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A Step Forward But Not Far Enough: Arysta Lifescience v EFSA on Disclosure of Co-Formulants

Published online by Cambridge University Press:  09 March 2026

Vania Noemi Gonzalez Campos Open the ORCID record for Vania Noemi Gonzalez Campos [Opens in a new window]
Vania Noemi Gonzalez Campos*
Affiliation:
Department of European Studies, University of Amsterdam Faculty of Humanities, Netherlands
*
Email: v.n.gonzalezcampos@uva.nl
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Abstract

This case note analyses the General Court’s judgment in Arysta Lifescience v EFSA (Case T-222/23), which addresses the tensions arising from the disclosure of the lists of co-formulant in the context of the EU risk assessment of pesticides. The decision consolidates the General Court’s interpretation of “information relating to emissions into the environment” under Article 6(1) of Aarhus Regulation, confirming its applicability to the list of co-formulants contained in representative products.

Keywords

co-formulantsEFSAplant protection productspublic access to informationrisk assessmenttransparency

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Type
Case Notes
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European Journal of Risk Regulation , First View , pp. 1 - 8
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© The Author(s), 2026. Published by Cambridge University Press

Case T-222/23, Arysta Lifescience v. European Food Safety Authority (EFSA), [2025] ECLI:EU:T:2025:609

Article 4(2) of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents OJ L 145, 31/05/2001 P. 0043 – 0048

Article 6(1) of Regulation (EC) No 1367/2006 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 L 264, 25.9.2006, pp. 13–19

I. Introduction

Transparency fosters the potential to enhance public trust. It can particularly favour trust in European Union (EU) agency decision-making, as “it enables public scrutiny, which in turn helps enhancing the epistemic quality as well as the integrity of agency science.”Footnote 1

Although transparency is a principle strongly embedded within the EU regulatory framework,Footnote 2 during its implementation the rights derived from transparency provisions need to be adequately balanced with other legitimate rights. In the context of the pesticide risk assessment process, the public interest enshrined in transparency provisions needs to be balanced by public agencies – such as the European Food Safety Authority (EFSA) – with the legitimate protection of commercial interests of the regulated industries, intellectual property rights or personal data.Footnote 3

In this layered regulatory context, and amid a persistent tension between industry resistance to transparency to safeguard economic interests and increasing public concern on pesticide exposure, administrative interpretation of transparency provisions applied to highly technical contexts is likely to be contentious.Footnote 4

Such is the case for transparency provisions applied to pesticide composition within the risk assessment process carried out by EFSA. Pesticides – referred to as a type of plant protection products by EU legislation – are marketed in formulations that contain various substances or preparations. The main ingredients are: (i) the active substance, defined by Article 2.2 of Regulation No. 1107/2009 (PPP Regulation)Footnote 5 as the substance having a general or specific action against harmful organisms, plants, parts of plants or plant products, and (ii) additional chemicals referred to as co-formulants, defined by Article 2.3(c) of the PPP Regulation as substances or preparations which are used in a plant protection product but are neither active substances nor safeners or synergists.Footnote 6

In practice, co-formulants perform a wide range of functions. They might “help dissolve the active ingredient, keep the product emulsified (or) act to help the product spread out over crop leaves.”Footnote 7

From a regulatory perspective co-formulants have often been overlooked in the risk assessment process of pesticides, even though they have on several instances been found to be more toxic than the active substance itself.Footnote 8 For instance, complete formulations of pesticides are not required to be tested by applicants for long-term toxicity.Footnote 9 Consequently, it has been pointed out that long-term effects of co-formulants in the evaluation of plant protection products are not sufficiently pondered.Footnote 10

In relation to the issues examined in this case note, it has also been criticised that EU regulations foster co-formulants secrecy.Footnote 11 From a regulatory perspective “specifically concerning the risk assessment of active substances carried out by EFSA at EU level-transparency of co-formulants is not ensured by the regulatory framework to the same extent as it is for active substances.

