Authorization and Use of Plant Protection Products
European Parliament and Council Regulation 1107/2009 sets out rules for the authorization of plant protection products (PPPs). PPPs (also referred to as ‘pesticides’) contain at least one approved active substance. Only PPPs containing active substances included in the list of approved active substances as established in Commission Implementing Regulation 540/2011 may be authorized for use in the EU. Before any PPP can be placed on the market or used, it must be authorized in the relevant Member State(s). According to Annex I of Regulation 1107/2009, the EU is divided in three different zones. Once a Member State approves the PPP, it can be mutually recognized and thus authorized within the EU. Maximum Residue Levels (MRLs) for substances that are not on the EU positive list will be set at a default level of 0.01 mg/kg. The legislation allows exporters to request an “import tolerance” for active substances not yet evaluated or in use in the EU.
Directive 2009/128 on the Sustainable Use of Pesticides (SUD) is also part of the so-called Pesticides Package, which is currently under revision. For more information see the European Commission website: https://ec.europa.eu/food/plants/pesticides_en
A key commitment of the European Commission’s F2F and Biodiversity Strategies is a 50 percent reduction of the use and risk of pesticides by 2030. The Strategies aim to protect and restore biodiversity and make the European agrifood sector more sustainable through pesticide reduction targets and wider adoption of integrated pest management (IPM) practices. As part of the F2F Strategy, the Commission proposed several initiatives that link to EU pesticide regulations supported by recommendations from the completed regulatory fitness and performance check of the EU legislation on plant protection products and pesticide residues, known as REFIT, including a revision of the Sustainable Use of Pesticides Directive (SUD). Please find here a link to the GAIN report on the Pesticide Initiatives in the Farm to Fork Strategy.
The European Commission’s proposal, released on June 22, 2022, for a new Regulation on the sustainable use of Plant Protection Products (SUR) introduces rules encouraging the reduction of pesticides through integrated pest management and alternatives to chemical pesticides. The European Commission considers the SUR to be a crucial tool to achieving the targets outlined in the European Green Deal and the Farm to Fork Strategy as it puts forward legally binding pesticide reduction targets to reduce the use and risk of chemical pesticides by 50% by 2030. The proposal is part of the Commission’s nature restoration package, which also includes a proposal to restore damaged ecosystems and bring nature back across Europe.
The proposal aims to reduce the risks from – and impacts of – pesticide use on human health and the environment by setting pesticide reduction targets and to promote the use of Integrated Pest Management (IPM) and alternatives to chemical pesticides. It sets out requirements for the National Action Plans (NAPs), IPM, sales of plant protection products, training and certification of professional users, pesticide application equipment etc.
Maximum Residue Limits (MRLs): Regulation 396/2005
European Parliament and Council Regulation 396/2005 harmonizes all MRLs in the EU on food or feed of plant and animal origin. Pesticide MRLs for processed or composite products are based on the MRLs of the raw agricultural ingredients. A general default MRL of 0.01 mg/kg applies where a pesticide is not specifically mentioned.
See the European Commission’s website at http://ec.europa.eu/food/plant/pesticides/max_residue_levels_en for the latest updates.
For a list of authorized active substances or pesticide-MRL combinations, see the European Commission’s online database.
In 2016, the European Commission notified a document to the WTO explaining its on-going review of MRLs (last updated July 2, 2021) in the EU to non-EU countries. The information submitted by the EU provided details about, explaining the on-going process in the European Union to review the of current maximum residue levels (MRLs) for pesticides under Article 12 of Regulation (EC) No. 396/2005 and how non-EU countries can actively contribute to the reviewing process. Article 12 of Regulation (EC) 396/20051 provides for a mechanism to review the existing maximum residue levels (MRLs) of all approved and certain non-approved pesticides. This review process has been on-going since 2008. It also includes references to the EFSA progress report for the Article 12 review of MRLs (last updated July 20, 2021).
Early Alert System For Active Substances and MRLs Under Review
The EU early alert system provides information on ongoing and upcoming reviews for active substances and MRLs that are of interest to U.S. stakeholders. The information presented in this document provides interested stakeholders with advance notice of which active ingredients are under review for renewal of approval in the EU and highlights which substances may be restricted or not renewed for approval. This list is not all-inclusive and other substances and MRLs may be undergoing review as well. For more information, please see:
If there is no EU legislation in place in the importing Member State, then the exporter can seek to obtain an “import tolerance” for active substances that have not been evaluated or used in Europe before. Applications for import tolerances must be submitted to the “Rapporteur Member State” (RMS). The Commission assigns a Member State if no RMS exists. The RMS-reviewed dossiers are evaluated by EFSA before being forwarded to the Commission. Information on import tolerances is available in the “Pesticide Use and Food Safety” guide published by the Croplife Europe. All MRLs, including import tolerances, have applied EU-wide since September 2008. The application form for an import tolerance can be found here.
Harmonized sampling methods are established for the official control of residues in and on products of plant and animal origin by
Commission Directive 2002/63/EC. Commission Implementing Regulation 2022/741 outlines the latest version of the coordinated multi annual control program of the EU for pesticides residues, which requires Member States to take and analyze samples for product and pesticide residue combinations in food of plant and animal origin. Annex I to the Regulation sets out the pesticide and product combinations to be monitored. Annex II sets out the number of samples that need to be taken for each combination. The Member States must submit results of the sample tests to the EU by August 31, 2024, 2025 and 2026 for samples tested in 2023, 2024 and 2025 respectively.