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} EN EN Table of Contents 1. INTRODUCTION ...................................................................................................................................... 1 1.1. Purpose of the evaluation .................................................................................... 2 1.2. Scope of the evaluation ....................................................................................... 2 2. BACKGROUND ........................................................................................................................................ 3 2.1. Intervention logic ................................................................................................ 4 2.2. Baseline — the situation before the PPP and MRL Regulation .......................... 8 2.2.1. Plant protection products under Council Directive 91/414/EEC ..................... 8 2.2.2. A patchwork regulatory system for MRLs of pesticides ................................ 12 2.3. Baseline — other points of comparison ............................................................ 14 3. IMPLEMENTATION / STATE OF PLAY .............................................................................................. 16 3.1. Societal and political developments .................................................................. 16 3.2. The PPP market ................................................................................................. 17 3.3. Approval of active substances ........................................................................... 18 3.4. Authorisation of plant protection products ........................................................ 19 3.5. Setting and reviewing MRLs ............................................................................. 19 3.6. Public information, risk communication and transparency ............................... 20 3.7. Enforcement and monitoring ............................................................................. 20 3.8. Court cases and complaints ............................................................................... 21 4. METHODOLOGY ................................................................................................................................... 22 4.1. Data collection ................................................................................................... 22 4.2. Limitations and robustness of findings ............................................................. 23 5. ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS ................................................ 24 5.1. Effectiveness ..................................................................................................... 24 5.1.1. Protecting human health ................................................................................. 26 5.1.2. Protecting the environment, including wildlife and water ............................. 37 5.1.3. Minimising animal testing .............................................................................. 41 5.1.4. Improving the functioning of the single market ............................................. 43 5.1.5. Improving agricultural production and competitiveness of EU agriculture ... 47 5.1.6. Facilitating international trade ........................................................................ 52 5.1.7. Enforcement ................................................................................................... 55 5.1.8. Transparency and risk communication ........................................................... 57 5.2. Efficiency .......................................................................................................... 61 5.2.1. Costs for industry, farmers and SMEs ............................................................ 62 5.2.2. Costs for the Member States, the Commission and EFSA ............................. 64 5.2.3. Benefits to human health and to the environment .......................................... 76 5.2.4. Societal and agricultural benefits and costs related to PPPs in the EU .......... 77 5.2.5. Benefits from the single market and international trade ................................ 78 5.3. Coherence .......................................................................................................... 79 5.3.1. Pesticides policy area ..................................................................................... 80 5.3.2. Other EU policy areas .................................................................................... 82 5.3.3. International agreements ................................................................................ 85 5.4. Relevance .......................................................................................................... 86 5.4.1. Sustainability .................................................................................................. 87 5.4.2. Innovation and scientific progress .................................................................. 90 5.5. EU added value ................................................................................................. 92 6. CONCLUSIONS .......................................................................................................... 96 7. REFERENCE LIST ..................................................................................................... 102 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