Background to the complaint

1. According to the Regulation concerning the placing of plant protection products^[1] on the market (the PPP Regulation),^[2] before an active substance[3] can be used in a plant protection product (‘pesticide’)[4] in the EU, it has to be approved by the Commission.[5] Active substances with certain properties are considered as ‘candidates for substitution’.[6] This usually indicates that a substance is more hazardous than others.

2. Once active substances are approved, companies can submit to the relevant authorities of EU Member States applications for authorisation to place on the market pesticides containing them.

3. When national authorities evaluate applications to authorise pesticides containing active substances that are ‘candidates for substitution’, they must carry out a ‘comparative assessment’ to determine if those pesticides can be replaced by others that contain less hazardous active substances or by non‑chemical alternatives. The PPP Regulation sets out four criteria to be taken into consideration in the comparative assessment, notably whether : (a) a safer authorised pesticide or non-chemical control or prevention method exists for the same uses; (b) substitution would not present significant economic or practical disadvantages; (c) the chemical diversity of the active substances or methods and practices of crop management and pest prevention are sufficient to minimise the risk that the target organism (or pest ) could develop resistance; and (d) the consequences on ‘minor use’ authorisations have been taken into account.[7]

4. The European and Mediterranean Plant Protection Organization (EPPO) is an international organisation responsible for cooperation and harmonisation in plant protection within the European and Mediterranean region. It has 52 member countries including all EU Member States.[8] The EU has permanent observer status in the EPPO.

5. The Commission issued a guidance document[9] concerning the comparative assessment of pesticides by Member State authorities (‘the guidance document’), which, in 2014, was endorsed by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF)[10]. The guidance document refers to a standard[11] developed by the EPPO on how to perform comparative assessment (‘the EPPO standard’). The guidance document of the Commission indicates that it “is meant to supplement the EPPO standard, i.e. to give Member States guidance on how to perform the comparative assessment of risks to health and the environment, and to provide an overall framework for comparative assessment”.

6. In 2020, an evaluation carried out as part of the Commission’s regulatory fitness and performance programme (REFIT)[12] identified issues with the rules for active substances that are candidates for substitution.[13] The evaluation found that the comparative assessment carried out by Member States is complex, resource-intensive and did not lead to any substitution. Therefore, the benefits for human health and the environment that were expected from substituting these more hazardous substances did not materialise.[14]

7. Between June 2021 and November 2022, the complainant, an environmental organisation, had exchanges with the Commission, in which it raised concerns about the EPPO standard and the guidance document’s reliance on it. In particular, the complainant took issue with how the EPPO standard interprets the provision in the PPP Regulation concerning ‘chemical diversity of active substances’[15] and how it treats ‘minor uses’ in the comparative assessment[16]. It also argued that the EPPO lacks sufficient safeguards to ensure the independence of its work.

8. Dissatisfied with the Commission’s replies, in January 2023, the complainant turned to the Ombudsman arguing that the EPPO standard is not compliant with EU law and that, by relying on it, the Commission has systematically hindered the substitution of hazardous substances.

The inquiry

9. The Ombudsman opened an inquiry into the Commission’s decision to rely on the EPPO standard in its guidance document and, in particular, how the Commission ensured that the EPPO standard is compliant with EU law.

10. In the course of the inquiry, the Ombudsman received the reply of the Commission on the complaint and the Ombudsman inquiry team met with representatives of the Commission and inspected relevant documents.[17] The Ombudsman also received the comments of the complainant on the Commission’s position.

Arguments presented to the Ombudsman

By the complainant

11. The complainant contended that the EPPO standard is at odds with EU law and that, for this reason, the Commission should not have relied on it in the guidance document.

12. Firstly, according to the complainant, the EPPO standard allows Member States to stop the comparative assessment when applications include minor uses.[18] This, the complainant considered, is contrary to the PPP Regulation, which only requires consequences on minor uses to be “taken into account” in the context of the comparative assessment, and runs counter the goal of promoting the substitution of hazardous active substances, as it allows applicants to include minor uses in their applications to avoid substitution.

