ANSES publishes its first phytopharmacovigilance fact sheets
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News of 02/02/2018
Today, ANSES is publishing the first in a series of fact sheets summarising the data it collects for each active substance under the phytopharmacovigilance scheme it coordinates. The aim of phytopharmacovigilance is to be able to take swift action on a product's marketing authorisation if a harmful effect is observed, in order to prevent its occurrence, for example by amending the product's conditions of use, limiting its uses, or even withdrawing the marketing authorisation. These summarised fact sheets, which contain all the information from the surveillance and vigilance schemes working in partnership with phytopharmacovigilance, are therefore particularly useful to ANSES in the context of the decisions associated with the process of examining marketing authorisation applications for plant protection products, as well as to risk managers, for defining the measures to be put in place if needed.
The phytopharmacovigilance scheme is a health monitoring system whose aim is to protect human and animal health and the environment by identifying any adverse effects associated with the use of plant protection products as early as possible. This scheme, which was set up in 2015, is unique in Europe: it takes all these adverse effects into account, whether they relate to human, animal or plant health, or food or the environment.
From today, ANSES is publishing fact sheets presenting all the data it collects as part of the phytopharmacovigilance scheme, for each active substance. This information comes from the systematic and regular collection of data and observations produced by the surveillance and vigilance bodies already in place, which work in partnership with the phytopharmacovigilance scheme.
These sheets therefore contain information for each active substance on:
- the use of the active substance,
- the presence of this active substance in media (water, food, ambient air, human blood concentrations),
- the risks to the population associated with exposure to this active substance,
- the observed impacts and any potential links with this active substance.
The availability of this new tool will provide insights for risk managers when defining appropriate risk management measures, and for ANSES when examining marketing authorisation applications for plant protection products, in addition to the information it receives from the applicants.
These fact sheets can also be used to identify gaps in knowledge to be addressed by strengthening the partner schemes or setting up specific studies. The information available will be supplemented and updated as new data are collected, knowledge is improved or the network is extended to include new partners.