The EU regulation on MRLs in food stipulates that decisions on MRLs should take into account cumulative effects of pesticides as and when the methods to assess such effects become available. In addition, the regulation covering the placing of pesticides on the market stipulates that pesticides should have no harmful effects – including cumulative effects – on humans.
Currently no such model exists, however EFSA and its European partners have taken a major step forward in their work on assessing the cumulative risks from exposure to pesticides. A software tool has been developed for carrying out exposure assessments of multiple pesticides. A pilot study, based on groups of pesticides that may affect the thyroid and nervous systems, will be published by the end of this year. In the longer term, EFSA hopes to start progressively incorporating high-level cumulative risk assessments into its annual analysis of the chronic and acute risks that pesticides pose to consumers using data collected by Member States.
The software – known as the Monte Carlo Risk Assessment (MCRA) tool – was initially developed through a project funded by the European Commission and overseen by the National Institute for Public Health and the Environment for the Netherlands (RIVM). In 2015, EFSA funded further development of the MCRA tool to allow the processing of cumulative assessment groups of pesticides containing up to 100 active substances and following the guidance of the EFSA Panel on Plant Protection Products and their Residues. This year EFSA will further support improvements to the tool regarding its accessibility by external users and data organisation and formatting.
Experience gained in the initial assessments will be used to optimise the tool to ensure its fitness for purpose in the context of regulatory decisions on applications concerning maximum residue levels (MRLs) of pesticides in food. This side of the project is being closely coordinated with the European Commission, which has established a working group to ensure that the project meets the needs of risk managers.
The substances to be assessed in the pilot exposure assessments were identified by EFSA’s pesticide experts using a methodology specially devised for classifying pesticides into “cumulative assessment groups” (based on the assumption that pesticides causing the same specific toxicological effects, well defined in terms of site and nature, can produce joint, cumulative toxicity – even if they do not have similar modes of action). Over the coming years, CAGs will be defined for other organs, tissues and systems. Data are already being collected to define groups of pesticides that affect the liver, kidneys, eyes, and the reproductive and developmental systems.
For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, firstname.lastname@example.org
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