13. The complainant claimed that some Member States do not perform a comparative assessment for any applications containing at least one minor use or for applications for extension to new uses including minor uses. It argued that this would amount to basing the substitution on the risk of consequences for minor uses only instead of weighing up all risks and benefits of substitution, and would imply that substitution for minor uses is not possible, which is not true. In addition, applicants can simply add a minor use to their application to ensure that the authorisation is not rejected due to successful substitution.

14. Secondly, the complainant argued that by using the ‘mode of action’[19] approach, the EPPO standard requires the availability of several classes of synthetic pesticides in order to conclude that substitution is possible. In practice, in its view, a certain number of chemical products with several (between three and five) modes of actions are required as a minimum regardless of the effectiveness of non-chemical alternatives. The complainant argued that this approach was essentially developed by the pesticides industry and had never been approved by the EU, and that the PPP Regulation established a less strict requirement, that is, simply a diversity of active substances.

15. In addition, the PPP Regulation mentions chemical diversity as a method of preventing pests developing resistance to substances used in pesticides, but it does not make it an essential condition for tackling resistance, unlike the EPPO standard. The comparative assessment should not be ended without taking into account all non-chemical alternatives.

16. The complainant also argued that the ‘mode of action’ approach is not scientifically justified, as the scientific community has established that focusing on the diversity of modes of action tends to increase resistance to substances. Only the use of non-chemical alternatives can overcome resistance.

17. More generally, the complainant raised concerns about the independence of the EPPO.

18. The complainant contended that the EPPO lacks sufficient rules to address conflicts of interest and includes representatives of the pesticides industry in the internal bodies preparing its work. In practice, one-fifth of the members of the working group on resistance are representatives of companies. In addition, an association representing the European pesticides industry has permanent observer status in the EPPO Working Party on Plant Protection Products.

19. As regards the EPPO standard in question, the complainant stated that the main author of the publication on which it is based had links with the pesticides industry. In 1997, he co-authored an article^[20] in a review published by a lobby organisation, which represented, among others, the pesticides industry.^[21] In that article, the authors thanked the chairperson of the resistance action committees, which are bodies within the association mentioned above, representing the industry that developed the concept of ‘modes of action’.

20. The complainant contended that the standard mirrors the position that the pesticides industry had taken in the context of the adoption of the PPP Regulation.

By the Commission

On the compliance of the EPPO standard with EU law

21. The Commission^[22] noted that all EU Member States are members of the EPPO and, when acting within the EPPO, they are bound by EU law and can prevent the adoption of a standard that is not in line with EU law. Based on the EU’s observer status in the EPPO, the Commission can raise concerns within the EPPO or during meetings with Member State representatives within the Council of the EU.

22. While the EPPO’s voting rules could, in theory, allow for certain decisions to be adopted by a majority of non-EU countries,^[23] in practice, all standards are adopted by unanimity. The Commission is not aware of any standards having been adopted by the EPPO where an EU Member State opposed the standard.

23. In this case, during the development of the EPPO standard, one of the authors of the publication^[24] on which the standard is based was working for the Commission as a seconded national expert^[25]. In this capacity, he attended the EPPO panel discussions as an observer and provided comments on the standard. The presence of Commission staff at the discussions ensured, already at an initial stage, that the standard would be compliant with EU law. In addition, the EPPO itself is very attentive to ensure that its standards are compliant with EU law. The standard at issue in this case was revised twice to align it with the interpretation and position of the Commission.^[26]

24. The Commission added that, before referring to an EPPO standard in a guidance document, the Commission always checks that the standard is in line with EU law. Standards are discussed and scrutinised by the Commission and the Member States in SCoPAFF and, where appropriate, stakeholders are consulted on a draft of the guidance document in the advisory group on sustainability of food systems, of which the complainant is a member.^[27] The guidance document at issue was discussed in SCoPAFF and, in 2014, on a proposal from the Commission, was endorsed by the Member States.^[28]

25. The Commission further noted that, in any case, both the standard and the guidance document are not binding. Member States can deviate from them and many have developed their own national guidance for comparative assessment.

