Table of contents 1. Introduction: Political and legal context 2. Problem definition 3. Why should the EU act? 4. Objectives: What is to be achieved? 5. What are the available policy options? 6. What are the impacts of the policy options? 7. How do the options compare? 8. Preferred option 9. How will actual impacts be monitored and evaluated? Annex 1: Procedural information Annex 2: Stakeholder consultation Annex 3: Who is affected and how? Annex 4: Analytical methods Annex 5: Relevant background analysis and other relevant policy initiatives of the commission Annex 6: Marketing authorisation of active substances Annex 7: Detailed overview of policy measures subject to impact assessment





Glossary Term or acronym Meaning or definition ADI Acceptable daily intake BAT Best available technology BTSF Better Training for Safer Food CAP Common Agricultural Policy CAPRI Common Agricultural Policy Regional Impact CWP Commission Work Programme DG Directorate-General DG AGRI Directorate-General for Agriculture and Rural Development DG SANTE Directorate-General for Health and Food Safety ECA European Court of Auditors EEA European Environment Agency EFSA European Food Safety Authority EFTA European Free Trade Association EPRS European Parliamentary Research Service ESTAT Eurostat: European Statistical Office EU European Union F2F target 1 First Farm to Fork Strategy pesticide use and risk reduction target to reduce the use and risk of chemical pesticides by 50% by 2030 F2F target 2 Second Farm to Fork Strategy pesticide use and risk reduction target to reduce the use of the most hazardous pesticides by 50% by 2030 FADN Farm accountancy data network FAO Food and Agriculture Organization of the United Nations FAS Farm advisory system FSDN Farm sustainability data network FTE Full-time equivalent GAEC Good Agricultural and Environmental Condition GAP Good Agricultural Practices GIS Geographic information system GMO Genetically modified organism GNSS Global Navigation Satellite Systems GPS Global positioning system H2020 Horizon 2020 HBM4EU Human bio-monitoring for EU HRI Harmonised risk indicator HRI 1 Harmonised risk indicator 1 HRI 2 Harmonised risk indicator 2 iMAP Integrated agro-economic modelling platform IPCHEM Information platform for chemical monitoring IPM Integrated pest management ISSG Inter-service steering group JRC Joint Research Centre of the European Commission LUCAS Land use/ cover area frame statistical survey MRL Maximum residue level MS Member State NAP National action plan NGEU Next Generation EU NGO Non-governmental organisation NGT New genomic technique NSP National strategic plan OCR Official Controls Regulation OECD Organisation for Economic Cooperation and Development PAE Pesticide application equipment PBT Persistent, bio-accumulative and toxic PPP Plant protection product REACH Registration, evaluation, authorisation and restriction of chemicals RSB Regulatory Scrutiny Board SAIO Statistics on agricultural inputs and outputs SDG Sustainable Development Goal SME Small and medium enterprise SO Specific objective SPS Sanitary and Phytosanitary SUD Sustainable use of pesticides Directive TFEU Treaty on the functioning of the European Union UAA Utilised agricultural area UN United Nations USDA United States Department of Agriculture VAT Value-added tax WHO World Health Organization



1. Introduction: Political and legal context 1.1. Overall context The European Green Deal I announced that all EU policies should contribute to preserving and restoring Europe’s natural capital II , and that the Farm to Fork Strategy III would reduce the environmental and climate footprint of the EU food system and lead a global transition to competitive sustainability of the food production system. Biodiversity IV loss and ecosystem collapse are one of the biggest threats facing humanity in the next decades. The world lost an estimated €3.5-18.5 trillion per year in ecosystem services from 1997 to 2011 owing to land-cover change V , and an estimated €5.5-10.5 trillion per year from land degradation . Biodiversity is crucial for safeguarding EU and global food security, underpins healthy and nutritious diets and improves rural livelihoods and agricultural productivity VI . Biodiversity loss threatens food systems, putting food security and nutrition at risk . The long-term trends observe a major decline in biodiversity in Europe. Agricultural intensification, intensive forest management and land abandonment or urban sprawl lead to a loss, fragmentation and degradation of natural and semi-natural ecosystems. In a recent survey 65% of EU citizens identified the destruction of natural habitats or the loss of animals or plant species as an immediate and urgent problem for rural areas. Environmental (e.g. pollinator decline, biodiversity loss) and health (potential exposure to pesticides) problems identified at the time of adopting the Sustainable Use of Pesticides Directive (SUD) VII in 2009 have remained unchanged or even been aggravated VIII . The SUD aimed to address these problems, by promoting a more sustainable use of pesticides in Europe. While pesticides are often considered a quick, easy, and inexpensive solution for controlling weeds and pests in both rural and urban landscapes, pesticide use comes at a significant cost. Pesticides have contaminated many parts of the environment with residues found in soil and air, in surface and ground water IX . The use of pesticides is a matter of strong concern for society and among European citizens X XI . A 2017 European Citizens Initiative with more than one million signatures called on the Commission to propose to Member States a ban on glyphosate (a herbicide XII ), to reform the pesticide approval procedure, and to set EU-wide mandatory reduction targets for pesticide use. While there will be cases where resort to the use of pesticides is necessary, EU policies are directed at protecting human and animal health, protecting the environment and ensuring a sustainable use of pesticides if they are needed XIII . The foresight study XIV accompanying this impact assessment highlighted the complex landscape surrounding pesticide use and confirmed the diverse and polarised views among stakeholders on this topic. The European Citizens Initiative “Save Bees and Farmers” XV calls on the Commission and European Parliament to act for the use of synthetic XVI pesticides to be gradually reduced by 80% in EU agriculture by 2030 and completely phased out by 2035. Not using any pesticides, such as fungicides, can jeopardise plant health and human health due to the development and effects of plant toxins and mycotoxins. However, numerous experiences XVII show that it is possible to phase out chemical pesticides, or to reduce very considerably their use, without negative impacts on the economy. Moreover, a large amount of additional research is ongoing to find alternatives to chemical pesticides, which will facilitate the switch to non-chemical alternatives, and new legislation, announced under the Farm to Fork Action Plan, is also being produced to make the authorisation procedure for these products easier. In organic farming systems pesticide input can be reduced by 97% and enhanced soil fertility and higher biodiversity may render these systems less dependent on external inputs XVIII . The European Commission target to have at least 25% of the EU’s agricultural land under organic farming and a significant increase in organic aquaculture by 2030 XIX is relevant in this context. The European Green Deal announced the aim of reducing the use and risk of chemical pesticides in general, and the use of more hazardous pesticides in particular. In the Farm to Fork Strategy XX , Biodiversity Strategy XXI , the Zero Pollution XXII Action Plan, and the Soil Strategy XXIII the Commission committed to take action to reduce by 50% the overall use of and risk from chemical pesticides by 2030 and reduce by 50% the use of more hazardous pesticides by 2030. The Biodiversity Strategy aims to protect nature and reverse the degradation of ecosystems. Biodiversity is suffering from inputs of nutrients, chemical pesticides, pharmaceuticals, hazardous chemicals, urban and industrial wastewater, and other waste including litter and plastics into the environment and all of these pressures must be reduced. The pesticide reduction targets are also relevant for meeting the objectives of the EU Pollinators initiative XXIV . As outlined in the Commission’s Zero Pollution Action Plan for water, air and soil, pollution must be better prevented, remediated, monitored and reported. The EU Chemicals Strategy XXV for sustainability is a central element of the EU’s zero pollution ambition. It aims to better protect citizens and the environment and boost innovation for safe and sustainable chemicals as well as better accounting for the cocktail and combined effect of chemicals when assessing their risks. Council conclusions on the Farm to Fork Strategy XXVI called for the prudent and responsible use of pesticides. A European Parliament Resolution XXVII of February 2019 stated that the EU “must act without delay to transition to a more sustainable use of pesticides” and called on the Commission to propose an ambitious EU-wide binding target for the reduction of pesticide use. The European Parliament re-affirmed its call for binding reduction targets in its resolution of 20 October 2021 on a Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system XXVIII . The foresight study accompanying this impact assessment explored possible future scenarios on the use of pesticides considered to represent plausible scenarios. Key insights included that policy strategies need to be equipped with adequate incentives as well as implementation and monitoring strategies. Pesticide use needs to be managed in the longer term, considering innovation, public understanding and consumer demands. Regulations should support a level playing field for farmers across the EU aiming to build a consensus among stakeholders concerning the use of pesticides in the future. 1.2. Specific context Plant protection products are pesticides that are used to protect crops against pests, diseases, or competing plants with the aim of optimising food production in conventional or organic farming XXIX . Pesticides are also used to maintain food quality (e.g. during storage) or to maintain certain areas in the condition needed for their proper functioning (e.g. railways, golf courses). Pesticides can be of chemical or non-chemical origin (e.g. micro-organisms) and their residues in food and feed can be harmful to consumers. Sales and use of pesticides across Europe vary greatly depending on the type and level of agriculture, with France, Germany, Italy and Spain being the highest users with 68% of the total EU sales market for pesticides. A breakdown of pesticide sales by Member State is presented in Annex 5 (Table 21). The European crop protection market is also highly consolidated, with the major companies accounting for more than 50% of the market share XXX . It is estimated to have an annual growth rate of 4.1% during a forecast period of 2021-2026 XXXI . Industry is expecting a higher demand for biopesticides due to an increasing demand for organic and sustainable foods. The market in biocontrol agents is growing rapidly. Between 2016 and 2019 the EU market for macroorganisms increased by 70%, for microbials by 228% and other substances 3-400% XXXII . Between 2020 and 2025 an annual growth rate of 11.3% is predicted XXXIII and between 2011 and 2017 this category represented around 50% of new applications for approvals of active substances received by the European Commission (see also Annex 5, Figures 16-18). Evidence is accumulating that in many cases such alternative products can effectively substitute the use of chemical pesticides. Data from Spain XXXIV show that the use of chemical pesticides in vegetable production in Almeria has been reduced by approximately 55% and that over 80% of crops grown in winter now depend on biological control to solve pest problems Almeria has more than 30,000 hectares of vegetable production and since 2005, the area of crops using biological methods against pests has increased from around 120 ha to 26,500 ha in 2021. Due to their potentially harmful effects, plant protection products are strictly regulated in the EU to provide a high level of protection to the environment and to the health of everyone in the EU. The SUD forms together with legislation on pesticide authorisation XXXV , residues XXXVI and statistics XXXVII a framework which is considered to be amongst the most stringent systems in the world XXXVIII . Pesticide authorisation Pesticides are authorised in a two-step system that reflects the principle of subsidiarity (see Annex 6). In the first step, the active substance of a pesticide is approved at EU level, provided it is demonstrated that at least one use with a formulated product is safe. In the second step, Member States authorise plant protection products containing the active substance for specific uses, according to specific standards (the so-called uniform principles XXXIX ) and good agricultural practices (GAP). The Member States consider local agricultural and geographical/climatic differences when authorising PPPs. Pesticide use The SUD provides the framework rules on the use of pesticides. It aims to reduce the risks and impacts of pesticide use on human health and the environment. It also aims to promote the use of integrated pest management (IPM) and alternative approaches or techniques, such as non-chemical alternatives to pesticides. The use of pesticides at farm level should be recorded in line with Article 67 of Regulation (EC) No 1107/2009 XL .

