Conclusion on Pesticides
Pesticides
The term “pesticides” is commonly used as a synonym for plant protection products. However, pesticides is a broader term that also covers products such as biocides, which are intended for non-plant uses to control pests and disease carriers such as insects, rats and mice and do not fall within the remit of EFSA.
Plant protection products are pesticides that are mainly used to keep crops healthy and prevent them from being destroyed by disease and infestation. They include herbicides, fungicides, insecticides, acaricides, plant growth regulators and repellents.
Plant protection products contain at least one active substance. These substances can be chemicals or micro-organisms, including viruses, that enable the product to perform its action. A major part of EFSA’s risk assessment work in the area of plant protection products focuses on these active substances.
EFSA’s role
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 Peer Review 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.
EFSA gives scientific advice to the European Commission on possible risks related to the presence of pesticide residues in food and feed treated with plant protection products and makes proposals regarding the setting of MRLs. Furthermore, EFSA also provides administrative and scientific support to the Panel on Plant Protection Products and their Residues (PPR Panel).
The PPR Panel and the relevant units have the task of developing and revising scientific methodologies, including guidance documents, for pesticides risk assessment. In this context, EFSA also outsources tasks to external organisations to assist with gathering scientific data and information or developing modelling tools. Furthermore, 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, the setting of MRLs or national authorisations of plant protection products.
EU framework
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.
Latest
In February 2023, EFSA published its revised guidance on the pesticide risk assessment for birds and mammals, which was first published in 2009. It outlines a tiered risk assessment scheme covering dietary exposure, exposure via secondary poisoning and exposure via intake of contaminated water. Following the principles of the existing guidance, risk assessment methodologies were clarified, updated and complemented, as needed. For the sake of harmonisation and transparency, an online evaluation tool was developed, which supports the risk assessment by performing calculations.
Peer review
Peer review of active substances
Since 2003, EFSA has been responsible for the EU peer review of active substances used in plant protection products. This task is carried out by EFSA’s Pesticides Peer Review Unit following procedures set out in the legislation and the latest scientific standards and methods. EFSA conducts its work in close collaboration with scientific experts from the Member States.
In general, active substances are evaluated through a phased approach:
- An application for approval of an active substance is submitted by the producer of the active substance to a designated rapporteur Member State (RMS), together with a dossier.
- For each substance an initial assessment report is produced by the RMS carrying out the first risk assessment.
- The RMS’s risk assessment is peer reviewed by EFSA in cooperation with all Member States.
- EFSA drafts a conclusion on the active substance.
- The European Commission takes a legislative decision whether or not to include the substance in the Union’s list of approved active substances.
EFSA is also responsible for the EU peer review of applications for renewal of the approval of active substances. Active substances are generally approved for a period of 10 years, after which it is possible for an applicant to apply for renewal. The application is submitted to an RMS, which provides its initial evaluation in a renewal assessment report (RAR). EFSA then carries out a peer review of the RAR in collaboration with Member States.
As part of the peer review of active substances, EFSA also assesses potential endocrine disrupting (ED) properties. An overview of the ED assessment of pesticide active substances in line with the criteria introduced by Commission Regulation EU 2018/605 is provided in a dedicated report, which is regularly updated and published on this website.
Furthermore, EFSA provides scientific assistance for the evaluation of applications concerning “basic substances”. Basic substances are, broadly speaking, active substances that are not predominantly used as plant protection products but which may be of value for plant protection. Criteria for their approval are laid down in the framework Regulation.
Finally, EFSA gives its scientific view on confirmatory data. An approval may be made subject to the submission of further confirmatory information, where new requirements have been established during the evaluation or as a result of new scientific and technical knowledge.
The outcome of the peer review and/or other consultation processes is presented in EFSA’s conclusions and technical reports.
Maximum residue levels
Maximum levels of pesticide residues in food
Pesticide residues resulting from the use of plant protection products (PPPs) on food or feed crops may pose a risk to public health. For this reason, a comprehensive legislative framework has been established in the European Union which defines rules for the approval of active substances, the use of plant protection products and for pesticide residues in food.