26. As regards the two specific issues put forward by the complainant, the Commission stated that the PPP Regulation recognises the importance of ensuring and increasing the availability of pesticides for minor uses and sets out specific procedures to facilitate the granting of authorisation for them.[29] It does not distinguish between pesticides containing candidates for substitution and those that do not. Minor uses are in fact extremely important for agriculture and food safety as they include the uses of pesticides for fruits and vegetables. This is reflected in both the guidance document and the EPPO standard.

27. The Commission said that, although the criterion regarding minor uses in the PPP Regulation is worded differently from the other criteria (the consequences on minor uses authorisations must be “taken into account”), it must be considered as of the same value as the other criteria. The Commission emphasised that the four criteria are cumulative. Thus, if that criterion is not fulfilled and as long as no unacceptable risks have been identified from the intended uses, the Member State that conducts the comparative assessment cannot refuse the authorisation of a pesticide containing a candidate for substitution, or restrict the product’s use only on the grounds that the pesticide contains a candidate of substitution.

28. The PPP Regulation does not prescribe a specific order in which to assess the four cumulative criteria. In line with this, the EPPO standard allows Member States to assess them in any order. It mentions the minor uses criterion first because, in practice, the national authorities usually start their comparative assessment from this criterion, which is the most straightforward one. Member States first consider if there are alternatives for the major (more widespread) uses of a pesticide. If so, they assess the consequences of substitution on the minor uses by determining the commercial viability of the pesticide for minor uses only, if the substance were no longer authorised for major uses. If they find that the pesticide would likely be withdrawn from the market altogether, meaning it would no longer be available for minor uses, they may decide to end the comparative assessment at that stage. This approach allows Member States to reduce the administrative burden and better comply with the applicable deadlines.

29. The Commission added that it is not the applicants for authorisation who excessively or artificially rely on ‘minor uses’ to maintain a product on the market, but rather the national authorities in the Member States encourage and facilitate ‘minor use’ applications to ensure that there are enough pesticides on the market to maintain the production of essential crops. This is because it is often not economically feasible for companies to keep a product on the market for minor uses only.

30. As regards the complainant’s concerns about how the Commission interprets the criterion relating to “the chemical diversity of the active substances”, the Commission said that the PPP Regulation refers to ‘chemical diversity of the active substances’ to avoid the development of resistance by the target pest. Chemicals that are very similar in their structures combat pests using the same mode of action, while those with different chemical structures use different modes of action. Scientifically, it is thus justified to translate the concept of chemical diversity into difference of modes of action to determine the risk of target pests developing resistance.

31. If substances that have the same mode of action are used against the same target pest repeatedly, the potential for the pest to develop resistance increases. Thus, to maintain the efficacy of pest control, it is crucial to have substances with a variety of modes of action available so that they can be used in alternation to avoid resistance. As a consequence, an application can be rejected and a pesticide substituted where there is another product with the same mode of action in the territory of the Member State. However, if in that Member State there is no other authorised product containing a substance with the same mode of action, the Member State may need to authorise the product to avoid resistance occurring. This is becoming even more important recently, as the number of available modes of action is decreasing.

32. In light of this, the reference in the EPPO standard to the ‘available chemical diversity of modes of action’ is in line with the PPP Regulation. 

33. The Commission added that the reference to modes of action does not exclude non-chemical alternatives, such as microorganisms, which also have a mode of action and can be taken into account under the EPPO standard. The Commission stated that its review of the PPP Regulation under the REFIT exercise had demonstrated that the main reason why comparative assessments have not led to any substitutions was the lack of alternative solutions with better risk profiles rather than the application of the EPPO standard. The Commission added that, to address the issue, it has been working on a proposal to amend Annex IV of the PPP Regulation to ensure that, where there is a non-chemical alternative that is proven to be effective, Member States should consider this to be sufficient to address the risk of resistance. However, Member States have not reacted particularly positively to the proposal and the work has not progressed.

