Background to the complaint

1. Under EU law (‘the Pesticides Regulation’), plant protection products (commonly referred to as ‘pesticides’) can only be placed on the market if they have “no unacceptable effects on the environment”[1], including their “impact on biodiversity and the ecosystem”[2].

2. The criteria to decide whether there are no such unacceptable effects on the environment are currently set out in several guidance documents developed for different environmental areas. In 2019, the Commission initiated a project on ‘specific protection goals’, which aims at reviewing the existing guidance documents and decision-making criteria. The project draws on guidance documents developed by the European Food Safety Authority (EFSA).[3]

3. The complainant is an environmental organisation that is concerned about the harmfulness and negative impact of pesticides on the state of insects, biodiversity and ecosystems.

4. In this context, in March 2023, the complainant sent a letter to EFSA expressing concerns about EFSA’s alleged failure to consider properly, in its current approach to risk assessment, “indirect effects” of pesticides on biodiversity and ecosystems. The complainant intended to “engage in a scientific discussion” with EFSA and encourage it to change its risk assessment practice. In the complainant’s view, methodological solutions for including indirect effects in risk assessment are already available and the fact that EFSA does not currently take them into account is at odds with the applicable legal framework.

5. On two occasions in May 2023, EFSA replied to the complainant’s letters.

6. In July 2023, dissatisfied with how EFSA had addressed its concerns, the complainant turned to the Ombudsman.

The inquiry

7. The Ombudsman opened an inquiry into the complaint to obtain more detailed answers from EFSA in relation to three main aspects raised by the complainant in its correspondence with EFSA, in particular:

• whether EFSA has a legal obligation to take into account, in its approach to risk assessment, the indirect effects of pesticides;
• EFSA’s role in the process of (re-)defining the specific protection goals of an environmental risk assessment in terms of what to protect, where to protect it, over what time period and with what degree of certainty; and
• the appropriateness of interim solutions for assessing indirect effects of pesticides on biodiversity and ecosystems, such as those referred to by the complainant.

8. In the course of the inquiry, the Ombudsman received EFSA’s reply and the complainant’s comments on EFSA’s reply.

Arguments presented to the Ombudsman

Applicable legal framework

9. The complainant argued that EFSA has a legal obligation, under the Pesticides Regulation,^[4] to take into account in its approach to risk assessment the indirect effects of pesticides on biodiversity and ecosystems. In the complainant’s view, the requirement that pesticides shall have “no unacceptable effects on the environment” encompasses both direct and indirect effects.

10. In this context, the complainant noted that EFSA took a wider approach in its risk assessment of glyphosate, by ‘flagging’ the issue of risks due to indirect effects to the risk manager, whereas it has not adopted such an approach more systematically.

11. EFSA replied that the definition of the generic goal of “no unacceptable effects” in the Pesticides Regulation implies quality judgements, which are the responsibility of the “risk manager”, that is, the Commission and the Member States, rather than EFSA, which is charged with the assessment of risk. As there is currently no clear definition of what is deemed ‘unacceptable’, EFSA in turn is not in a position to identify fully accepted scientific methods to assess indirect effects. EFSA added that the Commission is currently working on defining the term ‘unacceptable’, by developing specific protection goals of environmental risk assessments - in terms of what to protect, where to protect it, over what time period and with what degree of certainty.

12. Thus, given the absence of specific protection goals set by the risk managers, EFSA is not in a position to move forward autonomously by identifying legally binding standards on its own. This would de facto replace the role of the Commission.

13. As regards the risk assessment of the active substance glyphosate, EFSA clarified that precisely because no harmonised approach is available, a firm conclusion regarding risks due to indirect effects cannot be drawn. EFSA therefore merely signalled to the risk managers, during the peer review, the concerns related to indirect effects raised by the Member State (Germany) that conducted the initial risk assessment of glyphosate. The experts considered this as an important risk management issue. EFSA explained that until directly implementable specific protection goals for indirect effects are developed and endorsed, it can only review what is provided by the Member State that conducts the initial risk assessment.

14. The complainant responded by saying that, although EFSA says it needs a mandate to act, “EFSA often concludes without a guideline”. EFSA could use the publicly available literature from which it is clear that the state of insects has collapsed, which is mainly caused by pesticides. EFSA should draw its conclusions based on the latest insights, in accordance with the Pesticides Regulation. The complainant was not convinced by EFSA’s statement that it needs targets (specific protection goals) in order to move forward, as specific protection goals only concern the human benefit of ecosystems, and do not protect ecosystems themselves.