According to Regulation (EC) No 396/2005, maximum residue levels (MRLs) are the upper levels of pesticide residues that are legally permissible in or on food or animal feed, based on good agricultural practice (GAP) and the lowest exposure necessary to protect vulnerable consumers. They are derived after a comprehensive assessment of the properties of the active substance and the intended uses of the pesticide. These legal limits also apply to imported food, set as “import tolerances” to meet the needs of international trade.
Before an MRL is set or amended – for example because an applicant requests the authorisation of a new plant protection product – EFSA assesses the residue behaviour of the pesticide and possible consumer health risks from residues in food. If EFSA’s risk assessment does not identify any unacceptable risks to consumers, EU-harmonised MRLs are set (Database of MRLs in the EU) and the plant protection product can be authorised.
Applications for new or revised EU MRLs in accordance with Article 6 of Regulation (EC) No 396/2005 are received by EFSA, which in close cooperation with the evaluating Member State (EMS), assesses new MRL applications for an active substance/crops combination, performs a consumer risk assessment and determines the recommended MRLs. More information on this process can be found on our "Pesticide evaluations" page.
According to Article 12 of Regulation (EC) No 396/2005, EFSA also reviews the existing MRLs for an active substance in close collaboration with the rapporteur Member State (RMS). EFSA derives MRL proposals and performs a consumer risk assessment for all crops for which European authorisations or import tolerances are reported. The review of MRLs for an active substance is performed in line with the process agreed with the European Commission and Member States. More information on this process, including detailed work instructions, flowchart and supporting templates can be downloaded using the links provided below.
To allow stakeholders to better prepare and support the MRL review, EFSA updates on a quarterly basis its Overview of the MRL review progress under Article 12 of Regulation (EC) No 396/2005.
In all EFSA’s MRL assessments, chronic (long-term) and acute (short-term) dietary consumer exposure to pesticide residues are estimated using a calculation model developed by EFSA (PRIMo – Pesticide Residue Intake Model). The model is based on national food consumption data and unit weights provided by Member States and implements internationally agreed risk assessment methodologies.
The outcome of EFSA’s MRL assessments are presented as reasoned opinions and published in the EFSA Journal.
Article 12 review: Instructions and templates
Work instructions
STEP 2: GAPs collection
Template for GAPs reporting form
STEP 3: identification of cGAP
Template of the GAP overview file
Video Tutorial on the use of the new GAP overview file
STEP 4: data collection
Template for MSs Evaluation Report
Template for EURLs evaluation report
STEP 5: ER and PROFile
Template for RMS evaluation report
STEP 8: Member States consultation
Annual report
Annual Report on Pesticide Residues
Member States are obliged to carry out controls to ensure that food placed on the market is compliant with legal limits. The European monitoring programmes comprise one of the most comprehensive food survey programmes in the world, analysing more than 75,000 food samples for over 600 different pesticides every year. In 2022, over 110,000 food samples were collected in total, an unprecedented number.
EFSA prepares annual reports on the control activities of EU Member States[1] plus the two EEA countries Norway and Iceland. These reports identify areas of concern regarding compliance with legal limits for pesticide residues and assess the exposure of consumers to these residues via food placed on the market. In the latest EFSA report, the probabilistic assessment methodology introduced in 2023 was expanded to all pesticides analysed within the EU-coordinated programme.
In addition, EFSA provides recommendations on how to make future control programmes more efficient.
- Annual Reports on Pesticide Residues prepared by EFSA.
- From 1996 to 2006 the Annual EU-wide Pesticide Residues Monitoring Reports were published by the European Commission.
[1] : In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023, OJ L 102, 17.4.2023, p.87) in conjunction with section 24 of Annex 2 to that Framework, for the purposes of this report, references to Member States include the United Kingdom in respect of Northern Ireland.
FAQ
Pesticide residues are the measurable amounts of active substances – chemicals used to protect plants against disease and pests – and the related metabolites or degradation products that can be found on harvested crops or in foods of animal origin.