On the independence of the EPPO

34. The Commission explained that the work of the EPPO is split between two Working Parties, namely the Working Party on Plant Protection Products and the Working Party on Phytosanitary Regulations. Each Working Party oversees the work of several panels and expert working groups, which carry out the technical work.

35. The Commission noted that experts participating in EPPO panels or working groups are nominated by national plant protection organisations. Experts from the pesticides industry can participate in the EPPO panels and working groups so that their expertise can be taken into account. The membership of experts from the pesticides industry in the EPPO’s work on pesticides is approved by the EPPO Executive Committee consisting of seven government representatives from the EPPO.

36. Working groups take decisions by consensus. In case there is no consensus because experts from the pesticides industry are against a decision, the decision is taken only by the experts nominated by member countries. In this way, industry experts cannot block a decision. While working groups develop the standards, only the Working Party can decide that a standard is ready for approval by the ‘EPPO Council’^[30], which consists of representatives of the governments of the EPPO member countries.

37. Representatives from the pesticides industry are observers in the Working Party, but they do not take part in the decision making. In any case, the final approval of standards takes place in the annual meeting of the EPPO Council, at which industry experts do not participate. Only the member countries are allowed to vote.

38. The Commission further stated that the input of industry experts is transparent. In reports of all meetings of panels and working groups, experts from the pesticides industry are clearly indicated as such and their opinions are disclosed.

39. As regards the lack of participation of non-industry experts, the Commission said that it is not aware whether this is a deliberate policy of the EPPO or whether other stakeholders are invited to EPPO meetings but choose not to attend.

40. The Commission added that the EPPO has in place rules to avoid conflicts of interests. Experts are informed that they are not representing their country or company and are asked to flag if they have any conflict of interest.

41. While EPPO standards are normally based on the expertise of those drafting them, in the case of the standard at hand, it was based on a publication from three authors affiliated with universities or authorities of EPPO member countries. Moreover, as stated above, one of the authors of the publication was working for the Commission as a seconded national expert[31]. This author was thus bound by the conflict of interest rules applicable to Commission staff and the relevant national authorities. In this capacity, the expert attended the EPPO panel discussions as an observer and provided comments on the standard. According to the Commission’s knowledge, the expert never worked for the pesticides industry. In any case, having worked for the pesticides industry at a certain stage of one’s career does not mean that this person can no longer offer objective expertise.[32]

Further comments by the complainant

42. The complainant noted that, even if guidance documents are not binding, they are generally followed by Member States. The fact that the guidance document was endorsed by SCoPAFF does not guarantee that it is compliant with EU law. In the past, other guidance documents had been endorsed by the Member States, but were then found to be contrary to EU law.[33]

43. The complainant acknowledged that biological solutions operate via modes of action and can be taken into account under the EPPO standard. It also welcomed the Commission’s proposal to make this explicit in the proposed amendment to Annex IV. However, in practice, biological solutions are always found to be less efficient than chemical solutions, as the effectiveness of microorganisms is more variable than chemical products. According to EU case-law,[34] however, non-chemical alternatives should be given priority by the Member States.[35]

44. Regarding the independence of the EPPO, the complainant argued that the safeguards mentioned by the Commission are not sufficient when compared to those in place at EU level.[36] In the EPPO, the pesticides industry is perceived as an expert sharing knowledge, whereas in the EU it would be considered as a stakeholder providing its views on a certain topic. These views would be critically reviewed. The mere publication of participants’ names and opinions is not sufficient to ensure that EPPO procedures are independent and participative. Experts should be requested to submit declarations of interest. The fact that representatives of the pesticides industry cannot veto the adoption of a standard is the bare minimum and does not change the fact that it can influence the development of standards. Being an observer in the Working Parties also gives it a privileged position and the opportunity to lobby the member countries.

The Ombudsman's assessment

45. This case is about the Commission’s reliance in its guidance document on a standard developed by an international organisation, the EPPO. The complainant considers that this standard in not in line with EU law, concretely with the criteria for comparative assessment set out in the PPP Regulation. More generally, the complainant takes issue with the Commission’s reliance on an EPPO standard, in view of concerns about the EPPO’s independence from the pesticides industry.

