EUROPEAN COMMISSION Brussels, 20.5.2020 SWD(2020) 87 final COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides {COM(2020) 208 final}



Table of Contents 1. Introduction 1.1. Purpose of the evaluation 1.2. Scope of the evaluation 2. Background 2.1. Intervention logic 2.2. Baseline — the situation before the PPP and MRL Regulation 2.2.1. Plant protection products under Council Directive 91/414/EEC 2.2.2. A patchwork regulatory system for MRLs of pesticides 2.3. Baseline — other points of comparison 3. Implementation / State of Play 3.1. Societal and political developments 3.2. The PPP market 3.3. Approval of active substances 3.4. Authorisation of plant protection products 3.5. Setting and reviewing MRLs 3.6. Public information, risk communication and transparency 3.7. Enforcement and monitoring

3.8. Court cases and complaints 4. Methodology 4.1. Data collection 4.2. Limitations and robustness of findings 5. Analysis and answers to the evaluation questions 5.1. Effectiveness 5.1.1. Protecting human health 5.1.2. Protecting the environment, including wildlife and water 5.1.3. Minimising animal testing 5.1.4. Improving the functioning of the single market 5.1.5. Improving agricultural production and competitiveness of EU agriculture 5.1.6. Facilitating international trade 5.1.7. Enforcement 5.1.8. Transparency and risk communication 5.2. Efficiency 5.2.1. Costs for industry, farmers and SMEs 5.2.2. Costs for the Member States, the Commission and EFSA 5.2.3. Benefits to human health and to the environment 5.2.4. Societal and agricultural benefits and costs related to PPPs in the EU 5.2.5. Benefits from the single market and international trade

5.3. Coherence 5.3.1. Pesticides policy area 5.3.2. Other EU policy areas 5.3.3. International agreements 5.4. Relevance 5.4.1. Sustainability 5.4.2. Innovation and scientific progress 5.5. EU added value 6. Conclusions 7. Reference list Annex 1. Procedural information Annex 2. Synopsis report on the stakeholder consultation Annex 3. Methods and analytical models Annex 4. Costs and benefits Annex 5. Court cases and complaints to the Ombudsman GLOSSARY AND LIST OF ABBREVIATIONS Acceptable daily intake (ADI) ADI is a measure of the amount of a specific substance in food or drinking water that can be ingested (orally) on a daily basis over a lifetime without an appreciable health risk.

Active substances An active substance is the active component against pests or plant diseases contained in a plant protection product. Acute reference dose (ARfD) The acute reference dose is an estimate of a daily oral exposure for an acute duration (24 hours or less) to humans that is likely not to have deleterious effects during a lifetime. Adjuvant An adjuvant is a chemical or mixture of chemicals that enhances the efficacy of a plant protection product. Annex I renewal programme (AIR) The Annex I renewal programmes are working programmes for the renewal of approval of active substances. They were drawn up to cover all approved active substances and to balance the workload for the evaluating authorities. ALARA principle As low as reasonably achievable (ALARA) is a safety principle designed to minimise radiation doses and releases of radioactive materials. This principle is also applied to other areas involving safety management in particular for issues where no quantified safety level can be established. Basic substances Basic substances are substances that are not predominantly used for plant protection purposes but that may be useful in plant protection. They can be approved for plant protection use provided they are of no concern to human health or the environment. Some of these substances have traditionally been used by farmers, and they may include foodstuffs. Biopesticides Biopesticides include naturally occurring substances derived from animals, plants or bacteria that control pests, as well as microorganisms that control pests (microbial pesticides) Candidates for substitution (CfS) Candidates for substitution are active substances approved in the EU that meet any of the seven criteria listed in Annex II to the Plant Protection Products (PPP) Regulation. The criteria are based on the active substance’s intrinsic hazardous properties in combination with its use. The approval period of a CfS is limited to 7 years. Codex Committee on Pesticide Residues (CCPR) The CCPR is responsible for establishing Codex MRLs)for pesticide residues in specific food items or in groups of food or feed that move in international trade. Codex Limits (CXLs) These are international standards of maximum residue levels of pesticides set by the Codex Alimentarius Commission. CXLs that are considered safe for consumers by the European Food Safety Authority (EFSA) are taken over as MRLs in EU legislation to facilitate trade.

Commodity Food or feed product of plant or animal origin. Co-formulant Plant protection products may contain one or more active substances as well as other materials such as solvents, carriers, inert material, wetting agents, etc. These other materials are referred to as co-formulants. Cut-off criteria Active substances that meet the cut-off criteria cannot be approved in the EU or can only be approved under restricted conditions. These are active substances that are mutagenic; carcinogenic; toxic for reproduction; have endocrine disrupting properties; are persistent organic pollutants (POPs); are persistent, bioaccumulative and toxic (PBT); or are considered to be very persistent and very bioaccumulative (vPvB). Dossier Dossiers are submitted to the rapporteur Member State to support the approval or renewal of approval of an active substance. The dossier contains the required data compiled through experimental studies in line with internationally validated test guidelines or through peer-reviewed scientific publications. Draft (review/renewal) Assessment Report (dRAR) The dRAR contains the scientific assessment by the rapporteur Member State. It is based on the dossier submitted by the applicant in support of the approval or renewal of approval of an active substance. Emergency authorisation The Plant Protection Product (PPP) Regulation allows Member States to grant emergency authorisations for plant protection products that are not authorised. These emergency authorisations are limited to 120 days to combat a danger to plants that cannot be controlled by other reasonable means. Endocrine disruptor Endocrine disruptors are chemicals that alter functions of the endocrine system and consequently causes adverse health effects in both humans and wildlife. European Food Safety Authority (EFSA) EFSA is the European agency responsible for risk assessment in the area of food safety. Generic manufacturer Generic manufacturers are companies (mostly smaller companies) that produce generic plant protection products, i.e. non-patent protected products. Genotoxicity

Genotoxicity describes the property of chemical agents that damages the genetic information within a cell. This damage causes mutations, which may lead to cancer. Genotoxicity is often confused with mutagenicity - all mutagens are genotoxic, whereas not all genotoxic substances are mutagenic. Good agricultural practices (GAPs) Good agricultural practice means the nationally recommended, authorised or registered safe use of plant protection products under actual conditions at any stage of production, storage, transport, distribution and processing of food and feed. It also implies the application of the principles of integrated pest control in a given climate zone, as well as using the minimum quantity of pesticides and setting MRLs at the lowest level which allows the desired effect to be obtained. Hazard The terms ‘hazard’ and ‘risk’ are often used interchangeably. However, in terms of risk assessment, they are two very distinct terms. A hazard is the intrinsic property of an agent to cause harm to humans, property or the environment. Risk is defined as the probability that exposure to a hazard will lead to a negative consequence. More simply: a hazard poses no risk if there is no exposure to that hazard. Import tolerance Imported commodities must comply with the MRLs established in EU legislation. Import tolerances can be set for specific products (e.g. exotic fruit) for which EU uses either do not exist (as no applicant applied for such a use in the EU) or do not take into account the specific conditions in the country of origin (e.g. different climatic conditions). An import tolerance appears as any other MRL in EU legislation and must be safe for consumers. Integrated pest management (IPM) Integrated pest management is the careful consideration of all available pest-control techniques and subsequent integration of appropriate pest-control measures. These appropriate pest-control measures should discourage the development of pest populations and keep pesticides to levels that are economically justified. They should also reduce or minimise risks to human health and the environment. Limit of quantification (LOQ) The limit of quantification is the smallest amount of an agent that can be measured with stated and acceptable imprecision and inaccuracy (e.g. the smallest concentration of a chemical that can be measured with sufficient precision in a millilitre of water). Low-risk active substance An active substance can be approved as a low-risk active substance if it meets the regular approval criteria and also meets the low-risk criteria as specified in Annex II, point 5 of Regulation (EC) 1107/2009. There are specific criteria for low-risk chemical substances and for micro-organisms. Maximum residue level (MRL) The traces pesticides leave in treated commodities are called ‘residues’. A maximum residue level (MRL) is the highest level of a pesticide residue that is legally tolerated in or on food or feed when pesticides are applied correctly according to good agricultural practice during the production of the food or feed. Minor use A minor use of a PPP is a use on crops that are either not widely grown in a Member State, or widely grown but meet an exceptional plant-protection need. Mutual recognition In principle, mutual recognition allows market access for products that are not subject to EU harmonisation. Products lawfully sold in one EU Member State can be sold in another. In the specific context of the PPP Regulation, the authorisation of a PPP in one Member State is to be recognised by other Member States unless there are specific environmental or agricultural circumstances not to do so. Neonicotinoids