The application of IPM is a legal requirement under the current SUD but is not systematically recorded nor required to be recorded in most Member States. The level of official controls on pesticide use in Member States is limited. Even though the use of pesticides is legally required to be recorded at farm level, these data are not systematically collected or analysed leading to the lack of available comparable data on the use of specific plant protection products (e.g. how, when, where, why they are used, and the exact products used). Pesticide statistics Statistics on the placing on the market of pesticides based on data collected at Member State level are transmitted to ESTAT which validates those data and produces annual statistics on pesticide sales, and every five years on pesticide use, in agriculture in accordance with Regulation (EC) 1185/2009 XLI . In February 2021 the Commission adopted a proposal for a Regulation on statistics on agricultural inputs and outputs (SAIO) of the agricultural sector to inter alia replace the existing Regulation (EC) 1185/2009 . The proposal is pending adoption by the legislators. The main changes, if compared to Regulation (EC) No 1185/2009, are the annual collection of the data on pesticide use in agriculture and removal of the obligatory aggregation of active substances into major groups, categories of products and chemical classes before publication. SAIO would allow the Commission to publish data on the sale and use of pesticides, at the level of individual active substances provided that regular statistical confidentialty allows this. Consequently, the Commission would have accurate data on: •Annual sales of pesticides, broken down by active substance, •Annual use of pesticides in agriculture, broken down by active substance. Pesticide residues Finally, the Regulation on pesticide residues regulates the residues that are left on crops. It does this by setting maximum residue levels (MRLs) at EU level to protect all consumers, including vulnerable groups. MRLs apply to all products placed on the EU market, including imports. Pesticide enforcement and control Member States enforce compliance with the legislation in line with the Official Controls Regulation XLII . Illegal import and use of EU-banned pesticides from abroad and residues of EU-banned pesticides in imported foodstuffs are addressed via the legislation on pesticide authorisation and legislation on residues. The European Commission performs audits in Member States to check implementation and national control systems. Specific requirements of SUD The SUD XLIII sets out requirements to reduce the use and risks of pesticides, introducing specific provisions such as: ·Establishment of Member State national action plans (NAPs) to set objectives to reduce hazards, risks and dependence on chemical control for plant protection; ·Union-wide principles on IPM, and establishment of necessary conditions for implementation of IPM; ·Specific measures to protect the aquatic environment from pollution by pesticides and defining areas of significantly reduced or zero pesticide use and to protect sensitive groups; ·Measuring progress in risk reduction through appropriate harmonised indicators; ·Creating a system of training and awareness-raising for distributors and professional users of pesticides; ·Appropriate handling and storage of pesticides and their packaging and remnants; ·Regular inspection of pesticide application equipment (PAE) in order to reduce adverse impacts of pesticides on human health (in particular as regards operator exposure) and the environment during application;

·Prohibition of aerial spraying of pesticides, with derogations being possible, aiming to limit the risks of adverse impacts on human health and the environment, in particular from spray drift. ·Distributors selling pesticides to non-professional users need to provide general information to such users regarding the risks for human health and the environment of pesticide use. Domestic use of pesticides by non-professional users is covered by the current SUD. 1.3. SUD’s interaction with other EU policies and instruments This impact assessment takes place in the context of several parallel strategies at EU level. Concerning coherence, the evaluation accompanying this impact assessment found that the internal and external coherence of the SUD with other EU policies and instruments is generally strong with no major inconsistencies or overlaps. The evaluation found that the objectives of the SUD were, and still are, highly relevant to address the risks posed by pesticide use to the environment and human health. A large number of current or upcoming Commission initiatives link to the objectives of the SUD (see Annex 5 and in particular Table 25). Common Agricultural Policy (CAP) The evaluation found that the link between the SUD and the CAP is strong in theory, but weak in practice. Measures under the CAP could incentivise farmers to use pesticides more sustainably but have only been used to a limited extent. Under the new CAP (due to be implemented from 1 January 2023) Member States will set out National Strategic Plans (NSPs) which shall contribute to achieve the ambitions from the Green Deal and the linked strategies on Farm to Fork and Biodiversity. Member States will be able to fund actions in line with the Farm to Fork Strategy pesticide reduction targets, for example, on IPM. Member States can provide financial support to sustainable farming practices. All CAP payments received by the farmer are linked to complying with basic EU legal requirements including the SUD, with 90% of farmers and agricultural area, and thus the majority of professional pesticide users, being covered under the CAP. Non-compliance leads to possible reductions of CAP payments in case of infringement. Eco-schemes of voluntary support to be offered by Member States to farmers will represent 25% of the total CAP direct payments budget. The level of support will be decided by the Member States. Such eco-schemes can be used to better achieve the objectives of the SUD. Financial incentives are also possible with rural development instruments and market measures, e.g. for practices, investments and risk management. The CAP also foresees technical support to farmers through knowledge exchange (e.g. European Innovation Partnerships) and advice (Farm Advisory Services). The Commission aims to facilitate the identification of farming practices which must or may be implemented by farmers to comply with IPM principles. This will also facilitate making the link with the CAP and in particular Good Agricultural and Environmental Condition (GAEC) 8, which provides for farming practices relevant to IPM, such as biodiversity areas. The CAP is implemented by NSPs, which must describe the implementation of GAECs, the support schemes and their baseline. Environmental and chemicals policy The SUD interacts with a number of environmental policies and legislative acts, for example planned nature restoration targets, pollinators initiative XLIV to address the decline of pollinators in the EU and contribute to global conservation efforts, the lists of pollutants and regulatory standards in the Environmental Quality Standards XLV , Groundwater XLVI and Water Framework Directives XLVII . Possible contamination of water by pesticides is also a relevant issue for the planned revision of the Urban Waste Water Treatment Directive XLVIII . Associated objectives are also furthered by EU rules dealing with the health and safety of workers, pesticide users and bystanders, protection of the environment, habitats, birds and water etc. (see Figure 1). Figure 1. Interaction of the SUD with other EU legislation and policies relevant to plant protection products (under the responsibility of various Commission DGs) 1.4. Link with the UN Sustainable Development Goals The objectives of reducing the use and risk of pesticides, to protect health and the environment, are relevant to the Commission’s ambition XLIX to deliver on the UN Sustainable Development Goals (SDGs). With cross-cutting policy areas related to the sustainable use of pesticides, direct links to SDG goals 3 (health and wellbeing), 6 (clean water), 8 (decent work and economic growth), 11 (sustainable cities) 12 (sustainable consumption and production), 14 (life below water) and 15 (life on land) can be demonstrated. At a global level, the Food and Agriculture Organization of the United Nations (FAO) published the first global assessment of biodiversity for food and agriculture in 2019, which stresses the international level of concern for biodiversity loss. FAO also support a vision of sustainable agriculture supported by the IPM approach. 2. Problem definition 2.1. What are the problems The evaluation L of the SUD found that the SUD has not achieved its overall objectives to the extent envisaged in the impact assessment accompanying the Commission proposal LI in 2006. Reports from the Commission to the European Parliament and Council in 2017 LII and 2020 LIII identified significant shortcomings in the implementation, application and enforcement of the SUD in Member States. While the objectives of the SUD were, and still are, highly relevant to address the risks posed by pesticide use to the environment and human health, its relevance is hampered by its uneven implementation and limited effectiveness. A study LIV by the European Parliament Research Service (EPRS) found progress in many Member States but a limited overall achievement of the SUD’s objectives. A recent special report LV from the European Court of Auditors (ECA) on the sustainable use of plant protection products found that there is limited evidence of risks from the use of pesticides being reduced. The European Green Deal, Farm to Fork Strategy, Biodiversity Strategy and Zero Pollution Action Plan have all acted to highlight and even increase the relevance of the SUD to reduce the impacts of pesticides across air, water and soil that lead to harm to both health and biodiversity. These strategies also highlight the need to transition to a sustainable food system with resulting environmental, health and social benefits, while offering economic gains and ensuring a sustainable livelihood for primary producers. Consumers primarily see ‘sustainable’ as a synonym for environmentally friendly, without genetically modified organisms (GMOs) and pesticides, and produced locally, with some specificities across countries LVI . As described in Annex 5, the negative impacts of using chemical pesticides include; 1.Environmental contamination of air LVII , water (including coastal water LVIII ) and soil LIX LX , 2.Negative impacts on a range of non-target organisms, including in soil and water, with corresponding biodiversity loss. 3.Possible negative health impacts caused by exposure of operators, residents, bystanders and consumers,

