACH Regulation, under which the decision to include a substance in Annex XIV must specify, in particular, ‘the intrinsic property (properties) of the substance referred to in Article 57 [of that regulation]’. (21)

75.Furthermore, as regards the effects of inclusion of a substance, for several of the reasons set out in Article 57 of the REACH Regulation, in the candidate list of substances and in Annex XIV to that regulation, that latter inclusion is certainly capable of altering the obligations of the persons with an interest in the marketing or use of that substance. It follows from Article 60(2) of the REACH Regulation that, with a number of minor exceptions, an authorisation is to be granted if the risk to human health or the environment from the use of a substance arising from its intrinsic properties, specified in Annex XIV to that regulation, is adequately controlled, something which must be demonstrated by the applicant’s safety report.

76.Prohibiting that same substance from being included, at a later date, in the candidate list of substances for other reasons which were not initially recognised would therefore limit the effectiveness and comprehensiveness of the authorisation procedure, which is the fundamental component of the system regulating chemical substances in the internal market. Were that the case, once a substance was identified as a substance of very high concern, it could not subsequently be included in Annex XIV to the REACH Regulation for reasons that were unknown at the time of the first identification and be subjected to the authorisation procedure in respect of those reasons.

77.In addition, I believe it is common ground that the ECHA could, when it first identifies a chemical substance, include that substance in the candidate list of substances for several reasons set out in Article 57(a) to (f) of the REACH Regulation. If it did so, this would, to my mind, still be a matter of simply including that substance in the candidate list. For the reasons set out above, I do not see why such an operation could not take place in two phases. The ECHA would otherwise be discouraged from immediately including a chemical substance in the candidate list of substances, because it might later transpire that the substance had other intrinsic properties fulfilling the criteria for it to be a substance of very high concern within the meaning of Article 57 of the REACH Regulation. Nevertheless, to postpone the time at which the substance is subjected to the authorisation procedure is, in my view, contrary to the objectives of the REACH Regulation, in so far as that substance could still be marketed or used without having to comply with the obligations arising from inclusion in the candidate list of substances. In that context, it is worth noting that, according to Article 1(1) of the REACH Regulation, its primary purpose is to ensure a high level of protection of human health and the environment.

78.Accordingly, in the light of the unsatisfactory outcome of a literal interpretation of Article 59(8) of the REACH Regulation, and having regard to the unequivocal conclusions that follow from the schematic and teleological interpretation, the appellant’s argument based primarily on a reading of that provision cannot, in my view, succeed.

79.The first branch of the first ground of the appeal must therefore be rejected as being unfounded.

80.By the second branch of its first ground of appeal, the appellant complains that the General Court failed, in particular in paragraphs 85 to 98 of the judgment under appeal, to find that the fact that the Kingdom of Denmark amended its initial proposal was contrary to the decision-making procedure under the REACH Regulation. Specifically, it claims that the General Court erred in law when it found that the Kingdom of Denmark had not replaced its original proposal with a new proposal, but had merely divided that original proposal into eight separate parts, before withdrawing the proposals relating to identification of the three other substances in so far as concerned their effects on the environment, whilst retaining the proposal relating to DEHP.

81.The ECHA argues in its response that the Kingdom of Denmark submitted a dossier for each of the four substances concerned. The General Court, it argues, was therefore right to find that the decision at issue had been adopted in accordance with the requirements set out in Article 59 of the REACH Regulation.

82.In a similar vein, the Kingdom of Denmark states that, during the identification procedure established by Article 59 of the REACH Regulation, no information was added to the four dossiers which it had not submitted originally.

83.In response to the appellant’s argument disputing the process by which the decision at issue was adopted, it should 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, is to ensure that Member States and interested parties to that procedure can 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 the judgment under appeal, 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.

84.Article 59 of the REACH Regulation therefore does not prohibit a Member State from amending or withdrawing its proposals relating to substances which it believes meet the criteria set out in Article 57 of that regulation.

85.In the light of the objective of the procedure for identifying the substances covered by Article 57 of the REACH Regulation, which is to ensure that interested parties are heard, I am inclined to think that making a new proposal, not submitted originally, during that procedure contravenes the provisions of that regulation.

86.A Member State can propose to identify a substance as being of very high concern, on the ground that it has endocrine-disrupting properties, where there is scientific evidence that it could have serious effects on human health within the meaning of Article 57(f) of the REACH Regulation. That State could subsequently propose, in the same procedure, to identify the same substance as being of very high concern, on the ground that it has endocrine-disrupting properties, where there is also scientific evidence that it could have serious effects on the environment. In such a case, there would be a danger that one of the phases of the identification procedure for that proposal could take place without the participation of all the interested parties or may quite simply be omitted.

87.In any event, with the exception of the situation described above, it seems to me that the REACH Regulation does not, in principle, preclude a Member State from amending or withdrawing its proposal relating to the identification of chemical substances. In my view, such an amendment or withdrawal is permitted, provided that it does not have the effect of adding new elements to the original proposal. If it did, the content of the original proposal would be replaced by a new proposal.