46. The Ombudsman’s mandate is to assess the administrative work of the EU institutions and bodies. It does not cover non-EU bodies. The Ombudsman’s inquiry thus focussed on the Commission’s decision to rely on the EPPO standard in its guidance document.

47. According to the PPP Regulation, the Commission may adopt guidance documents, following a comitology procedure, for the implementation of that Regulation.[37] In practice, this means that the SCoPAFF, which consists of representatives from all Member States, endorses a guidance document before it is finalised. Furthermore, the PPP Regulation states that the Commission may ask the European Food Safety Authority (‘EFSA’) to prepare or contribute to the development of guidance documents.^[38]

48. While the Commission emphasised in its replies that the adopted guidance is not legally binding, the Ombudsman considers that it undoubtedly has significant practical effects on how the pesticides industry prepares and on how Member States examine applications for authorisations of pesticides. This understanding is reinforced by the PPP Regulation, which explicitly requires Member States, when examining applications for an authorisation of a pesticide, to “make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of application”.[39]

49. There is nothing in the PPP Regulation that would prevent the Commission from relying on standards from international organisations in its guidance documents. However, when doing so, the Commission must ensure that the standard is in line with EU law and that it was drafted in an independent, objective and transparent manner. 

Compliance of the EPPO standard with EU law

50. The complainant took the view that the EPPO standard is at odds with the criteria for comparative assessment set out in the PPP Regulation. More precisely, the complainant considered that the EPPO standard wrongly allows Member States to stop the comparative assessment when applications include minor uses, and wrongly interprets the criterion for comparative assessment that concerns “the chemical diversity of the active substances”.

51. The Ombudsman notes that the PPP Regulation sets out four criteria to be taken into consideration in the comparative assessment.[40]

52. The Commission considers that the four criteria for the comparative assessment are cumulative and that the PPP Regulation does not prescribe any specific order in which to address them. In line with this, the EPPO standard allows Member States to assess them in any order. Based on the wording of the PPP Regulation and the nature of the criteria, the Ombudsman considers this interpretation reasonable.

53. The Ombudsman understands that the Commission and the complainant fundamentally disagree on whether the wording of the fourth criterion (“the consequences on ‘minor use’ authorisations have been taken into account”) may be interpreted as meaning that, if substitution had a negative impact on minor uses, Member States could not refuse authorisation on the basis of the comparative assessment. Given the cumulative nature of the criteria, the Commission considers that Member States could thus decide to discontinue the comparative assessment at this stage.

54. The Ombudsman notes that the Commission’s position — that the criterion regarding minor uses should, despite its different wording, be considered to be of the same value as the other criteria — is based on the importance of (and difficulties in) keeping pesticides for ‘minor uses’ on the market. Verifying this explanation would entail an assessment of the importance of minor uses in the EU agricultural sector and of the seriousness of the consequences that substitution could have on essential crops. The Ombudsman is not a scientific body and cannot determine whether, scientifically, the importance given to minor uses is justified or not. However, she notes that the Commission has provided coherent explanations in support of this interpretation.

55. Regarding the interpretation of the criterion on “the chemical diversity of the active substances”, the Ombudsman notes that the PPP Regulation refers, for the assessment of the risk of resistance, to ‘chemical diversity of active substances’ and to ‘methods and practices of crop management and pest prevention’.

56. The complainant and the Commission essentially disagree on whether assessing the chemical diversity of active substances on the basis of their modes of action is appropriate when trying to minimise resistance. The Ombudsman considers that the Commission has provided clear and reasonable explanations regarding why, in its view, the ‘chemical diversity of active substances’ should be interpreted as referring to their ‘modes of action’.

57. Regarding the complainant’s argument that non-chemical alternatives are not given sufficient weight in the comparative assessment, the Ombudsman notes that the EPPO standard requires authorities to assess whether the product is an important component of the ‘resistance management strategy’ in light of both chemical and non-chemical alternatives.^[41] Depending on the risk of resistance, the standard requires a certain number of modes of action to be available.^[42] It is clear from the inquiry that the complainant agrees with the Commission that non-chemical alternatives also have a mode of action and can be taken into account under the EPPO standard. In this sense, the EPPO standard does not exclude non-chemical alternatives from the comparative assessment.