Neonicotinoids are a class of neuro-active insecticides chemically similar to nicotine. The neonicotinoid family includes acetamiprid, clothianidin, imidacloprid, nitenpyram, nithiazine, thiacloprid and thiamethoxam. Non-governmental organisation (NGO) NGOs are usually non-profit and independent of governments (though often funded by governments) that are active in humanitarian, educational, health care, social, human rights, or environmental causes. Organisation for Economic Cooperation and Development (OECD) The OECD is an intergovernmental economic organisation with 36 member countries, founded to stimulate economic progress and world trade. Persistent, bioaccumulative and toxic (PBT) substances A PBT substance is ‘persistent’ (i.e., the half-life in marine water is higher than 60 days; the half-life in fresh or estuarine water is higher than 40 days; the half-life in marine sediment is higher than 180 days; the half-life in fresh or estuarine water sediment is higher than 120 days; or the half-life in soil is higher than 120 days), AND ‘bioaccumulative’ (i.e. where the bioconcentration factor is higher than 2 000), AND ‘toxic’ (i.e., the long-term no-observed effect concentration for marine or freshwater organisms is less than 0,01 mg/l; the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2); or there is other evidence of chronic toxicity, as identified by the classifications STOT RE 1 or STOT RE 2). Persistent organic pollutants (POPs) Persistent organic pollutants are chemicals of global concern due to their: potential for long-range transport; persistence in the environment; ability to bio-magnify; and ability to bio-accumulate in ecosystems. Plant protection product (PPP) Plant protection products are formulations containing one or more active substances and intended to protect plants and plant products. Plant Protection Products Application Management System (PPPAMS) The PPPAMS is being developed by the European Commission to enable industry users to create applications for PPPs and submit these to EU Member States for evaluation, concluding with authorisation of the PPP or refusal of the application. Precautionary principle The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of the European Union. It may be invoked when a phenomenon, product or process may have a dangerous effect, identified by a scientific and objective evaluation, if this evaluation does not allow the risk to be determined with sufficient certainty. Rapporteur Member State The rapporteur Member State carries out the risk assessment for the approval of an active substance, which is then peer-reviewed by the other Member States and EFSA. A zonal rapporteur Member State is carrying out the risk assessment for the authorisation of a PPP on behalf of the other Member States in the same zone, e.g. in the northern, central or southern zone. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Registration report (for authorisations) The registration report is part of the procedure to authorise a PPP. The zonal rapporteur Member State makes the draft registration report available to the concerned Member States for commenting, and subsequently finalises the registration report after considering the comments received. European Commission’s regulatory fitness and performance programme (REFIT) REFIT is part of the Commission’s better regulation agenda. It makes sure that EU laws deliver their intended benefits for citizens, businesses and society while removing red tape and lowering costs. It also aims to make EU laws simpler and easier to understand. Risk Risk is the probability that exposure to a hazard will lead to a negative consequence. Safener A safener is a chemical contained in a PPP that protects crop plants from damage from the PPP. Small, medium and micro-sized enterprise (SME) The main factors determining whether an enterprise is an SME are (1) staff headcount, (2) either turnover or balance sheet total: Company category Staff headcount Turnover Balance sheet total Medium-sized < 250 < 250 ≤ € 43 m Small < 50 < 50 ≤ € 10 m Micro < 10 < 10 ≤ € 2 m Stop-the-clock procedure During the risk assessment stage, the rapporteur Member State or EFSA may request more data directly from the applicant, in which case the clock is stopped for the regulatory timetable until this is supplied. This period is a maximum of 6 months (where the rapporteur Member State triggers it) or 3 months (where EFSA triggers it). Synergist Synergists are chemicals that make the active substance in a PPP more effective. Very persistent and very bioaccumulative (vPvB) A vPvB substance is both ‘very persistent’ (i.e. the half-life in marine, fresh- or estuarine water is higher than 60 days; the half-life in marine, fresh- or estuarine water sediment is higher than 180 days; OR its half-life in soil is higher than 180 days), AND ‘very bioaccumulative’ (i.e. its bioconcentration factor is greater than 5 000). World Trade Organisation (WTO) The World Trade Organisation (WTO) is a global international organisation dealing with the rules of trade between countries.

World Trade Organisation — Sanitary and Phytosanitary Measures Agreement (WTO-SPS) The WTO-SPS is an agreement on how governments can apply food-safety and animal-and-plant-health measures. World Trade Organisation — Technical Barriers to Trade Agreement (WTO-TBT) The TBT Agreement aims to ensure that technical regulations, standards, and conformity-assessment procedures are non-discriminatory and do not create unnecessary obstacles to trade. 1.Introduction Plant protection products (PPPs), also called pesticides, are used to protect crops against pests, diseases, or competing plants with the aim of optimising food production in conventional or organic farming . 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. Because of their potentially harmful effects, PPPs 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. Harmonised regulation of PPPs also improves the functioning of the internal EU market as it enables manufacturers of PPPs to apply for authorisation according to the same rules and producers of food and feed can sell their products without barriers. It also gives people in the EU increased access to safe food produced outside their national territory. Pesticides and their residues are regulated under Regulation (EC) No 1107/2009 , hereinafter referred to as ‘the PPP Regulation’, and Regulation (EC) No 396/2005 , hereinafter referred to as ‘the MRL Regulation’ – in essence a risk management framework. The European Commission, the European Food Safety Authority (EFSA) and the Member States all play a role in the implementation of these Regulations. Based on scientific advice received from Member States and EFSA, the Commission approves active substances for use in PPPs and sets MRLs at safe levels for food and feed (including for imported products). Once an active substance is approved and its MRLs are set, Member States can authorise the use of PPPs containing the active substance in question. The Sustainable Use Directive and Regulation 1185/2009 on statistics of pesticides are additional parts of the ‘pesticide package’, which was adopted in 2009. Both these instruments help ensure a high level of protection of human health and the environment from pesticides. The European Parliament and the Council are involved in setting MRLs under the regulatory procedure with scrutiny. Both the Council and the European Parliament have addressed the issue of pesticides on several occasions in recent years. In 2016 and 2017, the European Parliament adopted resolutions on endocrine disruptors and on the active substances glyphosate and bentazone . The AGRIFISH Council of June 2016 endorsed recommendations on the acceleration of sustainable plant protection. Purpose of the evaluation The objective of the evaluation is to perform an evidence-based assessment of the implementation and application of the PPP and MRL Regulations, taking stock of the experience gained. This staff working document accompanies a report to the European Parliament and to the Council on the functioning of both Regulations . The evaluation assesses the accomplishment of the Regulations’ objectives in line with the better regulation guidelines . It covers the following five criteria: effectiveness, efficiency, relevance, coherence, and EU added value (including the potential for burden reduction, simplification and improving the delivery of the objectives). 1 1.1 Scope of the evaluation The evaluation assesses the implementation and functioning of both the PPP and MRL Regulations in all 28 Member States between their dates of application (in June 2011 and September 2008, respectively) and October 2018. The evaluation covers the essential elements of: (i) the PPP and MRL regulatory systems, (ii) the links between the two Regulations, and their implementing regulations. The evaluation also discusses the following topics for which the Commission has legal reporting obligations: ·mutual recognition of PPP authorisations and the functioning of the zonal system; ·the functioning of comparative assessment when authorising PPPs containing candidates for substitution (CfS);