88.It is common ground in this regard that, during the procedure which gave rise to the decision at issue, the Kingdom of Denmark did not make a new proposal in the sense described above. As the General Court found in paragraph 88 of the judgment under appeal, it does not emerge from the documents before the General Court that the Kingdom of Denmark completely withdrew its original proposal and that it was necessary to introduce a new proposal. As the General Court noted, that Member State merely divided its initial proposal into eight separate parts. That dividing-up was followed by a partial withdrawal of the proposals relating to the three other substances in so far as those proposals concerned the serious effects on the environment, while the proposal relating to DEHP was maintained.

89.Against that background it must be noted, secondly, that it is the dossiers prepared for the substances and which, according to the Commission or the Member State, meet the criteria set out in Article 57 of the REACH Regulation that are the main subject matter of the initial phase of the authorisation procedure, that is to say, the identification procedure under Article 59 of that regulation.

90.Once they have been prepared, those dossiers are made available to the Member States, which can submit observations on the identification of the substance in question. The same dossiers are then sent to the Member State Committee for which they form the basis of discussion with a view to reaching unanimous agreement in the case of a substance being identified as a substance of very high concern. The identification procedure, as established in Article 59 of the REACH Regulation, is therefore complied with where a dossier is drawn up for each substance and used throughout that procedure.

91.In the present case, as the General Court noted in paragraph 87 of the judgment under appeal, a separate dossier compliant with Annex XV to the REACH Regulation was submitted to the ECHA for each of the four substances covered by the Kingdom of Denmark’s initial proposal.

92.It is not apparent from the judgment under appeal that amendment and partial withdrawal of the Kingdom of Denmark’s initial proposal caused the dossier relating to DEHP to be replaced. The form of that initial proposal was indeed amended, but neither the original proposal by that Member State — to the extent to which it related to identification of DEHP as an endocrine-disrupting substance that may have serious effects on the environment within the meaning of Article 57(f) of the REACH Regulation — nor the dossiers sent to the ECHA were amended.

93.For those reasons, I find the second branch of the first ground of appeal to be unfounded.

94.By the third branch of its first ground of appeal, the appellant criticises the General Court for rejecting, in particular in paragraphs 105 to 132 of the judgment under appeal, its argument that the ECHA’s decision and the procedure conducted by ECHA prior to the adoption of its decision circumvented the legally binding procedure laid down by the Parliament and the Council with a view to ensuring the adoption of harmonised criteria for the identification of endocrine-disrupting substances.

95.On this point, the appellant relies on Decision No 1386/2013/EU, which provides, under priority objective 3, that the European Union will develop harmonised hazard-based criteria for the identification of endocrine disruptors, with a view to developing and implementing approaches to examine combination effects of chemicals and safety concerns related to endocrine disruptors in all relevant EU legislation. According to the appellant, the Commission, in particular, was given responsibility for adopting appropriate measures to achieve the priority objectives under Decision No 1386/2013. The appellant also argues that it is apparent from that decision that the criteria for harmonised application drawn up by the European Union for identifying endocrine-disrupting substances must be implemented having regard for all EU legislation, including the REACH Regulation.

96.The appellant also invokes Regulation (EU) No 528/2012, noting that, under Article 5(3) of that regulation, the Commission was required to adopt, by no later than 13 December 2013, measures specifying scientific criteria for the determination of endocrine-disrupting properties. In the same vein, the appellant points out that, under point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, the Commission was required to present, by no later than 14 December 2013, draft measures concerning specific scientific criteria for the determination of endocrine-disrupting substances.

97.Lastly, referring to the General Court’s findings, in paragraphs 122 and 123 of the judgment under appeal, relating to the roadmap which the Commission published in June 2014, the appellant contends that it did not, before the General Court, advance the thesis that that roadmap was legally binding. By contrast, it did mention that document, in particular in support of its argument that, in cases where EU law does not lay down the generally applicable criteria for identifying endocrine-disrupting substances and where legally binding EU legislation makes the Commission responsible for drawing up those criteria, identification of the substance DEHP under Article 57(c) of the REACH Regulation using the ECHA’s own ad hoc criteria is unlawful and unacceptable.

98.The ECHA, for its part, states in its response that there is no legally binding procedure defined by the Parliament and the Council for suspending application of Article 57(f) of the REACH Regulation in relation to endocrine disruptors.

99.The Kingdom of Denmark and the Kingdom of Sweden take the view that the General Court’s findings on the alleged circumvention of the binding procedure laid down by the Parliament and the Council are not vitiated by any error of law.

100.As regards, first, Decision No 1386/2013 and the development of harmonised hazard-based criteria for the identification of endocrine disruptors, at least at the present stage in the evolution of the system for regulating chemical substances, I believe that this is a matter of a directional or programmatic approach. Indeed, according to the second sentence of the third paragraph of point 50 of the annex to that decision, the European Union ‘will develop’ harmonised criteria.