EFSA’s role in defining ‘specific protection goals’

15. The complainant took the view that the approach of defining “unacceptable effects to the environment” based on specific protection goals is inadequate and too selective to protect biodiversity and ecosystems. In the complainant’s view, EFSA should immediately include in its approach to risk assessment the indirect effects of pesticides.

16. EFSA explained that the Commission, as risk manager, has initiated the process of defining special protection goals (“what to protect, where to protect it, over what time period and with what degree of certainty”), which, as mentioned above, are meant to implement the generic protection goal of “no unacceptable effects on the environment” in the Pesticides Regulation. The definition of specific protection goals requires a dialogue between risk assessors and risk managers, where the risk assessors provide scientific support to risk managers for the final decision on the desired level of protection for the relevant non-target organisms. To this end, EFSA has supported the Commission with its scientific input.[5] Following the definition of specific protection goals by the risk manager, EFSA can start developing new guidance documents.

17. The complainant replied that, although EFSA claims that it needs a mandate from the Commission, it already acts on various matters without such a mandate.

The appropriateness of interim solutions

18. The complainant referred in its exchanges with EFSA to interim methodological solutions, which, in the complainant’s view, would allow EFSA to consider the indirect effects of pesticides in its current approach to risk assessment. Specifically, the complainant referred to an approach developed by the German Environmental Agency (UBA)[6] and a report published by the Swedish Chemical Agency[7]. The complainant argued that EFSA failed to explain properly why it has not been able to implement these interim solutions.

19. In reply, EFSA clarified that it has drawn up a priority list for the revision of guidance documents, which was finalised at a meeting of the SCoPAFF[8] with the Commission and Member States in December 2022. The development of an interim methodological solution was not considered during the prioritisation exercise. Therefore, EFSA is not aware whether the approach proposed by the German UBA is envisaged or supported by Member States, considering other risk management options that Member States can implement when authorising pesticides, such as risk mitigation measures. As regards the report published by the Swedish Chemical Agency, EFSA noted that this document contains a systematic literature review of existing approaches, rather than the proposal of a specific method for assessing the indirect effects of pesticides. The authors of this report conclude that a combination of different existing approaches can be suggested, and EFSA noted that these suggestions can be considered in the context of the forthcoming development of a harmonised method.

20. EFSA added that the importance and sensitivity of the topic deserved the largest possible consensus, including the engagement of all relevant stakeholders.

21. The complainant replied by saying that it appears that EFSA has not made any attempt to seek consensus among Member States to implement the interim solution proposed by the German UBA.

The Ombudsman's assessment

22. This Ombudsman’s inquiry concerned how, in its current approach to risk assessment, EFSA considers indirect effects of pesticides on biodiversity and ecosystems. The Ombudsman is not a scientific body and it is not the Ombudsman’s role to examine the merits of scientific evaluations carried out by specialised bodies and scientific agencies, such as EFSA. In this context, it is not the Ombudsman’s role to question the choices of EFSA concerning how to assess the indirect effects of pesticides appropriately. In a case like this, the Ombudsman can assess whether the EU body explained its procedures and decisions in a clear and reasonable way, and whether it followed the applicable rules and procedures.

23. The replies that the complainant received from EFSA in this case did not address all the aspects and arguments that the complainant had raised. This inquiry thus provided EFSA with an opportunity to address the complainant’s concerns more substantively and to ensure that it conducts its work “as openly and as closely as possible to the citizen”[9].

Applicable legal framework

24. The Ombudsman asked EFSA to reply, in more detail, to the complainant’s claim that EFSA has a legal obligation to take into account, in its approach to risk assessment, the indirect effects of pesticides.

25. In reply, EFSA explained why, at this stage, it could not systematically include the consideration of indirect effects of pesticides in its approach to risk assessment, in particular given that the generic goal of “no unacceptable effects on the environment” has not yet been defined by the risk manager. To this end, EFSA referred to the Commission’s ongoing process of defining specific protection goals. In this context, EFSA also clarified why it could ‘flag’ the issue of indirect effects to risk managers in the approval of the active substance glyphosate.

26. The Ombudsman considers that EFSA has now clearly explained which tasks fall under its responsibility as risk assessor, and which tasks are the responsibility of the Commission (and the Member States) as risk managers. She finds EFSA’s position clear and reasonable.

27. That said, the Ombudsman notes with concern that there is still no clear definition of the aforementioned generic goal, despite the fact that the Pesticides Regulation took effect in 2009.

28. The Ombudsman trusts that when a Member State raises concerns regarding a particular active substance, such as in the case of glyphosate, EFSA will undertake the necessary steps to flag the issue of indirect effects to the risk managers.