·the application of the approval criteria, including the cut-off criteria; ·the effects of the provisions on data protection for studies involving vertebrate animals. The evaluation includes evidence-based conclusions and an assessment of whether, and to what extent, the Regulations have achieved their objectives. The results will be available to inform decisions on future policy actions, including potential amendments of the Regulations to improve their performance. As stated above, there are several other pieces of legislation that are relevant to this subject, but are not covered by this evaluation, namely the Sustainable Use Directive and Regulation 1185/2009 on statistics of pesticides. The implementation period for the Sustainable Use Directive for Member States ended in November 2016 and in October 2017 the Commission presented a first implementation report , which concluded that the Sustainable Use Directive offers the potential to greatly reduce the risks derived from pesticide use. However, until it is more rigorously implemented by the Member States, the improvements are limited, and certainly insufficient to achieve the environmental and health improvements it was designed to achieve. New assessments will soon begin of both the Sustainable Use Directive and Regulation (EC) No 1185/2009 on statistics of pesticides. In addition, the link of the PPP Regulation with Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures is assessed in a separate ‘fitness check’ by the Commission . Finally, the criteria for endocrine disrupting properties are not addressed in this evaluation, as the application of the criteria started on 10 November 2018 and will be subject to a dedicated assessment in the future. 2.Background Pesticides and their residues are regulated at EU level to respond to certain needs and to achieve several objectives. The PPP Regulation establishes a two-step system that reflects the principle of subsidiarity. In the first step, the active substance of a PPP 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 PPPs containing the active substance for specific uses, according to harmonised EU standards (the so-called uniform principles ) and good agricultural practices (GAPs). The Member States consider local agricultural and geographical/climatic differences when authorising PPPs. The Sustainable Use Directive provides the general rule on the use of PPPs. 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. Finally, the MRL Regulation regulates the residues that are left on crops. It does this by setting MRLs at EU level to protect all consumers, including vulnerable groups (see Figure 1 below). Figure 1. How pesticides and their residues are regulated in the EU Intervention logic The PPP Regulation was proposed after 13 years of experience gained from the application of Directive 91/414/EEC. The proposal for the MRL Regulation built on both national requirements and EU Directives that co-existed for many years. The sections below outline the needs identified and objectives of the PPP and MRL Regulations and the actions that were expected to lead to positive long-term impacts. PPPs can affect human health via direct exposure, i.e. through residues in food and occupational exposure, as well as indirect exposure through environmental contamination. Therefore, to address the need of protecting the health of operators, bystanders, workers and residents from the adverse effects of pesticides, the hazards and risks of active substances are rigorously assessed against strict approval criteria set in the PPP Regulation. Following the submission of a comprehensive data package by an applicant according to the provided requirements, a Member State assumes the role of rapporteur for the active substance. The rapporteur Member State conducts a scientific evaluation that is peer reviewed by EFSA and the other Member States. Based on the scientific evaluation by the Member States and EFSA, the Commission prepares a legal act to approve (or not) the active substance, which is discussed with and voted on by the Member States. Active substances that do not meet the approval criteria cannot be used in the EU. To promote the sustainable use of pesticides and reduce risks from the use of PPPs to human health and the environment, active substances with less problematic hazard profiles are promoted in the PPP Regulation. These substances include basic substances, which benefit from unlimited approval periods, and low-risk active substances, which enjoy longer approval and data protection periods. At the opposite end of the spectrum, particularly hazardous active substances are approved as ‘candidates for substitution’ (CfS) with shorter approval periods. When they authorise PPPs containing these more hazardous active substances, Member States must conduct comparative assessments aimed at replacing them with less hazardous active substances. In addition, the PPP Regulation introduced cut-off criteria for active substances that are: mutagenic; carcinogenic; toxic for reproduction; have endocrine disrupting properties; are persistent organic pollutants (POPs); are persistent, bioaccumulative and toxic (PBT); or are considered to be very persistent and very bioaccumulative (vPvB). Active substances that meet the cut-off criteria cannot be approved in the EU, or can only be approved under severely restricted conditions. This regulatory system should result in less hazardous PPPs being placed on the market, thereby ensuring a high level of protection of human and animal health and the environment. To keep abreast of scientific developments and the expectations of society, the Commission may review the approval of an active substance at any time. Active substances also have time-limited approvals and are periodically re-evaluated. The goal of this periodic review process is to create an up-to-date comprehensive set of data, ensure a clear division of tasks between the Member States, EFSA and the Commission, and reduce the hazardousness of PPPs on the market. In meeting these goals, the Regulation aims to create a transparent and predictable system with less administrative burden than the previous regulatory situation. The expected impacts on society of this review process are continued high levels of safety for operators, bystanders and consumers, as well as a high level of protection of the environment. Once an active substance is approved at EU level, applicants can submit applications for the authorisation of one or several PPPs containing that active substance to a Member State. To improve access to PPPs for farmers in different Member States and the functioning of the internal market, the EU is divided into three geographical zones: north, central and south. Applicants can choose one Member State in each zone to act as the zonal rapporteur. This zonal rapporteur Member State assesses the application on behalf of all Member States in the same geographical zone for which the application is intended, i.e. the concerned Member States. The zonal rapporteur Member State makes the draft registration report available to the concerned Member States for commenting, and subsequently finalises the registration report after considering the comments received. The finalised registration report then forms the basis for national product authorisations within the particular zone. Within each zone, Member States must, in principle, mutually recognise each other’s authorisations. This should enable Member States to benefit from the evaluations made by other Member States, while manufacturers of PPPs benefit by not having to submit product authorisations in each individual Member State of a zone. This is expected to reduce administrative burden, thus improving the functioning of the single market. Nevertheless, national product authorisations allow to address specific climatic, geographical or agricultural concerns. This two-step authorisation system is meant to harmonise the availability of PPPs within zones, resulting in a better functioning of the single market. The consideration of national environmental and climatic conditions should ensure a high level of protection of the environment. To address the problem of lengthy procedures under Directive 91/414/EEC, the PPP Regulation introduced strict deadlines for approval and authorisation procedures and encouraged cooperation between Member States with the aim of making PPPs timely available on the market. This would in turn help improve EU agricultural production and safeguard its competitiveness. Promoting low-risk active substances with faster market access is a way to improve the availability of such PPPs for EU farmers. The PPP Regulation includes further measures to ensure that farmers have access to PPPs in cases where they need to control a serious danger to plant health. At EU level, limited derogations are possible for the approval of active substances that meet the cut-off criteria, if the applicant has demonstrated that the active substance concerned is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods. At Member State level, emergency authorisations for non-authorised PPP can be issued for 120 days for limited use to address a danger to plant health which cannot be contained by any other reasonable means. The need to have safe food for consumers in the EU implies that PPPs should be used safely and assessed according to a predictable, trustworthy and transparent regulatory system, as described above. In addition, MRLs are set to ensure that pesticide residues on foods are safe in order to protect consumer health. When an application to authorise a PPP for a new use is submitted, the consumer risk assessment to establish MRLs is carried out in a two-step procedure: first by evaluating Member State and second by EFSA. Based on the scientific evaluation, the Commission prepares a legal act to set or amend MRLs. This legal act is then discussed with and voted on by the Member States. The result is meant to be an efficient procedure that ensures a high level of safety for consumers, including vulnerable groups. Implementation and enforcement must be efficient and consistent in all Member States. To meet these needs, and to improve the functioning of the single market, MRLs are harmonised at EU level. Food-business operators that sell their products in several Member States must comply with a single MRL, which is valid across the EU and publicly available. This reduces administrative burden, and makes relevant information readily available to users and consumers. Ultimately, these rules are expected to improve the functioning of the single market and ensure the consistent protection of consumers. Another aim of the MRL Regulation is to promote the smooth functioning of international trade and ensure that non-EU countries can export their produce to the EU. This aim is met by setting MRLs for all relevant pesticide residue-commodity combinations, including import tolerances resulting from the use of PPPs in non-EU countries. The EU benefits from facilitating trade: consumers can buy imported crops that are not grown in the EU, and there is a greater range of food products available throughout the year at a competitive price. The implementation of many actions, both procedurally and technically, is detailed in guidance documents. Guidance documents are produced by EFSA or the Commission together with the Member States. Because guidance is feeding into all areas the results and impacts are dependent on the availability of clear, commonly agreed and up-to-date guidance documents.

Finally, the identified need to minimise animal testing was addressed in the PPP Regulation by obliging industry to share data on studies involving vertebrate animals. This is expected to reduce the need to duplicate existing studies, and therefore reduce the number of animals involved. Figure 2 summarises the paragraphs above with boxes visualising: the needs identified, the objectives to be pursued, the actions taken; the outcomes produced; the general results achieved, and the impacts seen.



RELEVANCE Are the objectives of the policy consistent with the identified needs? EFFECTIVENESS Have the policies achieved the desired results and met their objectives? EFFICIENCY What is the relationship between the resources spent and the outcomes achieved? OTHER EU POLICIES Agriculture, Environment, Food Safety, Chemicals, etc. COHERENCE Do the Regulations complement or conflict with one another, with other EU legislation or with international policies? EXTERNAL FACTORS Public concern, Member State resources & capacity, International agreements, Political drivers, Technological developments. GUIDANCE DOCUMENTS EU ADDED VALUE How do the results compare with those expected if needs were addressed in other ways, e.g. nationally or internationally?

Baseline — the situation before the PPP and MRL Regulation The baseline for the evaluation is the situation before the Regulations became applicable. This baseline is different for PPPs and MRLs. However, other different points of comparison are used as described below and in section 2.3. 2.1.1.Plant protection products under Council Directive 91/414/EEC The situation in June 2011, when the PPP Regulation became applicable, is considered as the baseline for the evaluation of the PPP Regulation. The predecessor to the PPP Regulation was Directive 91/414/EEC , which laid down uniform rules on the approval of active substances and authorisations of PPPs in the EU. The system under Directive 91/414/EEC was similar to that created by the PPP Regulation: only PPPs containing approved active substances that did not pose a risk to human or animal health or the environment could be authorised. Authorisation was granted by Member States on their territory under uniform principles, and optional mutual recognition applied for the use of the same product under identical conditions. The PPP Regulation subsequently took on board these main principles and existing rules while reinforcing the approval criteria. Approval of active substances With Directive 91/414/EEC, there was a shift in the EU’s PPP regulatory system from maintaining a negative list of 17 banned active substances to maintaining a positive list of approved active substances deemed to be safe . The implementation of Directive 91/414/EEC began with an inventory of all active substances on the market in the Member States. This was followed by the establishment of four work programmes to evaluate these substances and which included calls for application. For most of the active substances in the inventory, no application or data were submitted by the industry and they thus disappeared from the market. As seen in Figure 3, this resulted in a reduction from around 1 000 active substances available in 1993 to less than 400 in 2010 . Figure 3. Number of available active substances in the EU between 1993 and 2010. Decisions on the approval of active substances under Directive 91/414/EEC were based on the outcome of risk assessments. Hazards were determined for classification and labelling purposes, but were not decisive by themselves for the approval assessment. Even very hazardous active substances could be approved. Approvals were valid for 10 years if acceptable risks were demonstrated for at least one use. To have an active substance approved under Directive 91/414/EEC, an applicant had to submit a dossier to a rapporteur Member State, which is similar to the current requirement in the PPP Regulation. The dossier had to contain the required data compiled through internationally validated test guidelines (e.g. OECD) or peer-reviewed scientific publications. The rapporteur Member State carried out the first risk assessment, compiling a draft assessment report (dRAR), which was sent to EFSA (or before 2002 to the Commission ) which performed a peer review of the assessment. Within 1 year of receiving the dRAR, EFSA had to prepare a conclusion summarising the discussions that took place in the peer review. Based on the EFSA conclusion, the Commission prepared a draft review report and draft Directive that were discussed with the Member States in the Standing Committee on the Food Chain and Animal Health. Following a vote in the Committee, the Commission adopted the Directive. The first approval of an active substance under Directive 91/414/EEC was adopted in 1997 . The approval procedure was inefficient as in 2001 (10 years after adoption of Directive 91/414/EEC), only 30 of the 979 existing active substances had completed the full evaluation procedure . In 2008, the number of evaluated and approved active substances had increased to 96, with another 186 active substances still under review. The average time from dossier submission until approval was 6 years. The preparation of the dRAR by the Member State took 27 months, and the peer-review process took between 5 and 87 months . The identified reasons for these delays were lack of resources, complexity of procedures but also the lack of incentives for industry to provide quickly additional data after submission of the dossier as PPPs could in the meantime be placed on the market through provisional national authorisations. Authorisation of PPPs

