OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 17 October 2018 ( 1 )

Case C‑82/17 P

TestBioTech eV

European Network of Scientists for Social and Environmental Responsibility eV

Sambucus eV

v

European Commission

(Appeal – Environment – Genetically modified products – Commission decision authorising the placing on the market of products containing genetically modified soya MON 87701 x MON 89788 – Regulation (EC) No 1367/2006 – Article 10 – Request for internal review of an administrative act under environmental law – Burden of proof)

Introduction

1. By the present appeal, TestBioTech eV, European Network of Scientists for Social and Environmental Responsibility eV and Sambucus eV (‘the appellants’) seek, first, to have set aside the judgment of the General Court of 15 December 2016, TestBioTech and Others v Commission (T‑177/13, not published, ‘the judgment under appeal’, EU:T:2016:736), whereby the General Court dismissed their action for annulment of the decision of the European Commission of 8 January 2013 ( 2 ) (‘the contested decision’), by which the Commission informed TestBioTech that it did not accept any of the allegations invoked to substantiate the request for internal review of [Commission Implementing] Decision 2012/347/EU of 28 June 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 × MON 89788 (MON-877Ø1-2 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council [ ( 3 )] (OJ 2012 L 171, p. 13; ‘the authorisation decision’). The appellants seek, secondly, the annulment of the contested decision as well as of identical decisions of the Commission addressed to European Network of Scientists for Social and Environmental Responsibility and Sambucus or, in the alternative, to refer the case back to the General Court.

2. As far as the present Opinion is concerned, the point of law raised by this appeal will lead the Court to examine the nature, the scope and the ‘burden of proof’ concerning the internal review mechanism as laid down in Article 10 of Regulation (EC) No 1367/2006. ( 4 )

Legal context

International law

3. Article 9(1) to (4) of the Aarhus Convention ( 5 ) provides: ‘1. Each Party shall, within the framework of its national legislation, ensure that any person who considers that his or her request for information under article 4 has been ignored, wrongfully refused, whether in part or in full, inadequately answered, or otherwise not dealt with in accordance with the provisions of that article, has access to a review procedure before a court of law or another independent and impartial body established by law. In the circumstances where a Party provides for such a review by a court of law, it shall ensure that such a person also has access to an expeditious procedure established by law that is free of charge or inexpensive for reconsideration by a public authority or review by an independent and impartial body other than a court of law. Final decisions under this paragraph 1 shall be binding on the public authority holding the information. Reasons shall be stated in writing, at least where access to information is refused under this paragraph. 2. Each Party shall, within the framework of its national legislation, ensure that members of the public concerned (a) Having a sufficient interest or, alternatively, (b) Maintaining impairment of a right, where the administrative procedural law of a Party requires this as a precondition, have access to a review procedure before a court of law and/or another independent and impartial body established by law, to challenge the substantive and procedural legality of any decision, act or omission subject to the provisions of article 6 and, where so provided for under national law and without prejudice to paragraph 3 below, of other relevant provisions of this Convention. What constitutes a sufficient interest and impairment of a right shall be determined in accordance with the requirements of national law and consistently with the objective of giving the public concerned wide access to justice within the scope of this Convention. To this end, the interest of any non-governmental organisation meeting the requirements referred to in article 2, paragraph 5, shall be deemed sufficient for the purpose of subparagraph (a) above. Such organisations shall also be deemed to have rights capable of being impaired for the purpose of subparagraph (b) above. The provisions of this paragraph 2 shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law. 3. In addition and without prejudice to the review procedures referred to in paragraphs 1 and 2 above, each Party shall ensure that, where they meet the criteria, if any, laid down in its national law, members of the public have access to administrative or judicial procedures to challenge acts and omissions by private persons and public authorities which contravene provisions of its national law relating to the environment. 4. In addition and without prejudice to paragraph 1 above, the procedures referred to in paragraphs 1, 2 and 3 above shall provide adequate and effective remedies, including injunctive relief as appropriate, and be fair, equitable, timely and not prohibitively expensive. Decisions under this article shall be given or recorded in writing. Decisions of courts, and whenever possible of other bodies, shall be publicly accessible.’

EU law

4. Recitals 11, 18, 19 and 21 of Regulation No 1367/2006 read as follows: ‘(11) Administrative acts of individual scope should be open to possible internal review where they have legally binding and external effects. ... ... (18) Article 9(3) of the Aarhus Convention provides for access to judicial or other review procedures for challenging acts and omissions by private persons and public authorities which contravene provisions of law relating to the environment. Provisions on access to justice should be consistent with the Treaty. It is appropriate in this context that this Regulation address only acts and omissions by public authorities. (19) To ensure adequate and effective remedies, including those available before the Court of Justice of the European Communities under the relevant provisions of the Treaty, it is appropriate that the Community institution or body which issued the act to be challenged or which, in the case of an alleged administrative omission, omitted to act, be given the opportunity to reconsider its former decision, or, in the case of an omission, to act. ... (21) Where previous requests for internal review have been unsuccessful, the non-governmental organisation concerned should be able to institute proceedings before the Court of Justice in accordance with the relevant provisions of the Treaty.’