58. It seems that, if there is an issue with how non-chemical alternatives are considered, these are not due to the wording of the standard, but rather to the practices of the competent authorities of the Member States, which do not fall within the mandate of the Ombudsman.

59. Based on her inquiry, the Ombudsman considers the Commission’s position that the EPPO standard is in line with the provisions of the PPP Regulation is reasonable.

How the standard was drafted

60. The Commission adopts guidance documents, amongst others, in order to assist Member States in making “an independent, objective and transparent assessment in the light of current scientific and technical knowledge” of applications for the authorisation of pesticides. In this context, it is essential that the Commission’s guidance documents themselves are drafted in an independent, objective and transparent manner. The PPP Regulation’s reference to the European Food Safety Authority (EFSA), which is tasked with providing independent and transparent scientific advice to the Commission and which may be asked “to prepare or contribute to the development of guidance documents”, underlines this point.

61. The adoption of guidance documents in the area of pesticides, which is subject to significant public interest, arguably demands particular public scrutiny and, thus, transparency. Where the Commission does not exclusively rely on EFSA for the development of its guidance documents, but relies on standards developed by international organisations, such as the EPPO, it should ascertain that such standards were drafted in an independent, transparent and objective manner.

62. The complainant expressed serious concerns as regards the general set up of the EPPO and the rules on conflict of interest it has in place, as well as regards a particular expert involved in the development of the standard in question.

63. The Ombudsman understands that, under the EPPO rules, experts are informed that they are not representing their country or company. They are also asked to signal whether they might have any conflict of interest. There seem to be no further measures in place on the prevention of conflicts of interest, such as a requirement to submit and update declarations of interest. The Ombudsman considers that these rules are very limited, in particular in comparison to EFSA’s policy on independence.[43]

64. She also considers it understandable that concerns are raised about the industry-only participation of stakeholders. In this context, the Ombudsman notes that the development of guidance applicable to the handling of pesticides authorisations is clearly a matter related to the environment within the meaning of the Aarhus Convention[44], to which the EU is a party. The Convention requires its parties to promote its three pillars in international environmental decision-making: “each Party shall promote the application of the principles of this Convention in international environmental decision-making processes and within the framework of international organisations in matters relating to the environment”.[45] According to the Almaty Guidelines on promoting the application of the principles of the Aarhus Convention in international forums, “[p]articipation of the public concerned in the meetings of international forums, including their subsidiary bodies and other groups established by the forums to contribute to the decision-making, in matters relating to the environment should be allowed at all relevant stages of the decision-making process, [...]”.[46] 

65. Therefore, if the Commission intends to continue to rely on the work done by the EPPO, the Ombudsman expects the Commission to promote actively a more stringent policy on conflicts of interest and a more balanced representation of stakeholders within the EPPO.

66. As regards the complainant’s concerns regarding a potential conflict of interest of one expert involved in the development of the EPPO standard, the Ombudsman’s inquiry did not bring to light any evidence supporting this.

67. Finally, the Ombudsman notes that, already in 2020, the Commission found that the rules governing substitution were not succeeding in their stated aim and had not led to the expected benefits for human health and the environment. The provisions in the PPP Regulation concerning substitution are a safeguard that the EU legislator put in place to manage the risks related to candidates for substitution. The fact that such rules are not working in practice is particularly concerning given that candidates for substitution are particularly hazardous substances.

68. While the Ombudsman welcomes that the Commission has been working on an amendment of Annex IV to the PPP Regulation to that end, and acknowledges that the amendment depends also on the willingness and cooperation of the Member States, she urges the Commission to prioritise this issue. 

Conclusion

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

There was no maladministration in the decision by the European Commission to rely on a standard adopted by the European and Mediterranean Plant Protection Organization (EPPO).

The complainant and the Commission will be informed of this decision.

