OPINION OF ADVOCATE GENERAL

TANCHEV

delivered on 24 September 2020(1)

Case C‑471/18 P

Federal Republic of Germany

v

Esso Raffinage SAS,

European Chemicals Agency (ECHA)

(Appeal – Regulation (EC) No 1907/2006 (REACH Regulation) – Articles 41, 42, 50 and 51 – Dossier evaluation – Compliance check of registrations – Statement of non-compliance – Action for annulment – Challengeable act – Standing – Legal basis – Allocation of competences between the European Chemicals Agency (ECHA) and the Member States – Articles 125 and 126 – Enforcement – Articles 13 and 25 – Reduction of animal testing)

Table of contents

I. Introduction

II. Legal framework

III. Background to the proceedings

A. The REACH Regulation and dossier evaluation

B. Events leading to the proceedings before the General Court

IV. Proceedings before the General Court and the judgment under appeal

V. Proceedings before the Court of Justice and the forms of order sought

VI. Analysis

A. First ground of appeal (admissibility of the action)

1. Summary of the arguments of the parties

2. Assessment of the first ground of appeal

(a) Challengeable nature of the contested measure

(1) Admissibility

(2) Substance

(i) ECHA’s powers under Article 42(1) of the REACH Regulation

(ii) The binding legal effects produced by the contested measure

(b) Legal interest

(c) Direct concern

B. Second ground of appeal (application of Article 42(1) of the REACH Regulation)

1. Summary of the arguments of the parties

2. Assessment of the second ground of appeal

(a) The scope of Article 42(1) of the REACH Regulation

(b) The allowance of adaptations to animal testing

(c) Complaints relating to alleged delays and potential abuse

VII. Costs

VIII. Conclusion

I.      Introduction

1.        This case arises out of a dispute between Esso Raffinage SAS (‘Esso Raffinage’) and the European Chemicals Agency (‘ECHA’ or ‘the Agency’) regarding a compliance check of a registration dossier under 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 (2) (‘the REACH Regulation’).

2.        As its name implies, the REACH Regulation aims to establish a comprehensive framework for the regulation of chemicals in the EU, organised around four main elements concerning their registration, evaluation, authorisation and restriction. ECHA is an EU agency created by the REACH Regulation to administer that regulation alongside the European Commission and the Member States.

3.        Within the context of evaluation, the REACH Regulation provides that ECHA is to conduct compliance checks of registrations on chemical substances submitted by manufacturers or importers, in order to verify that they contain all of the required information. According to that regulation, ECHA may take a decision to request a registrant to submit any information needed to bring the dossier into compliance (‘first compliance check decision’), and the registrant must submit that information to ECHA by the deadline set. Yet, the REACH Regulation does not delineate precisely what, if any, procedure ECHA is to follow in situations where it considers that the information submitted is not in conformity with that decision. This is so, in particular, where a registrant attempts to rely on alternative methods, referred to as adaptations as provided for in the REACH Regulation, instead of carrying out animal testing specified in that decision, and ECHA finds them inadequate. Thus, in such situations, ECHA would send a statement of non-compliance to the relevant Member State competent authority, informing it of the outcome of ECHA’s compliance check for enforcement purposes, as was done in the present case.

4.        Esso Raffinage brought an action for annulment before the General Court of the European Union, challenging the legality of ECHA’s letter of 1 April 2015 addressed to the Ministère de l'écologie, du développement durable, des transports et du logement (Ministry of Ecology, Sustainable Development, Transport and Housing, France) as the relevant competent authority in France (‘the French competent authority’), entitled ‘Statement of Non-Compliance following a Dossier Evaluation Decision under Regulation (EC) No 1907/2006’ (‘the contested measure’), which concerned the outcome of ECHA’s compliance check of Esso Raffinage’s registration dossier for a particular chemical substance.

5.        In this appeal, the Federal Republic of Germany, supported by the French Republic and the Kingdom of the Netherlands, asks the Court of Justice to set aside the judgment of 8 May 2018, Esso Raffinage v ECHA (T‑283/15, EU:T:2018:263; ‘the judgment under appeal’) by which the General Court annulled the contested measure. The main thrust of its appeal is that the REACH Regulation does not provide for further examination by ECHA of the conformity of the information submitted with the first compliance check decision, and that this matter falls within the competences of the Member States pursuant to the enforcement provisions of that regulation. In support of its position, it argues that a registrant must conduct animal testing specified in that decision, and cannot submit adaptations at that stage.

6.        The respective applicant and defendant at first instance, Esso Raffinage and ECHA, supported by the European Coalition to End Animal Experiments (‘the ECEAE’), Higher Olefins and Poly Alpha Olefins REACH Consortium (‘HOPA REACH’) and Higher Olefins & Poly Alpha Olefins VZW (‘HOPA’), are in agreement before this Court that the judgment under appeal should be upheld, and that the General Court correctly ruled that ECHA has exclusive competence to assess the conformity of the information submitted with the first compliance check decision, and to take binding decisions in that regard under Article 42(1) of the REACH Regulation, following the procedure set out in Article 41(3) of that regulation. In support of their position, they argue that a registrant must be able to submit adaptations in lieu of performing animal testing specified in the first compliance check decision.

7.        Consequently, the present case offers the Court the opportunity to rule for the first time on the provisions of the REACH Regulation concerning dossier evaluation and in particular on the allocation of competences between ECHA and the Member States for the purposes of assessing the conformity of registration dossiers with the requirements of that regulation. Undoubtedly, this case has considerable practical importance for the functioning of the system put in place by the REACH Regulation. It also has potentially broader implications for the promotion of animal welfare under EU law.

II.    Legal framework

8.        Title VI of the REACH Regulation, entitled ‘Evaluation’, devotes Chapter 1 to ‘Dossier evaluation’ and Chapter 4 to ‘Common provisions’. Chapter 1 includes in particular Articles 41 and 42. Chapter 4 contains in particular Articles 50 and 51.

9.        Article 41 of the REACH Regulation, entitled ‘Compliance check of registrations’, in the version applicable at the relevant time, (3) provides:

‘1.      The Agency may examine any registration in order to verify any of the following:

(a)      that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;

(b)      that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

…

3.      On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51.

4.      The registrant shall submit the information required to the Agency by the deadline set.

5.      To ensure that registration dossiers comply with this Regulation, the Agency shall select a percentage of those dossiers, no lower than 5% of the total received by the Agency for each tonnage band, for compliance checking. …

…’

10.      Article 42 of the REACH Regulation, entitled ‘Check of information submitted and follow-up to dossier evaluation’, provides:

‘1.      The Agency shall examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropriate decisions in accordance with these Articles, if necessary.

2.      Once the dossier evaluation is completed, the Agency shall notify the Commission and the competent authorities of the Member States of the information obtained and any conclusions made. …’

11.      Article 50 of the REACH Regulation, entitled ‘Registrants’ and downstream users’ rights’, states:

‘1.      The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. The Agency in turn shall inform the competent authority of the submission of the comments without delay. The competent authority (for decisions taken under Article 46) and the Agency (for decisions taken under Articles 40 and 41) shall take any comments received into account and may amend the draft decision accordingly.

…’

12.      Article 51 of the REACH Regulation, entitled ‘Adoption of decisions under dossier evaluation’, states:

‘1.      The Agency shall notify its draft decision in accordance with Articles 40 or 41, together with the comments of the registrant, to the competent authorities of the Member States.

2.      Within 30 days of circulation, the Member States may propose amendments to the draft decision to the Agency.

3.      If the Agency does not receive any proposals, it shall take the decision in the version notified under paragraph 1.

4.      If the Agency receives a proposal for amendment, it may modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2.

5.      The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account.

6.      If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the Agency shall take the decision accordingly.

7.      If the Member State Committee fails to reach unanimous agreement, the Commission shall prepare a draft decision to be taken in accordance with the procedure referred to in Article 133(3).

8.      An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 3 and 6 of this Article.’

13.      Title XIV of the REACH Regulation, entitled ‘Enforcement’, contains in particular Articles 125 and 126.

14.      Article 125 of the REACH Regulation, entitled ‘Tasks of the Member States’, states:

‘Member States shall maintain a system of official controls and other activities as appropriate to the circumstances.’

15.      Article 126 of the REACH Regulation, entitled ‘Penalties for non-compliance’, provides:

‘Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. …’

III. Background to the proceedings

16.      The background to the proceedings, as set out in paragraphs 1 to 19 of the judgment under appeal, can be summarised as follows for the purposes of the present case. It is necessary to provide some preliminary observations on the REACH Regulation and dossier evaluation (section A), before turning to the events leading to the proceedings before the General Court (section B).

A.      The REACH Regulation and dossier evaluation

17.      As noted in my introductory remarks, the REACH Regulation is a key legal instrument governing chemical regulation in the EU. As the Court has recognised, under Article 1(1) of the REACH Regulation, the purpose of that regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. (4)

18.      To that end, the REACH Regulation introduces an integrated system for monitoring chemical substances, including registration, evaluation and authorisation, together with possible restrictions on their use. The cardinal principles governing those elements were described by the Commission in its proposal for the REACH Regulation as follows: first, registration ‘requires industry to obtain relevant information on their substances and to use that data to manage them safely’; second, evaluation ‘provides confidence that industry is meeting its obligations and prevents unnecessary testing’; third, authorisation permits specific uses of certain substances of very high concern if the associated risks ‘are adequately controlled, or if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies’; and, fourth, restriction ‘provides a safety net to manage risks that have not been adequately addressed by another part of the REACH system’. (5)

19.      In particular, with regard to registration, the EU legislature, as is apparent from recital 19 of the REACH Regulation, requires manufacturers or importers to provide to ECHA data on their substances, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures. In light of the objective to protect human health and the environment, the registration of substances serves to improve information for the public and professionals down the supply chain as to the risks and thus must be regarded as a means of enhancing that protection. (6)

20.      Specifically, Articles 6 and 7 of the REACH Regulation establish a general obligation for manufacturers or importers whose production or importation of the substance in question equals or exceeds one tonne per year to register that substance with ECHA. Otherwise, a substance which is not duly registered with ECHA cannot be manufactured in the EU or placed on the EU market according to the ‘no data, no market’ rule in Article 5 of that regulation. Pursuant to Articles 10 and 12 of the REACH Regulation, a registrant must submit a registration dossier containing all of the required information, which includes information on the intrinsic properties of the substance under the testing requirements of Annexes VII to X thereto, depending on the applicable tonnage level. A registrant may meet those requirements by submitting information on the relevant study, or, in the alternative, by submitting a specific adaptation (under column 2 of the relevant annex) or a general adaptation involving alternative methods, such as weight of evidence and read-across approaches (under Annex XI to the REACH Regulation).

