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 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 is also part of the so-called Pesticides Package. For more information see the European Commission website http://ec.europa.eu/food/plant/pesticides/sustainable_use_pesticides/index_en.htm
“Endocrine disruptors” (EDs) refer to substances with the potential to alter and cause unintentional adverse health effects to the endocrine systems of humans and wildlife. Both the Plant Protection Products Regulation 1107/2009 (Pesticides) and the Biocidal Products Regulation 528/2012 (Biocides) introduced “endocrine disrupting properties” as one of the categories of hazard-based cut-off criteria. This allows the EU to ban certain products from the market based on hazard identification rather than risk assessment without taking exposure into account. The Commission published Regulation 2018/605, identifying endocrine disrupting properties under Regulation 1107/2009 on plant protection products, in the Official Journal. The criteria to identify endocrine
disruptors apply since November 10, 2018, to all on-going and future evaluations of active substances used in plant protection products. In June 2018, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) published a technical guidance document to implement the criteria for both biocides and pesticides.
Maximum Residue Limits
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. MRLs apply to 315 fresh products and to the same products after processing. 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 the on-going review of MRLs in the EU to non-EU countries, highlighting the active substances and relevant MRLs that are scheduled to be reviewed in the near future. It also refers to the EFSA progress report for the Article 12
review of MRLs (last updated October 8, 2019).
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 previously been evaluated or used in Europe. 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 the European Food Safety Authority before being forwarded to the Commission. Information on import tolerances is available in “Pesticide Use and Food Safety” guide published by the European Crop Protection Association (ECPA). Since September 2, 2008 all MRLs, including import tolerances, apply EU wide. The application form for an import tolerance can be found here.
Upcoming Review – REFIT
The European Commission did a regulatory fitness and performance check (REFIT) on the EU legislation on pesticides and pesticides residues. The evaluation process consisted of different steps, such as a roadmap, an external study, as well as a consultation strategy with an online public consultation, focus groups, in-depth interview, case studies etc. in order to collect data and information. In the first half of 2019, the European Commission finalized the final report concluding the REFIT of the EU pesticide legislation, but it has not yet been released.
In addition to the Commission’s evaluation, the European Parliament formed a special Committee on Pesticides that investigated glyphosate and other pesticide products. Some of the recommendations from the PEST Committee’s final report were also used in the final REFIT report.
Official Controls of Pesticide Residues in and on Products of Plant and Animal Origin
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 2019/533 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, 2021, 2022 and 2023 for samples tested in 2020, 2021 and 2022 respectively. For more information see the European Commission website http://ec.europa.eu/food/plant/pesticides/max_residue_levels/enforcement/index_en.htm.
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 active ingredients under review for renewal of approval in the EU and highlights which substances may have restricted or non-renewal of approval. This list is not all-inclusive and other substances and MRLs may be undergoing review as well.