In essence, transparency of co-formulants at EU level is governed by three legal acts. First, the PPP Regulation, amended in 2019 by the Regulation (EU) 2019/1381 (Transparency Regulation). Secondly, Regulation (EC) No 1049/2001 (Access to Documents Regulation).Footnote 12 And finally, when the information at issue is deemed to relate to emissions into the environment, Regulation (EC) 1367/2006 (Aarhus Regulation).Footnote 13 The scope and obligations derived from these regulations will be expanded upon hereunder.

Regarding the PPP Regulation, its scope on co-formulants is limited. This is because plant protection products (which include co-formulants) are only assessed at Member State level, while, on the other hand, active substances are assessed at EU level.Footnote 14

In sum, and regarding the risk assessment of active substances at EU level, Article 12 of the PPP Regulation establishes that EFSA “shall adopt a conclusion (…) on whether the active substance can be expected to meet the approval criteria provided for in Article 4” of the PPP Regulation. Based on EFSA’s conclusion, and “other factors legitimate to the matter under consideration” (Article 13(2) PPP Regulation), the European Commission shall adopt a decision regarding the approval of an active substance.

The approval criteria laid down in Article 4 requires the applicant to submit at least one plant protection product containing the active substance at issue. It is in the context of this representative use that a list of co-formulants must be conveyed by the applicant. Precisely the controversy on the transparency of this list originated in the case of Arysta Lifescience v. EFSA.

For the first approval or renewal of approval of an active substance Articles 10 and 16 of the PPP Regulation respectively enshrine public access to the dossiers submitted by the applicant, with the exception of the information which has been granted confidentiality pursuant Article 63.

Article 63 was substantially modified by the Transparency Regulation. Prior to this regulation, it listed the type of information that was deemed to undermine the protection of the commercial interests of an applicant and thus should not be disclosed by EFSA when requested by a third party.

Following the amendments introduced by the Transparency Regulation, Article 63 now outlines that an applicant may only request EFSA to treat certain parts of the information submitted as confidential when accompanied by “verifiable justification.” Thus, Article 63 now serves to limit the range of information for which confidential treatment can only be granted with appropriate justification by the applicant. This change of paradigm is relevant as it is crucial that the risk assessment process in the pesticide sector makes the information used “therein visible to outsiders and hence contestable.”Footnote 15

However, new Article 63(2)(d) of the PPP Regulation lists the “information on the complete composition of a plant protection product” as one of the items towards which confidentiality can be granted. Thus, potentially allowing for the possibility of co-formulants to be kept confidential even after the amendments introduced by the Transparency Regulation.

The second legal act governing transparency of co-formulants is the Access to Documents Regulation. This regulation provides access to documents produced or retained by EU institutions (Article 2), with a limited number of exceptions listed in Article 4, such as the protection of commercial interests of a natural or legal person (Article 4(2)). Through these exceptions, this regulation also fosters the possibility of co-formulants to be kept confidential, particularly when their publication may affect commercial interests.

Finally, if the list of co-formulants submitted in the context of a representative product is deemed to relate to emissions into the environment, Aarhus Regulation shall also be applicable. Article 6(1) of this regulation establishes an overriding public interest in the disclosure of information when the requested documents contain environmental information, to the effect that the exception concerning the protection of commercial interests set out in Article 4(2) of the Access to Documents Regulation does not apply.

In sum, both the PPP Regulation and the Access to Documents Regulation foster the possibility of maintaining secrecy of co-formulants, even after the Transparency Regulation’s amendments. However, the exceptions that allow for confidentiality shall not be applicable if the information at issue is deemed to relate to emissions into the environment within the meaning of Article 6(1) of Aarhus Regulation.

Consequently, the key question that arises in the context of the risk assessment process of an active substance is: are co-formulants listed as part of a representative product deemed to relate to emissions into the environment for the purposes of Article 6(1) of the Aarhus Regulation?

