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
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
- Introduction 1.1. Purpose of the evaluation 1.2. Scope of the evaluation
- 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
- 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
- Methodology 4.1. Data collection 4.2. Limitations and robustness of findings
- 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
- Conclusions
- 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.
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 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.
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.
Hazard A hazard is the intrinsic property of an agent to cause harm to humans, property or the environment. Risk is the probability that exposure to a hazard will lead to a negative consequence.
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.
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.
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.
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.
Maximum residue level (MRL) 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.
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.
Neonicotinoids Neonicotinoids are a class of neuro‑active insecticides chemically similar to nicotine.
Non‑governmental organisation (NGO) NGOs are usually non‑profit and independent of 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, bio‑accumulative and toxic (PBT) substances A PBT substance is ‘persistent’, ‘bio‑accumulative’ and ‘toxic’. The definitions include half‑life thresholds in water, sediment and soil, a bioconcentration factor > 2000 and toxicological classifications.
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 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.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006 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.
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) | Company category | Staff headcount | Turnover | Balance sheet total |
|---|---|---|---|---|
| Medium‑sized | < 250 | < 250 M€ | ≤ 43 M€ | |
| Small | < 50 | < 50 M€ | ≤ 10 M€ | |
| Micro | < 10 | < 10 M€ | ≤ 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 (rapporteur Member State) or 3 months (EFSA).
Synergist Synergists are chemicals that make the active substance in a PPP more effective.
Very persistent and very bio‑accumulative (vPvB) A vPvB substance is both ‘very persistent’ and ‘very bio‑accumulative’.
World Trade Organisation (WTO) The 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.
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.
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 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 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.
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.
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, by‑standers, 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.
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.
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. 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.
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.
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.
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.
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.
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, 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 of 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 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.
Data collection involved 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.
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.
Effectiveness
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 pesticide 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. 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.
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.
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 demonstrated 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.
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.
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 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. 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.
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.
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.
5.1.2 Protecting the environment, including wildlife and water
The use of pesticides has, to some extent, unavoidable impacts on biodiversity, which need to be balanced against the crop protection needs. The PPP Regulation aims to protect the environment with its strict approval criteria and the introduction of cut‑off criteria for active substances. Guidance documents complement these actions by specifying how environmental concerns should be evaluated by Member States during the risk assessment process. Since the PPP Regulation became applicable, 21 active substances have not been approved or approval has not been renewed due to environmental concern. The reasons include risks to groundwater, surface water, soil, aquatic organisms, soil‑dwelling organisms, wild mammals, non‑target terrestrial plants, and honeybees.
The Commission has also restricted certain uses of active substances to protect the environment. Since June 2011, 10 active substances have been approved with uses restricted to greenhouses, application rate restrictions to protect groundwater, and application frequency restrictions such as ‘one application every three years on the same field’. Member States take further protective measures for the environment when authorising PPPs.
Biodiversity and wildlife: The PPP Regulation aims to protect biodiversity and ecosystems by taking into account the impact on populations of organisms, as well as water, soil and air quality during the risk assessment. It does this by assessing the expected environmental exposure, covering a wide range of environmental scenarios which include the application of the PPP for several consecutive years. Based on this exposure assessment and experimental data on expected effects on a variety of different species, the potential risks are calculated.
Protecting bees and other pollinators: Pollinators provide important ecosystem services, pollinating more than 80 % of crops and wild plants in the EU. The decline of bee populations has been observed in the EU and globally. The approval criteria for active substances include specific considerations of honey bees. The EU has placed restrictions on the use of certain active substances to protect pollinators.
Protecting groundwater and surface water: Groundwater provides a major source of drinking water for many EU citizens. Monitoring shows that the chemical status of groundwater with respect to pesticides has changed little between 2009 (5 % of groundwater bodies with poor chemical status) and 2015 (6 %). The PPP Regulation has contributed to reductions in certain pesticides, such as atrazine and diuron, and the non‑approval of substances like isoproturon is expected to improve water quality.
5.1.3 Minimising animal testing
The PPP Regulation has a specific objective to minimise the use of animals in testing to approve active substances and authorise PPPs. Data owners and prospective applicants must make every effort to share tests and studies involving animals. This obligation applies both to vertebrate and non‑vertebrate animals. The numbers of animals used in testing have not shown a clear decreasing trend; however, the number of shared studies included in dossiers has increased.
5.1.4 Improving the functioning of the single market
Setting MRLs: The MRL Regulation replaced four earlier Directives, thus creating a single legislative framework in the area of pesticide residues. It is directly applicable in all Member States and does not need to be transposed. The same provisions and data requirements apply across the EU, as do common principles for conducting risk assessments.
The zonal system and mutual recognition of authorisations: The PPP Regulation divides Member States into three zones based on comparable agri‑environmental conditions to facilitate the granting of authorisations for PPPs, increase access to PPPs for farmers and avoid duplication of work. The zonal system has led to an increase in authorisations granted through the mutual recognition procedure, but large differences exist between Member States in the use of mutual recognition. The system is not working as well as expected, with various practical and trust‑related issues hindering its full potential.
5.1.5 Improving agricultural production and competitiveness of EU agriculture
PPPs are an important factor in agricultural production. All other things being equal, the improved availability and reduced cost of PPPs have a positive impact on productivity. However, the evidence on the impact of the PPP Regulation on agricultural competitiveness remains inconclusive. Some Member States have reported a decrease in the number of PPPs available, especially in larger markets such as France and Spain, while other Member States have seen increases.
Availability of PPPs for minor uses: Minor uses (crops with limited area or exceptional plant‑protection need) often suffer from a lack of authorised PPPs. The PPP Regulation includes a possibility to extend existing authorisations for minor uses via a simplified procedure, but availability remains insufficient. Emergency authorisations are frequently used to fill gaps for minor uses.
5.1.6 Facilitating international trade
Harmonisation of MRLs facilitates trade between countries. The EU’s MRL system has generally been viewed as positive for trade, although some trade partners claim that the EU does not comply fully with international standards (Codex). The EU has a high rate of harmonisation of Codex limits compared with other WTO members.
5.1.7 Enforcement
Enforcement of the PPP Regulation: All Member States carry out monitoring and official control activities to ensure compliance with the PPP Regulation. Illegal and counterfeit PPPs are estimated to represent around 10 % of the EU PPP market. Recent operations have seized more than 670 tonnes of illegal or counterfeit PPPs.
Enforcement of the MRL Regulation: Food‑business operators must ensure compliance with the MRL Regulation. The EU‑coordinated monitoring programme shows a high level of consumer protection, with 96.2 % of samples analysed in 2016 within legal limits.
5.1.8 Transparency and risk communication
The PPP Regulation aims to improve the transparency of procedures and access to documents, while balancing confidentiality. Several tools have been introduced, including the EU Pesticides Database, public consultations by EFSA, and the forthcoming Plant Protection Products Application Management System (PPPAMS) which will provide information on all PPP authorisations.
The evaluation finds that the PPP and MRL Regulations have contributed to improved protection of human health and the environment, increased transparency, and better functioning of the single market. However, several challenges remain, including variable enforcement across Member States, delays in approvals and renewals, limited implementation of certain provisions (e.g., co‑formulant list, cumulative risk assessment), and the need for better support for SMEs and minor uses.
(References omitted for brevity)
Annexes and glossary omitted for brevity.
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