Under Directive 91/414/EEC, several types of authorisations could be granted by the Member States. These are outlined below. ·National authorisations were granted for a maximum of 10 years after the assessment of a product dossier. The assessment was made by the concerned Member State only, without the involvement of the Commission or other Member States. ·Provisional national authorisations (granted for 3 years) could be used to fast-track the introduction of PPPs containing new active substances before a decision was made on the approval of the active substance at EU level. These could be granted 2 years after submission of the application for approval of the active substance. ·Emergency authorisations could be issued temporarily by the Member States in special circumstances for a maximum period of 120 days. The use of emergency authorisations was limited to situations of an unforeseeable danger to plant health which could not be contained by other means. In 2007, there were 59 such emergency authorisations in the EU; in 2008 there were 63; in 2009 there were 107; and in 2010 there were 321 . ·Mutual recognition of authorisations was optional for products already authorised in another Member State if applied for under identical conditions, but this provision did not work. Only three Member States applied mutual recognition to a significant extent. Member States often requested additional data or required the repetition of efficacy trials. This resulted in many Member States investing almost as much time in mutual recognition evaluations as in national authorisation evaluations . Under Directive 91/414/EEC, the market for PPPs in the EU remained fragmented. The number of authorised PPPs in the Member States varied from a few hundred to more than 4 000. Unauthorised cross-border sourcing of PPPs was also a major problem: 17 of 22 Member States that answered to a survey reported problems with unauthorised imports or use; 3 Member States had minor problems; and only 1 Member State had no problems before 2006 . As Directive 91/414/EEC was transposed into national legislation, the processes, timelines and authorisation fees varied between Member States. According to the timelines in the Directive, getting a product authorised should have taken between 1 and 2 years. But in practice, depending on the Member State, the actual time for evaluating applications for authorisations was between 1 and 4 years . Fees for the evaluation of applications for new active substances ranged between EUR 23 100 and EUR 450 000, with most Member States charging more than EUR 100 000. Fees for the authorisation of new PPPs ranged between EUR 10 000 and EUR 240 000, with most Member States charging more than EUR 50 000 . An impact assessment calculated the annual administrative burden of Directive 91/414/EEC for the EU-25 in 2005 at EUR 23 million . Data protection, data sharing and animal testing Provisions in Directive 91/414/EEC on data protection and data sharing for active substances caused several problems, both for Member States and applicants. The level of data protection granted depended on the status of the active substance and on when decisions were taken in the Member States. The data protection rules presented a particularly serious obstacle for generic competition (i.e. products no longer protected by patents). The market share of generic companies was low in most EU Member States, and in several Member States the approval of an active substance led to a reduction in generic competition because of data protection rules . Directive 91/414/EEC established rules on data sharing to avoid duplication of testing on vertebrate animals. Applicants were required to inquire with the Member States whether relevant experiments involving vertebrate animals had been already submitted and evaluated in earlier product authorisation applications. The applicant then had to reach an agreement with the existing authorisation holder so that the Member State concerned could use the data. If no such agreement could be reached, the Member State could, at its own discretion, introduce national measures to oblige sharing of the data within their territory. However, Directive 91/414/EEC did not oblige Member States to introduce these measures. Court cases Under the period of application of Directive 91/414/EEC, from 1991 to 2011, 21 court cases were initiated, mostly by industry. Almost all the cases related to the process of approval of active substances, and in particular contested the Commission’s decision based on the outcome of the risk assessment. Except for 2 cases , the outcomes were favourable for the Commission. See Annex 5 for an overview of all court cases. The PPP market In 2004, the global PPP market was valued at EUR 24.7 billion of which the European market share amounted to EUR 6.8 billion (27.4 % of the total) . At this time, the producers of agrochemicals could be separated into three main groups, as detailed below. ·Multinational companies: Following a consolidation wave between 1984 and 2003, the ‘big six’ multinational companies held 75 % of the global agrochemical market and 81% of the EU market. ·Smaller research-based companies: A number of medium-sized companies held 7% of the EU market in 2004. ·Generic manufacturers : Generics are non-patent-protected products, and represented two thirds of sales globally. However, a large share of non-patent-covered products were sold by multinational companies. Innovation was an important driver of growth in the global agrochemical market. However, only the multinational companies had a significant capacity to develop new active substances. Between 2005 and 2008, the average cost of discovery and development of a new plant protection product was estimated at EUR 189 million, including EUR 15.5 million fees for the approval and authorisation processes. In 2004, industry observers noted a decline in research and development activity in PPPs. This was illustrated by the declining rate of submissions of applications for the approval of new active substances in the EU, which between 1994 and 2004 decreased to 5-10 per year from an earlier average of 15-20 per year .

By 2004, biotechnology was the fastest growing segment of the global crop-protection market. In response, some of the multinational companies began to dedicate an increasing share of their research and development effort into this area, and decreased their investment in traditional PPP portfolio development . Pesticide sales fluctuated between 1994 and 2006, with an average of around 350 000 tonnes of active substances sold per year (the data covers 20 countries that are EU Member States in 2018) . For example, in 1995, 330 000 tonnes of active substances were sold, and in 1999, 377 000 tonnes were sold demonstrating that the volumes could fluctuate between the years. From Directive 91/414/EEC to the PPP Regulation The PPP Regulation was proposed after 13 years of experience gained from the application of Directive 91/414/EEC. Considering the scientific and technical developments, it appeared that the basic approach of Directive 91/414/EEC was still acceptable but that the system was overloaded and inefficient . To increase efficiency, corrective measures and new policy actions were proposed in the PPP Regulation. These are listed in the bullet points below. ·National provisional authorisations of not yet approved new active substances duplicated efforts in Member States, increased differences in the availability of PPPs between Member States and decreased incentives for industry to provide timely additional data requested to finalise the approval procedure. They were therefore removed in the PPP Regulation. ·The optional mutual recognition of authorisation of PPPs was only applied in rare cases. This led to a duplication of work and fragmentation of the single market for PPPs. The PPP Regulation introduced a zonal system and, in principle, mandatory mutual recognition within zones, thus encouraging cooperation and work sharing between Member States. The Regulation sets out three zones on the basis of similar climatic and agricultural conditions. For climate-independent uses (e.g. indoor uses, seed treatment) the zonal partition does not apply. ·To further protect human health and the environment the cut-off criteria in the PPP Regulation were introduced to increase the stringency of the approval criteria for active substances. ·To further minimise the risks to health and environment, the PPP Regulation sets out a list of active substances that are ‘candidates for substitution’ with shorter approval periods. When evaluating a PPP containing an active substance that is a candidate for substitution, Member States must conduct a comparative assessment to see if the PPP can be replaced with a safer alternative. ·The PPP Regulation harmonised the rules on data protection to facilitate competition by companies selling generic PPPs. 2.1.2.A patchwork regulatory system for MRLs of pesticides The situation in September 2008 when the Regulation came into force is the baseline for the evaluation of the MRL Regulation. Before 2008, there was a dual system in place for MRLs in the EU: Member States could set national MRLs, but some MRLs were set at EU level through a number of Directives . These Directives established EU MRLs for fruit and vegetables, cereals, foodstuffs of animal origin, and other plant products. Between 1976 and 2008, more than 45 000 EU MRLs were set for 245 pesticide residues in 190 commodities. However, these EU-level MRLs represented only a small subset of the MRLs that were set at national level (around 500 000) - there were more than 1 000 active substances on the market and national MRLs covered a larger range of commodities. The Directives setting EU-level MRLs were substantially amended several times. These amendments were transposed differently into national legislation by Member States. Moreover, minor crops were not always listed in the Directives, which led to legal uncertainty about the applicable MRLs for those crops. In view of the number of active substances which had been withdrawn under Directive 91/414/EEC in the early 2000s, a practical solution to this uncertainty had to be found to permit realistic enforcement action on MRLs. Reports from annual monitoring carried out in the EU showed that the number of analysed samples increased from around 41 000 samples in 1996 to 65 000 samples in 2006. The compliance rate was high, with 54 % of samples free of quantifiable residues, an additional 42 % of samples within legal limits, and 4 % of samples with residues exceeding the legal limits in 2006. The reports covered the national situations for pesticide-residue monitoring in EU Member States and three European Free Trade Association (EFTA) states . From a patchy regulatory system to the MRL Regulation The Commission carried out a series of audits in the Member States between 1998 and 2003 and between 2003 and 2006 to evaluate the control systems in place for pesticide residues. The main findings are set out in the bullet points below. ·In general, the control system for pesticide residues was better developed than the control system for placing on the market and use of PPPs. ·The fact that MRLs were not harmonised for all the pesticide residue-commodity combinations caused some problems with compliance in Member States. ·There was great variance in the planning, priorities and scope of monitoring programmes. Sampling deficiencies were also found. One of the weakest points in the residue area was in follow-up and enforcement where non-compliance with MRLs had been found. In some Member States, no or only limited enforcement action was taken, and there was a long delay between sampling for analysis and reporting of the analytical results. In the proposal for the MRL Regulation presented in 2003 , the Commission identified several reasons that justified the introduction of the Regulation. These reasons are set out in the bullet points below. ·For simplification and clarity, and to improve consistency with Directive 91/414/EEC, a single Regulation would replace the earlier Directives.

