Sustainable Pesticide Use in EU - Quo Vadis?

Dr. Lars Huber Senior Manager, Team Lead Biorationals, Biostimulants, Fertilisers and IPM	Dr. Carla Lorenz Manager Biorationals, Biostimulants, Fertilisers and IPM	Dr. Annerie Liebenberg Senior Manager Biorationals, Biostimulants, Fertilisers and IPM

European farmer protests in 2024 and the accompanying withdrawal of the Sustainable (Pesticide) Use Regulation (SUR) by EU Commission have triggered intensive discussions on the future of the European Green Deal, pesticide reduction goals, as well as the Farm to Fork (F2F) and Biodiversity strategies. All of them directly impacting the use of not only chemical pesticides but also biopesticides. 

The withdrawal of the SUR has often conveyed the impression that sustainability efforts in the EU will now come to a standstill or at least be significantly reduced and, thus, worsen the situation for biological crop protection and IPM again. However, the SUR is only one component of the Green Deal which was easy to renounce for the time being (at least from a political perspective), especially since this draft regulation was heavily criticized by many stakeholders right from the beginning. Another reason is that SUR was not a centrepiece of the farmer protests. Similar to greening and sustainability goals in general. Farmers' criticism was rather directed against EU’s Common Agricultural Policy (CAP), the associated administrative workload and the cessation of subsidies. EU's CAP has undergone substantial changes since it was established in 1962. Initially, CAP aimed to boost agricultural productivity, stabilize markets, ensure fair incomes for farmers, and provide affordable food. This was achieved through guaranteed prices and import controls, which led to overproduction and surplus stocks. These surpluses and the environmental impact of intensive farming led to policy adjustments. Starting in the 1980s, CAP shifted towards direct subsidies and land diversification. In the 1990s, further liberalisation aligned with global trade agreements, removing market-stabilizing measures. By the 2000s, subsidies were decoupled from production volumes, and rural development became a priority. Further changes in CAP 2021-2027 with reduced subsidies, pressured farmers' incomes and working conditions, resulting in recent widespread protests across Europe. Farmers argue that tax breaks on farm diesel, excessive regulations and unfair competition from non-EU producers put them at a disadvantage. Moreover, it is important to note that depending on country or region, European farmers have varying interests. Large, industrial farms benefit from substantial subsidies and support free trade due to their export capabilities. In contrast, smaller farms struggle with bureaucratic, administrative and regulatory burdens. These smaller farms heavily rely on subsidies and generally oppose free trade agreements, advocating for protectionist policies. 

Intensive analysis of EU’s natural capital has necessitated CAP's push for greener agriculture, through initiatives like the European Green Deal and the Farm to Fork Strategy, which aim to reduce pesticide use and promote sustainable farming practices. Results of the Integrated system for Natural Capital Accounting (INCA) project for example show that almost EUR 3.7 billion of EU’s annual agricultural output is directly attributed to pollinators (COM(2021) 261 final). However, these sustainability measures face resistance from farmers worried about productivity losses and increased costs. Rising energy and fertilizer prices, worsened by geopolitical tensions such as the Russia-Ukraine conflict, have further strained farmers' finances. Climate change also presents significant challenges, with more frequent droughts and floods affecting crop yields, adding to the uncertainties faced by farmers. The evolution of CAP underscores the complex relationship between agricultural policy, market forces, and environmental sustainability. The current dissatisfaction among farmers highlights the need for a more balanced approach that addresses both their economic and ecological concerns. The future of CAP will likely continue to evolve in response to both internal and external pressures, shaping the landscape of European agriculture in the years ahead.

Irrespective of future changes to the CAP, the farmers' protests have clearly highlighted the high level of bureaucracy as one of the main weaknesses of the European agricultural policy. Various EU Member States have already reacted and initiated programs to reduce the administrative burden for farmers. In addition, the discussion on the SUR has made it clear once again that the administrative and bureaucratic burden also represents considerable barriers in other areas, such as the authorisation of plant protection products, delays new developments and innovations and thus significantly impedes the implementation of the Green Deal. When it comes to the registration and market launch of biopesticides, the administrative workload for applicants and authorities and the resulting long duration of the authorisation procedure are one of the most criticised issues. However, recent experience with the registration of microbial plant protection active substances and products has shown that also the new data requirements for microorganisms introduced in 2022 – which in general represent a huge improvement over the previous requirements – are a good example of the increase in workload and administrative tasks. In 2022, the data requirements (Part B of Regulations 283/2013 and 284/2013) for the approval of microbial pesticides have been revised and refined to a more ″fit-for-purpose″ approach, where the biological properties of the microorganisms take a central role. The new requirements include several conditional ones, streamlined to the biological properties of the given microorganism. Moving away from the box-ticking to the fit-for-purpose approach is an advantage for microbial pesticide applications, as ″one set of rules″ cannot be applied to the different types of microorganisms as it was done in the past. However, the flexibility of the data requirements also leaves room for interpretation, not only for the applicant, but also for the evaluating authorities, which could lead to unharmonised acceptance/unacceptance of certain conditional requirements. 