In this scenario, the decision of the General Court of 18 June 2025 in the case of Arysta Lifescience v. EFSA on the disclosure of the full list of co-formulants relating to the procedure for renewing the approval of the active substance Captan constitutes a precedent that brings much-needed clarity to the interpretation of the rules governing the public disclosure of co-formulants.

II. Facts of the case

Arysta Lifescience (hereafter, the Applicant) markets in the EU the plant protection product Captan 80 WG, which is used as a fungicide. This product is composed of an active substance (Captan) and certain co-formulants.

The active substance Captan was assessed and approved in the EU for the first time on 1 October 2007 for a period of 10 years. Accordingly, it was included in the list of approved active substances in Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 (OJ 2011 L 153, p. 1). The expiry date for the approval of this substance was initially fixed for 30 September 2017 but subsequently extended to 15 November 2024.

In September 2014 the applicant submitted an application for the renewal of the approval of the active substance Captan.Footnote 16 As this dossier was initiated before the Transparency Regulation entered into force, this legislation is not applicable.

In the context of the renewal procedure for this active substance, an application for access to documents was submitted in December 2022 to EFSA by three members of the European Parliament under the Access to Documents Regulation. The request concerned specifically the full list of co-formulants present in the formulation intended for representative uses of the plant protection product Captan 80 WG.

On 24 January 2023 EFSA notified the Applicant of its decision to grant access to the list of co-formulants, as the information should be considered information relating to emissions into the environment in the context of Article 6(1) of Aarhus Regulation.

Subsequently, the Applicant contested this decision, as in its view the list at issue contained commercially sensitive and thus confidential information and its disclosure would infringe Article 63 of the PPP Regulation.

In February 2023 EFSA notified the applicant of its final decision: the list of co-formulants should be disclosed. Since the active substance Captan was already on the market, it had to be regarded as present in the environment.

The Applicant then brought an annulment action against EFSA’s decision before the General Court on the grounds that it infringed Article 4(2) of the Access to Documents Regulation and Article 6(1) of the Aarhus Regulation.

In essence, the Applicant claimed that EFSA made a manifest error of assessment by asserting that the list at issue was “information relating to emissions into the environment” within the meaning of Article 6(1) of Aarhus Regulation. Specifically, it argued that the information to be disclosed was clearly covered by the exception laid down in Article 4(2) of the Access to Documents RegulationFootnote 17 and that there was no other overriding public interest in its disclosure.

Furthermore, the applicant argued that the list at issue only concerned a “potential” formulation of a product (submitted for the purpose of showing the “in principle” regulatory viability of a plant protection product containing the active substance Captan), and not necessarily an actual plant protection product to be placed on the market.

Based on this distinction, the applicant claimed that the information relating to emissions into the environment may be provided only at the stage of the national authorisation procedure for plant protection products. As the procedure at issue related to the authorisation of the active substance Captan at EU level, the list of co-formulants had an insufficient link with emissions into the environment and thus Article 6(1) of Aarhus Regulation should not be applicable.

III. Summary of the judgment

The Court rejected as unfounded the applicant’s claim concerning infringement of Article 6(1) of Aarhus Regulation. The General Court first clarified that Article 6(1) of this regulation implements the principle that the public should have the widest possible access to information held by the institutions and bodies of the EU. Thus, a narrow interpretation of that provision could not be justified.Footnote 18

Building on this interpretation of Article 6(1) of Aarhus Regulation, the Court held that although the expression “information [relating] to emissions into the environment” is not explicitly defined in the regulatory framework, “it had to be understood to include data that will allow the public to know what is actually released into the environment or what, it may be foreseen, will be released into the environment under normal or realistic conditions of use of the product or substance in question (…).”Footnote 19

