Date: Thursday, 23 November 2023

Remote meeting via WebEx

Present

European Commission

Director - DG SANTE

Acting Head of Unit - DG SANTE

Head of Sector - DG SANTE

Legislative Officer - DG SANTE

Legal Officer - DG SANTE

Policy Assistant - DG SANTE

Senior Expert - SG

Trainee - SG

European Ombudsman

Ms Rosita Hickey, Director of Inquiries

Ms Tanja Ehnert, Inquiries Coordinator

Mr Vieri Biondi, Inquiries Officer

Mr Michał Krajewski, Inquiries Officer

Mr Josef Nejedly, Inquiries Officer

Ms Maria Eleni Kosmopoulou, Inquiries Trainee

Purpose of the inspection and meeting

The purpose of the meeting was for the Ombudsman inquiry team to

a) clarify certain issues concerning the compliance with EU law of the procedure to carry out a comparative assessment under Article 50(1) of the PPP Regulation, as set out in a standard[1] developed by the European and Mediterranean Plant Protection Organization and referred to in a European Commission guidance document[2];

b) obtain information on the rules and procedures applied by the European and Mediterranean Plant Protection Organization; and

c) obtain information on the actions taken by the Commission to revise the rules for the substitution of active substances.

Introduction and procedural information

The Ombudsman inquiry team introduced themselves, thanked the Commission representatives for meeting with them and set out the purpose of the meeting. They outlined the legal framework that applies to meetings held by the Ombudsman, in particular, that the Ombudsman would not disclose any information identified by the Commission as confidential, neither to the complainant nor to any other person outside the Ombudsman’s Office, without the Commission’s prior consent.^[3]

The inquiry team explained that they would draw up a draft report on the meeting to be sent to the Commission to ensure that the contents were factually accurate and complete. The meeting report would then be finalised, included in the file and provided to the complainant. No confidential information would be included in the report or otherwise provided to the complainant or any third party.

Documents inspected

The Ombudsman inquiry team obtained copies of the following documents, as requested in the Ombudsman’s letter of 25 October 2023 and during the meeting:

• Draft proposal for amendment - Regulation (EC) 1107/2009 - Annex IV;
• Commenting table on draft proposal for amendment - Annex IV - Regulation (EC) 1107/2009;
• Journal article, T. Rotteveel, L.N. Jorgensen and U. Heimbach, “Resistance management in Europe: a preliminary proposal for the determination of a minimum number of active substances necessary to manage resistance”;
• Email circulating the above article internally;
• Mission report on the EPPO general standard panel meeting of 3 and 4 March 2011;
• Report of the EPPO general standard panel meeting of 3 and 4 March 2011;
• Report on the workshop on possibilities to increase availability of PPPs of 26 October 2023;
• -Summary reports of ScoPAFF meetings of 31 January/1 February 2013, 15/16 July 2013, 13 December 2013, , 19/20 March 2014, 15/16/May 2014, 10/11 July 2014, and 9/10 October 2014.
• Draft Commission Communication accompanying the Regulation setting out the data requirements for plant protection products;
• Presentation on the European and Mediterranean Plant Protection Organization;
• Procedure of the European and Mediterranean Plant Protection Organization;
• Information provided to EPPO experts;
• Rules for validation of resistance cases proposed for the EPPO Database on Resistance Cases.

Information exchanged

On the adoption of EPPO standards

The Commission’s representatives first explained the procedure for the adoption of EPPO standards. They clarified that EPPO panels draft the standards, which are then submitted to the relevant EPPO working party. At this stage, EPPO member countries, as well as observers, may make comments and propose modifications.  However, only representatives of member countries vote on the standard in the EPPO Council.

The EPPO standard in question was first presented in 2011. At the time, one of the authors of the study on which the standard is based was working for the Commission as a seconded national expert. In this capacity, he participated in EPPO panel discussions on the standard, as observer, and provided comments on it. The presence of Commission staff at the panel discussions ensured, already at that stage, that the standard would be developed in compliance with EU law.

In addition, the Commission guidance document, which refers to the EPPO standard, was submitted for discussion with Member States in the SCoPAFF Committee in July 2013 and subsequent meetings. The SCoPAFF Committee approved the relevant guidance document in October 2014.

The Commission’s representatives noted that EPPO is very attentive to ensure that its standards are compliant with EU law. For instance, since its adoption, the standard at issue was revised twice in order to align it with interpretations and positions given by the Commission.

The standard’s compliance with EU law

The Commission’s representatives stated that the EPPO Standard is in line with Regulation 1107/2009 concerning the placing of plant protection products on the market (hereafter ‘the PPP Regulation’).

As regards how the EPPO standard takes into account ‘minor uses’, the Commission’s representatives noted that Article 50(1) of the PPP Regulation sets out four cumulative criteria. Only where the comparative assessment demonstrates that all four criteria are fulfilled, Member States shall not authorise or shall restrict the use of a plant protection product containing a candidate for substitution for use on a particular crop. The order in which the four criteria are to be assessed is therefore not fixed by the order in which they are listed in the legal text.