5. Article 10, headed ‘Request for internal review of administrative acts’, stipulates that: ‘1. Any non-governmental organisation which meets the criteria set out in Article 11 is entitled to make a request for internal review to the Community institution or body that has adopted an administrative act under environmental law or, in case of an alleged administrative omission, should have adopted such an act. Such a request must be made in writing and within a time limit not exceeding six weeks after the administrative act was adopted, notified or published, whichever is the latest, or, in the case of an alleged omission, six weeks after the date when the administrative act was required. The request shall state the grounds for the review. 2. The Community institution or body referred to in paragraph 1 shall consider any such request, unless it is clearly unsubstantiated. The Community institution or body shall state its reasons in a written reply as soon as possible, but no later than 12 weeks after receipt of the request. 3. Where the Community institution or body is unable, despite exercising due diligence, to act in accordance with paragraph 2, it shall inform the non-governmental organisation which made the request as soon as possible and at the latest within the period mentioned in that paragraph, of the reasons for its failure to act and when it intends to do so. In any event, the Community institution or body shall act within 18 weeks from receipt of the request.’

6. Pursuant to Article 12 of the same regulation (‘Proceedings before the Court of Justice’): ‘1. The non-governmental organisation which made the request for internal review pursuant to Article 10 may institute proceedings before the Court of Justice in accordance with the relevant provisions of the Treaty. 2. Where the Community institution or body fails to act in accordance with Article 10(2) or (3) the non-governmental organisation may institute proceedings before the Court of Justice in accordance with the relevant provisions of the Treaty.’

Background to the dispute

7. The appellants are German not-for-profit associations. TestBioTech eV promotes independent research and public debate on the impact of biotechnology. European Network of Scientists for Social and Environmental Responsibility eV has as its purpose the advancement of science and research for the protection of the environment, biological diversity and human health against the negative impacts of new technologies and their products. Sambucus eV engages in cultural activities.

8. On 14 August 2009 Monsanto Europe SA submitted to the competent authority in the Netherlands, in accordance with Articles 5 and 17 of Regulation No 1829/2003, an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from MON 87701 × MON 89788 soybean (‘the Soybean’). The application also covered the placing on the market of the Soybean as present in products other than food and feed containing or consisting of that soybean for the same uses as any other soybean, with the exception of cultivation.

9. On 15 February 2012 the European Food Safety Authority (EFSA) issued an overall opinion in accordance with Articles 6 and 18 of Regulation No 1829/2003. In paragraph 3 of that opinion, EFSA explained that its Scientific Panel on Genetically Modified Organisms had adopted a scientific opinion, on 25 January 2012, on the application (EFSA-GMO-NL-2009-73) concerning the placing on the market of the insect-resistant and herbicide-tolerant Soybean, for food and feed uses, import and processing under Regulation No 1829/2003 by Monsanto (The EFSA Journal 2012;10(2):2560, 1-34), finding that the Soybean was, in the context of its intended uses, as safe as its non-genetically modified comparator with respect to potential effects on human or animal health or on the environment. Moreover, the Scientific Panel had concluded that the crossing of modified soybean did not, in the context of its intended uses, result in interactions between the events that would affect the safety of the Soybean with respect to potential effects on human and animal health and on the environment. In this overall opinion, EFSA concluded that it ‘fulfil[led] the requirements of Articles 6 and 18 [of Regulation No 1829/2003] for the placing on the market of [the Soybean]’.

10. By the authorisation decision, the Commission authorised, subject to certain conditions, for the purposes of Article 4(2) and Article 16(2) of Regulation No 1829/2003: – foods and food ingredients containing, consisting of, or produced from the Soybean; – feed containing, consisting of, or produced from the Soybean; – the Soybean present in products other than food and feed ‘containing it’ or consisting of it, for the same uses as any other soybean, with the exception of cultivation.

11. In recitals 4, 6 and 7 of the authorisation decision, the Commission explained that, on 15 February 2012, EFSA had given a favourable opinion in accordance with Articles 6 and 18 of Regulation No 1829/2003, concluding that the Soybean, as described in the application, was as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment. Furthermore, the Commission stated that EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant was in line with the intended use of the products. On that basis, the Commission considered it appropriate to authorise the Soybean and all products containing it or consisting of it and for food and feed produced from it as described in the application for authorisation.

12. By letters of 6 August 2012, each of the appellants requested the Commission to carry out an internal review of the authorisation decision, pursuant to Article 10 of Regulation No 1367/2006. The appellants considered, inter alia, that the assessment that the Soybean was substantially equivalent to its counterpart was flawed, that the synergistic or combinatorial effects had not been taken into consideration, that the immunological risks had not been adequately assessed and that no monitoring of the effects on health had been required.