Suggestions for improvement

If the Commission intends to continue to rely on the work of the EPPO, it should, in coordination with EU Member States, use its position within the EPPO to actively promote that:

a) the EPPO adopts more stringent rules on conflicts of interest, including requiring experts to submit declarations of interest and making such declarations publicly available online; and

b) the EPPO allows participation of stakeholders other than the pesticides industry in its work and that these stakeholders are adequately informed of such a possibility.

 

Emily O'Reilly
European Ombudsman

Strasbourg, 22/08/2024

 

[1] Plant protection products are pesticides used to protect crops or desirable or useful plants.

[2] Regulation 1107/2009 concerning the placing of plant protection products on the market, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1107-20221121.

[3] An active substance is any chemical, plant extract, pheromone or micro-organism (including viruses), that has action against 'pests' or on plants, parts of plants or plant products.

[4] Formally, the regulation covers ‘plant protection products’, whereas pesticide is a more general term, covering uses not related to plants or crops, such as biocides. The word pesticide in this decision is used to refer to plant protection products.

[5] The rules for the approval of active substances are set out in Chapter II of the Pesticides Regulation.

[6] The conditions for an active substance to be considered a candidate for substitution are set out in point 4 of Annex II to the PPP Regulation. A list of candidates for substitution can be found in Part E of the Annex to Commission Implementing Regulation 540/2011, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02011R0540-20231216.

[7] See PPP Regulation Article 50(1); Annex IV to the Regulation provides further information on these four conditions and on how to carry out the comparative assessment.

[8] More information on the organisation can be found on its website, https://www.eppo.int/index.

[9] Guidance document on Comparative Assessment and Substitution of Plant Protection Products in accordance with Regulation (EC) No 1107/2009 SANCO/11507/2013 rev 12, https://food.ec.europa.eu/system/files/2023-03/pesticides_aas_guidance_comparative_assessment_substitution_rev_1107-2009.pdf.

[10] This committee is composed of representatives of the Member States. It reviews proposed measures on food and feed safety, animal health and welfare as well as plant health to assess whether they are practical and effective. It delivers opinions on draft measures that the Commission intends to adopt. More information on the SCoPAFF can be found at https://food.ec.europa.eu/horizontal-topics/committees/paff-committees_en.

[11] PP 1/271 Guidance on efficacy aspects of comparative assessment: https://pp1.eppo.int/standards/PP1-271-3.

[12] The European Commission’s regulatory fitness and performance programme (REFIT) aims to simplify existing EU laws and ensure that draft EU laws deliver their intended benefits for individuals and businesses.

[13] Report from the Commission to the European Parliament and the Council - Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides, available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0208.

[14] Report from the Commission to the European Parliament and the Council - Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides, section 2.1, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0208.

[15] As set out in the PPP Regulation, Article 50(1)(c).

[16] As defined by Article 3(26) of the Pesticides Regulation, minor uses are uses of pesticides in a particular Member State on plants or plant products that are: (a) not widely grown in that Member State; or (b) widely grown, to meet an exceptional plant protection need. See Article 50(1)(d), PPP Regulation.

[17] https://www.ombudsman.europa.eu/doc/inspection-report/188207.

[18] EPPO standard, Assessing effects on minor uses (stage A), question A2 reads as follows “[a]re minor uses sufficient to stop [the comparative assessment], according to the available national [comparative assessment] procedure?”. If so, the standard indicates that Member States can stop the comparative assessment.

[19] Modes of action refers to how the pesticide causes physiological disruption in the target organism.

[20] T. Rotteveel, J. de Goeij, A. van Germerden, Towards the construction of a resistance risk evaluation scheme, 1997, Pesticide Science, Volume 51, issue 3, pp. 407-411.

[21] SCI: Where science meets business, https://www.soci.org/.

[22] The arguments presented in the decision as arguments of the Commission were either provided to the Ombudsman in the Commission’s written reply or by the representatives of the Commission during the meeting with the Ombudsman inquiry team.

[23] The EPPO rules of procedure provide that the quorum for votes in the EPPO Council is one third of member governments and that decisions are taken by a majority of members present and voting.