21.      Evaluation generally concerns the review of the information submitted by manufacturers or importers on chemical substances. Thus, as indicated by recital 20 of the REACH Regulation, it constitutes the follow-up to registration, by allowing for checks whether registrations are in compliance with the requirements of that regulation (dossier evaluation), and if necessary by allowing for generation of more information on the properties of substances (substance evaluation). As such, evaluation under the REACH Regulation comprises two main types: dossier evaluation and substance evaluation. (7)

22.      Dossier evaluation is conducted by ECHA, and is divided into two processes: first, examination of testing proposals under Article 40 of the REACH Regulation and, second, compliance checks of registrations under Article 41 of that regulation, which is at issue here. In that regard, according to Article 41(1) of the REACH Regulation, ECHA may initiate a compliance check of any registration dossier to verify that the relevant information requirements are met, yet under Article 41(5) thereof, ECHA must give priority to dossiers meeting certain criteria, and must select a minimum percentage of dossiers for compliance checking. (8) This check may entail the preparation of a decision by ECHA pursuant to Article 41(3) of the REACH Regulation, requiring a registrant to provide any information to bring the registration into compliance, that is, the first compliance check decision, and that information must be submitted, according to Article 41(4) thereof, to ECHA by the deadline set. For both processes, Article 42(1) of that regulation requires ECHA to examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropriate decisions in accordance with those articles, if necessary.

23.      In contrast, substance evaluation is conducted by the Member State competent authorities in coordination with ECHA, and is concerned not with one particular registration dossier, but rather with all the information available for a given substance suspected of constituting a risk to human health or the environment. (9) It involves two steps: first, the listing of substances to be evaluated on a Community rolling action plan and, second, the evaluation procedure conducted by the relevant Member State competent authority. (10) It may entail a decision prepared by that authority to request a registrant to provide further information, which may extend beyond the existing registration information requirements. (11)

24.      Despite their differences, dossier evaluation and substance evaluation are guided by common provisions concerning, inter alia, registrants’ and downstream users’ rights and the procedure for the adoption of decisions. (12) In particular, under Article 50(1) of the REACH Regulation, a registrant has a right to comment on the draft decision and, pursuant to the procedure elaborated in Article 51 thereof, ECHA takes the decision, unless the Member State Committee within ECHA fails to reach unanimous agreement on draft decisions involving proposed amendments submitted by Member States, in which case the Commission takes the decision in accordance with the applicable comitology procedure. (13)

25.      In that connection, ECHA comprises several entities to carry out its tasks, including a Member State Committee, composed of Member State representatives, which is responsible in particular for resolving potential divergences of opinions on draft decisions in the context of evaluation; (14) a Secretariat, which undertakes, inter alia, the work required under the registration and evaluation procedures; (15) and a Forum for Exchange of Information on Enforcement (‘the Forum’), which coordinates a network of Member State authorities responsible for the enforcement of the REACH Regulation. (16)

B.      Events leading to the proceedings before the General Court

26.      Esso Raffinage is a company established in France. It produces and markets a substance for which it submitted a registration dossier to ECHA (‘the registration dossier’) under the REACH Regulation.

27.      On 9 July 2010, ECHA initiated a compliance check on the registration dossier pursuant to Article 41(1) of the REACH Regulation.

28.      On 28 June 2011, ECHA notified Esso Raffinage of a draft decision on a compliance check concerning the registration dossier, prepared under Article 41(3) of the REACH Regulation, and invited it to provide comments pursuant to Article 50(1) of that regulation. In that decision, ECHA considered that the registration dossier did not comply with all of the relevant information requirements, (17) and requested Esso Raffinage to submit, inter alia, a prenatal developmental toxicity study (‘PNDT study’) on one species, which is a vertebrate animal test. (18)

29.      On 28 July 2011, Esso Raffinage provided its comments on the draft decision. It also updated the registration dossier on 6 September 2011 to address the issues of non-compliance indicated in that decision.

30.      On 14 June 2012, ECHA notified the draft decision, along with Esso Raffinage’s comments, to the Member State competent authorities under Article 51(1) of the REACH Regulation, and invited them to submit proposals for amendment under Article 51(2) of that regulation. That decision indicated that ECHA had amended the draft decision based on Esso Raffinage’s updated registration dossier, deleting, inter alia, the request for a PNDT study on one species involving rats.

31.      On 18 July 2012, ECHA notified Esso Raffinage of the proposals for amendment submitted by certain Member State competent authorities, and invited it to provide comments pursuant to Article 51(5) of the REACH Regulation. In particular, in its proposals for amendment, the competent authority of the Kingdom of Denmark considered that a second-species PNDT study on rabbits was required.

32.      Esso Raffinage did not provide comments on those proposals.

33.      On 30 July 2012, ECHA referred the draft decision to the Member State Committee under Article 51(4) of the REACH Regulation.

34.      At its 25th meeting, held from 19 to 21 September 2012, the Member State Committee reached unanimous agreement on the draft decision, which included, inter alia, the proposal regarding a second-species PNDT study on rabbits. Esso Raffinage was present at that meeting. In particular, it expressed the view that that study was not necessary, whereas members of that committee disagreed.

35.      On 6 November 2012, ECHA issued and notified Esso Raffinage of its ‘decision on a compliance check of a registration pursuant to Article 41(3) of Regulation (EC) No 1907/2006’ (‘the decision of 6 November 2012’), thus constituting the first compliance check decision. In that decision, ECHA considered that the registration dossier was not compliant, and requested Esso Raffinage to submit, within one year, certain information to remedy the situation. That information included, inter alia, a second-species PNDT study on rabbits, along with long-term toxicity testing on sediment organisms.

36.      On 6 November 2013, Esso Raffinage updated the registration dossier in response to the decision of 6 November 2012. In particular, it submitted an adaptation, referred to as a weight of evidence under Annex XI to the REACH Regulation, in place of carrying out the second-species PNDT study on rabbits and the long-term toxicity testing on sediment organisms requested in that decision.

37.      On 1 April 2015, ECHA sent the contested measure to the French competent authority. It included a document entitled ‘Attachment to the statement of non-compliance following a dossier evaluation decision under Regulation (EC) No 1907/2006’ (‘the attachment’).

38.      The contested measure reads in relevant part as follows:

‘Pursuant to Article 41(3) of Regulation (EC) No 1907/2006 (REACH Regulation), the European Chemicals Agency (ECHA) has performed a compliance check on the dossier [on the registered substance]. ECHA has taken the decision [of 6 November 2012] attached to this letter in accordance with the procedure laid down in Articles 50 and 51 of the REACH Regulation.

The decision set a deadline for [Esso Raffinage] to submit the information requested by that decision to ECHA in the form of an updated dossier by 6 November 2013. An update of the dossier was submitted on 6 November 2013 …

ECHA has examined the information submitted in the updated dossier. In conclusion, the updated registration dossier does not contain all the information requested by the ECHA decision. A respective analysis of the reasons for this conclusion is enclosed …

On this basis ECHA states that:

–        [Esso Raffinage] has not met the obligations following from [the decision of 6 November 2012];

–        The registration dossier is not in compliance with Article 5 of the REACH Regulation; and

–        [Esso Raffinage] is in breach of Article 41(4) of the REACH Regulation.

The non-compliance with ECHA’s decision and the REACH Regulation may be subject to enforcement actions by the national authorities of the Member States as established in Article 126 of the REACH Regulation.

On this matter you are therefore asked to address the non-compliance in your own competence by means of enforcement to execute ECHA’s decision.

ECHA expects that the further communication on the non-compliance with ECHA’s decision is taking place between the registrant and the [French] Authorities until the case is resolved. When [Esso Raffinage] submits an update of [its] registration in response to the decision, [it] is expected to inform the [French] Authorities on this fact.

ECHA is looking forward to receiving your feedback concerning national actions taken on this case of non-compliance.’

39.      The attachment sets out ECHA’s reasons for concluding, inter alia, that the weight of evidence submitted by Esso Raffinage in place of the requested second-species PNDT study on rabbits and long-term toxicity testing on sediment organisms was not acceptable.

IV.    Proceedings before the General Court and the judgment under appeal

40.      On 29 May 2015, Esso Raffinage brought an action for annulment against the contested measure before the General Court.

41.      ECHA claimed that the action should be dismissed.

42.      By orders of 7 June 2016, the President of the Fifth Chamber of the General Court granted the Federal Republic of Germany, the French Republic and the Kingdom of the Netherlands leave to intervene in support of the form of order sought by ECHA.

43.      By the judgment under appeal, the General Court held the action to be admissible, upheld the first plea raised by Esso Raffinage and annulled the contested measure.

44.      First, the General Court held that the contested measure was a challengeable act under Article 263 TFEU, finding that it produced binding legal effects as regards Esso Raffinage and the French Republic (paragraphs 49 to 83 of the judgment under appeal).

45.      Second, the General Court held that Esso Raffinage was directly and individually concerned by the contested measure, such that it had standing under the fourth paragraph of Article 263 TFEU (paragraphs 91 to 97 of the judgment under appeal).

46.      Third, on the merits, the General Court upheld the first plea raised before it, alleging that the contested measure was ultra vires and adopted in breach of Article 42(1) of the REACH Regulation (paragraphs 107 to 117 of the judgment under appeal). Taking the view that ECHA adopted the contested measure without complying with the relevant rules as provided for in Articles 41, 42 and 51 of the REACH Regulation, the General Court annulled the contested measure. (19)

V.      Proceedings before the Court of Justice and the forms of order sought

47.      By the present appeal, lodged on 18 July 2018, the Federal Republic of Germany claims that the Court should set aside the judgment under appeal, dismiss the action brought by Esso Raffinage and order Esso Raffinage to pay the costs at first instance and on appeal.

48.      The French Republic and the Kingdom of the Netherlands, interveners at first instance in support of ECHA, support the form of order sought by the Federal Republic of Germany.

49.      Esso Raffinage claims that the Court should dismiss the appeal, order the Federal Republic of Germany to pay the costs and take any other measure as justice may require.

50.      ECHA claims that the Court should dismiss the appeal and order the Federal Republic of Germany to pay the costs.

51.      By order of the President of the Court of 12 March 2019, (20) the ECEAE, HOPA REACH and HOPA were granted leave to intervene in support of the form of order sought by Esso Raffinage.

52.      On 3 April 2020, the Court requested the main parties to express their views on the possibility of foregoing a hearing, which had been originally scheduled for 29 April 2020, but postponed due to the Covid‑19 pandemic. In light of the responses received, on 24 April 2020, the Court decided that a hearing would not be held, and invited the main parties to submit a written reply to the questions put to them for the hearing. ECHA, Esso Raffinage, the Federal Republic of Germany and the French Republic each submitted such a reply.