13. By the contested decision of 8 January 2013, the Commissioner for Health informed TestBioTech that the Commission did not accept any of the ‘legal and scientific allegations invoked to substantiate the request for internal review’ of the authorisation decision. The Commission considered, therefore, that the authorisation decision complied with Regulation No 1829/2003. More specifically, the Commission rejected the arguments put forward in TestBioTech’s request for internal review, to the effect that the authorisation decision was unlawful on the grounds that EFSA’s finding that the Soybean was ‘substantially equivalent’ was flawed, that the synergistic or combinatorial effects had not been taken into consideration, that the immunological risks had not been adequately assessed and that no monitoring of the effects on health had been required.

14. On the same date, the Commissioner for Health sent to the European Network of Scientists for Social and Environmental Responsibility and Sambucus, respectively, the second and the third decisions, which are substantially identical to the contested decision, sent to TestBioTech.

15. In those three decisions, the Commission acknowledged that the appellants satisfied the criteria set out in Article 11 of Regulation No 1367/2006 and were, therefore, as non-governmental organisations for the purposes of that article, entitled to make a request for internal review.

The procedure before the General Court and the judgment under appeal

16. By application of 18 March 2013, the appellants brought an action before the General Court seeking the annulment of the contested decision.

17. In support of their action, the appellants relied, in essence, on four pleas in law, alleging, first, the absence of substantial equivalence between the Soybean and its conventional counterpart; second, the failure to assess synergistic/combinatorial effects and toxicity; third, the absence of exhaustive immunological assessment; and fourth, the absence of post-market authorisation monitoring of consumption of products containing the Soybean.

18. The Commission, EFSA, as well as Monsanto Europe and Monsanto Company (‘Monsanto’) contended that the General Court should dismiss the action as being partly inadmissible and partly unfounded.

19. In the judgment under appeal, the General Court dismissed the action as being partly inadmissible and partly unfounded and ordered the appellants to pay the costs (with the exception of the costs incurred by the interveners).

Forms of order sought by the parties before the Court of Justice

20. By their appeal, the appellants claim that the Court should set aside the judgment under appeal and annul the contested decision or, in the alternative, refer the case back to the General Court and order the Commission to pay the costs.

21. The Commission contends that the Court should dismiss the appeal and order the appellants to pay the costs.

Assessment of the appeal

22. In support of their appeal, the appellants rely on five grounds of appeal. They claim, first, that the General Court erred in its conclusion that ‘certain of their arguments, items of evidence and/or materials’ were inadmissible. They claim, second, that the General Court erred in law when it applied an ‘incorrect and impossible burden of proof’ on not-for-profit associations which bring challenges under Articles 10 and 12 of Regulation No 1367/2006. Third, they claim that the General Court erred in law by failing to recognise that guidance issued by EFSA in accordance with its legal obligations gives rise to a legitimate expectation that that guidance will be followed. Fourth, they claim that the General Court erred in law by determining that the two-stage safety assessment required by Regulation No 1829/2003 did not need to be complied with. Fifth and last, they claim that the General Court erred in law by dismissing certain elements of the appellants’ claim that the Commission had failed to investigate adequately the potential toxicity of the Soybean and to require post-authorisation monitoring of the impact of the Soybean.

23. As requested by the Court, I will confine my analysis to the second ground of appeal. Given that this ground concerns the nature, the scope and the conditions of the internal review procedure and the judicial control of the review decision under Article 10 of Regulation No 1367/2006, I shall first examine those factors on an abstract level before specifically applying them to the second ground of appeal.

The nature, scope and conditions of the internal review procedure under Article 10 of Regulation No 1367/2006

24. I shall therefore interpret (in terms of wording, structure, legislative history and purpose) Article 10 of Regulation No 1367/2006 and propose concrete criteria to be observed in an internal review procedure.

The wording and structure of Article 10 of Regulation No 1367/2006

25. Pursuant to Article 10(1) of Regulation No 1367/2006, any non‑governmental organisation which meets the criteria set out in Article 11 of that regulation is entitled to make a request for internal review to the EU institution or body that has adopted an administrative act under environmental law. Such a request must be made in writing and within a time limit not exceeding six weeks after the administrative act was adopted, notified or published, whichever is the latest. The request must state the grounds for review. ( 6 ) According to paragraph 2 of Article 10, the EU institution or body referred to in paragraph 1 must consider any such request, unless it is clearly unsubstantiated. The EU institution or body must state its reasons in a written reply as soon as possible, but no later than 12 weeks after receipt of the request.

