Case T‑725/15

Arysta LifeScience Netherlands BV, formerly Chemtura Netherlands BV

v

European Food Safety Authority

(Plant protection products — Procedure for reviewing the approval of the active substance diflubenzuron — Article 21 of Regulation (EC) No 1107/2009 — Conclusion of the EFSA review — Partial publication of that conclusion — Article 63 of Regulation No 1107/2009 — Request for confidential treatment of certain sections — Protection of commercial interests — Refusal to grant confidential treatment — Interest in bringing proceedings)

Summary — Judgment of the General Court (Fourth Chamber), 14 December 2018

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Request for confidential treatment of information submitted to the European Food Safety Authority (EFSA) — Information that can receive such treatment — Information undermining the applicant’s commercial interests — Presumption of harm in the case of information concerning the specification of impurity of an active substance — Limits — Disclosure by EFSA to the public of the genotoxicity of an active substance in the interests of the protection of public health — Lawfulness

Judicial proceedings — Application initiating proceedings — Formal requirements — Brief summary of the pleas in law on which the application is based — Pleas in law not set out in the application — Reference to the whole of the annexes — Inadmissibility

Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Request for confidential treatment of information submitted to the European Food Safety Authority (EFSA) — Information that can receive such treatment — Conclusion of the peer review of EFSA issued during the process of reviewing the approval of an active substance — Included

Action for annulment — Natural or legal persons — Interest in bringing proceedings — Need for an actual and current interest — Action against a decision of the European Food Safety Authority (EFSA) relating to the publication of the conclusion of the peer review of EFSA during the process of reviewing the approval of an active substance — Applicant that has requested confidential treatment for information submitted to EFSA and contained in the conclusion — Admissibility

An applicant’s interest in bringing proceedings must be vested and current. It may not concern a future and hypothetical situation. That interest must, in the light of the purpose of the action, exist at the stage of lodging the action, failing which the action will be inadmissible, and continue until the final decision, failing which there will be no need to adjudicate. As regards an action against a decision of the European Food Safety Authority (EFSA) relating to the publication of certain sections of the EFSA peer review on the review of the approval of an active substance, the applicant has an interest in bringing proceedings since annulment of that decision is liable to procure it an advantage, in so far as the contested decision, having rejected the requests for confidential treatment under Article 63(1) of Regulation No 1107/2009 concerning the placing of plant protection products on the market made by the applicant in respect of the contested conclusion, led to the publication of a version of the conclusion issued during the review process containing sections for which the applicant has requested confidential treatment. In those circumstances, the applicant could, in the event of annulment of that decision, have, as a first step, the conclusion in question removed from EFSA’s website, for example, and, as a second step, have it published in a form reiterating in full or in part its requests for confidentiality that EFSA previously rejected. Moreover, the applicant’s interest in bringing proceedings does not disappear on account, first, of the adoption of a regulation authorising uses of the active substance under certain conditions and, second, of the bringing of the action challenging the legality of that implementing regulation before the EU judicature. The contested decision continues to produce effects, in so far as the conclusion in question is still accessible to the public. In addition, the applicant retains an interest in seeking annulment of that decision in order to obtain inter alia a finding, by the EU judicature, that an unlawful act has been committed against it, so that such a finding can then be the basis for any action for damages aimed at properly restoring the damage allegedly caused to his commercial interests by the publication of the contested conclusion. Neither the adoption of that regulation nor the result of the action pertaining to the legality of that regulation can procure such an advantage for the applicant, given that they have no impact on the question of whether EFSA was justified, in the contested decision, in rejecting the requests for confidential treatment under Article 63(1) of Regulation No 1107/2009 made by the applicant in respect of the contested conclusion. (see paras 67, 69-72)

See the text of the decision. (see para. 80)

There is no provision in Regulation No 1107/2009 concerning the placing of plant protection products on the market or in Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety that explicitly prohibits EFSA from publishing its opinions adopted in the context of a review process. It must be stated, moreover, that there is nothing in those regulations to suggest that the EU legislature had intended to prohibit EFSA from making such opinions available to the public. Such a prohibition cannot be inferred solely from the absence of an obligation, in the text of Article 21 of Regulation No 1107/2009, to make such opinions available. It is apparent, however, from a combined reading of Regulation Nos 1107/2009 and 178/2002 that EFSA is subject to transparency requirements which assume, in principle, that the public is informed of the results of its activities and thus can have access to its opinions adopted in the context of a review process. As EFSA indicated in its letter of 8 October 2015, it is those provisions which confer the power to publish such opinions. It is apparent, in particular, from Article 38(1)(b) and from Article 40(2) and (3), second subparagraph, of that regulation that the opinions of EFSA are, in principle, made public. Article 39(3) of the same regulation provides that the conclusions of the scientific opinions delivered by EFSA relating to foreseeable health effects are on no account to be kept confidential. As regards, more specifically, the placing on the market of plant protection products, it follows from a reading a contrario of Article 63 of Regulation No 1107/2009 that confidential treatment of such information is the exception, whereas public access to that information is the rule. Consequently, EFSA cannot be criticised for having considered, in a decision relating to the publication of certain sections of the EFSA peer review on the review of the approval of an active substance, that its power to publish the contested conclusion stemmed, inter alia, from the combined reading of Articles 38 to 40 of Regulation No 178/2002 and of Article 63 of Regulation No 1107/2009. (see paras 81-83)