The Commission’s representatives noted that, although indent (d) of Article 50(1), which refers to ‘minor uses’, is worded differently from the other criteria (“the consequences on minor use authorisations are taken into account”), it should be considered as of the same value. Consequently, if that criterion is not fulfilled, the Member State that conducts the comparative assessment cannot refuse the authorisation of a plant protection product containing a candidate for substitution, or restrict the product’s use only on the basis that the product contains a candidate of substitution as long as no unacceptable risks have been identified from the intended uses.

Given the agri-environmental and climatic differences between Member States, the EPPO standard  keeps the stepwise approach very flexible to allow Member States to assess the four criteria of Article 50(1) in any order. In practice, the national authorities of EPPO member countries usually start their comparative assessment with the ‘minor use’ criterion, as it is the most straightforward one. To this end, national authorities consider first if there are any alternatives for the major uses of a product. If there are, they assess the consequences of substitution for the ‘minor uses’ of the product by determining the commercial viability of the plant protection product if major uses were withdrawn from the authorisation. If they find that there is a negative impact on minor uses, leaving them orphan (i.e. without other means) in terms of phytosanitary protection, they may decide to end the comparative assessment at that stage. This practice is reflected in the EPPO standard, which mentions the ‘minor use’ criterion first.

Starting the comparative assessment with the criterion concerning ‘minor uses’ is thus efficient, as it significantly diminishes the administrative burden on the relevant national authorities, which is crucial for Member States which need to comply with deadlines in the regulatory processes.

The importance of ‘minor uses’ of plant protection products

The Commission’s representatives noted that one of the objectives of the PPP Regulation is to improve agricultural production in the Member States, which is of great importance for human health as it ensures food availability. The specific provisions in Article 51 of the PPP Regulation recognise the importance of ensuring and increasing the availability of plant protection products for minor uses.

Contrary to what the complainant argues, it is not the applicants who rely on ‘minor uses’ to maintain their products on the market, it is the Member States that encourage and facilitate ‘minor use’ applications to ensure that there are enough plant protection products on the market in order to be able to maintain agricultural production of this kind of crops, in particular fruit and vegetables.

Many essential crops, for instance fruit and vegetables, are ‘minor uses’. Plant production products for minor uses can be compared to so-called ‘orphan drugs’. It is often not economically feasible for a company to keep on the market a product only for minor uses. Refusing an authorisation because there are alternatives for the major use of a product can cause the unavailability of products for minor uses in the territory of a Member State. This may severely affect the agricultural production of such crops by farmers and restrict food availability, in particular for fruit and vegetables which are essential for a healthy diet. Therefore, an authorisation application can be rejected or the use of a plant protection product restricted only if there are alternatives (including non-chemical means) available for minor uses.

A recent workshop showed that, in small Member States, there are not enough products available on their markets. For instance, the Czech Republic recently authorised a product for a minor use on its own initiative, but the producer of the plant protection product decided not to market it there, as it was not economically viable.

To illustrate the importance that Member States attach to ‘minor uses,’ the Commission’s representatives mentioned that the Commission co-financed, together with three Member States, the EU Minor Uses Coordination Facility (MUCF) - which is hosted by the EPPO. The MUCF was established to coordinate and support the work of Member States and stakeholders on ‘minor uses’. Once the Commission stopped funding the MUCF (after three years of operation as it had always intended), Member States decided to fully finance it themselves to keep it operating through voluntary contributions.

The standard’s reference to modes of action instead of chemical diversity

The Commission’s representatives stated that, in practice, the PPP Regulation’s reference to chemical diversity of active substances should be interpreted as chemical diversity of modes of action.

Science shows that to avoid the development of resistance of the target pests to active substances, it is necessary to have active substances with a variety of modes of action (that is, the way a substance kills or controls the pest). As explained in the Commission’s written response, chemicals that are very similar in their structures operate via the same mode of action, while those that are different in structure may have different modes of action. Farmers need to be able to alternate PPPs with different modes of action as well as prevention methods, in order to avoid resistance building in the target pests. This implies that if, for example, an application for authorisation of a product containing an active substance is received in a Member State, and there is another product available containing a substance with the same mode of action in its territory, the application can be rejected and the product substituted. However, if an application concerns a product containing an active substance with a specific mode of action and no other authorised product contains a substance with that specific mode of action, then it may need to authorise that product in order to avoid occurrence of resistance.

The Commission’s representatives noted that the number of available modes of action is shrinking. Therefore, taking this aspect into account becomes more important with time.

The Commission’s representatives further said that, by referring to modes of action, the EPPO standard does not exclude non-chemical alternatives, as modes of action are not related to chemicals only. Non-chemical alternatives such as micro-organisms also have their modes of action and can be taken into account under the EPPO standard. This is clarified in the proposed amendment to Annex IV of the PPP Regulation. However, a minimum number of modes of action need to be kept.