26. It therefore follows from that wording that a prerequisite of consideration by the competent EU institution or body is that the request (1) must state the grounds for review and (2) should not be ‘clearly unsubstantiated’. What one cannot, however, directly infer from reading this provision are more precise criteria as to the substantiation of the grounds stated.

The internal review procedure in the structure and context of Regulation No 1367/2006

27. Article 12 of Regulation No 1367/2006, which is the last provision of Title IV of the regulation, on internal review and access to justice, stipulates in its first paragraph that the non-governmental organisation which made the request for internal review pursuant to Article 10 may institute proceedings ‘before the Court of Justice’ in accordance with the relevant provisions of the Treaty.

28. It would, in my view, contravene the principle of sound administration of justice if a party requesting review was allowed to add or specify grounds for the internal review in proceedings before the Courts of the European Union. A party requesting review must thus already explicitly state all grounds for internal review in the request itself.

29. In the context of proceedings before the General Court, another review procedure in EU legislation was resorted to by analogy. In paragraph 51 of the judgment under appeal, the General Court appears to draw a parallel ( 7 ) between Article 10 of Regulation No 1367/2006 and Article 4(5) and Article 8(3) of Directive 91/414/EEC. ( 8 )

30. I do not think that an analogy to Directive 91/414 is apposite. For, as the Court stated in the passage of the Stichting Zuid-Hollandse Milieufederatie judgment referred to by the General Court by way of analogy, ‘it is apparent upon reading Article 4(5) and Article 8(3) of Directive 91/414 that the purpose of that review is not a re-evaluation of an active substance in isolation but rather a re-evaluation of the final plant protection product and that it is at the initiative of the national authorities and not at the initiative of the individuals concerned that the relevant product is reviewed’. ( 9 ) Article 4(5) of Directive 91/414 thus provides for a review of authorisations for plant protection products ‘if there are indications that any of the requirements referred to in paragraph 1 [ ( 10 )] are no longer satisfied. In such instances the Member State may require the applicant for authorisation or party to whom an extension of the field of application was granted in accordance with Article 9 to submit further information necessary for the review. The authorisation may, where necessary, be extended for the period necessary to complete a review and provide such further information.’

31. It is apparent from the foregoing that the purpose of the review procedure under Article 4(5) and Article 8(3) of Directive 91/414 is the re-evaluation of a final plant protection product, that is to say the re-evaluation of a concrete output. By contrast, the internal review procedure under Article 10 of Regulation No 1367/2006, which incidentally applies to any ‘administrative act under environmental law’, refers to the review of an administrative procedure without necessarily affecting the material outcome of the authorisation decision. ( 11 )

32. Incidentally, the same must be said of the review procedure under Article 21 of Regulation (EC) No 1107/2009 ( 12 ). This regulation, which repealed Directive 91/414, provides in its Article 21 for a review procedure in the light of new scientific and technical knowledge and monitoring data. This cannot be the general idea of the internal review procedure under Article 10 of Regulation No 1367/2006. That internal review procedure is, as follows from paragraphs 2 and 3 of that provision, connected so closely chronologically to the authorisation procedure that the purpose of the internal review procedure cannot be that new scientific and technical knowledge and monitoring data that may have arisen should be taken into consideration. Rather, the internal review procedure exists to establish whether there are elements that could have been overlooked in the course of the authorisation procedure.

The legislative history

33. As is recalled in recital 3 of Regulation No 1367/2006, the Community signed the Aarhus Convention on 25 June 1998 and approved the Aarhus Convention on 17 February 2005. What is more, recitals 4, 5, 6, 7, 9, 12, 13, 16, 17 and 18 of that regulation explicitly refer to the Aarhus Convention.

34. Regulation No 1367/2006 contains, therefore, provisions which ‘apply the requirements of the Convention to Community institutions and bodies’. ( 13 ) Regulation No 1367/2006 thus contributes to the legislation transposing the Aarhus Convention into EU law. ( 14 ) It applies to the EU institutions and bodies in the context of application of the Aarhus Convention. ( 15 )

35. Articles 10 and 12 of Regulation No 1367/2006 are intended to transpose into EU law Article 9(3) of the Aarhus Convention, pursuant to which each party to that convention is to ensure that, where they meet the criteria, if any, laid down in its national law, members of the public have access to administrative or judicial procedures to challenge acts by private persons and public authorities which contravene provisions of its national law relating to the environment. ( 16 )

36. In this context, the internal review procedure under Article 10 is meant to facilitate for ‘qualified entities’ access to justice which those entities would not have under Article 263(4) TFEU as interpreted by the Court. ( 17 ) When a decision on the request for internal review is addressed to that qualified entity, the criterion of direct concern under Article 263(4) TFEU is satisfied and that entity may bring proceedings before the Court (Article 12 of Regulation No 1367/2006 in conjunction with Article 263(4) TFEU).