Environmental impacts Water pollution Pesticides can get into water due to spillages, application at or near watercourses, or through surface runoff or seepage into groundwater. Studies have shown an increase in the toxicity of applied insecticides to aquatic invertebrates LXI (see also Annex 5). Effects can be on watercourses or in groundwater potentially used for human consumption. In European countries, for rivers and lakes, one or more pesticides were detected above their effect threshold at 13 to 30% of all surface water monitoring sites each year between 2013 and 2019 LXII . Exceedances of one or more pesticides were detected between 3 to 7% of groundwater monitoring sites. A study across 101 sites of small lowland streams in Germany revealed that 83% of agricultural streams did not meet pesticide-related ecological targets and that agricultural non-point-source pesticide pollution was the major driver in reducing vulnerable insect populations in aquatic invertebrate communities LXIII . Water industry case studies refer to examples of additional activated carbon filtration and ozonation due to pesticides in drinking water resources costing a water processing company EUR 50 M in the period 2018-2020 LXIV . Another case study LXV examined the case of a UK water operator which found the pesticide metaldehyde in its treated drinking water and failed to meet the drinking water Directive limit value for the indicated pesticide threshold. Treating the water for metaldehyde would have cost €612.4M, entailing a 21% increase in consumer water bills. As an alternative to treating the water, the company used financial incentives to address the cost barriers to farmers to use an alternative to metaldehyde. This alternative cost €16.6M, 3% of the alternative cost of treating the water. A recent paper LXVI claims that various infrastructural, institutional and behavioural “pesticide lock-ins” hamper more effective actions being taken in this area. Air pollution Airborne levels of pesticides are also a concern LXVII . A recent study LXVIII has shown for example that airborne pesticide mixtures are ubiquitous in Germany. Samples were collected in 2019 and analysed for over 500 substances, 109 substances were detected, including 28 that are not authorised for use in Germany. There is evidence that pesticides and their related substances can travel through the air at least in the medium and possibly also in the long range (see further details in Annex 5). Soil pollution Soil hosts more than 25% of all biodiversity on the planet LXIX and is the foundation of the food chains nourishing humanity and above ground biodiversity. An estimated 60 to 70% of soils in the EU are not healthy LXX . Land and soil continue to be subject to severe degradation processes LXXI mainly due to unsustainable land use and management, overexploitation and emissions of pollutants including pesticides LXXII . Pesticide levels in EU soil samples are significant LXXIII and of concern. In a 2015 study LXXIV , the distribution of 76 pesticide residues was evaluated in 317 agricultural topsoil samples from across 11 EU Member States and 6 main cropping systems. Over 80% of the tested soils contained pesticide residues (25% of samples had 1 residue, 58% of samples had mixtures of two or more residues), in a total of 166 different pesticide combinations. Glyphosate and its metabolite AMPA, DDTs (DDT and its metabolites) and the broad-spectrum fungicides boscalid, epoxiconazole and tebuconazole were the compounds most frequently found in soil samples and the compounds found at the highest concentrations. The need for strategies to reduce the load of pesticides on agricultural soils, as well as for systematic pesticide monitoring, is the conclusion of another study LXXV carried out in 2015 in the Czech Republic, where arable soils were found to frequently contain multiple residues of pesticides at noticeable levels several months following the last possible application. A recent study LXXVI concludes that the occurrence of currently used pesticides in the soil of agricultural regions is alarming in many countries. Biodiversity The evaluation of SUD concluded that, while it has contributed to reducing the risks of using pesticides to human health and the environment, there is a continuing trend of a decline in biodiversity. Biodiversity is declining across the EU LXXVII , LXXVIII and chemical pesticides contribute to this biodiversity decline LXXIX . In the EU, a reduction of species, in particular insects and pollinators has been observed LXXX (see also Annex 5). It is estimated that 75% of global food crop types rely on animal pollination and 50% of land in the EU cultivated with crops dependent on pollinators faces a pollination deficit LXXXI LXXXII . A study LXXXIII on the effects of agricultural intensification on biodiversity carried out in eight European countries concluded that out of the 13 studied components of agricultural intensification, use of pesticides, especially insecticides and fungicides, had the most consistent negative effects on the species diversity of plants, ground beetles and ground-nesting farmland birds, and on the potential for biological pest control. In agricultural areas, there is a negative relationship between pesticide use and pollinator abundance, group richness, and diversity LXXXIV . Certain pesticides not only affect pollinators but ultimately crops that depend on them for pollination. Pesticides were found to affect their productivity, the abundance of floral visitors, and the mass of fruits; seed quantity and quality were significantly lower after treatment with pesticides. Exposure to such pesticides can be lethal or sublethal with chronic detrimental effect on the individual pollinator and the colony. What pesticides do to pollinators not only impacts their health and life span but also their abilities to function and live together due to several impairments resulting ultimately in colony collapse. Biodiversity enables farmers to produce safe, sustainable, nutritious and affordable food, providing them with the income they need to thrive. The ongoing decline in biodiversity and the degradation of ecosystems in the EU in the last ten years, poses threats to food production systems, and ultimately to food security. Health effects Pesticides can cause both acute and long-term health impacts. Chemical pesticides can have dermatological, gastrointestinal, neurological, carcinogenic LXXXV , respiratory, reproductive, and endocrine effects. LXXXVI LXXXVII High occupational, accidental, or intentional exposure to pesticides can result in hospitalisation and death. Already in 1990, the World Health Organization (WHO) estimated that about one million cases of unintentional pesticide poisonings occur annually, leading to approximately 20,000 deaths LXXXVIII . Occupational exposure is likely to be the most common source of exposure that results in unintentional acute intoxication. A recent review estimates that about 385 million cases of unintentional acute pesticide poisonings occur annually world-wide including around 11,000 fatalities LXXXIX . As described in Annex 5, there are a number of cases in which chemicals, initially believed to be safe, ultimately proved to be harmful for human health and / or the environment and their use had to be restricted or forbidden XC XCI . As an example, a recent decree in France has now classified prostate cancer after exposure to chlordecone as a professional/occupational disease. The problem tree The problem tree (Figure 2) provides the graphical representation of the problem analysis, focussing mainly on the risks from pesticides used in agriculture. The SUD regulates the use of pesticides, while the current monitoring framework does not collect, at EU level, data on the use of pesticides. Therefore, the exact proportion of total pesticide use at EU level within agricultural production, as opposed to other uses, is not known XCII . However, based on stakeholder consultations XCIII , it is assumed that approximately 90% of total pesticide use in the EU is in agriculture, with the rest in other areas such as forestry, urban green areas, sports grounds, and along roads and railways. Figure 2. Problem tree The evaluation of the SUD identified four main problems 1) The SUD does not reflect the ambition of the European Green Deal, Farm to Fork Strategy, Chemicals Strategy and the Zero Pollution Action Plan The SUD did not include an overall pesticide use and/or risk reduction target. In 2017 the Commission XCIV encouraged Member States to review and improve the quality of their NAPs, by establishing specific and measurable targets and indicators at national level, which they had been required to do in the SUD. These targets would then allow Member States to monitor progress in the implementation of the SUD, and to adjust their strategy where necessary. The Commission’s 2020 report found that only three Member States identified useful targets based on a review of their initial NAPs. It is clear that the SUD does not reflect the strengthened ambitions in the Farm to Fork Strategy to achieve specific pesticide use and risk reduction targets by 2030, as well as to accompany farmers in the transition towards a more sustainable production system. Similarly, it does not do enough to support the long-term objective for a zero pollution ambition for a non-toxic environment. It is therefore unlikely, as confirmed by stakeholder views,, that the ambition of the European Green Deal can be achieved with the current provisions of the SUD XCV . 2) Monitoring and data availability are limited

Limitations on pesticide use data arise in part from the lack of (1) systematic data transfer between professional pesticide users required to record such use and Member States, and subsequently between Member States and the EU level; (2) harmonisation in the aggregated dataset that would allow an analysis of trends overtime at the EU level. While professional users are required to keep records on pesticide application under the legislation on pesticide authorisation XCVI , these records are not collected in most Member States. Currently pesticide use statistics collected at EU level are based on statistical surveys. Pesticide sales and use statistics available at EU level XCVII are aggregated by chemical classes, categories of products and major groups and confidentiality and aggregation requirements prevent disaggregating them at EU level to the level of individual active substances. The usefulness of the survey-based pesticide use statistics is limited also by a lack of harmonisation of the reference year and crops for which data are collected XCVIII . The pesticide use statistics are collected only once in a 5-year period. Analysis of the data XCIX showed that the currently available pesticide statistics are not sufficient to effectively monitor the progress on the sustainable use of pesticides. Improved data related to use is seen as necessary to develop meaningful indicators related to the environmental impact of pesticide use, to facilitate the identification of specific sectors, substances and practices that may need specific measures at Member State and EU level and to enhance monitoring of implementation at both Member State and EU levels. 