Furthermore, performing an extensive literature search on the microorganism in question has become an essential tool to gather information on the biological properties and can be used to reduce the number of studies required significantly. For unknown or novel microorganisms, however, the data available might be limited and the search criteria might need to be adapted to include data on subspecies or even genus level. In addition, in 2021 two new guidance documents entered into force addressing the assessment of secondary metabolites produced by the microorganism used as plant protection active substance (SANCO/2020/12258), as well as the assessment of antimicrobial resistance genes and the transferability thereof (SANTE/2020/12260). For the assessment of possible secondary metabolites produced, a stepwise approach is foreseen. As a first step, a basic set of information should be gathered on the possible secondary metabolites the microorganism in question could possibly produce and the possible hazard of these metabolites. The guidance suggests using available literature and whole genome sequencing (WGS) data to compile the basic set of information. As there is mostly not enough information available/published in literature on strain level, the literature search needs to be extended to species or subspecies level, which leads to unhandleable amounts of publications, especially for well researched species like members of the Trichoderma or Bacillus genus or for strains and species already extensively used for other purposes. It is even more problematic if the microorganism was taxonomically reclassified and several species or even a complete genus needs to be included in the search. According to the guidance document, once the list of metabolites of potential concern is established, an additional literature search should be performed for each identified metabolite to determine if there is an indication for antimicrobial activity or hazardousness (Mombert et al, 2022). Identifying the possible secondary metabolites that could be produced by the strain/species or genus in question is one thing, but performing additional literature searches focusing on hazardous properties for each individual secondary metabolite that could potentially be produced is another matter as this can lead to hundreds of thousands of articles to be assessed. In 2022, the Plant Protection Product Unit of the National Institute for Agricultural and Food Research and Technology, Spain (INIA-CSIC) published their first experience with the guidance SANCO/2020/12258 using Bacillus amyloliquefaciens and Beauveria bassiana as case studies (Mombert et al, 2022). They concluded that ″the outcomes of the literature searches were a very exhaustive list of metabolites encoded in the genome of the strains with no specific information regarding their synthesis in the conditions of production of the MPCA (Microbial Pest Control Agent) or in situ, except for already well-known metabolites″. Furthermore, they stated that ″when ending up with an exhaustive list of all the possible metabolites encoded in the genome of the microorganism″, performing additional literature search for each identified metabolite to determine if there is an indication for antimicrobial activity or hazardousness, ″represents a tremendous amount of work″ (Mombert et al, 2022). 

Whole genome sequencing per se, is not a data requirement, however whole genome sequence data or at least genomic data plays an essential role for both assessments. The use of genomic data to predict the production of possible secondary metabolites has its limitations. Screening for genes associated with the production of secondary metabolites depends on the fundamental knowledge available for the microorganisms under evaluation. For novel microorganisms the information on possible secondary metabolites or genes associated might be limited and can lead to an incomplete assessment. Furthermore, screening the genome for the presence of a gene associated with a secondary metabolite has its limitations, too. Only when there is proof that the gene associated with the secondary metabolite is absent, WGS can be considered useful. The presence of a gene, however, is no proof that the gene is expressed, and the protein is functional since little information is known on the conditions in which such genes would be expressed, leading to the synthesis of the metabolite. Yet, this can trigger intensive literature searches to build up a scientific argumentation for non-relevance which increases administrative work in the registration process.

Another example is the administrative burden resulting from the new Transparency Regulation (Regulation (EU) 2019/1381), published in 2019 and enforced in 2021. Part of the Transparency Regulation stipulates that all studies started after March 27, 2021, and intended to be used in an EU procedure (including active substance renewals, new active substance and MRL applications) must be notified to EFSA before their starting date. In addition to this administrative step, the format in which dossiers are to be written and submitted has also changed. The IUCLID (International Uniform ChemicaL Information Database) format, which has already been used for chemicals (REACH) and biocides dossiers, is now also used in plant protection. In plant protection, however, with only a few exceptions, the entire dossier, including studies, is made publicly available.

To protect sensible data, all information qualified as business confidential must be blacked out by the applicant in all study reports. In addition, the applicant must redact all personal information, such as the names of study authors of non-published reports. Confidentiality claims can also be requested for certain IUCLID fields to protect the data entered directly in the IUCLID dossier. For all sanitizations applied, the applicant must provide a rationale, which will be reviewed by EFSA to decide if the information can remain redacted or if it must be disclosed. All these obligations require knowledge of Regulation 1107/2009 and the associated legislation. This can be particularly difficult for small and medium-sized companies not having the capacity to familiarise themselves with the complex European legal framework for plant protection. 