[24] T. Rotteveel, L. N. Jorgensen, U. Heimbach, Resistance management in Europe: a preliminary proposal for the determination of a minimum number of active substances necessary to manage resistance, 2011, EPPO Bulletin, Volume 41, Issue 3, pp. 432-438.

[25] Seconded national experts (SNE) are public sector employees in their home countries who are seconded to an EU institution for a fixed period.

[27] More information on the advisory group on sustainability of food systems (AGSFS) is available at https://food.ec.europa.eu/horizontal-topics/expert-groups/advisory-groups-action-platforms/advisory-group-agsfs_en.

[28] Summary report of the standing committee on plants, animals, food and feed held in Brussels on 9 and 10 October 2014, https://food.ec.europa.eu/system/files/2020-11/sc_phyto_20141009_pppl_sum.pdf.

[29] Pesticides Regulation, Article 51.

[30] The EPPO Council is the general assembly of the EPPO where all member countries participate. It meets once a year and decides about the policies and programme of activity of the EPPO and its budget. All EPPO Standards are submitted to the formal approval of the EPPO Council. 

[31] See above, footnote 25.

[32] The Commission referred to EFSA’s policy on independence, page 8, https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/policy_independence.pdf.

[33] Judgement of the Court of 19 January 2023, Pesticides Action Network and Others v État belge, C-162/21, https://curia.europa.eu/juris/document/document.jsf?docid=269405&mode=req&pageIndex=1&dir=&occ=first&part=1&text=&doclang=EN&cid=10072491.

[34] Pesticides Action Network and Others v État belge, paras 44-48.

[35] Article 14(1) of directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides reads as follows: “Member States shall take all necessary measures to promote low pesticide-input pest management, giving wherever possible priority to non-chemical methods [...]”, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0128-20190726.

[36] Commission decision establishing horizontal rules on the creation and operation of Commission expert groups, C(2016)3301, https://ec.europa.eu/transparency/documents-register/detail?ref=C(2016)3301&lang=en.

[37] PPP Regulation, Article 77.

[38] PPP Regulation, Article 77.

[39] PPP Regulation, Article 36(1).

[40] Notably whether: (a) a safer authorised pesticide or non-chemical control or prevention method exists for the same uses; (b) substitution would not present significant economic or practical disadvantages; (c) the chemical diversity of the active substances or methods and practices of crop management and pest prevention are sufficient to minimise the risk that the target organism could develop resistance; and (d) the consequences on ‘minor use’ authorisations have been taken into account. See also paragraph 3 above.

[41] EPPO standard, Stage B, point B5 reads as follows: “Given the available alternatives (chemical and non-chemical), is the candidate an important component [...] of the resistance management strategy for the target pest and other pests in the crop not themselves subject to [the comparative assessment]”.

[42] EPPO standard, Stage B, point B5, Note B(iii), “Based on expert judgement it is recommended that in a low resistance risk situation a sustainable resistance management strategy includes at least two [modes of action]. However, in the case where there is evidence of a medium risk of resistance to one or more of these PPPs or a medium risk of resistance in the target organism, at least three [modes of action] are recommended. In the case where there is evidence of a high risk of resistance to one or more of these PPPs or a high risk of resistance in the target organism, at least 4 modes of action are recommended (Rotteveel et al., 2011). The current resistance situation should be considered when evaluating the required number of modes of action”.

[43] EFSA’s Independence Policy applies to experts and professionals working with EFSA with a view to protect its work from any undue influence, https://www.efsa.europa.eu/en/corporate-pubs/efsas-independence-policy.

[44] Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, done at Aarhus, Denmark, on 25 June 1998 (‘UN Aarhus Convention’): https://www.unece.org/fileadmin/DAM/env/pp/documents/cep43e.pdf

[45] UN Aarhus Convention, Article 3(7).

[46] Almaty Guidelines on Promoting the Application of the Principles of the Aarhus Convention in International Forums, December 2005, point 29: https://www.unece.org/fileadmin/DAM/env/documents/2005/pp/ece/ece.mp.pp.2005.2.add.5.e.pdf