The European Union has a comprehensive legislative framework in place governing the use of pesticides. To ensure high consumer protection, legal limits – known as maximum residue levels (MRLs) – are set on the amount of pesticide residues that can be permitted in food. MRLs have been set for more than 650 pesticides in over 370 food products. To ensure that food placed on the market complies with the legal limits, EU Member States (plus Norway and Iceland) take samples of various food products, which they test for pesticide residues. This data is analysed and published annually by EFSA to give an overview of compliance in the EU and the exposure of European consumers to pesticide residues. In addition, EFSA makes recommendations for future monitoring programmes.
The latest data – collected in 2022 – show that 96.3% of the overall 110,829 samples analysed fell below the maximum residue level (MRL), 3.7% exceeded this level, of which 2.2% were non-compliant i.e. samples exceeding the MRL after taking account of the measurement uncertainty . For the subset of 11,727 samples analysed as part of the EU-coordinated control programme (see question 6), 1.6% exceeded the MRL and 0.9% were non-compliant. The non-compliance rate slightly decreased from 1% in 2019 to 0.9% in 2022, when the same selection of products was sampled.
If a sample contains pesticide residues exceeding the MRLs, the measurement uncertainty is taken into account and applied. When the level of pesticide residues is above the MRL after applying the measurement uncertainty, that sample is non-compliant. Non-compliance triggers legal action.
In line with previous years, in 2022 multiple residues were recorded in just below a quarter of samples (23%). The presence of multiple residues does not constitute non-compliance with MRL legislation as long as individual pesticides do not exceed legal limits. However, products with multiple residues should be assessed carefully by the national authorities (for example, to consider whether combinations of pesticides are being used deliberately to circumvent MRL limits on single substances).
The report contains two data sets:
- The EU-coordinated programme, under which the European Commission obliges reporting countries to analyse a common list of food products and pesticides. Different groups of food products are analysed in a three-year cycle. The samples are taken randomly to get statistically representative results for the food consumed by European citizens.
- National control programmes. The scope of these is defined by the individual Member States. The programmes are “risk-based”, focusing on those products which are expected to contain residues in concentrations exceeding the legal limits.
The figure of 96.3% is derived from the combined findings of the two reports. Results only from the EU-coordinated programme, which in 2022 covered 11,727 samples from 12 food products, showed that 98.4% of samples fell within legal limits.
This issue of the report expands the probabilistic assessment methodology introduced last year to all pesticides analysed within the EU-coordinated programme. That assessment estimates the probability of consumers to be exposed to a quantity of residues above the safe level (the Health-Based Guidance Value). For most substances, that probability is estimated to be zero; for some substances, a slightly higher probability was estimated for certain consumer groups.
Due to several uncertainties, risks may have been overestimated in this assessment. In the next years, EFSA will continue to adjust the methodology to further improve the accuracy of the results.
As part of its report, EFSA performs an acute (short-term) and chronic (long-term) dietary risk assessment by combining the data from the EU coordinated programme with food consumption information provided by Member States. Using the 2022 data, EFSA concluded that the risk for consumer health is estimated to be low.
- Maximum residue limit (MRL): the maximum amount of a pesticide residue allowed in foods. MRLs are also referred to as ‘legal limits’ or ‘permitted levels’.
- Non-compliant sample: samples with one or more pesticide residues exceeding the MRL after considering the measurement uncertainty.
- Health-Based Guidance Value (HBGV): a threshold value indicating the safe intake level of a substance for consumers. It is derived from evidence about health effects and takes into account uncertainties about the data and the duration of exposure.
- Limit of quantification ( LOQ Το όριο ποσοτικοποίησης (LOQ) είναι η χαμηλότερη συγκέντρωση μιας ουσίας που μπορεί να μετρηθεί με βεβαιότητα με τη χρήση τυποποιημένων δοκιμών.): the lowest residue concentration which can be quantified and reported by routine monitoring with validated control methods.
Expert group
Experts in chemistry, toxicology, ecotoxicology, exposure assessment and environmental sciences.