37. One could, therefore, argue on the basis of the legislative history that the prerequisites to be satisfied should not be too burdensome for the party requesting review. If the conditions for the internal review were too strict, the intention to facilitate access to justice would be defeated. However, more precise criteria cannot, in my view, be inferred from the legislative history of Regulation No 1367/2006.

The purpose of the internal review procedure

38. In paragraph 51 of the judgment under appeal, the General Court held that ‘the purpose of that review is not a re‑evaluation of the marketing authorisation for the products in question’.

39. That said, the purpose of the internal review still has to be defined. This question is dependent on the possible outcome of such an internal review procedure. In paragraph 52 of the judgment under appeal, the General Court held that the institution or body that adopted the authorisation decision ‘must consider the request and, once the internal review is concluded, may either reject the request for internal review as unfounded by reasoned decision or on the ground that the internal review did not lead to a different result than the one obtained by the authorisation decision or, as legally permitted, take any other measure it deems appropriate to amend the authorisation decision, including amendment, suspension or repeal of an authorisation’.

40. It follows from the foregoing that an internal review might lead to the withdrawal of the authorisation decision. The purpose of the internal review procedure is, therefore, to reconsider the procedure that led to the authorisation decision, in order to check whether new information or the re-evaluation of known information might justify the revision of the authorisation decision.

41. This purpose is perfectly in line with the precautionary principle in environmental law, pursuant to which where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. ( 18 )

42. The internal review procedure might help to unveil dangers that had not been detected in the course of the authorisation procedure.

43. This purpose is, moreover, in line with the purposes of the Aarhus Convention, which should undoubtedly be taken into account in the interpretation of Article 10 of Regulation No 1367/2006. ( 19 ) As is well known, that convention has the threefold purpose in environmental matters of, first, facilitating access to information, secondly, fostering public participation in decision-making and, thirdly, providing for access to justice, the relevant purpose for the case at hand obviously being access to justice. ( 20 )

44. Article 10 of Regulation No 1367/2006 provides that a decision is to be made upon a request for internal review. This decision – addressed to the non-governmental organisation that has initiated the review procedure – can, then, be attacked under Article 12 of Regulation No 1367/2006, read in conjunction with Article 263(4) TFEU. Articles 10 and 12 of Regulation No 1367/2006 therefore facilitate access to justice under the Treaty provisions, as their application leads to an individual decision for the purposes of Article 263(4) TFEU.

The criteria to be applied for the review procedure

45. It follows from the foregoing interpretation that the question whether a review procedure should be initiated cannot be left to the discretion of the institution or body which is competent to conduct the procedure. That would be contrary to the purpose of the review procedure as set out above.

46. As to the intensity of the review, I propose that the following criteria should apply and the following steps taken during a review procedure.

47. First, any argument presented in the request for internal review should be taken into consideration, unless the argument is ‘clearly unsubstantiated’, under Article 10(2) of Regulation No 1367/2006. The burden of proof is on the competent institution or body to demonstrate that the argument is clearly unsubstantiated. This can be inferred from the term ‘unless’ in Article 10(2) of the regulation.

48. Secondly, the competent EU institution or body should consult the EFSA or any other agency or institution that had been involved during the authorisation procedure in order to verify whether the arguments in the request are substantiated.

49. Thirdly, the competent EU institution or body should issue the decision on the request for internal review with a detailed statement of reasons responding concretely to any argument in the request, unless that argument is clearly unsubstantiated. The reasons given should enable the applicant to understand the reasoning of the competent institution or body.

The grounds to be stated by the party requesting review

50. It also follows from the purpose of the review procedure as set out above that the burden of raising and presenting the issues, allocated to the party requesting review in an internal review procedure, should not be too strict for the purposes of launching the internal review procedure. ( 21 )

51. Regarding the structure and the purpose of Articles 10 and 12 of Regulation No 1367/2006 as described above, it should be recalled that (1) the grounds must at least be ‘stated’ and (2) the request must not be clearly unsubstantiated. It follows that, on the one hand, clearly unfounded contentions are not sufficient to meet these criteria. On the other hand, there is no provision saying that the appellants must bear the material burden of raising and presenting the issues by means of producing supporting evidence.

52. However, if the party requesting review seeks more than a mere consideration of their arguments, it can be expected from the party requesting an internal review procedure that it should provide concrete and precise arguments which might be able to call into question the factual position on which the authorisation decision is based. As the authorisation decision is taken by an authority – the Commission – after the consultation of another administrative body – the EFSA –, there is a presumption of veracity, completeness and accuracy with respect to the authorisation decision, because it is in the very nature of these authorities that they are impartial. The request for a more intense internal review should therefore be based on arguments that call this into question. The applicants for review should be able to base their argument on any ground and/or evidence that would raise serious doubts as to the aforementioned presumption. Comprehensive proof is never needed. Speculation, on the other hand, would not be sufficient either.

