A large body of EU legislation regulates the marketing and use of plant protection products and their residues in food. Plant protection products cannot be placed on the market or used without prior authorisation. A dual system is in place, under which EFSA evaluates active substances used in plant protection products and Member States evaluate and authorise the products at national level. Plant protection products are principally regulated by framework Regulation (EC) No 1107/2009.
All matters related to legal limits for pesticide residues in food and feed are covered by Regulation (EC) No 396/2005. This regulation also contains provisions on official controls of pesticides residues in food of plant and animal origin that may arise from their use in plant protection.
EFSA gives independent scientific advice to risk managers based on risk assessments. The European Commission and Member States take risk management decisions on regulatory issues, including approval of active substances and setting of legal limits for pesticide residues in food and feed (maximum residue levels, or MRLs).
Before an active substance can be used within a plant protection product in the EU, it must be approved by the European Commission. Active substances undergo an intensive evaluation process before a decision can be made on approval.
EFSA’s Pesticides Unit is responsible for the EU peer review of risk assessments of active substances used in plant protection products, in close cooperation with EU Member States. The risk assessment of active substances evaluates whether, when used correctly, these substances are likely to have any direct or indirect harmful effects on human or animal health – for example, through drinking water, food or feed – or on groundwater quality. In addition, the environmental risk assessment aims to evaluate the potential impact on non-target organisms.
The Pesticides Unit also gives scientific advice to the European Commission on possible risks related to the presence of pesticide residues in food treated with plant protection products and makes proposals regarding the setting of MRLs. In addition, the Unit is responsible for preparing the Annual Report on Pesticide Residues in the EU. Furthermore, the Pesticides Unit provides administrative and scientific support to the Panel on Plant Protection Products and their Residues (PPR) Panel.
EFSA’s Panel on Plant Protection Products and their Residues (PPR) gives scientific advice on issues that cannot be resolved within the peer review of active substances, MRL applications/MRL reviews or when guidance is needed on more generic issues, commonly in the fields of toxicology, ecotoxicology, fate and behaviour and the development of risk assessment practice.
The PPR Panel and the Pesticides Unit have the task of developing and revising scientific methodologies, including guidance documents, for pesticides risk assessment. In this context, EFSA regularly outsources tasks to external organisations to assist with gathering scientific data and information or developing modelling tools. Stakeholder views on new guidance and methodologies are collected through public consultations. The guidance documents provide advice to applicants and Member States on how to conduct a risk assessment for a particular area in the context of the peer review of active substances or national authorisations of plant protection products.