3) Uneven and incomplete implementation of the SUD provisions in Member States Deficiencies persist in the implementation of numerous key aspects of the SUD such as national action plans (NAPs), integrated pest management (IPM) and pesticide application equipment (PAE) C . IPM is not implemented comprehensively by most farmers, even though in many cases it offers not only environmental, but also economic advantages. This may be due to a lack of sufficient incentives, training and advice offered to farmers in some Member States CI , or potentially because of a lack of available alternatives in some crop-pest combinations. The Commission’s compliance-monitoring index CII to quantify progress in the implementation by, and between, Member States revealed a particularly poor implementation of the SUD provisions with regard to IPM enforcement (34 % implementation by 2019), PAE (41 %) and NAPs (53 %). Qualitative assessments from stakeholders pointed to agreement with the Commission assessments of the deficiencies in implementation of the SUD CIII . The conclusions of the EPRS report CIV concurred with this view. Figure 3. Overview of implementation status of the provisions of the SUD Source: European Commission (2020). COM(2020) 204 final, Annex. Available at: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_sud_report-act_2020_annex_en.pdf This lack of implementation of the SUD was also raised in public feedback CV on the evaluation roadmap/inception impact assessment and interviews with stakeholders CVI . However, as shown in Figure 12 in Annex 2, cross-targeted surveys illustrate very contrasting views among different stakeholders on the extent to which they consider that different elements of the SUD are currently implemented. 4) New technologies are not sufficiently taken up by pesticide users Since the adoption of the SUD in 2009, various advances on precision farming techniques offer the potential to better achieve the objectives of the SUD and reduce the use and risk of pesticides. As described in Annex 5, precision farming or precision agriculture refers to agricultural management systems carefully tailoring soil and crop management to fit the different conditions found in each field CVII . Many technologies are now available for assessing and managing the spatial and temporal variability of the physical, biological, and chemical properties of soils. Global positioning systems, geographic information systems, yield monitors, and remote and proximal sensors can be used to identify crop variability possibly linked to pests, while automatic guidance of farm machinery and variable rate pesticide application technologies are used to target application and reduce the amount of inputs, including pesticides. The application of existing technology is seen as having the potential to significantly reduce pesticide usage. A consensus exists among stakeholders that new technologies that could help to reduce the use and risk of pesticides should be promoted CVIII . A recent paper CIX concluded that decision support systems could halve fungicide use, compared to calendar-based strategies, without increasing disease risk. According to pesticide users and industry the SUD acts as an impediment to the use of such new technologies. Stakeholders see a need for promotion of the uptake of technological developments in the area of digitalisation and precision agriculture CX , as this market is expected to grow and provide new ways of detecting and controlling pests. These developments are predicted to assist in the reduced risk and use of pesticides, providing farmers with the tools to prevent and control pests in a more sustainable way. 2.2. What are the problem drivers? The continued use of chemical pesticides to control pests is linked to multiple factors, including the well-established effectiveness and ease of use of chemical pesticides versus less hazardous and non-chemical alternatives and the overall economic pressures in the farming sector which may lead to an overreliance on pesticides as a pest control tool. Furthermore, EU farmers are subject to competition from other farmers and crop growers outside the EU who might use pesticides which are not or no longer authorised or used in the EU. While contested by environmental organisations, the prevalent perception among pesticide users appears to be that there is a lack of viable or equally efficient less hazardous and non-chemical alternatives and that chemical pesticides are cheaper and more effective or reliable than alternative methods CXI . This may act as a brake on the ambitions of individual Member States to pursue more strict and ambitious policies on the sustainable use of pesticides, in particular as regards alternative plant protection practices. Farmers consider that they could be exposed to risks of crop damage or pest control failures and associated financial losses if they switched to an alternative control tool which might or might not be as effective as the more hazardous pesticides that they are accustomed to using. There are 33 low-risk active substances approved for use in pesticides, and pesticides containing 23 of these substances are authorised in at least one Member State. The Commission does not currently have data on the total number of pesticides containing low-risk substances authorised in the Member States, the crops on which they are approved for use, or the proportion of pests against which pesticides containing low-risk active substances provide effective control, which is a significant limitation for monitoring implementation and progress. While financial support is available (e.g. through the CAP), there is a perceived absence of financial or other mitigation incentives to promote the sustainable use of pesticides CXII . Public feedback on the evaluation roadmap and inception impact assessment CXIII pointed to serious deficiencies in the implementation of the SUD in some Member States and urged the Commission to introduce stricter rules, for example in the form of a regulation at EU level to increase coherence and have more binding effects on policies in individual Member States. An apparent lack of ambition is illustrated by the delays of numerous Member States to prepare and subsequently review CXIV and update their NAPs CXV and the absence of quantitative targets or objective progress indicators for the reduction of risk in these NAPs CXVI , as required under Article 4 of the SUD. This is exacerbated by the limited human and financial resources allocated by some Member State authorities to implement the SUD nationally CXVII . Member States show differences with respect to the level of cooperation at different governance levels CXVIII , which is a significant issue on a cross-cutting topic such as the sustainable use of pesticides. Although IPM is seen as a key element in the sustainable use of pesticides, and many local examples of good practice can be seen CXIX , the assessment of the actual implementation of IPM through Member State controls and corresponding enforcement has been weak CXX . This results in limited evidence on the effective implementation of IPM across the EU. A number of drivers could be contributing to this, for example a need for more incentives, training and advice to pesticide users on how to successfully and effectively apply IPM, a lack of clear tools to monitor the implementation and enforcement of IPM, a view among mainly pesticide users and industry stakeholders that pesticides on the market are safe and effective and that no specific actions are required to reduce their use and/or that no equally effective alternatives to chemical pesticides exist, or a wish not to disadvantage pesticide users in an individual Member State compared to other Member States or non-EU countries which have potentially less restrictive policies on pesticide use. One of the reasons cited by Member States for a poor implementation of IPM is that they have not converted the IPM general principles into prescriptive and assessable criteria to be applied by users. It should be noted that pesticide user respondents to the public consultation CXXI stated that, following participation to a training course, their knowledge improved considerably. Additional training could therefore also be a viable tool to improve the implementation of IPM by pesticide users. Many of the problems which were identified with the SUD are also impacted by other pieces of EU legislation. For many stakeholders, especially researchers, the seed industry and farmers, the choice of crop varieties is important, including conventional selection, but New Genomic Techniques (NGTs) are also perceived by some farmers and industry as potential tools to create new crop varieties relatively quickly that would be resistant to certain pests. However, the development of such technologies is equally opposed by others including farmers, civil society and environmental NGOs. Stakeholders such as pesticide users and the pesticide industry consider that the SUD generally acts as a barrier to the use of new technologies such as precision farming and more targeted application of pesticides as part of precision agriculture (e.g. using drones, as they are considered to fall under the current general prohibition of aerial spraying under the SUD unless derogations are issued at a Member State level) CXXII . 2.3. How will the problem evolve? Most of the environmental and health issues identified at the time of adopting the SUD have remained unchanged or even been aggravated. A stronger awareness among consumers and society at large may act as a driver for change, although these aspects vary considerably among Member States CXXIII . Increasing concerns about the negative consequences of hazardous chemicals on the environment and health, and an awareness of chemical residues in food have increased the demand for products with higher environmental and health standards CXXIV . Future food production in the EU will be influenced by climate change, extreme weather events and altering pest pressures CXXV ., which in turn may influence pesticide risks and use, and the SUD will likely only be moderately relevant to address such future issues and needs Without an improved monitoring framework, supported by appropriate and timely data availability, it will be difficult to assess the effectiveness of policies to reduce the use and risk of pesticides (and adapt planned actions accordingly). Moreover, the objectives of better protecting health and the environment from the risks of pesticide use and meeting the specific pesticide targets included in the Farm to Fork and Biodiversity Strategies and the Zero Pollution Action Plan will likely not be achieved in the absence of any changes to the current policy framework. If the SUD was left unchanged, the current differences between Member States would be expected to remain or intensify, driven by such factors as political will and governance, market drivers, uneven effects from climate change and public opinion/consumer attitudes. These are expected to continue to differ between Member States leading to varying levels of pesticide use and risk, different levels of protection of human health and the environment and uneven competition on the internal market. As the situation currently stands, following 10 years since the deadline given to Member States for transposing the SUD, there is no indication that the identified problems would not persist in case of a “no-change” policy decision CXXVI . 3. Why should the EU act? 3.1. Legal basis The legal basis for action in this area is Article 192(1) of the Treaty on the Functioning of the European Union (TFEU), which empowers the European Union to take action in order to preserve, protect and improve the quality of the environment and to protect human health. EU action in this area is justified by the environmental, public health and Single Market issues at stake. If some Member States do not take action to reduce the use and risk of pesticides, this could negatively affect biodiversity, water and soil quality and human health in the whole EU. In addition, different rules on pesticide use across Member States might create unfair competition and undermine the proper functioning of the Single Market for food commodities, while recognising that Article 193 of the TFEU allows Member States to adopt more stringent provisions than the SUD. The variation in efforts across Member States to achieve the sustainable use of pesticides in practice underlines a need for more coordinated and uniform measures at EU level to drive progress in this area and respond to long-standing societal concerns concerning the use of pesticides. 3.2. Subsidiarity: Necessity of EU action