Discretion and judicial review

53. The Commission enjoys a wide discretion with regard to the outcome of the review: it may, first, come to the conclusion that the review does not require review of the authorisation (procedure); it may, secondly, reopen the authorisation procedure – with an open outcome; it may, thirdly, as the General Court, in paragraph 52 of the judgment under appeal, rightly held, ‘take any other measure it deems appropriate to amend the authorisation decision, including amendment, suspension or repeal of an authorisation’. Fourthly, in case of a clearly unsubstantiated request for internal review, it may – without respecting the second and third step proposed above – reject the request as clearly being unsubstantiated. This discretion depends on the quality of the arguments presented by the party requesting review: the more the arguments are substantiated the more the Commission must proceed in the direction of review of the authorisation procedure.

54. Concerning, then, the intensity of judicial review of an internal review decision under Article 10 of Regulation No 1367/2006, it should be said that Article 12, whose two paragraphs simply state that the addressee of the review decision may institute proceedings before the Court of Justice in accordance with the relevant provisions of the Treaty, does not contain any criteria as to the intensity of the judicial control.

55. As the General Court correctly pointed out in paragraph 77 of the judgment under appeal, pursuant to settled case-law, the judicial review of decisions is limited when they entail a complex assessment of facts and, therefore, involve a wide discretion of the authority making the decision. The EU judicature may not, when reviewing such decisions, substitute its assessment of the facts for the assessment made by the authority concerned. Thus, in such cases, the EU judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by that authority is not vitiated by a manifest error or a misuse of powers, and that it did not clearly exceed the bounds of its discretion. ( 22 )

56. This restriction is, as the General Court in paragraph 76 of the judgment under appeal also rightly pointed out, in perfect conformity with the Aarhus Convention. Article 9(3) of that Convention foresees that ‘each Party shall ensure that, where they meet the criteria, if any, laid down in its national law, members of the public have access to administrative or judicial procedure’. Adapted to the European Union, it is sufficient that the conditions for the access to justice are the same as those provided for in general under EU law. So, where there is a limited judicial review in EU law, this limitation can also be applied where the purpose of an EU legislative act is to be in line with the Aarhus Convention.

Second ground of appeal

Arguments of the parties

57. By their second ground of appeal, the appellants claim that the General Court erred in law by applying ‘an incorrect and impossible burden of proof’ on non-governmental organisations bringing challenges under Articles 10 and 12 of Regulation No 1367/2006.

58. According to the appellants, the General Court applied in paragraphs 67, 83, and 88 of the judgment under appeal the burden of proof in a different context which is inappropriate in the case at hand and, then, applied that burden of proof in a manner inconsistent with its own conclusion that non-governmental organisations are not required to prove that the genetically modified organism is unsafe.

59. Thus, in paragraph 67 of the judgment under appeal, the General Court transposed the evidential test outlined in Schräder v CPVO ( 23 ) to cases under Regulation No 1367/2006 and stated that ‘a third party challenging a marketing authorisation must adduce substantial evidence liable to raise serious doubts as to the lawfulness of the grant of that authorisation’. Separately, the General Court stated the requirement to be that the party requesting review ‘must provide a set of material raising serious doubts as to the lawfulness of the authorisation decision’ (paragraph 88 of the judgment under appeal). In the view of the appellants, it is not clear whether these tests are to be treated in the same way.

60. In any event, the General Court was wrong to conclude that such a high threshold test should be applied to cases brought under Articles 10 or 12 of Regulation No 1367/2006, because the situations in issue are not analogous. Challenges under Article 12 of Regulation No 1367/2006 are brought against the decisions made on requests for internal review ( 24 ) (submitted pursuant to Article 10 of Regulation No 1367/2006) and not against the decision on the marketing authorisation. The purpose of the requests for internal review is to have substantiated concerns taken into consideration. In Schräder v CPVO, ( 25 ) the Court was concerned with the evidential and legal burden imposed where a third party contested directly a decision not to annul an authorisation by means of totally different nullity proceedings.

61. The General Court, therefore, erred in law by concluding, on the basis of that burden of proof, in paragraphs 134, 135, 148 to 150, 157, 163 to 168, 170, 205 to 209, 217 to 224, 230, 231, 238 to 243, 246, 247, 256, 282, 287 and 289, that the appellants failed to show that the Soybean was unsafe.

62. The Commission holds that the standard of proof put forward by the General Court is entirely appropriate, due to the nature of the internal review procedure established by Regulation No 1367/2006. In this context, according to the Commission, it is logical that the General Court should rule that an applicant who challenges the validity of an internal review decision by reference to an underlying administrative act (an act that is not the object of annulment proceedings itself) must show that it presented in the internal review request material raising serious doubts as to the lawfulness of the underlying administrative act in order to have the internal review decision annulled. Without such a test, there would be no difference between the test for an applicant challenging the legality of the underlying administrative act and that for an applicant challenging an internal review decision relating to the same underlying administrative act.