The conclusion issued by the European Food Safety Authority (EFSA) during the process of reviewing the approval of an active substance is part of the review process referred to in Article 21 of Regulation No 1107/2009 concerning the placing of plant protection products on the market. That process is ended by the adoption of a decision of the Commission to maintain, withdraw or amend the active substance at issue. The EFSA conclusion therefore does not reflect the definitive position on that active substance in the review. The Commission alone has the power to take a definitive position on that matter. It is not apparent from a reading of Article 21 of Regulation No 1107/2009 that the Commission is obliged to follow EFSA opinions. In those circumstances, that conclusion must be regarded as constituting a preparatory act that cannot be subject to review by the Court, it being possible to invoke, where appropriate, the allegedly incorrect nature of the conclusion in question or the existence of a misuse of powers or a breach of procedural guarantees vitiating it in the context of an action against the decision of the Commission. (see para. 90)

See the text of the decision. (see para. 96)

It cannot be inferred from Article 63 of Regulation No 1107/2009 concerning the placing of plant protection products on the market that a person may request confidential treatment only for the information that he has submitted to the European Food Safety Authority (EFSA). That provision should be interpreted in the light of recital 41 of that regulation, from which it is not apparent that the EU legislature intended to restrict a request for confidential treatment to such information. Such an interpretation is also apparent from Article 39(1) of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety, which is the general provision laying down restrictions on public access to the information in EFSA’s possession according to which EFSA is not to divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified. Moreover, Article 63 of Regulation No 1107/2009 seeks to protect commercial interests, privacy and the integrity of the individual who requests confidential treatment for information submitted pursuant to that regulation. It cannot be ruled out, however, that those interests might be undermined by the disclosure of information submitted by a person other than the one who requested confidential treatment for it. (see paras 97-99)

The conclusion issued by the European Food Safety Authority (EFSA) issued during the process of reviewing the approval of an active substance constitutes information subject to the application of Regulation No 1107/2009 concerning the placing of plant protection products on the market. That conclusion is part of the review process referred to in Article 21 of Regulation No 1107/2009. First, assessments of active substances by EFSA are, in principle, based on information submitted to that authority. In that regard, where the Commission confers a mandate during the process of reviewing an active substance, according to which EFSA is requested to organise a peer review of the data previously submitted by an undertaking as well as the assessment of those data by the rapporteur Member State, the conclusion adopted by EFSA in response to that mandate is based on the information submitted by that applicant and by the rapporteur Member State. Therefore, the assessment contained in that conclusion cannot be regarded as being isolated from the information on which it is based. Second, as is apparent from recital 41 of Regulation No 1107/2009, the confidentiality rule applies to the documents in the possession of the competent authorities. Given that the assessment produced by EFSA is in its possession and in the absence of any other argument, there is no reason to consider that the confidentiality rule could not also be applied to such an assessment. (see paras 101-103)

So far as concerns the confidential treatment of information submitted to the European Food Safety Authority, Article 63 of Regulation No 1107/2009 concerning the placing of plant protection products on the market does not define the concept of commercial interests and is not limited to the types of information mentioned in paragraph 2 thereof considered to undermine those interests, with the result that it may be applied to a multitude of types of information, the sole criterion being that the person requesting confidential treatment provide verifiable evidence showing in a concrete manner that the disclosure of that information might undermine his commercial interests. However, the incorrectness of information does not constitute, as such, a relevant criterion for determining whether the disclosure of that information is likely to undermine commercial interests. That issue is separate from that of the correctness of information. A piece of information may be correct and yet undermine an applicant’s commercial interests on account of its disclosure. Conversely, the disclosure of false information does not necessarily harm those interests. (see paras 108, 109)

See the text of the decision. (see paras 113, 114)

As regards the confidential treatment of information submitted to the European Food Safety Authority (EFSA), it is true that the specification of impurity of the active substance is mentioned among the examples set out in the non-exhaustive list of Article 63(2) of Regulation No 1107/2009 concerning the placing of plant protection products on the market, which are, in principle, deemed to undermine the protection of commercial interests. However, Article 63(2)(b) contains an exception whereby the impurities that are considered to be inter alia toxicologically relevant are excluded from that protection. Moreover, in terms of the EFSA conclusion issued during the process of reviewing the approval of an active substance which reveals the genotoxic nature of that substance, EFSA cannot be criticised for having disclosed that conclusion in the interests of protecting public health, thereby giving precedence to the requirements related to the protection of those interests over economic interests. Article 168(1) TFEU requires that a high level of human health protection be ensured in the definition and implementation of all EU policies and activities. The protection of human health takes precedence over economic considerations, with the result that it may justify adverse economic consequences, even those which are substantial, for certain traders. (see paras 120, 133, 135)