The SUD established a framework to achieve a sustainable use of pesticides by reducing the risks and impacts of pesticide use on human health and the environment and improving the uptake of IPM. A continued divergence of measures taken in Member States would lead to different levels of protection of health and environment and diverging conditions for the main users of pesticides which would be against one of the fundamental objectives of the Treaties CXXVII . The threat to biodiversity and ecosystems crosses boundaries and necessitates a strong and EU-level action. A level playing field across the internal market, for example for pesticide users, is hampered by current varying levels of action in different Member States to reduce the risks for health and the environment linked to pesticide use. Moreover, pesticides pollution is transboundary and affects waters and the marine environment downstream in one Member State whilst the pesticide use may have taken place upstream in another Member State. Stakeholders’ views differ, but tend to call overall for a stronger EU action on the sustainable use of pesticides CXXVIII . Several Member State authorities point out that the effectiveness of a subsidiarity approach depends on the national transposition and implementation, which can differ substantially between Member States CXXIX . This variation means that the potential for harmonisation of rules is not fully realised and varying competitiveness in the single market continue to exist. The deficiencies in implementing the SUD in some Member States suggest that the previous approach of leaving the detailed rules to national transposition under a Directive has not worked. For example, the European Court of Auditors found a need for clearer criteria and more specific requirements in relation to IPM to help ensure enforcement and assess compliance CXXX . With so many complex agricultural variables in pest management, clear, uniform rules should reduce the compliance burden and improve enforcement. 3.3. Subsidiarity: Added value of EU action Coordinated EU action can effectively supplement and reinforce national and local actions on the sustainable use of pesticides. Coordination of action at EU level and, where possible, at global level, can contribute to achieving the relevant UN SDGs. EU action is compatible with the principle of subsidiarity. Consequences of more effective policies in this area could ultimately lead to improvements in biodiversity, water and soil quality, other environmental parameters and human health. Moreover, because of the cross-border and transboundary dimension of pollution, coordinated actions between upstream and downstream Member States are needed. The EU also possesses other key instruments in agricultural and food policies with which synergies exist and can be further improved, including by increasing legal and policy clarity and coherence, especially the CAP CXXXI . Linked to incentives and possible mitigation measures, it is expected that stronger action at EU level, including in association with related policies such as the CAP, can help to reduce currently varying national approaches and contribute to a more homogenous approach in the future. Other initiatives foreseen under the Farm to Fork Strategy are complementary, for example the organic farming action plan, research and innovation policies and planned Commission implementing acts revising the data requirements and assessment rules for pesticides containing active substances that are micro-organisms (as alternatives to chemical pesticides), specifying the approval criteria applying to them and updating uniform principles to assess and authorise plant protection products containing micro-organisms. These initiatives aim at facilitating the placing on the market of these products and increasing their availability to farmers (see Annex 5, Table 25 for further details of these initiatives). Several stakeholders in various consultations expressed the view that the legal instrument of a Regulation rather than the current Directive might contribute to a more harmonised and binding approach in this policy area in the future CXXXII . The reduction of current national differences in pesticide use policies could contribute to a better functioning of the internal market and a reduction of competitiveness differences which are exacerbated by pesticide use policies varying at Member State levels. The SUD is also relevant to the development of organic farming and achieving the Farm to Fork Strategy target of at least 25% of the EU’s agricultural land under organic farming by 2030 4. Objectives: What is to be achieved? In May 2020 the Farm to Fork Strategy and Biodiversity Strategy announced that the Commission will take action to reduce by 50% the overall use of and risk from chemical pesticides by 2030 and reduce by 50% the use of more hazardous pesticides by 2030. This commitment was re-stated by the Zero Pollution Action Plan in May 2021. The planned revision of the SUD announced in the Farm to Fork Strategy intends to make a substantial contribution to achieving these targets and to EU efforts to continue to reduce the use and risk of chemical pesticides as well as addressing the various problems identified as part of the evaluation concerning current policies and the present implementation of the SUD. A revised SUD should also aim to increase availability of alternatives to chemical pesticides and encourage use of these, therefore supporting farmers in the transition towards a more sustainable food production system. The levels of these targets were chosen to be both technically feasible and economically viable. The planned 50% targets allow substantial progress towards greater environmental and human health protection against the trade-off of increased challenges in political feasibility and economic viability. These challenges can be mitigated by additional actions while still addressing the negative impacts of pesticides on the environment and human health. While comparatively a lower ambition would make the targets more politically feasible with Member States and indeed be likely achieved as part of the baseline scenario without additional policy measures, they would likely fail to protect the environment and human health in a meaningful way. It is nevertheless acknowledged that, due to limitations in the quantity and quality of pesticide use and risk data currently available at EU level, the level of ambition of these targets can be objectively criticised as being of either an insufficient CXXXIII or excessive CXXXIV level of ambition. Limitations of available data and modelling and assessment tools CXXXV also make it difficult to comprehensively and holistically assess the impacts that a transition to more sustainable food systems (including reduced use and risk of pesticides) will have on the agricultural sector in particular and overall society more generally. The chosen reference period for the targets of 2015-2017 can also be challenged as regards Member States who may have made specific national progress in reducing the use and risk of pesticides either before, during or after this period CXXXVI . The reference period of 2015-2017 was chosen in order to take account of the most recent data available when the targets were announced in the Farm to Fork Strategy in 2020 and to provide for an average figure over a three year period, recognising the annual variation in pesticide use due to factors such as weather, pest and crop conditions. This is further expanded on in chapter 8 as regards the preferred option. 4.1. General objectives The SUD contributes to the overall EU goals of preserving, protecting and improving the quality of the environment as well as protecting human health and contributing to the completion and proper functioning of the internal market. 4.2. Specific objectives In line with the European Green Deal, the Zero Pollution Action Plan CXXXVII and the Farm to Fork Strategy to ensure a fair, healthy and environmentally-friendly food system, and Biodiversity Strategy for 2030, this policy intervention aims to significantly reduce the use and risk of chemical pesticides. This initiative will address the following specific objectives: 1.ensuring that current and future policies reflect the zero pollution ambition of the European Green Deal, Farm to Fork Strategy, Biodiversity Strategy and the Zero Pollution Action Plan, in particular to reduce the use and risk of chemical pesticides, in particular those containing more hazardous active substances, increase the application and enforcement of IPM and less hazardous and non-chemical alternatives to chemical pesticides for pest control; 2.improving the availability of monitoring data, e.g. on the implementation and application of the SUD, use and risk of pesticides and health and environmental monitoring, to ensure a better framework to implement, monitor and adjust, where appropriate, future policies; 3.improving the implementation, application and enforcement of the provisions of the SUD across all Member States with a view to improving the effectiveness and efficiency of current policies, including possible simplification and reduction of administrative burden where possible; 4.promoting the application of new technologies such as precision farming by pesticide users with the aim of reducing the overall use and risk of pesticides. 5. What are the available policy options? 5.1. What is the baseline from which options are assessed? The baseline describes the likely development where the SUD remains unchanged and is projected to the year 2030, i.e. the year by which the two pesticide-related Farm to Fork Strategy targets should be achieved. This scenario includes the main drivers that may impact the sustainable use of pesticides until 2030 and beyond. The development will be influenced by other parts of the EU pesticide legislation CXXXVIII , EU legislation on agricultural statistics CXXXIX and the CAP post-2020. These have been taken into account in the baseline assessment, apart from the Commission’s proposal for a nature restoration law which is not yet adopted. How will the use of chemical pesticides evolve in a no-change scenario?