63. The Commission contends that the standard of proof laid down by the General Court is not, contrary to the appellants’ view, ‘a high threshold test’. It does not mean that the party requesting an internal review would have to redo the risk assessment or bring evidence that the authorised genetically modified organism is unsafe: it must only, as the General Court clearly explained in paragraph 67 of the judgment under appeal, adduce substantial evidence liable to raise serious doubts as to the lawfulness of the adoption of the authorisation decision.

64. Contrary to what the appellants assert, namely that the ‘purpose of the requests for [internal review] is to have the concerns raised declared well founded’, according to the Commission, it cannot be the case that as soon as an applicant raises any doubt about the validity of an authorisation, even if that doubt is not serious, the institution must suspend the authorisation and investigate that doubt in order to ascertain whether it is well founded (for instance, by asking the applicant for authorisation to carry out further studies or trials). Consequently, the General Court did not err in law in paragraphs 67, 83, and 88 of the judgment under appeal.

65. Concerning the other points disputed by the second ground of appeal, the Commission maintains that the appellants do not dispute that the legal test applied in all those disputed points was the one of which the appellants complain in the first part of the second ground of appeal, namely that they were required to advance evidence casting serious doubts on the legality of the authorisation decision. As a result, no independent error of law is claimed in this part of the appeal. Against that background, the second part of the second ground of appeal should be rejected as being manifestly inadmissible.

Analysis

66. Pursuant to Articles 10 and 12 of Regulation No 1367/2006, (1) the grounds for the internal review request must at least be ‘stated’ and (2) the request must not be clearly unsubstantiated. As analysed above, unfounded contentions are not sufficient to meet these criteria. And yet, there is no provision to the effect that the applicants for review bear a real burden of raising and presenting the issues and must produce evidence.

67. However, as the Commission rightly pointed out, there is a fundamental difference between the authorisation procedure, leading to the authorisation decision, and the review procedure, the consequences of which can, but not necessarily need to, be the reopening of the authorisation procedure. At the same time, the appellants do not have the standing under Article 263(4) TFEU to challenge directly the authorisation decision itself, as they are neither directly nor individually concerned by the authorisation decision.

68. As outlined above, it can, if the appellants want a more thorough review procedure, thus, be expected from the party requesting an internal review procedure that they provide concrete and precise arguments which might be able to call into question the factual position on which the authorisation decision is based. As the authorisation decision is taken by an impartial authority – the Commission – after the consultation of another impartial body – the EFSA – there is a certain presumption of veracity, completeness and accuracy with respect to the authorisation procedure and the authorisation decision. The request for internal review should therefore be based on arguments that would call this into question. The applicants should be able to base their arguments on any ground and/or ‘evidence’ that would raise serious doubts as to the aforementioned presumption. Comprehensive proof is never needed. Speculation, on the other hand, would not be sufficient either.

69. The test developed by the General Court should, therefore, be understood as a material prerequisite which asks the party requesting a more thorough internal review to present arguments that would raise serious doubts as to the authorisation procedure and/or authorisation decision. Understood in this way, the General Court did not err in law in paragraphs 67, 83, and 88 of the judgment under appeal. ( 26 )

70. Concerning the other elements of the second ground of appeal, the Commission rightly highlighted the fact that the appellants do not dispute that the legal test used in all those disputed points was the one of which the appellants complain in the first part of the second ground of appeal, namely that they were required to advance material casting serious doubts on the legality of the authorisation decision. As a result, no independent error of law is claimed in this part of the appeal and this part must, in the following, be rejected as manifestly inadmissible.

71. The second ground of appeal must, therefore, be rejected.

Conclusion

72. In the light of the foregoing, and without pre-judging the merits of the other grounds of appeal, I propose that the Court should dismiss as being partly inadmissible and partly unfounded the second ground of appeal put forward by TestBioTech eV, European Network of Scientists for Social and Environmental Responsibility eV and Sambucus eV against the judgment of the General Court of 15 December 2016, TestBioTech and Others v Commission (T‑177/13, not published, EU:T:2016:736).

( 1 ) Original language: English.

( 2 ) Bearing the reference Ares(2013) 19605.

( 3 ) Regulation of 22 September 2003 on genetically modified food and feed (OJ 2003 L 268, p. 1)

( 4 ) Regulation of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13).

( 5 ) Convention on access to information, public participation in decision-making and access to justice in environmental matters, signed in Aarhus on 25 June 1998 and approved on behalf of the European Community by Council Decision 2005/370/EC of 17 February 2005 (OJ 2005 L 124, p. 1) (‘the Aarhus Convention’).