The Commission’s work to make the rules for substitution more efficient and effective

The Commission’s representatives said that the Commission has been working on a proposal for an amendment of Annex IV of the PPP Regulation. The draft amendment provides that, where there is a non-chemical alternative that is proven to be effective, Member States should consider this as sufficient to exclude a risk of resistance.

However, Member States have not reacted particularly positively to this proposal, and the work has not progressed the way the Commission hoped. In addition to the delay caused by the COVID-19 pandemic, the Commission also has to deal with an increasing number of requests for public access to documents and for internal review under the Aarhus Regulation. The handling of these requests requires significant resources as it is subjected to deadlines, contrary to discretionary horizontal work like the amendment to Annex IV.

The Commission’s representatives further noted that there are not many candidates for substitution left (about 12 % of all active substance). While identifying an active substance as candidate for substitution is based on intrinsic hazard properties of the active substances, any plant protection product containing a candidate for substitution is subject to a strict risk assessment and is only authorised if there are no risks for human health nor unacceptable risks for the environment. Particular conditions of use or mitigations can be imposed by Member States when granting the authorisations for use.

The Commission’s representatives added that, in any case, the Member States must comply with the requirements set out in the Sustainable Use of Pesticides Directive[4] (which among others requires the application of integrated pest management by users), and have a record keeping system in place.

The Commission’s representatives acknowledged the possibility of using all available tools at their disposal, including the EFSA protocols, which became available as from 2016, after the issuance of the Guidance Document in question, to determine whether the use of an active substance is essential. These protocols are used for the approval and renewal of active substances that do not fulfil the approval criteria, not for authorisations of plant protection products. However, they share the same underlying concept, as they are used to check whether a substance is, in light of the existing alternatives, essential to control a certain pest or a serious danger to plant health in the EU territory. The Commission’s representatives noted that the protocols apply the same concept of ‘mode of action’ as the EPPO standard.

The EPPO’s rules and procedures

The Commission representatives acknowledged that the voting rules of the EPPO bodies provide for low quorums when it comes to decision-making processes, which could, in theory, allow for certain decisions to be adopted by a majority of non-EU countries. However, in practice, all standards are voted by unanimity and the Commission representatives were not aware of standards having been adopted in the EPPO despite opposition from an EU Member State.  

This is because standards are first discussed in the working parties, where representatives of EU Member States participate. Amendments are proposed and discussed already at that stage. To the Commission’s knowledge, there has so far always been agreement in the EPPO working party on pesticides. Thus, when a standard is approved in the EPPO Council, there is already an agreement on it.

In case a member country of the EPPO raises an objection on a standard, this is normally addressed either by the panel or in the working party. EPPO member countries may thus make objections on three occasions. First, they can object to the proposed text in the EPPO panel discussions. Second, they can object during working party discussions. Third, they can object during the vote in the EPPO Council. In practice, the text is either amended to address the concerns or the issue is further discussed until the country withdraws its objection.

Regarding the EPPO’s conflict of interest rules, the Ombudsman inquiry team noted that, on the basis of the inspected documents, it seems that experts are informed that they are not representing their country or company and are asked to flag if they might have any conflict of interest. It asked whether the Commission is aware of any additional measures adopted by the EPPO on conflicts of interest, such as requesting experts to submit conflict of interest declarations.

The Commission’s representatives replied that they are not aware of any additional measures. However, the EPPO is transparent in its work and one can clearly identify from the documents the EPPO publishes which participants in meetings come from industry. The Commission’s representatives noted that the work done by the experts within the EPPO is highly technical and is related to the real situation in the field in an agricultural context. The experts are not chosen because of their affiliation, but rather for their expertise, which is needed for the work of the EPPO.

Regarding the lack of participation of stakeholders other than industry, such as non-governmental organisations, 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. The Commission’s representatives mentioned that the Commission has in the past invited NGOs to meetings and events and has received negative replies.

The independence of one of the authors of the study on which the EPPO standard is based

The Commission’s representatives rejected the complainant’s claim that one of the authors of the study on which the EPPO standard is based was not independent. They clarified that the fact that someone who has once accepted funding from industry, co-authored a paper or worked with industry, does not mean that their expert views can no longer be considered independent. For instance, EFSA’s policy on independence allows that experts contributing to EFSA’s work can benefit from research funding from the private sector as long as it does not exceed 25% of their total research budget.[5]

Specifically concerning the authors of the aforementioned study, the Commission’s representatives noted that all three authors were civil servants when they authored the paper. As already mentioned, the main author of the paper was a seconded national expert working for the Commission, who, at the end of his secondment, returned to the national ministry. To the knowledge of the Commission’s representatives, he never worked for industry and in any case he was bound by the conflict of interest rules applicable to civil servants in his home country and at the Commission.

Conclusion of the meeting

The inquiry team thanked the Commission’s representatives for their time and for the explanations provided, and the meeting ended.

 

Brussels, 6 February 2024

Rosita Hickey                                                                                                                      Vieri Biondi

Director of Inquiries                                                                                                        Inquiries Officer

 

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

[2] EU 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.

[3] Article 4.8 of the European Ombudsman’s Implementing Provisions.

[4] Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides.

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