The evolution is discussed for each target separately. For the F2F target 1, (first Farm to Fork Strategy pesticide use and risk reduction target to reduce the use and risk of chemical pesticides by 50% by 2030) an extrapolation of the current trendline taking into account the historical data, shows that further reductions can be expected in a no-change scenario, in the range of 1 and 5% per year, at an EU level. As an example of current trends, consumption of pesticides in the Czech Republic is reported to have already declined by 32% in the last 10 years CXL . Figure 4 presents the available data and trend line for F2F target 1 for EU27 CXLI . Figure 4 Data and trends for F2F target 1 for EU27 from 2011 to 2019 It is expected that Member States will continue to make efforts in line with the current SUD. These efforts include funding research into alternative pest control techniques and funding systems to disseminate these alternative techniques to farmers, such as demonstration farms. The CAP provides a range of incentives to reduce the use of chemical pesticides and these will be reinforced in the new CAP applying from 2023. These measures include area-based payments for participating in voluntary schemes to switch to organic agriculture, devoting a share of farm area to biodiversity and making support schemes conditional to those, to protect water courses, to establish wildlife refuges etc., grants towards the purchase of specialist equipment e.g. precision spraying and mechanical weeding equipment and the Farm Advisory System. This system, which all Member States must establish, helps farmers to meet EU requirements in a range of areas, including the safe use of pesticides and IPM. The development of cultivars resistant to pests, disease and environmental variations would also reduce need for pesticide use, and the possible use of NGTs could expand this potential. The share of improved, lower-risk plant protection products is anticipated to increase gradually in the baseline scenario thanks to investments in research and development to meet productivity gains and environmental standards and amendments to rules supporting their approval-authorisation before their placing on the market. Switching to organic agriculture and devoting area to biodiversity will reduce the use of pesticides in these areas. Some precision farming techniques continue, and will continue, to be adopted by an increasing number of farmers each year. Advances in the uptake of additional precision agriculture techniques will continue to contribute to reducing the use and risk of pesticides. These measures, while perhaps not leading to sudden or dramatically large changes in pesticide use, such as when existing substances are not re-approved, are cumulative over time and help users to transition away from chemical pesticide use. Finally, it is expected that under Regulation (EC) No 1107/2009 CXLII some substances classified as candidates for substitution will not be (re)approved and may be replaced by low risk alternatives. The baseline annual level of reduction is considered to be attributed to, and mainly driven by, some substances losing their approval and therefore no longer being sold/used and an expanded portfolio of, and hence increased sales/use of, low-risk substances and products. For the F2F target 1 it is expected that the positive reduction trend at the EU level would continue. Still, at a medium reduction rate of 3% per year, this would leave a “gap” of 12 index points, towards reaching by 2030 the 50% reduction target expressed in the Farm to Fork strategy. The F2F target 2 (second Farm to Fork Strategy pesticide use and risk reduction target to reduce the use of the most hazardous pesticides by 50% by 2030) will be influenced by the same mechanisms, actions and initiatives as the F2F target 1. The sales and use of these substances were broadly stable in the 2011-2018 period. Under the ongoing renewal programme, some substances classified as candidates for substitution will not be (re)approved and will thus not be available for use. The impact of this process first manifested itself in the reduced use of these pesticides in 2019, and it is likely to result in further declines in the sale and use of these products over time. Consequently, pesticide users will be forced to shift to alternative substances or methods. While in the short term, some professional users may switch to another candidate for substitution product rather than a low-risk alternative, the diminishing pool of these substances (due to further non-renewals) should lead to the continuation of the trend starting from 2019 of a steady reduction in the use of more hazardous substances over time. Substitution rate until now was based on “easy wins” leading to a decline rate of 5% between 2015-2017. This process is expected to slow down as further substitutions will be more difficult to achieve and is expected to be between 2 and 3% annually. The efforts made by Member States to restrict use of more hazardous substances (for example restricted to only professional use and/or banning of their use in public areas) will likely continue, leading to further reduction. Based on current and historic trendlines, it can be expected that use of more hazardous substances would reduce by between 0.05 and 2% per year until 2030. As illustrated by the estimation, the F2F target 2 of reducing the use of more hazardous substances by 50% in 2030 will likely not be met in a no-change scenario. Only limited progress can be expected towards this target if the situation remains unchanged, and thus an accelerated reduction in F2F target 2 is needed. Figure 6. Estimated trends in the F2F target 2 The gains manifested at EU level towards reaching the F2F target 1 in the baseline scenario, would risk being offset by a continued high variation at Member State level. As shown in the evaluation of the current SUD, the ambition and progress on reducing the risk of pesticides use varies strongly between Member States. The available evidence on trends illustrates the uneven progress in Member States up to the present day which would likely continue in a no-change scenario. This could impede the even playing field for professional users, and in particular farmers, if some Member States restrict access to pesticides (in particular more hazardous pesticides), thereby leading to a situation where farmers compete on the internal market under different conditions (costs of production, risk of yield losses). The magnitude of these impacts is not possible to quantify. How will environmental, economic and social/health impacts of pesticide use evolve in a no-change scenario? In a no change scenario it is expected that environmental status and eco-system services will further decline. While the current negative trends are not solely attributable to use of pesticides for plant protection, it is one of the environmental pressures contributing to a decline in biodiversity, soil quality, pollinators, and water quality CXLIII . The baseline scenario estimates that the use of more hazardous substances will decrease at a slower rate than the uptake of low-risk substances, thereby posing a continued risk to the environment. Use of pesticides is also an enabler of intensive mono-culture practices which further limits habitats and opportunities for nature to flourish. While a (quantified) causal link cannot be established between pesticide use and deteriorating environmental status, intensive farming prioritises food (and biofuel) production over environmental considerations. Intensification of agriculture has a range of negative consequences for the health and quality of natural ecosystems. Partly, this arises from the use of intensive inputs such as pesticides and chemical fertilisers, and partly it is a function of the prevalence of ‘monocultural landscapes’ in which there is little opportunity for nature. In turn, the loss of biodiversity leads to a need to intensify agriculture further CXLIV , as natural predators decline. The planned nature restoration law may address these issues through mandatory targets for nature restoration, however the legislative proposal has not yet been adopted and therefore its potential impacts are not estimated or quantified here. The economic impact in terms of agricultural income in the baseline is uncertain, with variable decrease percentages by crop category anticipated in the various policy reviews and impact assessments. According to the latest EU Agricultural Market Outlook (EC, 2021) CXLV , total farm income at constant (2010) prices is projected to decrease by 1.2% per year during the period 2021-2031, compared to the previous decade. Overall use of chemical pesticide is expected to decrease in the baseline scenario, which could lead to input savings, however these may be offset by the need to invest in IPM and alternative methods, including precision agriculture. The economic impact of the (continued) decline in eco-systems services and biodiversity is not possible to quantify but would be very high if the lack of progress to reverse the development leads to system collapse. In this respect the continued use of more hazardous substances, classified as Persistent, Bioaccumulative and Toxic (PBT) is likely to pose higher risks than more low risk chemical pesticides in the long term. Other uncertainties in the baseline relate to climate change and the impact of adverse weather events on food production. In the no-change scenario health impacts are difficult to assess precisely and with certainty. Harmful effects on human health from pesticides have been established, such as acute and chronic poisoning, links to certain types of cancer and Parkinson’s disease. However, across these identified diseases, evidence from academic studies CXLVI and EFSA annual reports conclude that it is difficult to categorically link specific pesticides with increased risk to human health. Currently available data from meta-analysis by Inserm (2021) points to greater links between risk of diseases and the use of herbicides and insecticides compared to other categories. Among the 57 active substances that are currently classified as candidates for substitution there are 8 substances that are identified on human health grounds, based on their carcinogenic, repro-toxic and endocrine disrupting properties, 10 substances are identified based on their low acceptable daily intake (ADI) and 38 substances are identified based on the PBT criteria (4 active substances are classified as candidates of substitution on several of the criteria). Due to limits in the current state of knowledge, it is not possible to estimate the impact on human health of a no-change scenario where the use of the candidates for substitution remains on the current trend-line (see Annex 5), but it is apparent that there would be no improvement over the current situation. 5.2. The pesticide reduction targets As described in the Farm to Fork Strategy, the EU Biodiversity Strategy and the Zero Pollution Action Plan, the European Commission announced two pesticide reduction targets: ·Target 1: to reduce by 50% the use and risk of chemical pesticides by 2030

·Target 2: to reduce by 50% the use of more hazardous pesticides by 2030 An important issue to be considered is whether the setting of targets of a lower or higher ambition than 50% would be appropriate. Currently, in the absence of pesticide use data at EU level, the F2F target 1 for the use and risk of chemical pesticides is calculated using a modified version of the current harmonised risk indicator 1 (HRI 1) methodology, based on sales of different hazard categories of pesticides (see Annex 4 for a detailed description of the harmonised risk indicators and methodology for their calculation). F2F target 2 was chosen to specifically reduce the use of these more hazardous pesticides, given that their use increased by 9% in the six year period from the 2011-2013 period to 2018, whereas it was expected they would have reduced. 