VI.    Analysis

53.      The Federal Republic of Germany raises two grounds of appeal. The first ground of appeal is directed at the General Court’s findings concerning the admissibility of the action. The second ground of appeal is directed at the General Court’s substantive findings concerning the application of Article 42(1) of the REACH Regulation.

54.      For the reasons set out below, I consider that the two grounds of appeal are unfounded in law and that the appeal should be dismissed.

A.      First ground of appeal (admissibility of the action)

1.      Summary of the arguments of the parties

55.      By the first ground of appeal, the Federal Republic of Germany, supported generally by the Kingdom of the Netherlands and in more detail by the French Republic, contends that the General Court erred in law, in paragraphs 67, 69 to 72, 81, 82 and 91 of the judgment under appeal, in declaring the action brought by Esso Raffinage admissible.

56.      First, the Federal Republic of Germany claims that the General Court erred in law by holding that the contested measure constitutes a challengeable act under the first paragraph of Article 263 TFEU. In its view, that measure has no decision-making effect and is only a statement of an informational nature. This is because, first, ECHA did not intend to give binding effects to the contested measure at the time when it was produced; second, its wording demonstrates that it has no binding effects as regards Esso Raffinage and the French authorities; third, its context within the REACH system for dossier evaluation confirms its non-binding nature, as it represents an informal practice between ECHA and the Member States; and, fourth, it is not based on Article 42(1) of the REACH Regulation, but rather is taken within the scope of the general support required of ECHA under Article 77(1) of the REACH Regulation. This is reinforced, in its view, by Article 22(2) and (3) of the REACH Regulation, which, read in conjunction with Article 20(2) thereof, shows that Article 42(1) of that regulation does not conclusively govern the examination of information submitted in response to the first compliance check decision.

57.      Second, the Federal Republic of Germany submits that the General Court erred in law by failing to appreciate that Esso Raffinage has no legal interest in bringing proceedings, since the contested measure does not impose new obligations on Esso Raffinage as to adversely affect its position. It claims that the decision of 6 November 2012 already required Esso Raffinage to provide information by a given time limit, and failure to comply with that obligation created, in itself, a situation of non-compliance which exposed Esso Raffinage to the possibility that enforcement measures could be executed against it.

58.      Third, the Federal Republic of Germany contends, in the alternative, that the General Court erred in law by holding that Esso Raffinage was directly concerned by the contested measure within the meaning of the fourth paragraph of Article 263 TFEU. It argues that since the Member States have discretion regarding the enforcement of the first compliance check decision, the implementation of that decision does not result exclusively from EU rules, and involves intermediate rules based on national law.

59.      The Federal Republic of Germany adds that the General Court’s assessment of the allocation of competences between ECHA and the Member States is incorrect. It does not dispute that ECHA has exclusive competence with regard to dossier evaluation procedures within the meaning of Article 41 of the REACH Regulation. However, in its view, that does not preclude Member States from identifying failures to comply with the registration requirements in the context of their enforcement activities under the REACH Regulation; otherwise, it would not be possible for chemical oversight under the REACH Regulation to operate in an orderly manner.

60.      Esso Raffinage contends that the first ground of appeal is inadmissible and unfounded.

61.      First, Esso Raffinage claims that the General Court did not err in law in holding that the contested measure is a challengeable act under Article 263 TFEU. It submits that the arguments raised by the Federal Republic of Germany essentially seek a new assessment of the relevant facts and evidence, without asserting any distortion thereof, and are thus inadmissible. In any event, it claims that such arguments are unfounded, since the General Court fully considered the subjective understanding of the parties, the wording and the context of the contested measure in finding that it produced binding legal effects. In its view, that measure can only be based on Article 42(1) of the REACH Regulation; it is not general advice rendered by ECHA under Article 77 of that regulation, nor is it related to ECHA’s completeness check of the registration dossier under Articles 20 and 22 thereof, especially as that check was completed long beforehand. (21) It emphasises that the General Court’s finding that ECHA has exclusive competence to evaluate the compliance of registration dossiers under Articles 41 and 42 of the REACH Regulation is supported in particular by the objectives and origins of that regulation.

62.      Second, Esso Raffinage submits that the General Court correctly ruled that the contested measure imposed new obligations on Esso Raffinage, adversely affecting its position. This is because ECHA found for the first time in that measure that Esso Raffinage was in breach of its obligations under the REACH Regulation, and it was only ECHA’s finding that the adaptation was inadequate which produced legal effects requiring it to carry out the animal testing requested.

63.      Third, Esso Raffinage refutes the existence of any error of law regarding the General Court’s findings that it was directly concerned by the contested measure. It argues that that measure contained a finding of infringement of obligations which directly affected its legal situation, and left no discretion to the French authorities in that regard.

64.      ECHA considers that the first ground of appeal is unfounded.

65.      First, ECHA contends that it was on the basis of a correct analysis of the applicable legal framework and ECHA’s competences that the General Court determined the binding nature of the contested measure. In its view, based on the wording and origins of Articles 41 and 42 of the REACH Regulation, the EU legislature intended to confer exclusive competence on ECHA to perform compliance checks of registration dossiers, and if Member States were given responsibility for carrying out such checks, this could lead to possible conflicts between decisions taken by ECHA and the Member States.

66.      Second, ECHA submits that the General Court committed no error of law in finding that the contested measure produced direct and binding legal effects on Esso Raffinage’s legal situation. In particular, it submits that that measure was not taken within the scope of ECHA’s general advisory tasks under Article 77 of the REACH Regulation. Nor was it the outcome of a completeness check under Article 22(2) and (3) of that regulation, since it contained a qualitative assessment of the kind excluded by Article 20(2) thereof.

67.      Third, ECHA claims that the contested measure established new obligations for Esso Raffinage. It points out that that measure contained ECHA’s new assessment of an adaptation submitted in response to the first compliance check decision, which was not present in the registration dossier at the time that ECHA took that decision. Thus, in its view, given that the contested measure rejected the adaptation and required Esso Raffinage to perform the requested tests, Esso Raffinage has a legal interest in seeking its annulment.

68.      The ECEAE supports the arguments of Esso Raffinage and ECHA.

69.      In particular, the ECEAE submits that, in so far as the General Court properly characterised the contested measure as a decision under Article 42(1) of the REACH Regulation, it follows that the criteria for admissibility and standing are met, as that measure can be considered to produce direct and binding legal effects on Esso Raffinage’s position. It also points out that the completeness check decision issued by ECHA indicated its intention to assess the compliance of the information submitted under Article 42(1) of the REACH Regulation.

70.      HOPA REACH and HOPA also support the arguments of Esso Raffinage and ECHA.

71.      In particular, HOPA REACH and HOPA contend that the evaluation of registration dossiers under the REACH Regulation must be subject to a centralised process falling within the exclusive competence of ECHA, as compared to the procedure for the evaluation of substances, which involves the Member State competent authorities. They emphasise that if Member States could conduct their own compliance checks of registration dossiers, this is likely to result in inconsistent decisions by ECHA and the national authorities, and would make compliance with the REACH Regulation difficult for registrants.

2.      Assessment of the first ground of appeal

72.      By the first ground of appeal, the Federal Republic of Germany contends that the General Court erred in law in holding that the action for annulment brought by Esso Raffinage was admissible.

73.      In essence, this ground is divided into three parts. In the first part, the Federal Republic of Germany contests the General Court’s legal assessment that the contested measure is a challengeable act for the purposes of Article 263 TFEU (section a). In the second part, the Federal Republic of Germany calls into question the General Court’s legal assessment that Esso Raffinage was adversely affected by the contested measure for the purposes of having a legal interest in bringing proceedings under Article 263 TFEU (section b). In the third part, the Federal Republic of Germany criticises the General Court for having misinterpreted the requirement of direct concern laid down in the fourth paragraph of Article 263 TFEU (section c).

(a)    Challengeable nature of the contested measure

74.      The first part of the first ground of appeal is based on the claim that the contested measure is a non-binding act and thus cannot be challenged under the first paragraph of Article 263 TFEU, which permits the Court to review the legality of acts of EU institutions and bodies ‘intended to produce legal effects vis-à-vis third parties’, that is to say, binding acts.

(1)    Admissibility

75.      It should be pointed out at the outset that Esso Raffinage’s arguments challenging the admissibility of the first part of the first ground of appeal (see point 61 of this Opinion) cannot succeed.

76.      Under established case-law, provided that the appellant challenges the interpretation or application of EU law by the General Court, the points of law examined at first instance may be discussed again in the course of an appeal. Indeed, if an appellant could not base his or her appeal on pleas in law and arguments already relied on before the General Court, an appeal would be deprived of part of its purpose. (22) Moreover, where the General Court has determined or assessed the facts, the Court of Justice has jurisdiction on appeal to review their legal characterisation and the legal conclusions which were drawn therefrom. (23)

77.      In the present case, by the first part of the first ground of appeal, the Federal Republic of Germany specifically seeks to challenge the legal reasoning which led the General Court to hold that the contested measure produced binding legal effects as regards Esso Raffinage and the French Republic. Thus, it criticises the consequences in law drawn from the judgment under appeal with regard to the challengeable nature of the contested measure under Article 263 TFEU, which constitutes a point of law subject to review by the Court of Justice on appeal. (24)

78.      Therefore, in my view, the first part of the first ground of appeal is admissible.

(2)    Substance

79.      It should be recalled that, according to settled case-law, which was mentioned in paragraphs 49 to 51 of the judgment under appeal, an action for annulment is available against all measures adopted by EU institutions and bodies, whatever their nature or form, which are intended to have binding legal effects capable of affecting the interests of natural or legal persons by bringing about a distinct change in their legal position. (25) In order to determine whether such a measure produces binding legal effects, it is necessary to examine the substance of that measure and to assess those effects on the basis of objective criteria, such as the content of that measure, taking into account, as appropriate, the context in which it was adopted and the powers of the EU institution or body which adopted it. (26) The intention of the author of the measure concerned may also be taken into account in that regard. (27)

80.      Having regard to that case-law, I observe that the first part of the first ground of appeal raises novel and complex questions relating to the extent of ECHA’s powers under Article 42(1) of the REACH Regulation, which permeate all aspects of this appeal. Indeed, the issue, as a matter of admissibility, whether ECHA may take the contested measure pursuant to Article 42(1) of the REACH Regulation for the purposes of ascertaining whether that measure produces binding legal effects, along with Esso Raffinage’s interest and standing as challenged in this appeal, coincides with the issue, as a matter of substance, whether Article 42(1) of the REACH Regulation can serve as the proper legal basis for the contested measure, which is also disputed in this appeal. Thus, the ruling which the Court is called upon to give on the first part of the first ground of appeal will dictate to a great extent its rulings on the other complaints raised in this appeal. (28)

81.      Accordingly, I will first examine the extent of ECHA’s powers under Article 42(1) of the REACH Regulation to adopt the contested measure (section i). I will then consider whether binding legal effects are produced by that measure (section ii).

