The term “pesticides” is often used as a synonym for plant protection products, which are mainly used in agriculture to keep crops healthy and prevent them from being destroyed as a consequence of disease and infestation. This is the only group of pesticides dealt with by EFSA and it has the longest history of legislation.
Plant growth regulators (used to influence particular growth processes in plants) and herbicides (which control unwanted plants) are also treated as plant protection products under EU legislation. However, biocides, which are intended for non-plant uses to control various pests and disease carriers such as insects, rats and mice, do not fall within the remit of EFSA.
The active substances used in plant protection products are the chemicals or micro-organisms including viruses that are the essential component enabling the product to do its job. For example, they may destroy unwanted plants in the case of herbicides or protect the plant against insects or fungi which destroy plants or reduce crop yields. Much of EFSA’s risk assessment work in the field of pesticides focuses specifically on these active substances.
A large body of EU legislation regulates the marketing and use of plant protection products and their residues in food. Pesticides are principally regulated by Directive 91/414/EEC on the placing of plant protection products on the market. Plant protection products cannot be placed on the market or used without prior authorisation. A two tier system is in place, where the Community evaluates active substances used in the plant protection products and Member States evaluate and authorise, at national level, the products.
All matters related to the Maximum Residue Levels (MRLs) for pesticide residues in food and feed are covered by Regulation (EC) No 396/2005. Additionally, it covers monitoring and control of pesticides residues in products of plant and animal origin that may arise from their use in plant protection.
A new Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market has been published on 24 November 2009. It replaces Directive 91/414/EEC and will become fully applicable as of 14 June 2011. It streamlines mainly the national authorisation procedures for plant protection products and enshrines EFSA’s role in the assessments at EU level.
- Plant protection – Legal Framework - European Commission, DG Health and Consumers
- Pesticide residues - European Commission, DG Health and Consumers
EFSA's work on pesticides
EFSA has the job of giving independent scientific advice to risk managers based on risk assessments. The Commission and Member States take management decisions on regulatory issues including approval of substances and setting MRLs - EFSA does not take such decisions. The risk assessment of pesticides evaluates whether, when used correctly, these products can be shown to have no direct or indirect harmful effect on human or animal health, e.g. through drinking water, food or feed and do not adversely affect groundwater quality. In addition, the environmental risk assessment aims to evaluate the potential impact on non target organisms when the products are correctly used.
Peer review of active substances
The European Commission started a peer review programme in 1993 to evaluate the safety of all active substances used in plant protection products in the EU. Once a substance is approved for use in the EU, it is included in the positive list of authorised active substances, and Member States may authorise the use of products containing it.
Since mid-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. The Unit is responsible for the peer review of the existing substances used in the EU as well as the evaluation of new active substances. EFSA conducts its work in close collaboration with scientific experts from the Member States.
In December 2008 EFSA completed its work on the peer review of the existing active substances used in pesticides on the market in 1993 to enable the Commission to decide on the list of active substances that may be included in plant protection products throughout the EU. EFSA assessed the safety of over 150 active substances between 2003-2009. A further set of active substances, which have already been risk assessed by Member States, will also undergo EFSA’s peer review by 2012.
In September 2008, EFSA set up a new Pesticide Steering Committee, which is made up of representatives from EFSA, the European Commission and Member States. It was established with the specific responsibility to manage and plan the overall pesticide risk assessment and consider ways to further streamline the process in the face of an ever-growing workload and evolving regulatory environment.
Maximum Residue Levels
Maximum Residue Levels (MRLs) are the upper legal levels of a concentration for pesticide residues in or on food or feed, based on good agricultural practice and the lowest consumer exposure necessary to protect vulnerable consumers. Regulation (EC) No 396/2005 establishes the MRLs of pesticides permitted in products of animal or vegetable origin intended for human or animal consumption. The Regulation repeals the previous fragmentary legislation and replaces all national MRLs with harmonised EU MRLs for all foodstuffs. Prior to this, each Member State applied its own MRLs for active substances which were not yet covered by EU MRL legislation.
As of September 2008 the Regulation is fully applicable. EFSA is the single risk assessment body involved in the MRL-setting procedure and EFSA’s Pesticides Unit is engaged in the risk assessment of MRLs in accordance with the legislation. The unit has already carried out important tasks in the framework of MRL-setting work including assessing the safety of proposed temporary European MRLs in 2007 and adopting reasoned opinions on MRLs for a number of active substances of concern based on requests from the European Commission. In addition, numerous applications on the modification of MRLs were assessed.
Annual Report on Pesticide Residues
EFSA publishes an Annual Report on Pesticide Residues in the EU based on monitoring information of the official controls on pesticide residues in food received from the 27 EU Member States and two EFTA countries (Iceland and Norway). The report assesses the exposure of European consumers to pesticide residues through their diets.