57 of the approximately 450 active substances approved for use in the EU, approximately one seventh of active substances, fall into this category and because of their inherent hazard characteristics they are given a high hazard weighting of 16. Achieving the second target would correspond to reducing the F2F target 1 by only around 8-10%, according to ESTAT estimates and thus is seen as complementary to F2F target 1, but, given the specific hazard of this group of pesticides, it is considered fully justified to set a separate reduction target for these more hazardous products. The Commission does not have robust use data on the crops and pests on which these pesticides are used. However, for each of the main product types (herbicides, fungicides and insecticides), there are some active substances that fall into the more hazardous group and some less hazardous, meaning that in some situations the possibility to switch to lower risk alternatives already exists. For some others there are not currently available alternatives and thus the gradual trajectory towards achieving this 50% target for F2F target 2 by 2030 allows time to bring such alternatives to the market. The Commission intends to monitor the progress in each of the targets annually. This will enable the progress and relationship/articulation between the two targets to be more specifically assessed over time. Along with the new data provided for by the proposed policy options, it will allow for the consideration of setting further and possibly more differentiated targets for different groups of substances (and hazard categories) beyond 2030. The setting of any EU level targets in the field of the environment involves the trade-off between three interconnected factors: environmental and human health protection, political feasibility and economic viability. This is particularly true for the setting of the Farm to Fork Strategy pesticide targets which operates at the intersection between these three interlinking factors (as demonstrated in figure 7 below). The demonstrated effect of pesticide use on health and the environment necessitates a change in approach and means no-change is not seen as an option. This has to be offset against consideration for actions being proportionate and viable, and for mitigating actions to reduce the economic impact at both a micro (farm) and macro (global) level. The potential negative economic effects of further biodiversity decline must also be considered. Political feasibility has to consider this trade off with additional considerations of context, implementability and enforcement. To provide further context, the graph below presents the Farm to Fork Strategy first and second pesticide use and risk reduction targets and the estimated decreases based on the baseline. As the above diagram shows a 20-30% reduction would be expected to occur with the existing projected reduction rate, without significant changes to the SUD. This can be seen as easily achieved and without significant additional economic cost, thus having little economic impact. It would not have the required positive impact on human health and the environment, thus not achieving the overall policy objective. A 40-60% reduction target would represent a medium level of ambition compared to the no-change scenario. Given the current no-change estimates, the baseline assumes that this target would not be met without significant changes in the SUD legislation. A reduction ranking between 40-60% is likely to be challenging yet achievable, requiring in the region of a 10-30% reduction beyond the baseline scenario. It would require additional actions by professional users and Member States and is thus seen as having a positive impact on human health and the environment, and particularly so in the reduction of the more hazardous substances under F2F target 2. Politically, this should allow those Member States with existing ambitions to still achieve these, while allowing those Member States with lower ambitions to improve. Whilst there would be some likely economic impact, this is seen at a level at which support such as the CAP, changes in support through advisors and availability of alternatives would mean the effect is lessened to one which is politically acceptable. The uptake of precision agriculture and organic farming is also seen to have a quantifiable positive impact with an estimated 20% reduction in pesticide use by 2030 due to these changes if predicted expansion is achieved (see also analysis in Annex 5). Additional factors can also be considered such as changes in consumption patterns, reduction in food waste and increased demand for sustainable foodstuffs that will also mitigate the current foreseen impacts, but these are uncertain and difficult to quantify. Whilst the impact cannot currently be quantified, the potential for NGT to provide varieties resistant to pests is also considered to offer potential for pesticide use reduction, alongside reducing other agricultural inputs. The JRC supported the European Commission Study in Light of the Court of Justice’s Judgment in Case C-528/16 regarding the Status of New Genomic Techniques under Union Law CXLVII through reports on the scientific and technological state-of-the-art as well as on current and future market applications of NGTs CXLVIII . In the context of the latter study, a database was compiled to provide a general overview of NGT products under development globally. The database currently has 113 entries of a broad range of crops with an improved pest and disease tolerance. Of these 37 are already in an advanced development stage and at least two have been reviewed by regulatory bodies in other countries. An impact asessement is ongoing to decide on the appropriate regulatory oversight for the concerned plant products, ensuring a high level of protection of human and animal health and the environment. Taking a higher scenario of 70-80% reduction in pesticide use and risk presents the most ambitious range of reduction, and would require a significant annual decrease in pesticide use and risk. It would have the greatest effect on human health and environmental protection but, as it would require rapid and drastic changes to farming practices before alternatives are available, it is likely to have a greater effect on crop yield, and subsequently the greatest economic cost both for farmers and for the whole economy. It would be politically difficult to accept therefore for Member States. Given the trade-offs between each of the scenarios, the 40-60% target range presents the most balanced and realistic option in working towards increased protection of the environment and human health while balancing the political and economic challenges that would likely occur, within the given timescale. If criteria influencing this rationale, such as developments in IPM uptake supported by CAP and technology, trends in organic farming uptake and development of precision agriculture become clearer and more certain closer to 2030 then consideration should be given to reassessing the targets beyond that timeline. 5.3. Description of the policy options The policy options considered include a variety of regulatory and non-regulatory approaches of varying levels of ambition. Annex 7 outlines in detail the various policy options which have been subject to impact assessment. These have been classified as being of either least/lowest ambition (Policy option 1), moderate ambition (Policy option 2) or highest/most ambition (Policy option 3) in addressing the identified problems and objectives. Where compatible, the more ambitious policy options build on those of a lower ambition. Pesticide reduction targets of either a lower or higher ambition than those specified in the Farm to Fork Strategy and Biodiversity Strategy have been analysed in section 5.2 above and in Annex 5. Potential costs, benefits and changes in administrative burden for affected stakeholders have been specifically taken into account in the impact assessment CXLIX . 5.3.1. Specific objective (SO1): Pesticide reduction targets reflected in SUD The operational objective pursued is to establish a roadmap for reaching by 2030 the F2F targets. In option 1 (least ambitious) the targets would remain non-legally binding, the Commission would monitor progress towards reaching the targets at EU and Member State levels annually, supported by mandatory reporting of corrective measures taken in each Member State in case of underperformance towards reaching the targets. It also includes prohibiting the purchase and use of more hazardous pesticides by non-professional pesticide users, as is already the case in several Member States. Option 2 (moderately ambitious) would set the 50% reduction targets in legislation as mandatory targets to be achieved at EU level, with Member States setting their own national reduction targets where they can justify a reduction from the 50% target taking into account a formula considering their existing national situation and level of progress in reducing the use and risk of pesticides. There would be a limit on the reduction in ambition permitted and the Commission would make recommendations on any targets not meeting the required ambition and would identify corrective measures to be taken in case of underperformance towards reaching the EU targets with regular monitoring. Once established, these national targets would become legally binding. To reduce the use and risk of pesticides, the use of more hazardous pesticides in sensitive areas such as urban green areas would be prohibited.

Option 3 (most ambitious) would establish the 50% reduction targets as mandatory legally binding targets to be achieved both at EU and Member State levels, with the Commission identifying corrective measures in case of underperformance towards reaching the targets and taking account of the different starting points of Member States. The use of all chemical pesticides would be prohibited in sensitive areas such as urban green areas. 5.3.2. Specific objective (SO2): Monitoring and data are widely available The operational objectives pursued are to ensure that pesticide use data is sufficient to monitor risks from pesticide use and that knowledge on pesticide use and risk is improved and available data used to the full. In option 1, Member States would share with the Commission detailed information on existing health and environment monitoring indicators which are already used at a national level concerning the use of and/ or risks from pesticides, with a view to examining if it would be appropriate to apply such indicators at EU level. In option 2, records of pesticide use already required to be kept by pesticide users under Regulation (EC) 1107/2009 would be required to be kept in electronic form and in a more granular format to facilitate the collection and analysis of these data. This information could support the development of future monitoring and risk indicators and allow realistic use and exposure assessments. This would be combined with an obligation for Member States to analyse these pesticide use data and to report annually to the Commission on trends in such data. Building on option 1 and based on the additional data available, the Commission would propose in the future possible new additional harmonised risk indicators concerning pesticide use and risk at EU level. Option 3 would be identical to option 2. 5.3.3. Specific objective (SO3): Strong implementation of clearer SUD provisions in Member States Operational objectives here included to improve technical advisory services to train and advise farmers and other professional pesticide users on IPM practices, promote crop-specific IPM rules, improve the implementation of IPM, strengthen the effectiveness of Member State NAPs and also address identified deficiencies in the current testing of PAE. Option 1 would require additional training for advisors on IPM, clarification of SUD text on IPM principles including by highlighting the potential role of new practices and technologies, request Member States to develop or approve (including at regional levels) mandatory crop-specific IPM rules covering at least 90% of utilised agricultural area (UAA) nationally. These changes would be reflected in the CAP as regards the better implementation and enforcement of IPM through obligations on, and potential financial incentives for, pesticide users. This could be complemented by the Commission taking action (including through available financial support and/or training) to support the development of any necessary guidelines, standards and promotion of knowledge-sharing for the testing of PAE. The registration of PAE in registers (already implemented in some Member States) could be introduced as a recording, monitoring and enforcement tool and a mandatory training certificate could be required for PAE operators and not just for purchasers of pesticides as under the current SUD. The Commission would also outline clearer specifications concerning expected mandatory content of Member State NAPs, especially as regards steps to progressing towards indicators and targets, with a view to making NAPs more effective tools to achieve the reduced use and risk of pesticides. Option 2 would require an obligatory independent advisory service to professional pesticide users (decoupled from an economic interest of selling pesticides and PAE) to ensure the promotion of increased use of alternatives to chemical pesticides as they are available. A compulsory electronic IPM record-keeping by professional pesticide users would also be considered, with possible links to the electronic record-keeping of pesticide use data mentioned under SO2. The Commission would take further action to promote the application of best available technologies (BATs) and support the development of any currently missing standards for PAE. The more detailed Commission guidance for Member State NAPs under option 1 would be supplemented by annual reporting to the Commission by Member States on progress in implementing their NAPs, rather than the current requirement of a review of NAPs by Member State competent authorities only every 5 years. Member States would also set their own targets of specific actions such as percentage sales of biocontrol agents, to contribute towards the targets. This would create a direct link between the NAPs and the progress to achieving the targets, and allow greater accountability for Member State actions. Annual reporting would relate to progress towards achieving all national targets and other quantitative data relating to implementation of the revised legislation. An additional element would be an increased emphasis on the existing framework of Member State risk based controls, enforcement and penalties (where relevant), and control systems such as internal audits, making full and detailed use of the various existing mechanisms already offered under the Official Controls Regulation CL with the aim of improving overall implementation of the SUD in general, and IPM in particular. Option 3 would be identical to option 2. 