(i)    ECHA’s powers under Article 42(1) of the REACH Regulation

82.      The General Court ruled, in paragraphs 54 to 61 of the judgment under appeal, that, having regard to the applicable legal framework and the allocation of competences between ECHA and the Member States, ECHA is solely competent to initiate a compliance check of a registration dossier under Article 41 of the REACH Regulation, and to assess the conformity of the information submitted in response to the first compliance check decision under Article 42(1) of that regulation, as part of the same, single procedure. It is rather for the Member States under Article 126 of the REACH Regulation to impose appropriate sanctions on registrants who have been held in breach of their obligations pursuant to Article 42(1) of that regulation.

83.      In my view, those findings are not vitiated by an error of law.

84.      It should be recalled that Article 41(1) of the REACH Regulation provides that ECHA may initiate a compliance check of any registration dossier in order to verify that the relevant information requirements are met. This check may entail a decision prepared by ECHA on the basis of Article 41(3) of the REACH Regulation, requesting a registrant to submit any information needed to bring the registration into compliance, that is, the first compliance check decision, which is adopted according to the procedure laid down in Articles 50 and 51 of that regulation. Article 42(1) of the REACH Regulation states that ECHA ‘shall examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropriate decisions in accordance with these Articles, if necessary’.

85.      It therefore follows from its wording that Article 42(1) of the REACH Regulation requires ECHA to examine any information submitted to it by a registrant, such as Esso Raffinage, in response to, in particular, the first compliance decision taken under Article 41(3) of that regulation, such as the decision of 6 November 2012, and to draft any appropriate decisions in accordance with Article 41 of that regulation.

86.      Admittedly, Article 42(1) of the REACH Regulation does not explicitly state that ECHA may adopt a decision on compliance or non-compliance in response to the first compliance check decision. Nevertheless, Article 41(3) of the REACH Regulation refers, in turn, to the procedure laid down in Article 51 of that regulation, which concerns the ‘adoption of decisions under dossier evaluation’. Thus, it may be considered on the basis of the combined interpretation of Articles 41, 42 and 51 of the REACH Regulation that ECHA has been conferred decision-making power which may lead to binding decisions that a registrant has infringed its obligations under the REACH Regulation by submitting non-compliant information, as in the present case.

87.      Furthermore, there are strong indications, in light of the wording, context, origins and objectives of Articles 41 and 42(1) of the REACH Regulation, that ECHA has exclusive competence under those provisions to initiate the compliance check of registration dossiers and to evaluate the conformity of the information submitted in response to the first compliance check decision.

88.      First, having regard to their wording as just mentioned, along with their titles, Article 41 (‘Compliance check of registrations’) and Article 42(1) (‘Check of information submitted…’) of the REACH Regulation appear to represent a single procedure for compliance checks of registration dossiers in the context of dossier evaluation, involving the first compliance check decision and the assessment of the information submitted in response to that decision, which is carried out by ECHA.

89.      By contrast, under Articles 125 and 126 of the REACH Regulation, Member States have been given the central role of enforcing that regulation, and, in principle, it is within the competence of each Member State to decide how to carry out the relevant enforcement measures for the provisions of that regulation. (29) However, there is nothing to suggest on the basis of those articles that Member States are tasked with carrying out their own assessments of the conformity of registration dossiers with the requirements of the REACH Regulation in the circumstances of the present case, in which there is a single procedure for compliance checks of registration dossiers involving ECHA. To interpret Articles 125 and 126 of the REACH Regulation to that effect would be liable to undermine the competence conferred on ECHA under Article 42(1) of that regulation to examine the conformity of any information submitted by a registrant in response to the first compliance check decision, and thus to empty Article 42(1) of the REACH Regulation of its substance.

90.      This interpretation is consistent with the context of Articles 41 and 42(1) of the REACH Regulation. In particular, Article 46 of the REACH Regulation, concerning substance evaluation, combines ‘requests for further information and check of information submitted’ in the same provision, which suggests that the two elements are part of the same procedure, as distinguished from Article 48 of that regulation on ‘follow-up to substance evaluation’ once that evaluation has been completed, which is comparable to Article 42(2) thereof.

91.      Moreover, Articles 41 and 42(1) of the REACH Regulation do not mention Member State competent authorities conducting compliance checks of registration dossiers within dossier evaluation, (30) as compared to the provisions on substance evaluation, such as Articles 45 and 46 of the REACH Regulation, which expressly task those authorities with carrying out the evaluation of substances and preparing decisions requesting further information from registrants in that regard. This is apparent from other provisions of the REACH Regulation in the context of evaluation. For example, Article 50(1) of the REACH Regulation, which concerns registrants’ and downstream users’ rights, refers to the relevant Member State competent authority for decisions taken in the context of substance evaluation, and to ECHA for decisions taken in the context of dossier evaluation.

92.      This interpretation is also in line with the origins of Articles 41 and 42(1) of the REACH Regulation. Indeed, one of the key points extensively discussed in the decision-making process leading to the adoption of the REACH Regulation was whether ECHA or the Member States should be responsible for evaluation. (31) In the Commission’s proposal, the Member State competent authorities were initially given responsibility for both dossier and substance evaluation. (32) In its first reading of that proposal, the European Parliament, (33) along with the European Economic and Social Committee, (34) supported a stronger role for ECHA in evaluation, covering both dossier and substance evaluation. In the Council’s common position, the responsibility for dossier evaluation (both for checking testing proposals and for compliance checks) was transferred to ECHA, whereas ECHA was responsible for coordinating the substance evaluation process relying on the Member State competent authorities to perform the evaluations. (35) This arrangement was maintained in the final text as adopted. Thus, it may be inferred from the rejection of the Commission’s proposal and the agreement to transfer competence to ECHA concerning dossier evaluation without reservation that the EU legislature intends for ECHA to have exclusive competence over the evaluation of registration dossiers, which may be considered to include all stages of the procedure.

93.      Lastly, there are grounds for considering that this interpretation is consonant with the objectives of the REACH Regulation. In particular, it appears consistent with the role played by evaluation in the REACH Regulation and the objectives pursued by that regulation to protect human health and the environment whilst ensuring the free circulation of substances on the internal market that there is a centralised process administered by ECHA for the assessment of the conformity of registration dossiers.

94.      As indicated by Article 75 of the REACH Regulation, read in conjunction with recital 15 thereof, ECHA is envisaged to be a central entity to ensure the effective management of the technical, scientific and administrative aspects of the REACH Regulation at the EU level, (36) which would seem to be particularly important in the context of dossier evaluation. This is suggested by recital 65 of that regulation, which states that ‘it is necessary to instil confidence in the general quality of registrations and to ensure that the public at large as well as all stakeholders in the chemicals industry have confidence that natural and legal persons are meeting the obligations placed upon them’, and for this reason a certain percentage of registration dossiers must be checked for compliance by ECHA under Article 41(5) of that regulation. (37)

95.      In addition, as indicated by ECHA, Esso Raffinage, the ECEAE, HOPA REACH and HOPA, letting Member States conduct their own assessments of the conformity of registration dossiers with the first compliance check decision would seem to me to invite the risk of coordination problems and inconsistencies between decisions taken by ECHA and those by national authorities, which would be liable to preclude the effectiveness of the procedure for the evaluation of registration dossiers put in place by the REACH Regulation.

(ii) The binding legal effects produced by the contested measure

96.      In light of its findings concerning the allocation of competences between ECHA and the Member States in the matter, the General Court held, in paragraphs 64 to 72 of the judgment under appeal, that, having regard to its content, the contested measure corresponded to a decision which ECHA was required to prepare pursuant to Article 42(1) of the REACH Regulation and which should have been adopted on the basis of Article 41(3) of that regulation. Therefore, that measure had binding legal effects on Esso Raffinage’s legal situation because it constituted ECHA’s definitive assessment that the information submitted in response to the decision of 6 November 2012 was non-compliant and that Esso Raffinage was in breach of its obligations under that decision and the REACH Regulation. That measure also had binding legal effects on the French Republic, since it contained findings from which the French authorities could not generally depart.

97.      The General Court further considered, in paragraphs 74 to 79 of the judgment under appeal, that ECHA’s intention not to adopt a binding act was of subsidiary importance, and the fact that the contested measure was situated in the context of an informal system of cooperation between ECHA and the Member States could not call into question the allocation of competences under the REACH Regulation.

98.      In my view, no error in law is discernible in those findings.

99.      With regard to its content, as seen in points 38 and 39 of this Opinion, the contested measure states that ECHA examined the information submitted by Esso Raffinage in response to the decision of 6 November 2012, and concluded that it had not provided all of the information requested. On that basis, ECHA considered that Esso Raffinage had not met its obligations under that decision, that the registration dossier did not comply with Article 5 of the REACH Regulation and that Esso Raffinage was in breach of Article 41(4) thereof. ECHA invited the French Republic to take enforcement measures under Article 126 of the REACH Regulation as regards Esso Raffinage’s non-compliance with ECHA’s decision and the REACH Regulation.

100. As the General Court, correctly in my view, pointed out in paragraphs 67 to 72 of the judgment under appeal, in light of the powers conferred on ECHA under Article 42(1) of the REACH Regulation, the contested measure is in substance more than an opinion or a communication of information. Rather, that measure constitutes ECHA’s definitive analysis of non-compliance, which produced binding legal effects as regards Esso Raffinage, namely that its registration dossier was not in conformity with the ‘no data, no market’ rule in Article 5 of the REACH Regulation, which prohibits a registrant from manufacturing in the EU or placing on the EU market a chemical substance which has not been duly registered (see point 20 of this Opinion), and that it infringed its obligation to submit the required information in the first compliance check decision under Article 41(4) of that regulation. Likewise, the contested measure produced binding legal effects as regards the French Republic, in so far as that Member State cannot deviate from the assessment carried out by ECHA and conduct its own analysis for the purposes of its enforcement activities under Articles 125 and 126 of the REACH Regulation.

101. On that basis, the arguments advanced by the Federal Republic of Germany that the contested measure was taken in the context of ECHA’s advisory tasks under Article 77 of the REACH Regulation are not convincing. Article 77(1) of that regulation states as a general matter that ECHA is to provide the Member States and the EU institutions ‘with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation’.