To this effect the Court concluded that, as the active substance Captan was already on the market and the list of co-formulants communicated by the applicant in the course of the renewal procedure was almost identical to the list of co-formulants of the plant protection product Captan 80 WG, it came under the category of “information [relating] to emissions into the environment” within the meaning of Article 6(1) of Aarhus Regulation.Footnote 20

The Court emphasised that just like the active substances contained in a plant protection product, “co-formulants contained in such a product are discharged into the environment in the course of its normal or realistic use.”Footnote 21 Consequently, in the case at hand, as the active substance was already authorised, the list of co-formulants at issue concerned emissions that are foreseeable and not purely hypothetical.Footnote 22

Based on these considerations, the Court rejected the applicant’s claim concerning infringement of Article 6(1) of Aarhus Regulation as unfounded and dismissed the action in its entirety.

IV. Comment

The Arysta Lifescience v. EFSA ruling consolidates the General Court’s line of case law to catalogue technical information submitted in the context of the approval or renewal of approval of an active substance as relating to emissions into the environment for the purposes of Article 6(1) of Aarhus Regulation.

What is novel is that the Court expressly extended this reasoning to co-formulants. The ruling therefore established that information on co-formulants, even when submitted only as part of a representative product, is still capable of relating to emissions into the environment within the meaning of Article 6(1) of Aarhus Regulation and should therefore be disclosed.

In the cases T-329/17 Hautala and others v. EFSA and T-716/14 Tweedale v. EFSA, the Court had already adopted interpretation of Article 6(1) of Aarhus Regulation regarding the carcinogenicity and developmental toxicity studies on glyphosate submitted by the applicant. In these cases, the Court clarified that toxicity studies must be regarded as information which relates to emissions into the environment within the meaning of Aarhus Regulation.Footnote 23

Moreover, in Tweedale v. EFSA the Court explained that in the course of the normal use of pesticides foreseeable emissions into the environment are intended by virtue of its function, therefore its foreseeable emissions could not be regarded as purely hypothetical.Footnote 24

Therefore, it is clear from previous case-law that technical information relating to active substances assessed in the context of the PPP Regulation such as toxicological studies is to be interpreted as information relating to emissions into the environment in the context of Article 6(1) of Aarhus Regulation.

However, the list of co-formulants submitted during the assessment of an active substance does not directly relate to the substance under assessment, but rather to a representative (and potentially purely hypothetical) plant protection product. Therefore, regarding the transparency of the co-formulants list submitted at this stage of the assessment, there is space for administrative discretion.

In this setting, the ruling on the case Arysta Lifescience v. EFSA clears some of the abovementioned ambiguity. By setting a precedent that specifically favours the disclosure of the list of co-formulants, this ruling will advance towards EFSA’s transparency the decisions when dealing with transparency requests from the public or confidentiality requests from applicants in the context of the risk assessment process of a pesticide active substance.

However, while the ruling in the case Arysta Lifescience v. EFSA brings clarity in the context of the list of co-formulants in renewal of approval dossiers, uncertainty on the transparency of such list in first approval dossiers remains.

Part of the Court’s reasoning to consider the list of co-formulants as information relating to emissions into the environment was based on the fact that Captan was already on the market and the list of co-formulants communicated by the applicant in the course of the renewal procedure was almost identical to the list of co-formulants of the plant protection product Captan 80 WG.Footnote 25 Whether the Court will still consider the list of co-formulants for representative products as emissions that are foreseeable and not purely hypothetical when an active substance is not yet in the market can only be speculated upon.

Judicial controversies that reveal the tensions between commercial confidentiality and environmental transparency regarding critical technical aspects of a dossier may continue to arise. Thus, delayed public access to pivotal technical information remains imminent until legislative reforms or consolidation of administrative or judicial interpretation that strongly favour transparency of technical aspects relevant for the risk assessment of an active substance are adopted.