5.3.4. Specific objective (SO4): new and more efficient techniques are taken up by pesticide users Operational objectives under this heading would be to promote the implementation of precision farming and new technologies, including monitoring technologies, big data supporting the decision-making process to apply pesticides only when strictly necessary, such as more targeted pesticide application as part of precision agriculture (e.g. by sensor-assisted sprayers), smart machinery and robotics, pesticide applications in limited areas of fields and ensure that the potential of such technologies to reduce the overall use and risk of pesticides would be properly reflected in the IPM principles currently outlined in the SUD and implemented through the activities foreseen under SO3 regarding IPM (e.g. training, IPM record-keeping). Option 1 would make these changes to the SUD to emphasise the potentially important role of these technologies to reduce the use and risk of pesticides. The current SUD definition of “aerial spraying” in Article 3 of the SUD would be amended to make clear whether spraying by drones falls under the SUD general prohibition of aerial spraying, given the uncertainty among stakeholders linked to fact that this Article refers in general to “aircraft (plane or helicopter)” and the term drones is not mentioned in the SUD provision currently in force CLI . This would be combined with the Commission, together with Member States, promoting targeted training and advice measures for precision farming to professional pesticide users, promote the use of pest forecasting tools and prediction models which could potentially reduce the overall use and risk of pesticides and continue to support the development of alternative methods to chemical pesticides. Option 2 would build on option 1 and foresee to amend the SUD to allow more targeted pesticide application as part of precision agriculture within certain parameters, to be defined in a future annex to a legislative EU act based on advances in the underlying scientific data concerning associated pesticide use and risk. Under option 3 any type of more targeted pesticide application as part of precision agriculture, for example spraying by drones, under certain specifications would be allowed and the Commission would propose additional relevant delegated acts to amend or supplement the legislation, as required, to account for future technological progress. 5.4. Legal instrument Given the complex variety of factors influencing the sustainable use of pesticides under different national and regional agronomic and climatic conditions, it might be thought that a Directive better satisfies the principle of subsidiarity. However, as confirmed by the evaluation, the approach of leaving detailed rules to national transposition of the SUD has yielded inadequate results in many cases. As more extensively described in the evaluation CLII , audits, fact-finding missions and implementation reports by the Commission, the EPRS study on the implementation of the SUD, and a recent report of the European Court of Auditors on plant protection products all point to weaknesses in the implementation, application and enforcement of the SUD and a failure to sufficiently achieve its overall objective. The generally looser language of a Directive has been insufficiently precise to ensure an adequate level of compliance. Thus, a Regulation is considered to be a better instrument in order to provide for more binding and uniform rules. 5.5. Options discarded at an early stage Policy options considered by the Commission but discarded at an early stage included:

·Colour-coded labelling of pesticides to reflect their hazard profile, e.g. as in a traffic light system (green, amber, red). Based on consultation with Member State competent authorities and stakeholders, this option was considered to have limited effectiveness potential, as well as being considered difficult to establish objective risk criteria for the categorisation of all pesticides into three simple hazard categories. Feedback received stated that such a colour-coded categorisation could be misleading and that, if it was the objective to reduce or prevent the use of certain pesticides, other more effective tools are available for that purpose. ·Strengthened provisions on the collection and recycling of empty pesticide containers or packaging, in line with objectives of the Circular Economy Action Plan Feedback from Member State competent authorities and stakeholders was that this issue should be best left to Member States to address nationally and that in many Member States official or industry schemes are already in place and operating quite effectively on this issue. ·Require the testing of new PAE prior to being placed on the market to identify and address any defects before the PAE enters into use, with the objective to better protect health and the environment The Commission considered that such a provision would be legally incompatible with the provisions of the EU Machinery Directive CLIII (and proposed Regulation CLIV ) that no extra barriers shall be placed to such new PAE being placed on the market. Feedback from Member States and stakeholders indicated that any defects in new PAE occur at quite a low frequency and would be identified subsequently when PAE is subject to a regular routine test in any case. ·Include PAE within the scope of Official Controls Regulation (EU) 2017/625 with the aim to make use of relevant enforcement and reporting tools and potentially improve implementation of SUD provisions related to PAE Member States specifically opposed and insisted on the exclusion of PAE from the scope of the Official Controls Regulation when it was originally agreed, based on concerns concerning subsidiarity and potential conflict of interest related to control of private sector bodies involved in the testing of PAE in some Member States. The Commission considered that such a policy option could offer the potential to improve controls, enforcement and reporting tools, but consultation with Member State competent authorities demonstrated that the views prevailing at the time of the adoption of the Official Controls Regulation persist. Member States continue to oppose such a provision and therefore it was discarded as a policy option. ·Delete the requirement for Member States to develop SUD NAPs, in an effort to reduce potential administrative burden, especially if these are seen as being not very effective tools in any case and potentially duplicating the obligation on Member States to prepare CAP National Strategic Plans (NSPs) Member States and stakeholders generally consider that NAPs are not overly burdensome to prepare and update and provide a useful opportunity for relevant stakeholders to input to national policies on the sustainable use of pesticides. Furthermore, not all pesticide use would be captured in CAP NSPs which would only cover the agricultural use of pesticides linked to specific CAP provisions. ·Adapt the taxation of pesticides at EU level, whether through value-added tax (VAT) or excise taxes to discourage the use of all or more hazardous pesticides Several Member States have introduced specific national taxes on pesticides. Member State competent authorities and pesticide users and industry expressed opposition to such an idea, while environmental NGOs supported it. Given that agreement on taxation at EU level requires unanimity among Member States and is based on a separate Treaty legal base compared to the environmental legal base of the SUD, it was concluded that it would not be legally or practically possible to include this element in a potential revision of the SUD. A proposal to phase out currently applied reduced VAT rates for pesticides has been discussed in Council and agreed in April 2022 CLV (see Table 25 in Annex 5). ·Prescription system for the purchase by professional users of more hazardous pesticides A national prescription system for pesticides has been introduced in countries such as Hungary, Greece and Switzerland CLVI . However such prescription systems impose high costs and administrative burden both on pesticide users, prescribers and competent authorities and have a generally low efficiency and effectiveness in changing pesticide use and risk patterns CLVII . Introducing a prescription system in each Member State was therefore discarded as a policy option 6. What are the impacts of the policy options? This section will discuss and assess the social, environmental and economic impacts of the proposed policy options. For each type of impact, the assessment discusses who (or what) will be affected and how, what magnitude of effects can be expected and what conditions or mitigating actions may be necessary to offset undue negative effects of the policy options. A transversal assessment across social, economic and environmental impacts needs to consider the inherent tradeoffs of the initiative for different stakeholder groups. It should be noted that small and medium enterprises (SMEs) would be specifically affected by several potential changes to the SUD. These SMEs would include agricultural advisers, handlers of agricultural produce and pesticides, food processors and intermediaries, agricultural contractors, farmers and other SMEs using pesticides. 6.1. Social impacts Social impacts include the direct effects from pesticide use on people, including those operators and workers in direct contact with pesticides or pesticide treated areas, bystanders indirectly exposed to them and the public including vulnerable groups, as consumers of food/water containing residues of pesticides. More indirect effects include access to affordable and nutritious food and raw materials as well as access to recreational space and nature and other ecosystem services.

6.1.1. Health impacts Reductions in the use and risk of chemical pesticides in line with the targets announced in the Farm to Fork Strategy would have a direct impact on the level of exposure to pesticides. It is important to separate the risks to human health for 1) the users of pesticides (professional and non-professional) and 2) citizens living close to areas where pesticides are applied as well as 3) consumers of food products. Reaching both Farm to Fork targets would lead to a reduction in exposure, in particular for professional pesticide users (handling and applying less pesticides) and by-standers (through reduced spray-drift from treatments) CLVIII . There are no clear aggregated data at the EU level on the level of risk related to current exposure, but meta-analysis of academic and scientific literature point to similar and recurring conclusions on the risks and possible impacts and strong presumed links for several exposure–disease combinations CLIX (see also Annex 5). A 2016 review CLX suggested that the economic costs of pesticide use have been underestimated and that the benefit-cost ratio of pesticide use may have fallen below 1 if the cost of illnesses and deaths triggered and favoured by chronic exposure to pesticides was taken into account. An assessment focussing primarily on the US, estimated the total losses from pesticides use for public health at $1.1 billion per year in the US (2009) CLXI . In relation to health impacts from exposure through consumption of food, the current limits on allowed maximum pesticide residues on food are set for single substances CLXII CLXIII and the current measures to protect human health do not adequately address potential for mixture effects. Studies on consumer risks from the combined exposure to multiple chemicals have been performed focusing on prioritised toxicological effects (neurotoxicity and thyroid mediated toxicity). EFSA has concluded that cumulative dietary exposure is, with various degrees of uncertainty, below the threshold that triggers regulatory action for all population groups CLXIV . Overall, most epidemiological studies point to evidence of presumed links (or statistical associations), but so far regulatory risk assessment approaches, including some on mixtures, point to low risk. This is a significant scientific challenge which makes it difficult to conclude on the causality of observed links (or statistical associations) and the potentially differing conclusions of risk assessment methodologies and epidemiological studies. However, if confirmed as causal relationships, the observed links carry major societal and health costs which support the case for reducing exposure and risk. It has been shown that combinations of chemicals present at even low levels may contribute to the overall risk of adverse health effects such as cancer and reproductive toxicity CLXV and the majority of epidemiological studies point to several statistically significant associations or presumed links. There are no studies available linking exposure and health effects to specific currently approved substances and it is not feasible to differentiate the impact between the two Farm to Fork Strategy pesticide reduction targets. It could be that achieving the second Farm to Fork Strategy pesticide target on the reduction of more hazardous substances by 50% would yield higher health benefits, but current evidence does not allow for this to be established. More hazardous substances generally have a broader spectrum of action (different types of pests, types of crops), hence replacing a