EFSA presents cumulative assessment group methodology for pesticides
The European Food Safety Authority (EFSA) has developed a new approach for grouping pesticides that paves the way for the implementation of cumulative risk assessment A method of assessing risks to health or the environment posed by multiple substances such as chemicals. - a sophisticated technique to assess the risk posed by exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to multiple pesticide Substance used to kill or control pests, including disease-carrying organisms and undesirable insects, animals and plants. residues. The general methodology for classifying pesticides into so-called cumulative assessment groups (CAGs) is based on identifying compounds that exhibit similar toxicological properties in a specific organ or system. As a first step the Authority’s Panel on Plant Protection Products and their Residues (PPR) 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 A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. as required by European law[i]. This approach will be gradually introduced in regulating the use of pesticides in the European Union. EFSA highlighted that the cumulative assessment group methodology applies to pesticides only and does not include other types of chemicals potentially present in food.
Broad criteria for consumer protection
The methodology developed by the PPR Panel uses broad criteria for inclusion of pesticides in groups to maximise consumer protection. This follows on from the formal consultation of the European Commission on general recommendations regarding the desired level of protection to be achieved.
Groups are formed by identifying pesticides that produce similar toxic effects in a specific organ or system. The methodology consists of four stages:
- Identifying specific and unambiguous toxic effects that adversely affect an organ or system - known as hazard identification The first step in risk assessment, this involves the identification of biological, chemical, and physical agents capable of causing adverse health effects. (e.g. imbalance of the thyroid system).
- Hazard characterisation The second step in risk assessment, this involves defining the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. The process should, if possible, involve an understanding of the doses involved and related responses. that describes the precise nature of this adverse effect A change in the health, growth, behaviour or development of an organism that impairs its ability to develop or survive to specific organs or systems (e.g. identifying the most appropriate indicator for the specific effect, for instance, a hormone).
- Data collection – gathering data on the indicators (e.g. changes in hormone levels at the dose The total amount of a substance (e.g. a chemical or nutrient) given to, consumed or absorbed by an individual organism, population or ecosystem. where the adverse effect occurs) that point to a specific toxic effect (e.g. imbalance of the thyroid system) in an organ/system.
- Grouping of pesticides that exhibit a similar toxicological effect into cumulative assessment groups by organ or system (e.g. thyroid).
This approach requires expert scientific judgment as it involves the analysis and interpretation of large volumes of complex data. In addition to identifying pesticides that affect the thyroid and nervous systems, the PPR Panel has carried out a large body of preliminary work for the development of groups for effects on other organs/organ systems such as the reproductive system, the liver, eye and adrenals.
Future steps
EFSA will now begin the gradual implementation of cumulative risk assessment in its work on pesticides and, in dialogue with the European Commission, will set future priorities to develop the methodology further. The Authority is also due to hold an ‘Information Session’ for stakeholders in 2014 on implementing cumulative risk assessment.
EFSA’s work in cumulative risk assessment of pesticides is just one area where it is actively engaged in evaluating the risk to human health and the environment from exposure to chemical mixtures. The Authority’s Science Strategy highlights the need to develop a harmonised and consistent approach for the risk assessment of chemical mixtures in food.
EFSA’s work in the field of pesticides relates to two main areas: risk assessment of maximum residue levels (MRLs) and the peer review of active substances.
- Maximum Residues Levels (MRLs) are the upper levels of a concentration of pesticide residues legally permitted in or on food or feed to ensure the lowest possible consumer exposure. Before an MRL is set a risk assessment must be carried out to ensure consumer safety. EFSA’s risk assessments of pesticides evaluate whether, when used correctly, these products can be shown to have no direct or indirect harmful effect on human or animal health, or the environment.
- Peer review of active substances – active substances used in pesticides are the chemicals or micro-organisms that are the essential component enabling the product to do its job. EFSA is responsible for the evaluation – or peer review - of the existing active 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.
[i] Regulation (EC) 396/2005, Regulation (EC) 1107/2009 and Regulation (EC) 396/2005 require that cumulative effects of pesticide residues need to be considered.
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