The fundamental principles underlying ANSES’s vigilance schemes
ANSES coordinates seven vigilance schemes aimed at identifying adverse effects caused by several types of products and foods. What are the fundamental principles underpinning this mission at the Agency? What do the new vigilance schemes for cosmetics and tattoos involve? What is the outlook for these schemes? Juliette Bloch, Director of Health Alerts and Vigilance, answers our questions.
What do all the vigilance schemes coordinated by ANSES have in common?
The seven vigilance schemes we coordinate are all very different. They monitor adverse effects in a wide variety of areas. Although each one has its own way of operating, they are all based on the same principle: identifying adverse effects associated with specific products and exposure situations. Several of these schemes are based on reports we receive from healthcare professionals, manufacturers and individuals via dedicated reporting sites, in particular the ANSES website and the Ministry of Health’s reporting portal.
We analyse each report received and discuss it with our experts, in particular those from poison control centres. Next, we look for similar cases in our databases and, in the event of an anomaly, we pass on the alert to the competent authorities, which then take appropriate action. The act of reporting therefore benefits the whole community. It is a gesture that can help us to quickly identify the toxic effects of certain food supplements and everyday items such as hygiene products, as well as the adverse effects associated with a new veterinary medicinal product, for example.
The seven vigilance schemes coordinated by ANSES
Nutrivigilance aims to quickly identify possible adverse effects related to the consumption of food supplements, fortified foods or novel foods.
Toxicovigilance monitors toxic effects on humans, whether acute or chronic, following exposure to natural or synthetic substances or substance mixtures available on the market or present in the environment. This scheme is supported by the network of poison control centres.
The objective of phytopharmacovigilance is to document the presence of plant protection product residues in different media (including food) and identify any adverse effects on human, animal or environmental health associated with the use of these products.
Veterinary pharmacovigilance monitors the side effects of veterinary medicines on the health of treated animals, veterinarians and individuals, as well as on the environment and food, after these products have been placed on the market.
The objective of the National Network for Monitoring and Prevention of Occupational and Environmental Diseases (RNV3PE) is to identify risk situations in the workplace based on data from consultations carried out at the 28 occupational and environmental disease consultation centres
The aim of cosmetovigilance is to identify any adverse effects in humans associated with the use of cosmetics.
The goal of tattoovigilance is to monitor the adverse effects caused by the use of tattoo products.
Could you explain the major fundamental principles behind these vigilance schemes as you described them in the scientific document you recently published?
Each vigilance scheme is managed by a dedicated scientific team. A vigilance coordination committee oversees the implementation of general fundamental principles (PDF in French). These guarantee the same level of quality in the analysis of reports; they also ensure consistency in the methods used to characterise a signal and a health alert, the monitoring of reports, and the dissemination of our analyses. In accordance with these principles, we work to develop robust methods for determining causality that are scientifically tested and validated. These enable us to estimate the strength of the causal link between exposure to a product, for example, and an adverse effect that has been reported. We are also committed to monitoring the alerts sent to the authorities and the measures taken to address them. This is a performance indicator for our vigilance missions. To raise awareness among the groups most concerned, especially healthcare professionals, and highlight the value of reporting, we have created the Vigil’Anses newsletter, which features articles that are quick to read and can be understood by non-specialists.
What is the outlook for the years to come?
Since January 2024, we have been responsible for two new areas of vigilance: cosmetics and tattoo products. These were previously managed by the French National Agency for Medicines and Health Products Safety (ANSM). We are deploying the resources needed to successfully carry out these two missions; in practical terms, we are recruiting new staff members to increase our skills in these highly regulated areas and to be able to analyse a greater number of reports. Another challenge for the vigilance schemes is to develop the detection of weak signals. Together with Santé publique France and the ANSM, we are working on automated detection models for identifying new phenomena and unusual events in large datasets, including discussion forums.