101.Moreover, analysis of the first and second paragraphs of point 50 of the annex to Decision No 1386/2013 suggests to me that, in the context of that decision, the ‘harmonised criteria’ must be understood as being the criteria that are not intended to replace those already set out in Article 57 of the REACH Regulation and that the ECHA applies in relation to the procedure under Article 59 of that regulation. Under the first sentence of the first paragraph of point 50 of the annex to Decision No 1386/2013, the chemicals legislation, including the REACH Regulation, provides ‘baseline protection for human health and the environment’. Moreover, as is apparent from the first sentence of the second paragraph of point 50 of that annex, efforts need to be stepped up to ensure that all relevant substances of very high concern, including substances with endocrine-disrupting properties, are placed on the candidate list of substances. In any event, even though Decision No 1386/2013 envisages the development of harmonised criteria, in my view this refers to future criteria that will probably be more stringent than those established by the REACH Regulation.

102.Secondly, in relation to Regulation No 528/2012, the General Court acted correctly in stating, in paragraph 109 of the judgment under appeal, that, as is apparent from Article 2(3)(j) thereof, Regulation No 528/2012 applies 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.

103.Thirdly, to my mind the same can be said of point 3.6.5 of Annex II to Regulation No 1107/2009. The General Court correctly found, in paragraphs 117 and 118 of the judgment under appeal, that under that point it is permissible to ascertain whether a substance has 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]’. I note that the use of the word ‘including’ does not mean that the effects of the ECHA’s analyses, carried out in accordance with the REACH Regulation, can be excluded from those ‘other available data and information’.

104.Fourthly and lastly, for the same reasons, I find the appellant’s arguments based on the roadmap published by the Commission in June 2014 to be untenable. As the appellant indicates, that document relates to Regulations No 528/2012 and No 1107/2009. As emerges from points 102 and 103 of this Opinion, the criteria applicable under those regulations cannot at the present time replace the criteria set out and applied under the REACH Regulation.

105.I therefore find that the third branch of the first ground of appeal must be rejected as being unfounded.

106.In the light of the foregoing, the first ground of appeal, comprising its three branches, must, in my view, be rejected in its entirety.

VII. Conclusion

107.For those reasons I propose that the Court should reject the first ground of appeal in its entirety as being unfounded.

(1) Original language: French.

(2) T‑115/15, EU:T:2017:329; ‘the judgment under appeal’.

(3) Regulation 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; ‘the REACH Regulation’).

(4) Judgment of 15 March 2017 (C‑323/15 P, EU:C:2017:207, paragraphs 24 and 25).

(5) Judgment of 15 March 2017 (C‑324/15 P, EU:C:2017:208, paragraphs 24 and 25).

(6) Commission Regulation of 17 February 2011 amending Annex XIV to Regulation No 1907/2006 (OJ 2011 L 44, p. 2).

(7) See Article 55 and recital 22 of the REACH Regulation. On the authorisation procedure, see, also, the Opinion of Advocate General Mengozzi in Polynt v ECHA and Hitachi Chemical Europe and Polynt v ECHA (C‑323/15 P and C‑324/15 P, EU:C:2016:727, points 49 to 51).

(8) Article 59(2), (3) and (5) of the REACH Regulation.

(9) Article 59(6) to (8) of the REACH Regulation.

(10) For a few reflections on the obligations resulting from the inclusion of a substance in the candidate list of substances, see Bergkamp, L., Herbatschek, N., ‘The “Once an Article, Always an Article” Approach: Reflections on the Advocate General’s Opinion on the Concept of “Articles” Under REACH’, European Journal of Risk Regulation, 2015, 6(1), p. 156. Academic writers have also identified other consequences of a chemical substance being included in the candidate list of substances, including the ‘stigmatisation’ of that substance in the market. This is apparent, on the one hand, in the preferences of consumers who try to avoid products containing the ‘stigmatised’ substances and, on the other, in choices made by professionals who tend to stop using such substances. See Nordlander, K., Simon, C.‑M., Pearson, H., ‘Hazard v. Risk in EU Chemicals Regulation’, European Journal of Risk Regulation, 2010, 1(3), p. 248.

(11) Judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207, paragraphs 24 and 25).

(12) Judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA (C‑324/15 P, EU:C:2017:208, paragraphs 24 and 25).

(13) Judgment of 10 September 2015 (C‑106/14, EU:C:2015:576).

(14) Judgment of 15 March 2017 (C‑323/15 P, EU:C:2017:207).

(15) Judgment of 15 March 2017 (C‑324/15 P, EU:C:2017:208).

(16) Judgment of 15 March 2017 (C‑323/15 P, EU:C:2017:207, paragraph 24).

(17) Judgment of 15 March 2017 (C‑324/15 P, EU:C:2017:208, paragraph 24).

(18) Emphasis added.

(19) Judgment of 15 March 2017 (C‑323/15 P, EU:C:2017:207).

(20) Judgment of 15 March 2017 (C‑324/15 P, EU:C:2017:208).

(21) Emphasis added.

(22) Decision 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).

(23) Regulation 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).

(24) Regulation 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).