At the same time, it seems that the general discussion on bureaucratic hurdles and added administrative burdens, triggered by farmer protests and the withdrawal of the SUR, intensified authority efforts to improve the situation not only for farmers but also for applicants registering biological plant protection products. One example is the German initiative ‘Plant protection product authorisation 2030’ (Pflanzenschutzmittel-Zulassung 2030; BVL 2024). The initiative developed recommendations for modernisation of the authorisation process on national and EU level. The results of this initiative should improve the availability of plant protection products prioritising nature- and environmentally friendly alternatives to synthetic chemical plant protection products. On national level, BVL intends to improve the authorisation procedure for plant protection products regarding efficiency and predictability and especially improve the responsiveness, accessibility and communication of authorities. It also aims to prioritise the processing of authorisation applications with biological active substances through legal amendments in order to increase and accelerate the availability of biological plant protection products. Even more so because plant protection products based on biological active substances are of enormous importance for organic farming and are a valuable tool for integrated pest management. The initiative noted that to date, almost all authorised low-risk active substances are natural substances but that these products often have a lower efficacy and/or require more specific application conditions. The criteria for efficacy assessment in the authorisation procedure should therefore be adapted accordingly, e.g. considering effectiveness of products not only on an individual basis but also in the scope of integrated plant protection application schedules. The initiative also notes that natural substances can fall under the existing categories of active substances, basic substances or plant strengthening agents according to German national plant protection law, as well as under the category of biostimulants in the scope of the EU fertilising regulation 2019/1009. This means that a plant strengthening agent cannot be listed according to national German plant protection law if it contains small quantities of a substance defined as an active substance according to the EU plant protection Regulation 1107/2009. The initiative, therefore, suggests that the definition of plant strengtheners and biostimulants should be reviewed to see whether a ‘dual use’ approach would be possible. If necessary, the creation of a corresponding legal framework allowing the simultaneous use of plant strengtheners and biostimulants should be considered. Furthermore, for many of the potential low-risk active substances (e.g. plant extracts), the current guidance documents for study conduct, particularly regarding ecotoxicology and analytics, are not suitable. This often leads to an overly conservative assessment and the assignment of specific risk minimisation measures, which can result in an active substance not achieving a low-risk status. According to the results of this initiative, the rules for differentiating between specific and non-specific risk mitigation measures for the authorisation of products containing low-risk active substances should therefore be adapted at EU level.

All these examples show, on the one hand, that, regrettably, there is still a huge potential for improvement but, on the other hand, that there are various efforts being made to ensure that the necessary improvements are also achieved. As already indicated, SUR, the withdrawal of which caused tremendous outrage especially among the stakeholders of the biocontrol industry, is only a small part of the Green Deal. In addition, the Sustainable Use Directive 2009/128 is still in place and sustainability targets can, theoretically, be implemented unimpeded since the reduction and sustainability goals are legally codified not by the SUR, but by the already adapted Green Deal laws. Regarding the withdrawal of the Sustainable Use Regulation, the lack of harmonisation, unfortunately, will very likely result in a patchwork of measures between Member States implementing the reduction targets of the Farm to Fork Strategy and, thus, also delay them. For Member States that have already implemented the reduction targets to a good extend, it is also important that different handling of sustainability goals between member States does not lead to further distortions of competition and, thus, to further discontent of farmers.

Overall, farmers’ protests and the withdrawal of SUR have triggered or intensified some long overdue and necessary discussions on the whole concept of European agriculture and specifically on the sustainable use of pesticides, reinforcing the necessity of increased availability and use of low-risk biological pesticides. Reduced bureaucratic and administrative burden for all stakeholders would also be desirable. 

References:

BVL (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit; 2024): Pflanzenschutzmittel-Zulassung 2030. https://www.bvl.bund.de/SharedDocs/Fachmeldungen/04_pflanzenschutzmittel/2024/2024_07_09_Fa_Zulassung_2030_Abschlussbericht.html.

COM(2021) 261 final: Report From The Commission To The European Parliament, The Council, The European Economic And Social Committee And The Committee Of The Regions - Progress in the implementation of the EU Pollinators Initiative.

Mombert, P., Díaz-Otero, P.G., Alonso-Prados, J.L. (2022) Study of the different evaluation areas in the pesticide risk assessment process. Focus on pesticides based on microorganisms EFSA Journal 20(S1) Special Issue: EU-FORA Series 4.

SANCO/2020/12258 Rev 1 (21 March 2024) Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances in accordance with Art. 77 of Reg. (EC) 1107/2009.

SANTE/2020/12260 (23 October 2020) Guidance on the approval and low-risk criteria linked to ″antimicrobial resistance" applicable to microorganisms used for plant protection in accordance with Reg. (EC) 1107/2009.

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