What is phytopharmacovigilance?
The phytopharmacovigilance scheme is a vigilance system that collects and analyses monitoring data on plant protection products. The goals are to identify, as early as possible, any adverse effects related to the use of these products and by doing so, protect the health of living beings and ecosystems.
This scheme, which was set up in 2015, is unique in Europe: it takes all adverse effects into account, whether they relate to human, animal or plant health, food or the environment.
These signals can lead to measures being taken to prevent or limit risks.
ANSES set up this scheme under the French Act on the future of agriculture, food and forestry of 13 October 2014. It is fully in line with the objective of the Ecophyto plan to assess, control and reduce the risks and impacts of plant protection products for human health and the environment. Designed to further protect human, animal and plant health from biologically active products, the phytopharmacovigilance scheme is an essential complement to ANSES's other missions, in particular the assessment of the effectiveness of plant protection products and of the risks associated with their use, which gives rise to the issuing or refusal of marketing authorisations.
What data are collected?
The phytopharmacovigilance scheme continuously collects and examines information produced by several partner networks and monitoring and vigilance organisations, in relation to:
- the contamination of media – air, water, soil, food and drinking water – by residues including metabolites of plant protection products;
- exposure, contamination levels and impacts on living organisms and ecosystems as a whole: humans, farm animals, wildlife, crops, and flora;
- resistance phenomena in the organisms targeted by these substances: pathogens, weeds, and insect pests.
This information is collected and published in the form of fact sheets for each active substance.
Moreover, the phytopharmacovigilance scheme takes into account international data and studies, namely epidemiological studies.
Who are the phytopharmacovigilance network's partners?
The organisations involved in phytopharmacovigilance are appointed by the Ministerial Order of 16 February 2017 amended by the Ministerial Order of 14 December 2018.
How are effects reported and analysed?
The main role of phytopharmacovigilance is to collect reports from professionals such as users of plant protection products and healthcare professionals. Several partners of the phytopharmacovigilance scheme offer services for reporting or recording adverse effects: these include the Phyt'attitude scheme for toxicovigilance in agricultural areas, managed by the Agricultural Mutual Insurance Scheme (MSA), and the bee mortality reporting system, run by the French Ministry of Agriculture.
Each report is analysed to decide whether it constitutes an alert, requiring the implementation of risk management measures, or whether it needs to be further investigated, in particular via ad hoc studies or increased surveillance.
What types of studies are conducted under the phytopharmacovigilance scheme?
Every year, the phytopharmacovigilance scheme has a budget of around €1.4 million to fund specific studies and generate new knowledge, for example when a new signal is detected. Each of these ad hoc studies has one of the three following objectives:
- consolidate and develop surveillance tools and methods;
- improve the characterisation of a signal;
- generate new knowledge.
These are observational studies carried out with plant protection products in actual conditions of use: epidemiological studies, studies on concentration levels in the population, measurements in environmental media, and surveys of practices.
To fill identified gaps in data, ANSES defines three-year strategies laying down priority themes that should be considered when choosing studies to be funded. For the 2018-2021 period, it identified the four following themes:
- ambient air for the general population and for specific populations;
- exposure and the impact on agricultural workers;
- bees and other pollinators;
- biodiversity and environmental media (soil).
Since it was created, the phytopharmacovigilance scheme has helped implement or initiate more than 40 studies including the national exploratory campaign to measure pesticides in ambient air, conducted with INERIS and the approved air quality monitoring associations; the GEOCAP-Agri study by Inserm and Santé publique France on the association between paediatric cancers and the proximity of agricultural areas; the study of the National Museum of Natural History on a statistical analysis cross-referencing monitoring data on animal populations with data on sales of plant protection products; and the PestiRiv study on the exposure to pesticides of people living near vineyards.
What are the data and knowledge produced through the phytopharmacovigilance scheme used for?
The data collected and produced as part of the phytopharmacovigilance scheme are used to:
- adapt, if necessary, the marketing authorisation conditions of products already on the market, for example by reducing doses, changing the conditions of application or withdrawing a marketing authorisation;
- take management measures to reduce high-risk exposure, for example for the protection of people in the vicinity of treated areas;
- help improve, if necessary, the risk assessment methods used at European level before products are placed on the market.