delivered on 24 September 2020 (1)

Case C‑471/18 P

Esso Raffinage SAS,

(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

II. Legal framework

III. Background to the proceedings

(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

(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

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;

…

…’

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.

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.

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).

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)

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)

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)

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).

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)

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.

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)

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)

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)

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.

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

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)

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.

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.

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.

Esso Raffinage did not provide comments on those proposals.

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

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.

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.

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.

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’).

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.’

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.

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

ECHA claimed that the action should be dismissed.

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.

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.

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)

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.

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.

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.

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)