102. Despite the reference to advice in that provision, it is apparent that ECHA has been given powers to take decisions with binding legal effects on natural and legal persons in specific procedures under the REACH Regulation. (38) Indeed, Article 77(2)(c) of that regulation states that the Secretariat is to perform the tasks allotted to it under Title VI of the REACH Regulation on evaluation, which, in accordance with Article 76(1)(g) thereof, involves in particular ‘the work required of the Agency’ under the evaluation procedure, thereby including decisions taken by ECHA in the context of the evaluation of registration dossiers. It should be added that the contested measure does not mention Article 77 of the REACH Regulation, but rather refers to the fact that the assessment of the information submitted is conducted in consequence of the decision of 6 November 2012 taken on the basis of Article 41(3) of that regulation. Thus, the contested measure in substance represents a decision which should have been taken on the basis of Article 42(1) thereof.

103. Contrary to the arguments advanced by the Federal Republic of Germany, Article 22(2) and (3) of the REACH Regulation does not invalidate this analysis. Situated within the context of registration, Article 22(2) and (3) of the REACH Regulation specifies that a registrant must submit to ECHA an update of the registration dossier containing the information requested, inter alia, by the first compliance check decision based on Article 41(3) of that regulation, and that ECHA conducts a completeness check of that dossier according to Article 20(2) thereof. Under Article 20(2) of the REACH Regulation, ECHA must undertake a completeness check of each registration in order to verify that all of the information requirements are filled, but it does not review the quality or adequacy of the information submitted.

104. It follows that the completeness check of updates of registration dossiers under Articles 20 and 22 of the REACH Regulation may constitute a step along the way to the dossier evaluation process, but there is nothing to suggest from those provisions that Article 42(1) of that regulation cannot be the basis of the contested measure. Rather, they direct attention to the fact that a qualitative assessment of the information submitted in response to the first compliance check decision should be taken pursuant to Article 42(1) of the REACH Regulation, as illustrated by the completeness check decision in the present case. (39)

105. With regard to the context of the contested measure, it should be pointed out that, as explained in paragraph 42 of the judgment under appeal, that measure is part of an informal practice agreed upon between ECHA and the Member State competent authorities within the Forum (see point 25 of this Opinion), whereby ECHA would inform the Member States of its opinion regarding situations of non-compliance, whilst leaving them free to take a different position.

106. Consequently, as the General Court, rightly in my view, held in paragraphs 77 and 78 of the judgment under appeal, that informal practice cannot undermine the allocation of competences established by the REACH Regulation. As mentioned in point 89 of this Opinion, such a practice would effectively deprive ECHA of the competence conferred on it under Article 42(1) of the REACH Regulation regarding the evaluation of registration dossiers. In those circumstances, it seems to me that such a practice does not invalidate the binding nature of the contested measure.

107. With regard to ECHA’s intention not to adopt a binding act, it should be considered that the General Court, in paragraphs 74 and 75 of the judgment under appeal, took due account of this aspect, while attaching lesser importance to it than the other criteria set out in the Court of Justice’s case-law (see point 79 of this Opinion), namely the content of the contested measure and the powers attributed to ECHA under the REACH Regulation. It might be added that, as indicated by the ECEAE, the completeness check decision indicates ECHA’s intention to examine the information submitted by Esso Raffinage in response to the decision of 6 November 2012 under Article 42(1) of the REACH Regulation. (40)

108. In light of the foregoing considerations, I propose that the first part of the first ground of appeal should be rejected as unfounded.

(b)    Legal interest

109. By the second part of the first ground of appeal, the Federal Republic of Germany alleges that Esso Raffinage lacked a legal interest in bringing proceedings due to the fact that the contested measure did not have adverse effects on its legal position in addition to those already resulting from the decision of 6 November 2012.

110. The General Court held, in paragraphs 81 and 82 of the judgment under appeal, that the contested measure contained a new assessment conducted by ECHA relating to the information put forward by Esso Raffinage in response to the decision of 6 November 2012, which had not previously been considered by ECHA.

111. In my view, no error of law is discernible in those findings.

112. In line with my analysis propounded in point 100 of this Opinion, the contested measure constituted ECHA’s definitive assessment based on Article 42(1) of the REACH Regulation that the information submitted by Esso Raffinage in response to the decision of 6 November 2012 was inadequate and that Esso Raffinage had infringed its obligations under that regulation. That measure thus contained new findings and conclusions by ECHA regarding the non-compliance of the adaptations to the animal testing specified in the first compliance check decision. On that basis, it should be considered that Esso Raffinage clearly has a legal interest in seeking the annulment of the contested measure since it adversely affected its position.

113. I therefore propose that the second part of the first ground of appeal should be rejected as unfounded.

(c)    Direct concern

114. By the third part of the first ground of appeal, the Federal Republic of Germany alleges, in the alternative, that Esso Raffinage is not directly concerned by the contested measure because it requires national implementing measures.

115. Under the fourth paragraph of Article 263 TFEU, natural or legal persons may institute proceedings against, inter alia, an EU measure which is not addressed to them if that measure is of direct and individual concern to them. (41)

116. According to settled case-law, which was mentioned in paragraph 91 of the judgment under appeal, the requirement that the measure forming the subject matter of the proceedings must be of direct concern to a natural or legal person requires the fulfilment of two cumulative criteria: first, the measure must directly affect the legal situation of the natural or legal person and, second, the measure must leave no discretion to the addressees who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from EU rules alone without the application of other intermediate rules. (42)

117. The General Court held, in paragraphs 92 to 94 of the judgment under appeal, that, with respect to the first criterion, the contested measure directly affected Esso Raffinage’s legal situation because it set out ECHA’s assessment of whether the registration dossier was compliant, having regard to the information submitted in response to the decision of 6 November 2012. The second criterion was also met, given that Member States have no discretion concerning the finding in itself of a failure to comply with the obligations arising under that decision and the REACH Regulation.

118. In my view, no error of law is discernible in those findings.

119. On the basis of the analysis advanced in points 85 to 95 and 100 of this Opinion, I consider it clear that in the present case both criteria for direct concern are satisfied. First, the contested measure directly affects Esso Raffinage’s legal situation, since it constitutes a measure with binding legal effects as regards Esso Raffinage’s non-compliance with its obligations under the first compliance check decision and the REACH Regulation. Second, the implementation of the contested measure is automatic and leaves no room for discretion on the part of the Member States regarding the assessment of non-compliance, as that assessment is undertaken solely by ECHA under Article 42(1) of the REACH Regulation and thus does not rest on provisions of national law with regard to enforcement.

120. I therefore propose that the third part of the first ground of appeal should be rejected as unfounded.

B.      Second ground of appeal (application of Article 42(1) of the REACH Regulation)

1.      Summary of the arguments of the parties

121. By the second ground of appeal, the Federal Republic of Germany, supported generally by the Kingdom of the Netherlands and in more detail by the French Republic, contends that the General Court erred in law, in paragraphs 57, 58, 60 to 63, 71, 78, 108 and 112 of the judgment under appeal, by incorrectly applying Article 42(1) of the REACH Regulation.

122. First, the Federal Republic of Germany submits that Article 42(1) of the REACH Regulation relates to situations involving a request for further, additional information after the requested information in the first compliance check decision has been supplied. Thus, that provision is not applicable to cases such as the present one, involving non-compliance with that decision.

123. Second, the Federal Republic of Germany claims that the REACH Regulation does not provide for any further examinations in the context of the evaluation of registration dossiers and Article 42(1) of that regulation cannot be interpreted to that effect. In particular, such an interpretation undermines the objective of the REACH Regulation to protect human health and the environment by causing delays during which time dangerous chemicals can be marketed in the EU.

124. Third, the Federal Republic of Germany contends that adaptations in place of animal testing can only be assessed at the stage of the first compliance check decision taken under Article 41(3) of the REACH Regulation. In its view, the principle that animal testing must be undertaken as a last resort in Article 25(1) of the REACH Regulation does not come into play if the first compliance check decision requires animal testing to be performed and that decision has become final. It argues that the General Court’s approach, whereby ECHA is not required to assess adaptations pursuant to Article 42(1) of the REACH Regulation if the registrant relies on manifestly unreasonable elements, is not laid down in the REACH Regulation and is impracticable, since it makes enforcement difficult, causes uncertainties for all parties involved and carries the potential for abuse.

125. Fourth, the Federal Republic of Germany asserts that the General Court’s approach departs from general EU administrative law because an addressee of a decision cannot require EU institutions and bodies to reconsider a lawfully issued decision which has become final. This is so, especially as regards decisions on the evaluation of registration dossiers, which are taken by ECHA in concert with the Member States and based on a comprehensive balancing of interests, as the REACH Regulation does not provide for such decisions to be subsequently called into question.

126. Fifth, the Federal Republic of Germany argues that the General Court’s approach is likely to prolong the review of registration dossiers concerning substances of particular relevance which ECHA selects for compliance checking under Article 41(5) of the REACH Regulation.

127. Esso Raffinage contends that the second ground of appeal is unfounded.

128. First, Esso Raffinage submits that the interpretation of Article 42(1) of the REACH Regulation advanced by the Federal Republic of Germany is contrary to the wording of that provision, which covers the evaluation of any information submitted to ECHA in response to the first compliance check decision, thereby including the situation arising in the present case. It is also inconsistent with the context of Article 42(1) of the REACH Regulation and in particular Articles 41(3) and 42(2) thereof, which are chronologically applicable before and after it.

129. Second, Esso Raffinage asserts that the examination of information submitted in response to the first compliance check decision is not a re-examination of that decision. Thus, the arguments drawn from general EU administrative law are irrelevant. Moreover, it contends that the Federal Republic of Germany’s concerns about alleged delays and potential abuse are unfounded, given that the General Court outlined situations in which a decision under Article 42(1) of the REACH Regulation would be unnecessary and enforcement actions could be taken against retrospective breaches of the REACH Regulation. In any event, it asserts that the timeframe for the adoption of a decision under Article 42(1) of the REACH Regulation is reasonable in order to ensure that a registrant’s right to be heard and the objectives pursued by that regulation are respected.

130. Third, Esso Raffinage argues that that there is no support in the REACH Regulation or other provisions of EU law, such as Article 13 TFEU, for precluding registrants from submitting adaptations in response to the first compliance check decision. Such an approach is also at odds with, inter alia, the growing consensus concerning weight of evidence adaptations and the move away from animal testing in EU law. It emphasises that registrants are required under Articles 13(1) and 25(1) of the REACH Regulation to reduce animal testing whenever possible by submitting adaptations at all stages of the dossier evaluation process. It adds that its submission of a bona fide adaptation is not in question in this case, and that ECHA has now accepted the adaptation, which vindicates its decision to submit it in the first place.