·The Regulation was needed to define the role of EFSA and separate responsibilities in the areas of risk assessment and risk management. ·A practical solution was needed for the enforcement of MRLs for the active substances that were withdrawn under Directive 91/414/EEC. ·All existing MRLs needed to be harmonised at EU level and set on the basis of: (i) data on national diets, (ii) the authorisations granted by the Member States, and (iii) their agricultural practices. In exceptional cases, MRLs could be set on the basis of monitoring data. ·There was a need to recognise that different agricultural practices outside the EU led to different residue levels on imported products. This meant there was a need to set import tolerances for imported products provided they were safe for consumers. ·The workload for pesticide residues was expected to increase, and the existing legislation did not provide a basis to recover costs. A framework within which Member States could set fees for the evaluation of dossiers was desirable. Baseline — other points of comparison To complement the historical comparison, this evaluation will in a few places compare the MRL Regulation and PPP Regulation with other regulatory systems. The regulatory system for review of pesticide registration in the United States The United States has unlimited registration periods for active substances but has a re-registration process to review active substances to ensure that they meet current scientific and regulatory standards. The United States Environmental Protection Agency (EPA) assesses both the active substances and the products containing it in one step . The EPA is both the risk assessor and risk manager, which is different from the EU where there is a clear division between the risk assessors and risk managers . To initiate a review of an active substance, the EPA establishes a ‘public docket’, which is open for public comment for at least 60 days. The docket contains a preliminary work plan with: (i) facts about the pesticide and its use, (ii) the anticipated risk assessment, (iii) the anticipated data needs, and (iv) an estimated timeline for the review. Anyone may submit data or information to the public docket, and based on the information received, a final work plan is developed. The EPA then holds focus meetings, which typically involve registrants and other players such as NGOs. Focus meetings are intended to address any areas of uncertainty, such as unclear labels or missing studies. By obtaining better information early in the process, the EPA claims that it can narrow the scope of pesticide re-evaluations to areas that pose real concerns. The EPA then assesses any changes that have occurred since the last registration decision to determine whether the pesticide still satisfies the standard for registration or if a new risk assessment must be conducted. If a new assessment of the pesticide is needed, the EPA determines if they need new data or information. If additional data or information are needed, the EPA will issue a ‘data-call in’ notice to the registrants. The EPA then makes the draft risk assessment available for public review. If risks are identified, the public is invited to submit suggestions for mitigating the risks. Finally, the EPA decides whether a pesticide meets the standard for registration. In 2007, the median time for the re-registration process was 30 months and the average 54, i.e. some assessments were relatively straightforward while others required considerable resources. In 2019, the review of an active substance was reported to take on average 6 years. The regulatory system for review of pesticide registration in Canada In Canada, re-evaluations of PPPs must be initiated no later than 16 years from the last major regulatory decision. This is to ensure that all pesticides continue to meet the health and environmental safety standards. Each re-evaluation process takes about 2-4 years depending on the complexity and the implementation of the decision (e.g. amendments to product label) may take another 2-3 years. The number of re-evaluations that the Canadian authorities is required to initiate is increasing: there are currently 125 re-evaluations ongoing and 145 re-evaluations are anticipated in the next 5 years. This is double the number of initiations compared to the previous 5-year period. The Canadian authorities have noted that the scale and complexity of re-evaluation reviews continue to increase. The main issues identified are (1) a continuous stream of new data being generated which needs to be considered; (2) multiple data providers with varying quality of information; (3) increased expectation for stakeholder engagement; and (4) users, registrants, public, health/environmental groups have opposing positions. The EU Biocidal Products Regulation The Biocidal Products Regulation regulates pesticides used for non-agricultural purposes in the EU . The Biocidal Products Regulation and the PPP Regulation are both built on a two-step approach, where active substances are first approved at EU level. However, the second step differs in the two Regulations. For the PPP Regulation, products containing the approved active substances are authorised by Member States. For the Biocidal Products Regulation, biocidal products containing the active substances are in most cases also authorised by Member States but can also be authorised at EU level by the Commission for certain products which have similar uses across the EU, e.g. hand disinfectants, and can then be placed on the market in all Member States. The Biocidal Products Regulation provides for the risk assessment to result in a single opinion by the Biocidal Products Committee in the European Chemicals Agency (ECHA). In general, the opinion is adopted ‘by consensus’, which means unanimous support by the Member States experts in the Biocidal Products Committee. Consequently, most of the decisions on the approval of active substance proposed by the Commission were unanimously supported by the Member States in the Standing Committee on Biocidal Products. For new biocidal active substances, the procedure for approval takes on average 44 months. The Biocidal Products Regulation provides for a coordination group to facilitate authorisations through mutual recognition by resolving disagreements between Member States. In the Biocidal Products Regulation, it is also possible to request the authorisation of a group of similar products via one application. 3.Implementation / State of Play This section describes the current situation in the EU. The MRL Regulation and PPP Regulation have been applicable since September 2008 and June 2011, respectively. The vast majority of the measures and activities provided for in the Regulations are in place, such as: the data requirements for active substances and products ; the uniform principles for authorisations ; the labelling requirements ; the renewal Regulation ; criteria to define endocrine disruptors ; a list of potential low-risk active substances ; and five work programmes for renewals . In addition, to detail and clarify the implementation, there are 39 procedural guidance documents and 49 technical guidance documents . Additional guidance documents are also under development. Some provisions in the PPP Regulation have not been fully implemented. Work is ongoing to identify unacceptable co-formulants. A work programme should be created to review safeners, synergists and adjuvants. However, this work has not yet started.

Parts of the MRL Regulation are not yet implemented. Work has not yet started on drawing up a list of harmonised concentration or dilution factors for certain processing and/or mixing operations. Nor has work begun on drawing up specific MRLs for processed products, feed and fish. The development and application of a methodology to take into account cumulative and synergistic effects of pesticides is still ongoing. The evaluation focusses on the effectiveness of the implemented aspects of the PPP and MRL Regulations. Discussed is also the progress made to date and, to the extent possible, how the missing elements impact the overall effectiveness of the system. Societal and political developments In recent years, there has been growing public and media attention on the way food is produced. Europeans are paying greater attention to the topic of pesticides for both health and environmental reasons. The European Citizens’ Initiative on glyphosate, which collected over 1 million signatures across Europe in less than 9 months in 2017, is an example of this increasing societal interest. The European Citizens’ Initiative called for a ban on glyphosate, and for more transparency in the process for assessing pesticides. It also called for a reduction in the use of PPPs, with the ultimate goal of a pesticide-free future. In the run-up to the renewal of the approval of glyphosate, the European Parliament adopted two Resolutions in April 2016 and October 2017 . After the renewal, the European Parliament created a special committee on the EU pesticides authorisation procedure (PEST). This special committee had a mandate to analyse and assess the procedure for placing PPPs on the EU market and identify potential failures in the process. The Parliament adopted the final report of the Committee in January 2019. In addition, the European Parliament adopted in September 2018 a report from the Environment Committee on the implementation of the PPP Regulation . Citizens and their political representatives have repeatedly called for more transparency in the procedures leading to the placing on the market of PPPs — be it at the risk assessment stage or at the risk management stage. This led the Commission to adopt in April 2018 a proposal on the transparency and sustainability of EU risk assessment in the food chain . The content of the proposal is described in a text box in section 5.1.8. This amendment of the General Food Law has been adopted by the Council and the European Parliament on 13 June 2019 and will become applicable in March 2021. At international level, the EU strict approach to pesticides is often criticised by a number third countries who argue that certain aspects of the EU legal framework and practice are not in line with the WTO SPS Agreement and are too restrictive. There is a growing tension between the expectations of European consumers that imported food should not contain pesticides that are not approved in the EU and the international commitments of the EU, in particular in the context of the WTO. At the same time, there is criticism from within the EU that MRLs are set for non-approved active substances, which allow imports of products treated with active substances that are not available to EU farmers, thus negatively affecting the competitiveness of EU agriculture, as well as the environment in third countries. The PPP market In 2016, the six largest agrochemical firms reported global agrochemical sales of EUR 32 billion . In Europe, the crop-protection market generated revenues of EUR 12 billion in 2016 . Since 2016, the ‘big six’ firms have consolidated further, following three global mergers of Syngenta and ChemChina; Dow and Dupont; and Bayer and Monsanto. Together with BASF, these multinational companies are now the ‘big four’ . There are also a number of smaller research-based PPP companies (see page 11), and generic manufacturers, i.e. for non-patent-protected products. In 2014, the discovery and development of a new plant protection product was estimated to cost EUR 250 million and to take about 10 years . Globally, biotechnology continues to play an important role, as demonstrated by the Bayer/Monsanto merger in which Monsanto’s biotechnology portfolio was combined with Bayer’s more traditional PPP portfolio. Sales of pesticides were reported to be relatively unchanged between 2011 and 2016, with around 350 000 tonnes of active substances sold per year . Based on the limited data provided by Member States, most active substances contained within PPPs marketed in the EU are manufactured abroad. Increasingly, formulation which is the mixing of PPPs, is also moving to non-EU countries. There is also a lot of trade within the EU, so most PPPs are not used in the Member State in which they are actually imported or manufactured . Approval of active substances As of December 2018, 484 active substances were approved in the EU . This is a 15 % increase compared to 2011. In some cases, one approval decision covers several individual substances, so the number of approval decisions for these substances was around 430 . Active substances currently approved under the PPP Regulation have been subject to different approval criteria depending on when they were approved or when the application for approval was submitted. These differences are discussed in the bullet points below. ·Active substances approved under Directive 91/414/EEC were deemed to have been approved under the PPP Regulation. These active substances have then been reviewed under one of the renewal programmes. Some active substances in this category fall under the cut-off criteria. However, the cut-off criteria will only impact the approval status of the active substances at the time of renewal of approval. ·New active substances for which applications had been submitted under Directive 91/414/EEC (i.e. before June 2011), but approved under the PPP Regulation were subject to the approval criteria in Directive 91/414/EEC. ·Active substances are reviewed and assessed according to the updated data requirements that came into force in 2013. If approval is renewed, the active substances are in most cases approved for another 15 years. As of December 2018, 68 renewal procedures have been completed. For 53 active substances the approval has been renewed, and for 15 active substances the approval has not been renewed. In addition, 72 active substances approved earlier are no longer supported by any company at EU level under the AIR 3 and AIR 4 work programmes. ·New active substances for which approval has been sought under the PPP Regulation must meet the strict approval criteria set out in the Regulation. Dossiers for these substances must be submitted according to the updated data requirements. Since June 2011, applications for 69 new active substances have been submitted. The rapporteur Member States for these applications have mostly been France, the Netherlands and the UK (France was rapporteur Member State for 16 applications, the Netherlands for 14 and the UK for 12). Table 1 provides an overview of the number of new active substance applications received per year: of the 69 applications between 2011 and 2018, 26 have been approved. New active substances can be new innovative active substances never before placed on the market in the EU. New active substances can also be active substances that were previously not approved in the EU or that were withdrawn from the market under Directive 91/414/EEC and for which the applicant is making a new application under the PPP Regulation.

