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.
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.
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 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.
List of available rapporteur Member State assessment Reports (published before 22 September 2014)
- 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.
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 levels of pesticide residues in food
Pesticide residues resulting from the use of plant protection products 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 used in plant protection products, the use of plant protection products and for pesticide residues in food.
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 and the lowest consumer exposure necessary to protect vulnerable consumers. They are derived after a comprehensive assessment of the properties of the active substance and the intended use of the pesticide. These legal limits also apply to imported food.
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. Provided that 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.
As well as assessing new MRLs, the Pesticides Unit, in close cooperation with Member States, reviews the scientific basis of existing MRLs and performs consumer risk assessments to ensure they are compliant with current data requirements and are safe for consumers.
The outcome of EFSA’s MRL assessments are presented as reasoned opinions.
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.
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.
The Pesticides Unit is responsible for preparing annual reports on the control activities of EU Member States plus the two EEA countries Norway and Iceland. These reports summarise the results of pesticide analyses of food, identify areas of concern regarding compliance with legal limits and assess the exposure of consumers to pesticide residues via food placed on the market. 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. What are pesticide residues?
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.
2. What is the EFSA pesticides report?
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 on food (see question 6). MRLs have been set for more than 500 pesticides in over 370 food products. To ensure that food placed on the market complies with the legal limits, EU Member States carry out control programmes and take samples of various food products, which they test for pesticide residues. This data is analysed and published 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.
3. What is the main finding of the latest report?
Ninety-seven per cent of food samples collected in the European Union in 2014 were found to be free of pesticide residues or to contain traces that fall within legally permitted levels. The figure is derived from 83,000 samples collected from the 28 EU Member States – including, for the first time, Croatia – as well as Iceland and Norway.
4. Who decides which foods and chemicals are analysed?
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.
- The 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.
5. What does “free of pesticide residues” mean?
It means that the analysis of the sample failed to detect the presence of quantifiable residues. To be a bit more technical, the pesticide chemicals were not detected in concentrations exceeding the limit of quantification (LOQ). The LOQ is the smallest concentration of a substance that can be quantified with acceptable precision. For most pesticides the LOQ is between 0.01 mg/kg and 0.05 mg/kg. A concentration of 0.01 mg/kg is roughly equivalent to five teaspoons of sugar diluted in an Olympic-sized swimming pool. In 2014, 53.6% of the samples were found to be free of quantifiable pesticide residues.
6. So where does the figure of 97% come from?
In addition to the 53.6% of samples that were residue-free, 43.4% were found to contain residues that fell within legal limits (i.e. not exceeding the MRLs. See question 1). So, overall, 97% of samples fell within legal limits.
7. How are maximum residue levels (MRLs) set?
Before a pesticide can be approved for use in Europe, the applicant (usually the producer of the pesticide) has to provide a wide range of scientific studies. These should demonstrate that its use will not pose unacceptable risks to consumers (via residues in food), the operator (the farmer or worker using the pesticide) and the environment (by seeping into drinking water or hurting wildlife, for example). The applicant also has to provide studies that enable the expected residue level in the harvested crop to be estimated. EFSA then assesses whether this residue concentration would pose a health risk to consumers. An MRL is set at the lowest level at which the desired protective effect can be achieved. The EU maintains a database of current MRLs.
8. Are MRLs equivalent to toxicological safety levels?
No, MRLs are not primarily toxicological safety limits. They are set at a level that does not pose a risk to consumers, but they also reflect the minimum level of a pesticide that can be used to achieve effective plant protection i.e. to keep crops healthy and prevent them from being destroyed as a consequence of disease and infestation. MRLs are often set at levels far below toxicological limits. Furthermore, the presence of pesticides in food at a level exceeding the MRL does not necessarily imply a safety concern.
9. What about food that contains residues from more than one pesticide?
Residues of more than one pesticide were found in 28.3% of samples for the 2014 report. 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, are combinations of pesticides being used deliberately to circumvent MRL limits on single substances?). EFSA did not consider cumulative risk assessment in its latest report because it is currently finalising a tool for assessing cumulative exposure to multiple pesticides. The tool is being piloted to investigate the cumulative effects of pesticides on the nervous system and the thyroid. The results will be published in 2017.
10. Are there differences between samples taken from goods produced within the EU and those from outside?
1.6% of samples sourced from within the EU/EEA countries were found to contain residues that exceeded permitted levels. Among samples from third countries the figure was 6.5%, a slight increase on 2013 (5.7%). Of the 3,265 samples that exceeded the legal limit in the 2014 collection, 1,253 concerned pesticides not approved or no longer approved in the EU. Most of these cases (957) involved imported products.