131. Fourth, Esso Raffinage submits that the General Court’s approach does not result in registration dossiers selected by ECHA for compliance checking under Article 41(5) of that regulation being treated in a manner which is likely to be prolonged.

132. ECHA contends that the second ground of appeal is unfounded.

133. First, ECHA disputes that Article 42(1) of the REACH Regulation only relates to the submission of further, additional information once the first compliance decision has been complied with. In its view, ECHA is generally required to assess the information submitted and prepare a decision pursuant to that provision. It emphasises that the General Court’s interpretation of Article 42(1) of the REACH Regulation correctly balances the procedural rights afforded to registrants, the requirement for registrants to avoid animal testing whenever possible and the objective of the REACH Regulation to ensure a high level of human health and environmental protection.

134. Second, ECHA submits that the General Court addressed the Federal Republic of Germany’s concerns about alleged delays and potential abuse by clarifying that it is unnecessary for ECHA to prepare a decision under Article 42(1) of the REACH Regulation where the information submitted is manifestly unreasonable and that Member States may take enforcement measures against registrants for non-compliance with their obligations under Article 41(4) of that regulation starting from the time limit set in the first compliance check decision. It also asserts that the Federal Republic of Germany failed to explain why the manifestly unreasonable criterion renders the judgment under appeal unlawful.

135. Third, ECHA refutes the Federal Republic of Germany’s arguments based on general EU administrative law, since there is no obligation to reconsider a decision in the circumstances of the present case. It points out that, following from the judgment under appeal, a registrant may submit an adaptation, which stems directly from Article 13(1) of the REACH Regulation, instead of carrying out animal testing specified in the first compliance check decision, and that ECHA is required to examine it and take a new decision pursuant to Article 42(1) of that regulation, having regard for the procedure set out in Articles 41, 50 and 51 thereof, in cases where it deems the adaptation invalid.

136. Fourth, ECHA disputes the assertion that the General Court’s approach prolongs the review of registration dossiers which it selects for compliance checking under Article 41(5) of the REACH Regulation.

137. The ECEAE supports the arguments of Esso Raffinage and ECHA, while adding two sets of considerations relating to the interpretation of Article 42(1) of the REACH Regulation.

138. First, the ECEAE claims that the interpretation of Article 42(1) advanced by the Federal Republic of Germany is contrary to the importance which the EU legislature attaches to animal welfare in the REACH Regulation, which reflects Article 13 TFEU. This is because it would mean that animal testing would still have to be carried out even if new information, not available to ECHA at the time of the first compliance check decision, showed that a suitable adaptation was available. It notes that this is especially pertinent to the present case, since there were grounds for considering that, based on the relevant provisions of the REACH Regulation, ECHA should have evaluated the results of the first PNDT study before requesting the second. It emphasises that the duties imposed on registrants to rely on alternative methods and to undertake vertebrate animal testing as a last resort, as respectively set out in Articles 13(1) and 25(1) of the REACH Regulation, apply throughout the dossier evaluation process.

139. Second, the ECEAE argues that Article 42(1) of the REACH Regulation cannot be interpreted as meaning that examination is only necessary where it may lead to a requirement for yet further information and only when a registrant has done what the first compliance check decision required it to do. This is because, first, such an interpretation is not supported by the provisions of the REACH Regulation; second, ECHA cannot know until it carries out the examination whether further information might be scientifically desirable; and, third, in any event, except in rare cases, ECHA has no power to expand the relevant information requirements.

140. HOPA REACH and HOPA also support the arguments of Esso Raffinage and ECHA.

141. In particular, HOPA REACH and HOPA submit that the generation of adaptations to animal testing is not only provided for in the REACH Regulation, but also is subject to a comprehensive set of regulatory, technical and scientific requirements designed to avoid abuse and to be verified by ECHA. They emphasise that adaptations are required to prevent unnecessary animal testing, which is a key objective of the REACH Regulation, and should be available to registrants at any point in time before the execution of such testing.

2.      Assessment of the second ground of appeal

142. By the second ground of appeal, the Federal Republic of Germany contends that the General Court erred in law in finding that Article 42(1) of the REACH Regulation applied to the contested measure.

143. The second ground of appeal is based on the claims that the contested measure does not fall within the scope of Article 42(1) of the REACH Regulation (section a), that registrants are not permitted to submit adaptations to animal testing specified in the first compliance check decision (section b) and that the General Court’s misapplication of that provision results in alleged delays and potential abuse of the procedure for the evaluation of registration dossiers (section c).

144. I should state at the outset that I consider that the claims advanced in the second ground of appeal are unfounded.

(a)    The scope of Article 42(1) of the REACH Regulation

145. The General Court held, in paragraphs 107 to 109 of the judgment under appeal, that, based on its considerations concerning the allocation of competences between ECHA and the Member States regarding the evaluation of registration dossiers, the contested measure corresponded to a decision which ECHA was required to prepare pursuant to Article 42(1) of the REACH Regulation and which should have been adopted in accordance with the procedure set out in Article 41(3) of that regulation, referring to Article 51 thereof.

146. In my view, those findings are not vitiated by an error of law.

147. It should be recalled that, as noted in points 84 to 86 of this Opinion, Article 42(1) of the REACH Regulation requires ECHA to examine ‘any information submitted’ by a registrant in response to, in particular, the first compliance check decision and to draft any appropriate decisions in accordance with the procedure referred to in Article 41(3) of that regulation. It follows from its wording that Article 42(1) of the REACH Regulation makes no distinction as regards the information requested. Therefore, that provision should not be considered as limited to requests for further, additional information once the information requested in the first compliance check decision has been supplied.

148. None of the arguments raised by the Federal Republic of Germany invalidates that conclusion. In particular, as Esso Raffinage points out, while Annexes VII to X to the REACH Regulation provide for the carrying out of further testing, those annexes generally specify that such requests are to be made by ECHA pursuant to Article 41, and not Article 42(1), of that regulation. (43) It should also be noted that the reference to ‘more information’ in recital 20 of the REACH Regulation concerns substance evaluation and not dossier evaluation (see point 21 of this Opinion).

149. It is true that the Commission, in the Explanatory Memorandum of its proposal for the REACH Regulation, considered that the provision corresponding to what is now Article 42(1) of that regulation related to the drafting of ‘a further decision if yet further information is required’. (44) Yet, this does not seem to me to be conclusive, since there is nothing to suggest that other kinds of information are excluded from the scope of that provision, having regard to its wording.

150. Furthermore, I am in agreement with ECHA and Esso Raffinage that the application of Article 42(1) of the REACH Regulation to the contested measure does not involve re-examination or further examinations of the first compliance check decision taken on the basis of Article 41(3) of that regulation. Article 42(1) of the REACH Regulation involves the assessment by ECHA of the conformity of the information which has been submitted by a registrant in response to the first compliance check decision to ascertain whether that information fulfils the information requirements specified therein, as illustrated by the present case. Consequently, the arguments advanced by the Federal Republic of Germany drawn from general EU administrative law seem to me to be irrelevant in the circumstances of this case.

(b)    The allowance of adaptations to animal testing

151. The General Court held, in paragraphs 62 and 63 of the judgment under appeal, that where, in response to the first compliance check decision, a registrant submits an adaptation to animal testing in accordance with Annex XI to the REACH Regulation, ECHA is generally required to assess that adaptation pursuant to Article 42(1) of that regulation, following the procedure mentioned in Article 41 thereof (except in certain situations: see points 164 and 167 of this Opinion). It added that ECHA must perform that assessment, irrespective of whether the adaptation at issue rests on substantial and new facts which were not known at the time when the first compliance check decision was taken under Article 41(3) of the REACH Regulation. (45)

152. In my view, no error of law is discernible in those findings.

153. First, it should be borne in mind that limiting animal testing is one of the guiding principles underlying the REACH Regulation, (46) as is apparent from its various articles and recitals. (47)

154. In particular, Article 13(1) of the REACH Regulation states that, with regard to the evaluation of the human toxicity of chemical substances, information must be generated whenever possible by means other than vertebrate animal testing through the use of alternative methods. (48) Moreover, Article 25(1) of the REACH Regulation provides: ‘In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort’. (49)

155. As further indicated by recital 47 of the REACH Regulation, implementation of that regulation is based on the use of alternative test methods ‘wherever possible’, and the Commission and ECHA should ensure that the reduction of animal testing is a key consideration in particular ‘in the Agency’s own procedures’. More specifically, Annex XI to the REACH Regulation, which establishes general rules for the submission of adaptations, states that ECHA may assess these adaptations under dossier evaluation. (50)

156. It follows that Articles 13(1) and 25(1) of the REACH Regulation oblige registrants (51) (as well as ECHA, as the case may be (52)) to use alternative methods in place of vertebrate animal testing whenever possible and are framed in a general way such that they apply in particular to compliance checks of registrations within dossier evaluation.

157. Consequently, I am in agreement with ECHA, Esso Raffinage, the ECEAE, HOPA REACH and HOPA that, in light of their wording, the duties imposed under Articles 13(1) and 25(1) of the REACH Regulation may be considered to apply to all stages of the procedure for the evaluation of registration dossiers. Contrary to arguments advanced by the Federal Republic of Germany, in my view, there is nothing to suggest from those provisions, along with Annex XI to the REACH Regulation, that adaptations to animal testing may be submitted only up to the stage of the first compliance check decision.

158. This interpretation is consistent with the objectives pursued by the REACH Regulation. As mentioned in point 17 of this Opinion, Article 1(1) of the REACH Regulation declares that the purpose of that regulation is ‘to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation’. (53) The quoted language gives expression to the consideration of animal welfare through the reduction of animal testing as one of the objectives pursued by the REACH Regulation. (54) Viewed more broadly, as indicated by Esso Raffinage and the ECEAE, the promotion of animal welfare and alternative methods to animal testing in the REACH Regulation reflects Article 13 TFEU, (55) pursuant to which, in formulating and implementing the European Union’s policies, the European Union and the Member States are to pay full regard to the welfare requirements of animals. (56)

159. Moreover, the circumstances of the present case demonstrate the importance of applying Article 42(1) of the REACH Regulation to the submission of adaptations by registrants in response to the first compliance check decision.