Year 2011 2012 2013 2014 2015 2016 2017 2018 New active substance applications 4 8 12 6 15 10 4 10 Authorisation of plant protection products The number of PPPs authorised varies between Member States. For instance, in 2016 there were 134 in Malta, 322 in Sweden, 753 in Germany, 1 825 in France, 3 300 in the UK, and 4 200 in Italy . The number of products available in a particular Member State somewhat correlates with the size of the Member States, the size of their agricultural sector, and their climatic conditions. Setting and reviewing MRLs When the MRL Regulation came into force in 2008, temporary MRLs were set for all pesticide residue-commodity combinations previously covered by national MRLs. EFSA carried out a preliminary risk assessment of those temporary MRLs on the basis of the information provided by Member States . The MRL Regulation requires a review of all existing MRLs for active substances 1 year after their initial approval or non-approval. MRLs for substances that were already approved at the time of the implementation of the Regulation must also be reviewed. This includes a review of existing import tolerances and Codex Limits (CXLs). The timeframe for this review (i.e. 1 year) was overly ambitious, in particular because the Regulation did not set out a procedure on how the review should work in practice (resources, responsibilities, etc.). Therefore, Member States, the Commission and EFSA agreed on an ad-hoc procedure under which Member States provide support to EFSA to share the workload. In spite of this effort, the MRLs of only about half of the substances have now been reviewed. Part of the initial delay can be attributed to the need for the development of a new procedure. After a Member State revokes an authorisation for a PPP, the Commission may prepare a draft measure to delete the relevant existing MRLs. In practice, the Commission only makes use of this procedure when all existing authorisations for PPPs containing a specific active substance have been revoked (e.g. following non-approval or non-renewal). Provided they are judged safe for EU consumers, MRLs corresponding to CXLs based on uses in non-EU countries are not deleted, nor are MRLs that had been specifically set as import tolerances. As a result, MRLs are either set to a default value of 0.01 mg/kg, or, where specific data on analytical feasibility are available, they are set to the relevant limit of quantification (LOQ) of the active substance. The EU reference laboratories for pesticide residues are consulted on the appropriate LOQ and residue definitions to be used for enforcement purposes. In exceptional circumstances, a lower level than the default can be set for substances with high toxicity. As the lowering of MRLs affects trade, WTO members must be consulted under the SPS agreement . Since 2008, more than 1 000 applications were submitted to Member States to set or review MRLs, either for uses in the EU or to set import tolerances (see Table 2). Currently, 486 approved and 247 non-approved substances are covered by the MRL Regulation, which sets 190 000 MRLs . Note that for 130 active substances, no MRLs are required, because of their low-risk profile or because they naturally occur in the environment and are considered safe. Procedure Applications Setting of MRLs 518 Setting of import tolerances 94 Review of MRLs 487 Public information, risk communication and transparency Access to information has been built into the risk assessment and risk management processes. Efforts have been made to ensure that relevant information can be accessed easily and in a timely manner. The EU Pesticides Database provides data on the status of all active substances and on all MRLs. The plant protection products application management system (PPPAMS) currently being developed by the Commission aims at increasing transparency on authorisations granted in the Member States. It also aims at facilitating the implementation of mutual recognition and parallel trade permits. Since July 2016, Member States have accepted to notify emergency authorisations only within the PPPAMS. To populate the PPPAMS and create a public website, the Commission is currently working with Member States to collect data on all existing authorisations held in national databases. Enforcement and monitoring Member States are required to perform official checks to verify compliance with the PPP and the MRL Regulations. In addition to the general obligation laid down to this effect in Regulation (EC) No 882/2004, which requires Member States to plan and perform official controls at all stages of the agri-food chain, special rules are also laid down in the PPP and MRL Regulations . For the MRL Regulation, checks consist mostly of: (i) an EU-coordinated programme of sampling and analysis, the results of which are reported to EFSA on an annual basis, and (ii) risk-based official controls planned at national level, the results of which are also reported to EFSA along with the enforcement actions taken. Under the EU-coordinated programme, the Commission and the Member States agree every year on the number of samples (approximately 80 000) to be taken that are representative of ‘the residue situation of food products available to consumers’. They also agree on the active substances to be analysed. These two measures ensure the adaptability of the programme to cover those pesticides of high interest. Together with other relevant information, the results of the EU-coordinated programme are also used to determine whether increased levels of import controls are required on certain products . For the PPP Regulation, Member States monitor and control the manufacturing, import, distribution and use of PPPs. They also send annual reports to the Commission to inform about the activities they have carried out. Since 2011, the Commission has conducted several series of audits in Member States . These audits have focused on how Member States organise their official controls and other official activities in this area (e.g. the controls of PPPs, official laboratories and sampling methods, the authorisation of PPPs). Further enforcement action to detect counterfeit and illicit PPPs is taking place through coordinated measures supported by Europol and the European Anti-Fraud Office through the Silver Axe joint operation. Some significant changes have recently been introduced to strengthen enforcement of the PPP Regulation by the Member States. These changes include: ·a new obligation for national enforcers to perform dedicated official checks aimed at identifying possible fraudulent and deceptive practices, including in imported products;