- Annual Reports on Pesticide Residues
- From 1996 to 2006 the Annual EU-wide Pesticide Residues Monitoring Reports were published by the European Commission
Cumulative Risk Assessment
EFSA’s work on cumulative risk assessment aims to develop methodologies to assess the cumulative effects resulting from consumer exposure to pesticides. The work looks at those groups of pesticides which have similar chemical structure and toxic effects to see if their impact on human health should be assessed collectively rather than just on an individual basis.
As part of EFSA’s broader work on cumulative risk assessment, in 2006 a “Scientific Colloquium on Cumulative Risk Assessment” was held which helped guide further developments in the field. In 2008, the PPR Panel issued and opinion on all types of combined toxicity of pesticides, including the interaction of different chemicals. It concluded that only cumulative effects from concurrent exposure to substances which have a common mode of action raised concerns and needed further consideration.
In September 2009 and following these recommendations, the Panel selected some pesticides from the group of triazole fungicides in order to test the methodologies proposed and concluded that it would be necessary to reach international agreement on which groups of pesticides could be looked at together through a cumulative risk assessment approach. The Panel also concluded that the application of new cumulative risk assessment methodology required additional work and that further guidance on appropriate methodologies for exposure assessment was also still needed.
In July 2013, the PPR Panel published a general methodology for classifying pesticides into so-called cumulative assessment groups (CAGs) . The approach is based on identifying compounds that exhibit similar toxicological properties in a specific organ or system. The methodology uses broad criteria for inclusion of pesticides in groups to maximise consumer protection. As a first step, the PPR panel has applied this methodology to define groups of pesticides which are toxic to the thyroid and central nervous systems.
Identifying pesticides to be included in these groups is a major step forward in EFSA’s ongoing work to implement cumulative risk assessment as required by European law. This approach will be gradually introduced in regulating the use of pesticides in the European Union. The Authority, in dialogue with the European Commission, will also set future priorities to develop the methodology further.
- Scientific Opinion on the identification of pesticides to be included in cumulative assessment groups on the basis of their toxicological profile – Published: 12 July 2013
- Opinion on Risk Assessment for a Selected Group of Pesticides from the Triazole Group to Test Possible Methodologies to Assess Cumulative Effects from Exposure through Food from these Pesticides on Human Health - Published: 10 September 2009
- Opinion to evaluate the suitability of existing methodologies and, if appropriate, the identification of new approaches to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs for those pesticides - Published: 30 May 2009
- EFSA's 7th Scientific Colloquium - Cumulative Risk Assessment of Pesticides to Human Health: the Way forward - Parma , 28 November 2006
Activities of the Panel on Plant Protection Products
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, or when further scientific guidance is needed on more generic issues, commonly in the field of toxicology, eco-toxicology, fate and behaviour of pesticides. The European Commission may also request scientific opinions of the PPR Panel on residues of pesticides in fields outside the remit of the Pesticides Unit.
The PPR Panel has the task of revising and updating existing guidance and developing new guidance documents for pesticides risk assessment. The first to be updated was the guidance for assessing pesticide risks for birds and mammals under Council Directive 91/414/EEC.
On 17 December 2009 EFSA published guidance for applicants and Member States on the best available options for assessing the risk posed to birds and mammals in case they are exposed to pesticides. The document streamlines the pesticide assessment process and potentially reduces the number of field trials and additional animal testing. The revised guidance is based on the 2008 Opinion of the Panel on Plant Protection Products and their Residues on scientific options for such assessments . The EFSA guidance is also based on a report produced by a Joint Working Group, chaired by the European Commission and comprising representatives of Member States and EFSA, which decided on the outlined options and included recommendations on how to finalise the revision of the EFSA guidance. This output will provide guidance on how best to carry out a risk assessment with the data companies are legally obliged to submit when applying for market authorisations for pesticides. It will assist Member States in assessing the direct impact on birds and mammals of those pesticides, as required under EU legislation. This new guidance revises the one originally published by the European Commission in 2002. The PPR Panel also launched a number of public consultations in 2008 on proposals regarding new and existing guidance documents, covering issues such as dermal absorption, aquatic and terrestrial ecotoxicology, and emissions from protected crop systems.
- Guidance of EFSA - Risk Assessment for Birds and Mammals
The guidance documents provide guidance to notifying organisations and Member States on how to conduct a risk assessment for a particular area in the context of the peer review of active substances used in plant protection products. These documents do not produce legally binding effects and by their nature do not prejudice any measure taken by a Member State within the implementation of prerogatives under Annexes II, III and VI of Directive 91/414/EEC, nor any case law developed with regard to these provisions. The documents also do not preclude the possibility that the European Court of Justice may give one or another provision direct effect in Member States.
For more information
- Plant protection – European Commission, DG Health and Consumers
- Pesticide residues - European Commission, DG Health and Consumers
- Guidance documents - European Commission, DG Health and Consumers