160. To recall, in the decision of 6 November 2012, ECHA requested Esso Raffinage to carry out a second-species PNDT study on rabbits, along with long-term toxicity testing on sediment organisms (see point 35 of this Opinion). (57) In particular, it should be borne in mind that the first study, that is, a toxicity study of the chemical substance at issue on the prenatal development of rabbits, required testing on vertebrate animals and involved administering that substance to a significant number of female rabbits throughout their gestation period, killing them on the day before giving birth, and then dissecting the mothers and foetuses in order to look for any abnormalities or alterations produced by exposure to that substance. (58) In response, Esso Raffinage submitted a weight of evidence adaptation, within the meaning of point 1.2 of Annex XI to the REACH Regulation, which did not involve animal testing. In the contested measure, ECHA assessed that adaptation, and found it was inadequate.

161. As is apparent from points 28 to 34 of this Opinion, Esso Raffinage’s submission of the adaptation in question was in regards to a request to conduct animal testing which was not mentioned in the draft decision notified by ECHA, and Esso Raffinage did not have the opportunity to express its views on the findings made by ECHA concerning non-compliance of that adaptation before ECHA issued the contested measure, as would have been the case if that measure had been taken on the basis of Article 42(1) of the REACH Regulation, following the procedure set out in Articles 41, 50 and 51 thereof. (59)

162. It should be added that, as indicated by the ECEAE, there are reasonable grounds for a registrant, such as Esso Raffinage, to consider, especially at the time that the decision of 6 November 2012 was issued, that a second-species PNDT study was not necessary under the relevant provisions of the REACH Regulation (60) and thus that the submission of a bona fide adaptation was appropriate in the circumstances. Indeed, Esso Raffinage raised this issue at first instance, but the General Court found it unnecessary to rule on its plea. (61) The matter was addressed in a ruling of the ECHA Board of Appeal after the decision of 6 November 2012 was issued (62) and is currently the subject of cases pending before the General Court. (63)

163. Furthermore, it should be emphasised that precluding an adaptation in response to the first compliance check decision would have a devastating result, requiring a registrant to perform the animal test requested, even though a bona fide adaptation would have become available by the time limit fixed in that decision. ECHA’s evaluation of adaptations under Article 42(1) of the REACH Regulation, irrespective of whether or not they are new, permits a registrant to submit improved adaptations from what was set out in the registration dossier in order to meet the relevant information requirements. (64)

(c)    Complaints relating to alleged delays and potential abuse

164. The General Court rejected, in paragraphs 111 to 113, read together with paragraphs 62 and 71, of the judgment under appeal, arguments advanced by ECHA that recourse to the procedure set out in Articles 41, 50 and 51 of the REACH Regulation for decisions based on Article 42(1) of that regulation could lead to an endless procedure of new decisions, jeopardising the application of ECHA decisions. It considered that ECHA is not required to follow that procedure in every case and therefore, where a registrant relies on manifestly unreasonable elements, amounting to an abuse of procedure equivalent to a complete failure to respond, ECHA may find that the registration dossier is non-compliant by means of a simple communication of information to the Member State concerned and the interested party.

165. The General Court further held, in paragraph 114, read together with paragraph 61, of the judgment under appeal, that if a decision is taken pursuant to Article 42(1) of the REACH Regulation that the registration dossier is non-compliant, that lack of compliance relates, at the least, to the end of the time limit set under the first compliance check decision taken under Article 41(3) of the REACH Regulation. It would then be for the Member State concerned to exercise the power reserved to it under Article 126 of the REACH Regulation to carry out enforcement measures for the period during which the registration dossier was not compliant.

166. In my view, there is no error of law in that reasoning.

167. First, it should be pointed out that, as is clear from paragraph 112 of the judgment under appeal, the General Court’s reasoning is based on the wording of Article 42(1) of the REACH Regulation, which indicates that ECHA is to draft a decision under that provision, following the procedure set out in Articles 41, 50 and 51, ‘if necessary’. That wording implies that there may be exceptional circumstances in which ECHA would not be required to prepare such a decision. In line with this, the General Court’s elaboration of circumstances involving a complete failure to respond to the first compliance check decision and the submission of manifestly unreasonable elements amounting to an abuse of procedure on the part of the registrant does not seem to me be open to criticism. The application of such circumstances in a particular case would in principle fall within ECHA’s discretion, subject to judicial review before the EU Courts. (65)

168. Furthermore, the period of time associated with ECHA’s preparation of a decision pursuant to Article 42(1) of the REACH Regulation, following the procedure set out in Articles 41, 50 and 51 of that regulation, seems to me to be reasonable in light of the timeline set down in those provisions. (66) I am therefore in agreement with ECHA and Esso Raffinage that, based on the information put before the Court, ECHA’s review of registration dossiers under Article 41(5) of the REACH Regulation would not be unduly prolonged.

169. Likewise, the General Court’s reasoning that appropriate enforcement measures which may be taken by the Member States under Article 126 of the REACH Regulation apply for the period of non-compliance starting from the time limit set in the first compliance check decision follows from Article 41(4) of that regulation. In my view, such an approach may be considered to guard against potential abuse of the procedure for the evaluation of registration dossiers, since it aims to ensure that a registrant is subject to enforcement measures by the Member State concerned for breach of its obligations under the REACH Regulation, even if the registrant may bring its dossier into compliance after the adoption of a decision finding that it did not comply pursuant to Article 42(1) of the REACH Regulation.

170. I therefore propose that the second ground of appeal should be rejected as unfounded.

VII. Costs

171. Under Article 184(2) of its Rules of Procedure, 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 appeals pursuant to 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.

172. In the present case, since Esso Raffinage and ECHA have applied for costs, and the Federal Republic of Germany has been unsuccessful, the Federal Republic of Germany should be ordered to bear its own costs and to pay those incurred by Esso Raffinage and ECHA.

173. Pursuant to Article 140(1) of the Rules of Procedure, which applies to appeals by virtue of Article 184(1) thereof, Member States which have intervened in the proceedings are to bear their own costs. Under Article 184(4) of those rules, the Court may decide that an intervener at first instance who takes part in the appeal proceedings is to bear its own costs. Accordingly, the French Republic and the Kingdom of the Netherlands must bear their own costs.

174. Finally, Article 140(3) of those same rules, which applies to appeals by virtue of Article 184(1) thereof, provides, inter alia, that the Court may order an intervener other than a Member State or an EU institution to bear its own costs. It should therefore be decided that the ECEAE, HOPA REACH and HOPA are to bear their own costs.

VIII. Conclusion

175. In light of the foregoing, I propose that the Court should:

–        dismiss the appeal;

–        order the Federal Republic of Germany to bear its own costs and to pay the costs incurred by Esso Raffinage SAS and the European Chemicals Agency; and

–        order the French Republic, the Kingdom of the Netherlands, the European Coalition to End Animal Experiments, Higher Olefins and Poly Alpha Olefins REACH Consortium and Higher Olefins & Poly Alpha Olefins VZW to bear their own costs.

1      Original language: English.

2      OJ 2006 L 396, p. 1.

3      See footnote 8 of this Opinion.

4      See, for example, judgment of 15 March 2017, Polynt v ECHA (C‑323/15 P, EU:C:2017:207, paragraph 20).

5      See, for example, judgment of 17 March 2016, Canadian Oil Company Sweden and Rantén (C‑472/14, EU:C:2016:171, paragraph 25).

6      See, for example, judgments of 7 July 2009, S.P.C.M. and Others (C‑558/07, EU:C:2009:430, paragraphs 46 and 49), and of 17 March 2016, Canadian Oil Company Sweden and Rantén (C‑472/14, EU:C:2016:171, paragraph 29).

7      For a detailed discussion, see, for example, Biwer, A.P., ‘Evaluation’, in Drohmann, D. and Townsend, M. (eds), REACH Best Practice Guide to Regulation (EC) No 1907/2006, C.H. Beck/Hart/Nomos, 2013, pp. 411-441.

8      Recently, the minimum percentage under Article 41(5) of the REACH Regulation was increased from 5% to 20% in Commission Regulation (EU) 2020/507 of 7 April 2020 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the percentage of registration dossiers to be selected for compliance checking (OJ 2020 L 110, p. 1).

9      See the REACH Regulation, Articles 44 to 48; recitals 20, 21 and 66.

10      See, in that regard, Herbatschek, N. et al., ‘The REACH Programmes and Procedures’, in Bergkamp, L. (ed.), The European Union REACH Regulation for Chemicals: Law and Practice, Oxford University Press, 2013, pp. 83-170, at pp. 126, 130-133.

11      See the REACH Regulation, Article 46.

12      See the REACH Regulation, Articles 50 to 54.

13      Under Article 52 of the REACH Regulation, the procedure in Article 51 thereof is applicable to decisions under substance evaluation, subject to modification because the Member State competent authority prepares the draft decision.

14      See, in particular, the REACH Regulation, Articles 76(1)(e) and 85(3); recitals 67 and 103.

15      See, in particular, the REACH Regulation, Articles 76(1)(g) and 77(2)(c); recital 98.

16      See, in particular, the REACH Regulation, Articles 76(1)(f) and 86; recital 105.

17      As indicated in paragraph 2 of the judgment under appeal, the information requirements for the registration dossier at the relevant time concerned the greater than 1 000 tonnes per year tonnage level.

18      See further point 160 of this Opinion.

19      The General Court considered that there was no need to examine the other seven pleas raised by Esso Raffinage, alleging breach of: (1) the principle of proportionality; (2) the principles of legal certainty and legitimate expectations; (3) the right to be heard and the rights of defence; (4) the right to good administration; (5) the obligation to state reasons; (6) the right to a fair trial; and (7) the provisions of the REACH Regulation concerning the request to provide a second-species PNDT study (paragraphs 100 and 117 of the judgment under appeal).

20      Germany v Esso Raffinage (C‑471/18 P, not published, EU:C:2019:198), as rectified by order of 10 April 2019 (C‑471/18 P, not published, EU:C:2019:328).

21      In that regard, Esso Raffinage refers to ECHA’s ‘decision on the update of your registration under Regulation (EC) No 1907/2006’ of 8 November 2013 (‘completeness check decision’), annexed to its response, indicating that, according to Articles 20(2) and 22(3) of that regulation, the update of the registration dossier, which was required by the decision of 6 November 2012 to be submitted by 6 November 2013, was complete. That decision states: ‘Pursuant to Article 42(1) of the REACH Regulation, ECHA will examine any information submitted in consequence to the above mentioned decision after this date. The present letter and the completeness of your update within the meaning of Article 20(2) of the REACH Regulation have no bearing on the dossier evaluation process and your obligations under Article 41 of the REACH Regulation’.

22      See, for example, judgments of 4 September 2014, Spain v Commission (C‑197/13 P, EU:C:2014:2157, paragraph 45), and of 19 January 2017, Commission v Total and Elf Aquitaine (C‑351/15 P, EU:C:2017:27, paragraph 31).