·explicit powers for national enforcers to inspect the production chain ‘upstream’ (including manufacturing, transport distribution of substances and products) and take remedial action in the event of established violations; ·strengthened rules for cross-border cooperation if fraudulent products move from one Member State to the other; ·strengthened penalties for fraud; and ·the possibility for the Commission to adopt specific rules to govern official controls and other enforcement activities in this area. Court cases and complaints Since 2011, 25 court cases related to PPPs and MRLs have been initiated by industry and NGOs against the Commission. The cases are not only about approval or non-approval decisions of active substances. They also deal with: restrictions of approvals, internal reviews under the Regulation implementing the Aarhus Convention, the inclusion of active substances in the list of candidates for substitution, and requests for interim measures to suspend the action that is subject to the court case. Industry most often challenges the Commission’s decisions on active substances based on arguments related to the risk assessment and procedural rights . A comprehensive analysis of the outcomes cannot be performed at present as more than 50 % of the cases are still pending . In addition, 4 complaints to the Ombudsman have been made both by industry and NGO’s. These complaints relate to: (i) the Commission’s practice of approving an active substance while simultaneously requesting data confirming its safety ; (ii) the Commission’s practice of extending the approval periods of active substances; (iii) the Commission’s compliance with rules on the approval of active substances, including whether MRLs for new active substances should be set after approval of a substance or before ; and (iv) the Commission’s response to 18 applications for access to documents . A complete list of court cases and complaints to the Ombudsman is provided in Annex 5. 4.Methodology The roadmap for the REFIT evaluation was published in November 2016 and this Staff Working Document answers the questions posed in the roadmap. Feedback on the roadmap was received from 21 stakeholders and taken into consideration when drafting the terms of reference for the external support study. The final report of a study commissioned to an external contractor was published on 18 October 2018 (and is referred to elsewhere in this report as ‘the support study’). The REFIT evaluation was supported by an inter-service steering group with representatives from relevant Commission DGs (see Annex 1 on procedural information). More information on the support study and methodology can be found in Annex 3. In addition to the support study, several other reports and studies have been published recently on the implementation of the PPP Regulation and the functioning of the regulatory system for pesticides in the EU. These publications are listed in Annex 1 and have been carefully considered in the analysis. Data collection The Commission drew up a consultation strategy together with the terms of reference for the support study in order to collect stakeholder perceptions and quantifiable data. This quantifiable data included the costs for preparing a dossier for approval and renewal, and the number of full-time staff equivalents working with the PPP and MRL Regulations. A literature review was carried out to gather key information from: impact assessments; position papers; academic and scientific research; papers and reports prepared by relevant scientific bodies; and regulatory submissions. Stakeholders contributed to one or several consultations, as planned in the consultation strategy (see Table 3). These stakeholders included: public authorities in the Member States; EFSA; the Commission; the pesticides industry; the food industry; NGOs for environment, health, protection of animals and transparency; consumers, citizens and farmers; and authorities and other stakeholders from non-EU countries. Despite efforts to get their contribution, only three respondents from the research community participated in the stakeholder survey. A summary of the views collected in the consultations is provided in the synopsis report on the stakeholder consultation in Annex 2. The Commission set-up a webpage to inform the public about the REFIT evaluation in general and the consultation activities in particular . Consultation Target/participants When? Contributions Open public consultation Consumers, citizens and farmers. 13 Nov 2017 - 12 Feb 2018 9 847 SME consultation panel Distributed via the Europe Enterprise Network to target small, medium and micro-sized companies. 14 Nov 2017 - 15 Jan 2018 294 Stakeholder survey Trade and industry associations covering the chemical industry; retailers and wholesalers; the food and feed industry; environmental, health and consumer NGOs; farmers’ associations. 14 Nov 2017 - 12 Jan 2018 240 Member State survey Member States and European Economic Area (EEA) countries. 16 Nov 2017 - 19 Feb 2018 30 Focus groups Member State authorities, EFSA, the Commission, stakeholders working with risk assessment. 24 Jan 2018 28 Feb 2018 5 Mar 2018 9 Mar 2018 8 9 7 8 First Workshop Member State authorities; the Commission; trade and industry associations; NGOs at EU level. 12 Sep 2017 40 Second Workshop Member State authorities; the Commission, trade and industry associations; NGOs at EU level. 16 May 2018 50 In-depth interviews Trade and industry associations, NGOs at EU level, Member States, non-EU countries, EFSA, the Commission. 10 Jan 2018 - 25 Apr 2018 60 Limitations and robustness of findings The following shortcomings and challenges limit the analysis. ·The Regulations are still at a relatively early stage of implementation, with some provisions still to be implemented. This is especially the case for the PPP Regulation as it takes a long time to evaluate each active substance. All active substances or MRLs have not yet been reviewed, so the evaluation will not capture all the impacts or expected benefits from the Regulations. ·It is difficult to quantify the benefits of the Regulations. This is due to attribution problems and a lack of studies establishing a causal link between the use of single pesticides or specific MRLs and health or environmental outcomes. Data on the use of pesticides also do not exist in a harmonised way in the EU, and quantities alone do not necessarily reflect risk, given that each substance has a particular hazard profile and some more recently introduced active substances have a more ‘specific activity’ affecting less non-target organisms. This limits the assessment of how effective the MRL and PPP Regulations are in protecting human health and the environment. An additional limitation is that most scientific publications rely on old data and consider effects from already non-approved active substances. They are therefore of little use in this evaluation, which focuses on impacts after 2008 and 2011, respectively. Better health and environmental information could be obtained through more and better targeted monitoring and controls. Health and environmental impacts could be investigated through research projects and epidemiological studies. Further inclusion of pesticides in human biomonitoring (such as HBM4EU) could be considered. Possible solutions to collect use data are: new technologies such as intelligent application equipment that directly transmits the data or remote sensing by satellite (e.g. via Copernicus).

·Despite efforts to collect data on costs through surveys and specific queries (in addition to Eurostat data and other publicly available data), it was not always possible to fill data gaps. Therefore, cost estimates should be considered only as an approximation of the costs incurred by the different stakeholders. Better cost data could be collected by systematically requiring applicants to submit cost figures as part of their application dossiers. Member States could keep better records of the time and resource costs. ·Farmers were consulted as part of the public consultation, and efforts have been made to analyse the answers given by farmers in the part of the survey that contained an open question in which they were free to write at length. ·Data from Regulation 1185/2009 on statistics of pesticides could only be used on an aggregated level due to confidentiality restrictions set in the Regulation by the European Parliament and the Council. This restricted the possibility of assessing the impacts of approval decisions on use patterns in the EU, and such analysis is therefore omitted. ·It has not been possible to distinguish the effect on human health and the environment of the approval of an active substance from the authorisation of the PPP containing that active substance. This is because of the difficulty in disentangling the impact from the two processes, as an active substance is only released into the environment in the form of a PPP. Despite these limitations, the evaluation relied on, as described above, an extensive literature review and data collection through desk research. The wide stakeholder consultation made it possible to collect the opinions of many stakeholders. To ensure the reliability of the data collected, different sources of data were compared, and opinions from stakeholders were examined against other evidence (i.e. triangulation) as much as possible. 5.Analysis and answers to the evaluation questions Effectiveness ØTo what extent have the objectives been achieved as a result of the implementation of the PPP and MRL Regulations at both EU and at Member State level? ØWhere expectations have not been met, what factors have hindered their achievement? ØWhich unintended effects were observed? ØDid other factors influence the results observed? MAIN FINDINGS The Regulations are to a large extent effective in protecting human health. The number of highly hazardous active substances is low in the EU and will decrease in the future, while the proportion of low hazard active substances is increasing albeit slowly. The level of compliance with MRLs is high showing that the food available to consumers is safe. Although the Commission has not yet made use of the possibilities given by the MRL Regulation to establish specific MRLs for certain product groups (fish, feed, processed foods) as well as a harmonised processing factors, this has not decreased consumer protection. Developing a method for cumulative risk assessment for residues is still on-going as it turned out to be much more complex and require more resources than initially envisaged. The protection of human health is expected to improve in the coming years when the review programmes for active substances and MRLs will be finalised. Less progress has been made in the development of methodology for the cumulative risk assessment of active substances under the PPP Regulation. The approval criteria in the PPP Regulation are effective in protecting the environment. Monitoring shows a reduction in the contamination of surface water by certain individual pesticides, although the monitoring data available do not cover all pesticides used. The restrictions on active substances with negative impacts on pollinators should contribute to their protection. However, increased monitoring would make it possible to assess the effectiveness of the PPP authorisation in more detail, and to identify illegal uses that may pose a threat to the environment. Enforcement of the Regulations varies between Member States and this negatively affects overall effectiveness. It is estimated that illegal and counterfeit PPPs represent around 10 % of the EU market, which is a concern as this may decrease the level of protection of human health and the environment otherwise achieved by the PPP Regulation. The MRL Regulation ensures that effective and timely enforcement action can be taken, however some problems have been experienced in practice, in particular with substances coming from multiple sources. The Regulations have overall improved the functioning of the single market, in particular the harmonisation of MRLs. The zonal system created with the PPP Regulation is not working as well as expected. The lack of cooperation between Member States and lack of harmonisation between national requirements decreases effectiveness. In some cases the MRL Regulation was found to lack flexibility to provide quick responses to newly emerging issues, such as unexpected findings of pesticides residues in food and residues as a result of emergency uses to address plant health risks. More information on the relationship between the use of different PPPs and agricultural productivity is needed in order to fully assess the PPP Regulation’s impact on the competitiveness of EU agriculture. Farmers and food-business operators expressed concern about more active substances being taken off the market in the future and not being replaced by sufficient low-risk active substances. This would limit farmers’ choices related to resistance management and the handling of pest outbreaks. The setting of MRLs has contributed to the smooth functioning of international trade. However, when MRLs are decreased, the length of the procedure for setting import tolerances may create barriers to trade.