( 6 ) For detailed procedural rules governing the request for internal review, see Commission Decision of 13 December 2007 laying down detailed rules for the application of Regulation (EC) No 1367/2006 of the European Parliament and of the Council on the Aarhus Convention as regards requests for the internal review of administrative acts (2008/50/EC) (OJ 2008 L 13, p. 24). Under that decision the party requesting review must provide ‘the relevant information and documentation supporting those grounds’, see Article 1, point 3, of that decision.

( 7 ) The General Court refers to judgment of 10 November 2005, Stichting Zuid-Hollandse Milieufederatie (C‑316/04, EU:C:2005:678, paragraph 68).

( 8 ) Directive of the Council of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).

( 9 ) See judgment of 10 November 2005, Stichting Zuid-Hollandse Milieufederatie (C‑316/04, EU:C:2005:678, paragraph 68).

( 10 ) Which essentially concern the safety and effectiveness of the product. Footnote added.

( 11 ) See also Opinion of Advocate General Jääskinen in Joined Cases Council and Parliament v Commission and Commission v Vereniging Milieudefensie and Stichting Stop Luchtverontreiniging Utrecht (C‑401/12 P to C‑403/12 P, EU:C:2014:310, point 130). The action under Article 12 of Regulation No 1367/2006 does not relate to the authorisation decision but to the reply sent by the institution or body to which the request for internal review is made, which is, in the case at hand, the contested decision.

( 12 ) Regulation of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1).

( 13 ) Recital 4 of Regulation No 1367/2006.

( 14 ) See, moreover, Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice Council Directives 85/337/EEC and 96/61/EC (OJ 2003 L 156, p. 17), and Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ 2003 L 41, p. 26).

( 15 ) But the Aarhus Convention is historically even more intertwined with EU law. Indeed, there is a cross-fertilisation between EU environmental law and the Aarhus regime under international law, as the former Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (OJ 1985 L 175, p. 40) and Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (OJ 1990 L 158, p. 56) served as ‘a model at international level and their basic philosophy is taken over by the Aarhus Convention’. See Proposal for a regulation of the European Parliament and of the Council on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to EC institutions and bodies, COM(2003) 622 final, p. 3.

( 16 ) Yet, as the Court has clarified, one cannot rely on Article 9(3) of the Aarhus Convention in order to assess the legality of Article 10(1) of Regulation No 1367/2006, see judgment of 13 January 2015, Council and Others v Vereniging Milieudefensie and Stichting Stop Luchtverontreiniging Utrecht (C‑401/12 P to C‑403/12 P, EU:C:2015:4, paragraph 61).

( 17 ) See Proposal for a regulation of the European Parliament and of the Council on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to EC institutions and bodies, COM(2003) 622 final, p. 7. See also Opinion of Advocate General Jääskinen in Joined Cases Council and Parliament v Commission and Commission v Vereniging Milieudefensie and Stichting Stop Luchtverontreiniging Utrecht (C‑401/12 P to C‑403/12 P, EU:C:2014:310, point 123 et seq.)

( 18 ) Judgment of 9 September 2003, Monsanto Agricoltura Italia and Others (C‑236/01, EU:C:2003:431, paragraph 111 and the case-law cited).

( 19 ) See, to that effect, point 36 above and, more generally, my Opinion in Saint-Gobain Glass Deutschland v Commission (C‑60/15 P, EU:C:2016:778, points 37-41)

( 20 ) For aspects of access to information, see e.g. my Opinion in Saint-Gobain Glass Deutschland v Commission (C‑60/15 P, EU:C:2016:778, point 37 et seq.).

( 21 ) In this context, it should be recalled that there is a difference between the – procedural – burden of proof (onus probandi) and the – material – burden of raising and presenting an issue (onus proferendi). In this case the question is not on whom lies the burden of proof in an adversarial procedure before a court but whether and to what extent the applicant has to substantiate his request for an internal review. See in this respect my Opinion in combit Software (C-223/15, EU:C:2016:351, point 42 with footnote 18) and the Opinion of Advocate General Kokott in Spain v Lenzing (C‑525/04 P, EU:C:2007:73, points 27-29).

( 22 ) Judgments of 9 June 2005, HLH Warenvertrieb and Orthica (C‑211/03, C‑299/03 and C‑316/03 to C‑318/03, EU:C:2005:370, paragraph 75), and of 21 January 1999, Upjohn (C‑120/97, EU:C:1999:14, paragraph 34 and the case-law cited).

( 23 ) Judgment of 21 May 2015 (C‑546/12 P, EU:C:2015:332, paragraph 57).

( 24 ) Confusingly, the application refers at times to the term ‘reconsideration’, instead of ‘review’.

( 25 ) Judgment of 21 May 2015 (C‑546/12 P, EU:C:2015:332).

( 26 ) I should also like to stress at this point that I do not see a discrepancy between paragraphs 88 and 170 of the judgment under appeal. Paragraph 88 refers to the criteria to be applied, whereas paragraph 170 constitutes the result of the analysis.