23      See, for example, judgments of 28 February 2019, Council v Growth Energy and Renewable Fuels Association (C‑465/16 P, EU:C:2019:155, paragraph 47), and of 28 February 2019, Council v Marquis Energy (C‑466/16 P, EU:C:2019:156, paragraph 35).

24      See, for example, judgments of 16 June 1994, SFEI and Others v Commission (C‑39/93 P, EU:C:1994:253, paragraph 26), and of 20 December 2017, Trioplast Industrier v Commission (C‑364/16 P, not published, EU:C:2017:1008, paragraphs 25 and 26).

25      See, for example, judgments of 31 January 2019, International Management Group v Commission (C‑183/17 P and C‑184/17 P, EU:C:2019:78, paragraph 51), and of 25 June 2020, CSUE v KF (C‑14/19 P, EU:C:2020:492, paragraph 69).

26      See, for example, judgments of 25 October 2017, Romania v Commission (C‑599/15 P, EU:C:2017:801, paragraph 48), and of 20 February 2018, Belgium v Commission (C‑16/16 P, EU:C:2018:79, paragraph 32).

27      See, for example, judgments of 26 January 2010, Internationaler Hilfsfonds v Commission (C‑362/08 P, EU:C:2010:40, paragraph 52), and of 20 November 2018, Commission v Council (Antarctic MPAs) (C‑626/15 and C‑659/16, EU:C:2018:925, paragraph 62).

28      It should be noted that the Court has found that the question whether an act produces binding legal effects may be considered together with the substantive issues raised by the dispute. See, for example, judgments of 16 June 1993, France v Commission (C‑325/91, EU:C:1993:245, paragraph 11), and of 20 March 1997, France v Commission (C‑57/95, EU:C:1997:164, paragraphs 9 and 10). The Court has also taken other approaches depending on the circumstances, and held, for example, that the question whether an act has binding legal effects should not be considered in the context of admissibility, but rather on the merits. See judgment of 2 October 2018, France v Parliament (Exercise of budgetary powers) (C‑73/17, EU:C:2018:787, paragraph 15); see also Opinion of Advocate General Sharpston in Council v Commission (C‑660/13, EU:C:2015:787, point 58, footnote 17). In the present case, it seems to me that, while some overlap is unavoidable, the issues relating to admissibility and substance should be dealt with separately, especially on account of the various arguments raised in respect of each ground of appeal.

29      See also, in that regard, the REACH Regulation, recitals 120 to 122.

30      As opposed to other tasks carried out by the Member States in the context of dossier evaluation, such as with regard to the Member State Committee (see, in that regard, the REACH Regulation, recital 67) and the exchange of information (see, in that regard, the REACH Regulation, recital 119).

31      See, for example, Doc 9234/04, 6 May 2004, pp. 6-8; Doc 9248/05, 24 May 2005, pp. 3-5; Doc 8717/05, 2 June 2005; Doc 15472/05, 8 December 2005, p. 13. See further, in that regard, Martens, M., ‘Executive power in the making: the establishment of the European Chemicals Agency’, in Busuioc, M. et al. (eds), The agency phenomenon in the European Union, Manchester University Press, 2012, pp. 42-62.

32      See Commission Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}, COM(2003) 644 final, 29 October 2003 (‘Proposal’), in particular Explanatory Memorandum, point 1.6.

33      See Position of the European Parliament adopted at first reading on the Proposal, 17 November 2005, in particular draft recital 69 and draft Articles 44 to 54.

34      See Opinions of the European Economic and Social Committee on the Proposal, 31 March 2004 (OJ 2004 C 112, p. 92), points 3.2.6, 3.4.2 and 4.5, and on Chemicals legislation – REACH, 13 July 2005 (OJ 2005 C 294, p. 38), point 6.4.

35      See Common position (EC) No 17/2006 adopted by the Council on the Proposal, 27 June 2006 (OJ 2006 C 276 E, p. 1), Statement of the Council’s Reasons, Title VI – Evaluation.

36      See also, in that regard, the REACH Regulation, recital 95.

37      It is worth noting that this is apparent from recent activities of the Commission and ECHA to improve the compliance check process, such as increasing the amount of registration dossiers checked by ECHA under Article 41(5) of the REACH Regulation: see, for example, Commission and ECHA, REACH Evaluation Joint Action Plan: Ensuring compliance of REACH Registrations, 24 June 2019, available at https://echa.europa.eu/; see further footnote 8 of this Opinion.

38      See, in that regard, judgment of 22 January 2014, United Kingdom v Parliament and Council (C‑270/12, EU:C:2014:18, paragraph 81). See further, for example, Bergkamp, L. and Park, D., ‘The Organizational and Administrative Structures’, in The European Union REACH Regulation for Chemicals: Law and Practice, cited in footnote 10 of this Opinion, pp. 23-39, at pp. 25-27.

39      See footnote 21 of this Opinion.

40      See footnote 21 of this Opinion.

41      There is no question raised in this case regarding the other limbs of the fourth paragraph of Article 263 TFEU, given that the contested measure is not formally addressed to Esso Raffinage (see paragraphs 87 to 89 of the judgment under appeal), and it is not a non-legislative act of general application for the purposes of qualifying as a regulatory act (see, for example, judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci (C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 23)).

42      See, for example, judgments of 28 February 2019, Council v Growth Energy and Renewable Fuels Association (C‑465/16 P, EU:C:2019:155, paragraph 69), and of 3 December 2019, Iccrea Banca (C‑414/18, EU:C:2019:1036, paragraph 66).

43      See, for example, the REACH Regulation, Annex X, points 8.6.3, 8.6.4 and 8.9.1.

44      See Proposal, cited in footnote 32 of this Opinion, Explanatory Memorandum, draft Article 41, first paragraph.

45      The General Court thus in substance rejected the ECHA Board of Appeal’s approach in Solutia Europe v ECHA, Decision A-019-2013, 29 July 2015 (‘Solutia’): see paragraphs 44 to 47 and 106 of the judgment under appeal.

46      See, in that regard, Proposal, cited in footnote 32 of this Opinion, Explanatory Memorandum.

47      See, in particular, the REACH Regulation, Articles 13(1) and (2), 25(1), 26(1) and (3), 27(1), 30(1) and (3), 40(2), 117(3) and 138(9); recitals 13, 33, 37, 38, 40, 47, 49, 50 and 64.

48      See, in that regard, judgments of 21 July 2011, Nickel Institute (C‑14/10, EU:C:2011:503, paragraph 74), and of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 108).

49      My emphasis.

50      See the REACH Regulation, Annex XI, second paragraph.

51      It is worth noting that the European Ombudsman recognised that ECHA must verify a registrant’s compliance with Article 13(1) of the REACH Regulation in the compliance check procedure (see Case 1568/2012/AN), as well as in the evaluation of testing proposals (see Case 1606/2013/AN), within the dossier evaluation context.

52      In that regard, the ECHA Board of Appeal found in Honeywell Belgium v ECHA, Decision A-005-2011, 29 April 2013, paragraphs 87 to 99, that the obligation imposed on registrants under Article 25(1) of the REACH Regulation is assumed by ECHA in circumstances where it requires animal testing to meet an information requirement which it has itself identified under the relevant provisions of that regulation.

53      Emphasis added. See also the REACH Regulation, recital 1.

54      See, for example, Doc 16216/06, 4 December 2006, p. 5.

55      Situated within Title II of the FEU Treaty (‘Provisions having general application’), Article 13 TFEU states: ‘In formulating and implementing the Union’s agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage’. For a detailed discussion, see, for example, Beqiraj, J., ‘Animal welfare’, in Ippolito, F. et al. (eds), The EU and the Proliferation of Integration Principles under the Lisbon Treaty, Routledge, 2019, pp. 136-159.

56      See, for example, judgment of 26 February 2019, Oeuvre d’assistance aux bêtes d’abattoirs (C‑497/17, EU:C:2019:137, paragraph 44). See also Opinion of Advocate General Bobek in European Federation for Cosmetic Ingredients (C‑592/14, EU:C:2016:179, points 20 and 21).

57      As indicated in paragraph 13 of the judgment under appeal, the second-species PNDT study on rabbits was requested in order to satisfy the information requirement in point 8.7.2 of Annex X to the REACH Regulation and, as regards the long-term toxicity testing on sediment organisms, point 9.5.1 of that annex. The latter testing generally involves invertebrate animal and plant species. See ECHA, Guidance on Information Requirements and Chemical Safety Assessment, Chapter 4.7b: Endpoint specific guidance, Version 4.0, June 2017, point R.7.8.7.

58      See, in that regard, Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to [the REACH Regulation] (OJ 2008 L 142, p. 1), B.31 Prenatal Developmental Toxicity Study.

59      It is worth noting that in paragraphs 87 to 89 of Solutia, cited in footnote 45 of this Opinion, the ECHA Board of Appeal found, inter alia, that, in the circumstances of the case involving a request for vertebrate animal testing, the procedure in Articles 50 and 51 of the REACH Regulation might have helped to ensure that such testing was undertaken only as a last resort under Article 25(1) thereof.

60      See, in that regard, column 2 of point 8.7.2 of Annex IX to the REACH Regulation (‘A decision on the need to perform a [PNDT] study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data’) (emphasis added). See also footnote 57 of this Opinion.

61      See footnote 19 of this Opinion.

62      See Lanxess Deutschland v ECHA, Decision A-004-2012, 10 October 2013, paragraphs 71 to 87, in which the ECHA Board of Appeal found that, under point 8.7.2 of Annex X to the REACH Regulation, registrants are required to perform a second-species PNDT study, unless certain adaptations apply. The ECEAE lodged an appeal against that decision before the General Court, but it was dismissed as inadmissible: see order of 13 March 2015, European Coalition to End Animal Experiments v ECHA (T‑673/13, EU:T:2015:167).

63      See, in particular, Nouryon Industrial Chemicals and Others v Commission, T‑868/19, pending.

64      It is worth noting that the allowance for ECHA’s evaluation of improved adaptations under Article 42(1) of the REACH Regulation has been recognised in decisions of the ECHA Board of Appeal: see, for example, Clariant Plastics & Coatings (Deutschland) v ECHA, Decision A-011-2018, 4 May 2020, paragraph 52.

65      In that regard, in Symrise v ECHA, Decisions A-012-2019 and A-013-2019, 16 September 2019, the ECHA Board of Appeal found that ECHA’s ‘information of a failure to respond to a dossier evaluation decision’ was not a decision for the purposes of Article 42(1) of the REACH Regulation, and thus did not fall within its jurisdiction; yet, that measure could be challenged before the General Court.

66      See, in that regard, the REACH Regulation, Articles 50(1) and 51(2) to (6).