5.1.1.Protecting human health

Approval criteria for active substances The approval criteria in the PPP Regulation, which are underpinned by the precautionary principle, are frequently referred to as the most stringent in the world. As seen in Figure 3 in section 2.1, the number of active substances placed on the market in PPPs decreased by more than 50 % under Directive 91/414/EEC. This means that the level of protection of human health was already increasing before the PPP Regulation came into force. With the PPP Regulation, active substances have been reviewed against the strengthened approval criteria to further increase the protection of human health in the EU. When the PPP Regulation became applicable in 2011, there were 427 active substances available (see Table 4). On 31 December 2018, there were 484 approved active substances in the EU, a slight reduction compared to 2017 because of a number of recent non-renewals of approvals. The increase in available active substances between 2011 and 2018 is due to new active substances, for which applications for approval were submitted mostly still under Directive 91/414/EEC. Year 2011 2012 2013 2014 2015 2016 2017 2018 Total approved active substances 427 432 443 467 483 490 494 484 of which basic substances 3 9 12 18 20 of which low-risk active substances 3 7 11 13 of which candidates for substitution* 1 5 8 10 *This refers only to the active substances approved as candidates for substitution and listed in Annex E to Regulation 540/2011 Since 2011, the renewal process has been initiated for all approved active substances and finalised in 68 cases. A first full cycle should be finalised by 2025 . Only when all approved active substances have been re-assessed against the current criteria will it be possible to fully assess the impact of the PPP Regulation on the number of active substances and their toxicological profile — and by extension the positive effect on human health. The decisions to not approve, not renew the approval, or withdraw 22 active substances because of health-related concerns has contributed to avoiding serious health risks in the EU. Potential hazards such as genotoxicity, long-term toxicity, carcinogenicity and reproductive toxicity have been reduced for consumers, operators, workers, bystanders and residents . Even if some benefits are evident, it remains challenging to assess the impact of the PPP Regulation on human health because of the difficulties of linking exposure to a single active substance with a certain health effect. Only one relevant scientific study was found: it used data from 2003 to assess the health impact and damage cost of pesticides in the EU . This study found that 13 active substances contributed to 90 % of overall health impacts. Only 3 of these 13 active substances are still on the market in the EU and they are currently being re-evaluated. The study concluded that, although it was possible to partially assess health impacts, more detailed statistics on PPP use are required to make a full assessment and to evaluate pesticide policy measures. The study discussed above demonstrates that it is possible to link health impacts with individual active substances, even if results are uncertain as they rely on a series of assumptions. Regardless, the study’s findings imply that the PPP Regulation has contributed to reducing adverse health effects in the EU. No other study was found that used more recent data and linked active substances used in the EU with health effects. To further assess the effectiveness of the PPP Regulation as regards protecting human health, the following discussion in this section provides an overall picture of the hazard profile of active substances on the market in the EU. To visualise the trend towards using less hazardous active substances, all active substances approved in the EU since 2011 have been mapped according to their hazard classification and divided into three groups: low hazard, intermediate hazard and high hazard. Figure 4 compares the toxicological profiles of approved active substances for 2011, 2018 and a projection for 2022 (made by removing all active substances that are no longer supported at EU level ). The proportion of less hazardous substances used is increasing, and there is a small decrease in the proportion of more hazardous substances. Note that this comparison of the hazard profiles of active substances only considers the number of active substances and does not take into consideration the actual volume of PPPs used, nor their specific activity, as such data are not readily available and would be difficult to collect in the EU. As a second best option, data on pesticide sales could have informed the analysis. However, due to confidentiality restrictions, data on sales of individual active substances collected under Regulation 1185/2009 were not available . By the end of 2022, the number of active substances will have decreased as the approval of 60 active substances that are no longer supported at EU level will have expired. Several of those are active substances with hazard classifications meeting the cut-off criteria or ones that are listed as candidates for substitution, which means that they will not adversely affect health much longer. Moreover, 40 % of all applications for the approval of new active substances are for micro-organisms or for presumed low-risk active substances. There was an increase in these in 2018 and a further increase is predicted in 2022. Figure 4. Distribution of toxicological profile of approved active substances in 2011, 2018 and 2022 Furthermore, the proportion of high hazard active substances is very small (14 active substances) and it is expected that this will be reduced further by at least two thirds (five active substances) in 2022. Although a full assessment of the impacts of the PPP Regulation’s approval criteria cannot be carried out at this time, there is a clear positive trend towards less hazardous substances. The decisions on the non-renewal of approvals taken in recent years show the stringency of the PPP Regulation and confirm that active substances posing a risk to human health can no longer be placed on the EU market. Cut-off criteria The cut-off criteria introduced under the PPP Regulation are mainly based on the intrinsic properties of active substances, i.e. the properties that are considered so severe that any exposure to the substance poses an unacceptable level of risk. The criteria were introduced to improve the protection of human health and the environment. Their introduction also intended to reduce the workload for the evaluating authorities because if an active substance meets any of the cut-off criteria, the risk assessment can be discontinued and the active substance not approved. Very limited derogation possibilities exist for substances for which the applicant demonstrates that exposure is negligible , or which are needed in order to control a serious danger to plant health and this cannot be contained by other available means. Application of these derogations has caused delays in the re-assessment of several active substances (see the discussion of the inefficiency of cut-off criteria in section 5.2.2). The cut-off criteria are both criticised (by industry and non-EU countries) and welcomed (by NGOs). Member States are divided in their opinions of the usefulness of these criteria. The main critique is that a substance’s intrinsic properties do not accurately signal potential risk because exposure is not taken into consideration. Active substances might therefore not be approved even though they could pass the risk assessment if exposure to them is low. The main argument in favour of the cut-off criteria is that high hazard substances should never be used and that exposure assessments are hampered by uncertainty; in line with the precautionary principle, it is therefore appropriate to ensure that the risks related to exposure to these substances are completely avoided. The main effect of the cut-off criteria observed so far is the low application rate for the renewal of approval of active substances that are expected to meet them. In the AIR 3 programme, six of nine active substances expected to meet the cut-off criteria were no longer supported . In the AIR 4 programme, 12 active substances that may meet the cut-off criteria were identified. Of these, seven are no longer supported and their approval will expire by the end of 2021 .

So far, the approvals of three active substances have not been renewed because of the cut-off criteria . However, there were several other problematic issues with these active substances and they also failed the overall risk assessment . In conclusion, the cut-off criteria have been effective in contributing to the protection of human health as they discourage applicants from re-applying for approval. However, it appears that for the cases in which the criteria were applied during decision-making, the outcome of the risk assessment would also have led to non-approval of the active substance. In addition, delays in assessing some active substances due to the application of derogations have possibly failed to protect human health as the substances remained on the EU market under the previous approval conditions for a longer time. Authorisation of PPPs Member States must authorise PPPs according to uniform principles, taking into consideration all product ingredients, i.e. active substance(s) and all co-formulants listed by the applicant. The risk assessment conducted for approved active substances feeds into the PPP assessments as Member States take into consideration all relevant information (endpoints). Member States must ensure that every use of an authorised PPP does not pose any unacceptable risk to human or animal health or to the environment. If an authorisation does no longer fulfil the criteria, the Member States concerned must withdraw or amend the authorisations. In 2017, Member States reported 378 authorisation amendments or withdrawals . Withdrawals or amendments show Member States’ continuous work to ensure that PPPs placed on the market are safe to use. However, the available evidence does not make it possible to measure the extent to which the authorisation procedure contributes to protecting human health. This is because of the difficulty in distinguishing between the impact of approving active substances and the impact of authorising PPPs. NGOs and the European Parliament have expressed concerns about the two-step approval and authorisation system and consider that the process is not rigorous enough to protect human health. They claim that the data requirements for PPPs are not sufficient and that the performance of Member States leaves room for improvement. This is despite the fact that: (i) the PPP Regulation requires the application dossiers for authorisations to be much more ‘data rich’ than registration dossiers under REACH; and (ii) Member States are required to assess the safety of the PPP with all its ingredients during the authorisation. NGOs and the European Parliament have further criticised the Commission for the delay in compiling a list of unacceptable co-formulants . Many co-formulants are considered of no or low concern (e.g. water and dyes), but some of them have the potential to cause harm to human health or the environment. This was the case for the co-formulant POE-tallowamine, which was used in some PPPs containing glyphosate and according to EFSA had a significant toxicity level. To ensure a high level of protection of human health, the Commission proposed in 2016 to ban the use of this co-formulant in PPPs containing glyphosate . This has led to Member States withdrawing hundreds of authorisations for PPPs containing glyphosate and POE-tallowamine, which is expected to have contributed to the protection of human health. For co-formulants in general, Member States agree that a harmonised list of unacceptable co-formulants at EU level would be beneficial and could improve protection . However, as co-formulants are already part of the scientific assessment of PPPs prior to authorisation, the additional protection of an EU list is likely to be relatively low. Nevertheless, the Commission has given priority to compiling such a list : a first draft was discussed with Member States in the Standing Committee for Plants, Animals, Food and Feed in December 2018 and a draft Regulation was published for commenting under the Better Regulation Feedback Mechanism from 16 January until 13 February 2020. Adoption is foreseen in the course of 2020. The review of safeners, synergists and adjuvants is delayed due to a lack of resources (see also section 5.2.2). However, it is expected that the added value from the EU-level assessment of safeners and synergists is lower than that arising from the identification of unacceptable co-formulants. This is due to the relatively low number of safeners and synergists and their perceived low health risk. As regards adjuvants, a majority of Member States agree that a harmonised approach is required as adjuvants are effectively co-formulants. After PPPs are authorised, users are obliged to use them correctly and according to their labels, in accordance with good agricultural practices and the Sustainable Use Directive. A guidance document covering both human health and environmental monitoring is available for Member States enforcement activities . In addition, human biomonitoring programmes have recently been agreed in the context of the HBM4EU project . The project aims to support policy making by providing better evidence of citizens’ actual exposure to chemicals and the possible health effects of such exposure. Several active substances used in PPPs have been included in the priority lists for monitoring. To further improve the protection of human health and the environment, there are calls to introduce similar chemical and biological monitoring in the post-authorisation phase in order to compare modelling results and estimations with empirica