Granting all stakeholders access to the co-formulants submitted in these representative products allows them to access critical information to the outcome of the risk assessment process. As both active ingredients and co-formulants can cause human and environmental toxicity,Footnote 26 a regulatory framework that strongly supports transparency of co-formulants will support the EU regulatory framework to better achieve the aim of a high level of protection of human and animal health and the environment.

Furthermore, as highlighted by the Court of Justice in the case ClientEarth v Commission, “openness enables the EU institutions to have greater legitimacy and to be more effective and more accountable to EU citizens in a democratic system (…) by allowing divergences between various points of view to be openly debated.”Footnote 27

In conclusion, the recent ruling of the General Court in the case Arysta Lifescience v. EFSA and other landmark cases such as Hautala and others v. EFSA and Tweedale v. EFSA have contributed to much-needed clarity in the technical and layered realm of pesticides transparency. However, these rulings also reflect the existence of gaps within the legislative framework to systematically grant public access, in a timely manner, to critical technical information submitted in the context of the risk assessment process of pesticides.

Regarding co-formulants, ambiguity has been cleared by the Court through the Arysta Lifescience v. EFSA ruling where a renewal of approval dossier is concerned. However, clarity is still needed for first approval dossiers, where the active substance is not yet in the market and the link of co-formulants in a representative product and emissions into the environment could be deemed to be weaker.

Acknowledgements

The author would like to thank Dr. Marta Morvillo for her invaluable comments on an earlier draft.

Competing interests

The author has no conflicting interests to declare.

References

1 E Hickey and M Weimer, “The Transparency of EU Agency Science – Towards a New Proactive Approach Post-Covid19” (2021) 38 Amsterdam Centre for European Law and Governance Research Paper 1.

2 For instance, at a primary law level, Art. 10(3) of the Treaty on European Union (TEU) states that “every citizen shall have the right to participate in the democratic life of the Union. Decisions shall be taken as openly and as closely as possible to the citizen.” Furthermore, Art. 11(2) TEU provides for EU institutions to “maintain an open, transparent and regular dialogue with representative associations and civil society.” Similarly, Art. 15(1) of the Treaty on the Functioning of the European Union (TFEU) outlines that “in order to promote good governance and ensure the participation of civil society, the Union’s institutions, bodies, offices and agencies shall conduct their work as openly as possible.” Moreover, Art. 15(3) TFEU expands on this and requires EU institutions, bodies and agencies to “ensure that its proceedings are transparent.” Finally, Art. 42 of the Charter of Fundamental Rights of the EU provides that citizens and people residing in the EU have a “right of access to documents of the institutions, bodies, offices and agencies of the Union, whatever their medium.”

3 In this regard, it is in some cases relevant to adequately ponder the transparency principle with some of the rights recognised by the EU Charter of Fundamental Rights it may collide with. For example, Art. 8 outlines “everyone has the right to the protection of personal data concerning him or her.” Furthermore, Art. 16 enshrines the “freedom to conduct a business” and Art. 17 recognises “the right to property” which includes the protection of intellectual property.

4 C Robinson and others, “Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions” (2020) 11 European Journal of Risk Regulation 450.

5 Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market [2009] OJ L309/1.

6 As the PPP Regulation provides a definition by exclusion of co-formulants, it is relevant to add here the legal definitions for safeners and synergists. Safeners are the “substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants” (Art. 2.3(a) PPP Regulation). While synergists are the “substances or preparations which, while showing no or only weak activity, can give enhanced activity to the active substance(s) in a plant protection product” (Art. 2.3(b) of the PPP Regulation).

7 EA Straw, “End Co-Formulant Secrecy” (2024) 154 Environmental Science & Policy <https://doi.org/10.1016/j.envsci.2024.103701> (last accessed 9 September 2025).

8 Ibid.

9 C Robinson and others, “Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions” (2020) 11 European Journal of Risk Regulation 450. On this matter, see also: G‑E Seralini and others, “Scientist’s Warning: We Must Change Paradigm for a Revolution in Toxicology and World Food Supply” (2025) 37 Environmental Sciences Europe 182.