EFSA’s role in defining specific protection goals

29. EFSA explained that the Commission, as risk manager, has initiated the process of defining special protection goals (“what to protect, where to protect it, over what time period and with what degree of certainty”), which, as mentioned above, are meant to implement the generic protection goal of “no unacceptable effects on the environment” in the Pesticides Regulation.

30. The Ombudsman understands that, fundamentally, the complainant disagrees with the approach of defining “unacceptable effects to the environment” based on specific protection goals, including EFSA’s scientific input that has so far supported the Commission’s decision making in that regard. The complainant considers the approach inadequate and too selective to protect biodiversity and ecosystems.

31. As a non-scientific body, the Ombudsman cannot assess whether the approach of defining specific protection goals to implement the generic goal of “no unacceptable effects on the environment” is, scientifically, the most adequate approach to consider the indirect effects of pesticides on the environment. She also notes that it will ultimately be for the Commission to decide on the approach, taking into account the scientific input provided by EFSA. In that regard, the Ombudsman understands, also from a previous inquiry into the matter,[10] that the process of defining specific protection goals has been initiated by the Commission in 2019 already, but is still ongoing. This is concerning. The Ombudsman will consider whether it is necessary to follow up with the Commission on the state of play of that process.

32. However, the Ombudsman considers that EFSA has now comprehensively explained its role in defining the specific protection goals.

The appropriateness of interim solutions

33. In reply to the complainant’s concerns that EFSA is ignoring the availability of interim solutions to take into account indirect effects of pesticides, EFSA explained how, in consultation with the Commission and Member States, it has prioritised its work on the revision of guidance documents. The development of an interim methodological solution was not considered during the prioritisation exercise.

34. The Ombudsman is not in position to take a stance on the prioritisation exercise that EFSA performed together with the Commission and the Member States. She trusts, however, that should the delay in finalising the specific protection goals persist, EFSA will revisit its work priorities and adapt them, if necessary.

35. Overall, the Ombudsman welcomes EFSA’s engagement with the complainant’s concerns about the indirect effects of pesticides on biodiversity and ecosystems. That said, she understands the complainant’s frustration that EFSA entered into such a dialogue only after her intervention. The Ombudsman finds this regrettable. However, as EFSA has now comprehensively replied to the complainant, no further inquiries into this matter are justified.

36.  In this context, the Ombudsman reminds EFSA of its obligation to conduct its work as openly as possible[11], and to maintain an open, transparent and regular dialogue with civil society[12]. She will make a suggestion for improvement to this end below.

Conclusion

Based on the inquiry, the Ombudsman closes this case with the following conclusion:

No further inquiries are justified.

The complainant and EFSA will be informed of this decision.

Suggestion for improvement

The Ombudsman makes the following suggestion for improvement:

When responding to (scientific) concerns about the effects of pesticides on biodiversity and ecosystems, EFSA should seek to address those concerns substantively in view of its duty to conduct its work as openly as possible and to maintain a dialogue with civil society and other stakeholders.

 

Emily O'Reilly
European Ombudsman

Strasbourg, 10/10/2024

 

[1] See article 4(3)(e) of Regulation 1107/2009 concerning the placing of plant protection products on the market: https://eur-lex.europa.eu/eli/reg/2009/1107/oj  (hereafter: ‘Pesticides Regulation’)

[2] See article 4(3)(e)(iii) of Regulation 1107/2009

[3] EFSA, ‘Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services’ of 2016, available at: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2016.4499

[4] See article 4(3)(e)(iii) of Regulation 1107/2009: The pesticide “shall have no unacceptable effects on the environment, having particular regard to the following considerations [...] where the scientific methods accepted by the Authority to assess such affects are available [...] its impact on biodiversity and the ecosystem.”

[5] EFSA referred to its ‘Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services’ of 2016, available at: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2016.4499

[6] “IMPACT OF PESTICIDES ON IN-FIELD NONTARGET PLANTS AND ARTHROPODS WITH CONSEQUENCES FOR ´FOOD-WEB-SUPPORT´ – EXPANDED RISK ASSESSMENT METHOD FOR NATIONAL PRODUCT AUTHORISATION IN GERMANY” UBA, 2022.

[7] KEMI, Methods for assessing the effects of plant protection products on biodiversity, 2020

[8] SCoPAFF stands for “the Standing Committee on Plants, Animals, Food and Feed”. More information can be found at: https://food.ec.europa.eu/horizontal-topics/committees/paff-committees_en

[9] Article 10(3) TEU.

[10] Decision on how the European Commission involved stakeholders and managed conflicts of interest in reviewing the protection goals for assessing environmental risks of pesticides (case 1402/2020/TE), available at: https://www.ombudsman.europa.eu/en/decision/en/148938

[11] See article 15(1) TFEU.

[12] See article 11(2) TEU.