07/02/2018

Phytopharmacovigilance fact sheets: for more information on plant protection substances

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. This information, from partner monitoring and vigilance schemes, is summarised in descriptive fact sheets for each active substance and made available on the Agency’s website, for use by all the stakeholders.

Phytopharmacovigilance relies on three fundamental and complementary methods of data collection and knowledge production: a network of surveillance or vigilance bodies, ad hoc studies and collection of spontaneous reports.

As part of the phytopharmacovigilance scheme, ANSES regularly reviews information from surveillance and vigilance schemes that work in partnership with phytopharmacovigilance. This data is specific to France. For each active substance, this information concerns:

  • 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.

This information is combined in a descriptive summarised fact sheet, for each active substance.

In addition, an information note (PDF) presents the sources of information used as input for these summarised fact sheets.

These sheets present a set of data collected in the framework of the phytopharmacovigilance scheme, specifically for France. They are taken into account in the risk assessment processes in the context of the examination of marketing authorisation (MA) applications for plant protection products, as stipulated by Regulation (EC) No 1107/2009. They therefore enable observations made specifically on French territory to be taken into account. They can also provide input for analyses in the event of health reports or alerts concerning humans, animals or the environment. Depending on the nature and significance of the reported effects and the conditions under which they occur, the information contained in these sheets, together with all the scientific data from other sources available to ANSES, may, after analysis, lead to changes being made to the MA that was initially issued.

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.

However, they do not constitute a summary of all the knowledge relating to an active substance at international level.

The results presented in these fact sheets can also give rise to local management measures, on a case-by-case basis, by the State services.

The information available in the sheets will be updated as new data are collected, knowledge is improved or the network is extended to include new partners. ANSES publishes these updates on a regular basis. New fact sheets, for new substances, will also be produced and published at regular intervals.

See the PPV fact sheets (in French)