10 M Liszewska et al., “Endocrine-Disrupting Chemicals – Pesticide Regulatory Issues from the EU Perspective” (2024) 154 Regulatory Toxicology and Pharmacology, <https://doi.org/10.1016/j.yrtph.2024.105735> (last accessed 21 August 2025).

11 EA Straw, “End Co-Formulant Secrecy” (2024) 154 Environmental Science & Policy, <https://doi.org/10.1016/j.envsci.2024.103701> (last accessed 9 September 2025).

12 Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents [2001] OJ L145/43.

13 Regulation (EC) 1367/2006 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 [2006] OJ L264/13.

14 Conversely – at EU level – co-formulants are not assessed per se. Once an active substance has been authorised by the European Commission, a producer may request the competent authorities of each Member State for the approval of specific plant protection products – with specific co-formulants – to be marketed within its jurisdiction. Therefore, the assessment of co-formulants is relegated to the Member States where a plant protection product is requested to be marketed (Art. 28 PPP Regulation).

15 A de Boer, M Morvillo and S Röttger-Wirtz “Fragmented Transparency: The Visibility of Agency Science in European Union Risk Regulation” (2023) 14 European Journal of Risk Regulation 313, 314.

16 ADAMA Agriculture BV, Notification for Approval Renewal: Captan – Summary Report (Sanitised Version) (Document ID: Summary Report AIR 3, renewal procedure, September 2014, updated November 2014) <https://open.efsa.europa.eu/questions/EFSA-Q-2016-00185?search=captan>.

17 Art. 4(2) of Access to Documents Regulation sets out that EU institutions “shall refuse access to a document where disclosure would undermine the protection of: (…) commercial interests of a natural or legal person, including intellectual property.”

18 Case T-222/23 Arysta Lifescience v EFSA (General Court, 18 June 2025, ECLI:EU:T:2025:609) para 35. This framework for interpretation of Art. 6(1) of the Aarhus Regulation is also invoked in Case C-673/13 Commission v Stichting Greenpeace Nederland and PAN Europe (General Court, 23 November 2016, EU:C:2016:889) para 54.

19 Case T-222/23 Arysta Lifescience v EFSA (General Court, 18 June 2025, ECLI:EU:T:2025:609) para 37. Along these lines, see also Case C-673/13 Commission v Stichting Greenpeace Nederland and PAN Europe (General Court, 23 November 2016, EU:C:2016:889) para 79.

20 Case T-222/23 Arysta Lifescience v EFSA (General Court, 18 June 2025, ECLI:EU:T:2025:609) para 41.

21 Ibid, para 47.

22 Case T-222/23 Arysta Lifescience v EFSA (General Court, 18 June 2025, ECLI:EU:T:2025:609) para 43. See, by analogy, judgments of 7 March 2019, Tweedale v EFSA, T 716/14, EU:T:2019:141, paragraph 82, and of 7 March 2019, Hautala and Others v EFSA, T 329/17, not published, EU:T:2019:142, paragraph 89).

23 Case T-329/17 Hautala and Others v EFSA (General Court, 7 March 2019, EU:T:2019:142) para. 120.

24 Case T-716/14 Tweedale v. EFSA (General Court, 7 March 2019, ECLI:EU:T:2019:141) para. 81–2.

25 Case T-222/23 Arysta Lifescience v EFSA (General Court, 18 June 2025, ECLI:EU:T:2025:609) para 41.

26 EA Straw, “End Co-Formulant Secrecy” (2024) 154 Environmental Science & Policy <https://doi.org/10.1016/j.envsci.2024.103701> (last accessed 9 September 2025).

27 Case C-57/16 P ClientEarth v Commission (Court of Justice, 4 September 2018, ECLI:EU:C:2018:660) para.75