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A new online reporting website for the French nutrivigilance scheme

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News of 11/02/2021

The French nutrivigilance scheme collects reports of adverse effects associated with the consumption of certain food products, including food supplements. Healthcare professionals, manufacturers or distributors and individuals can now report these adverse effects more quickly and easily on a new website. By submitting reports to this site, they are helping to improve knowledge of these products and consumer safety.

Nutrivigilance, a scheme devoted to improving consumer safety

Supported by ANSES since 2009, the French Nutrivigilance scheme seeks to improve consumer safety by rapidly identifying possible adverse effects associated with the consumption of certain foods such as food supplements, foods or beverages fortified with vitamins, minerals or herbal extracts, novel foods and ingredients, and products intended as food for specific categories of the population (infants, patients suffering from metabolic disorders, malnutrition, etc.).

To do this, ANSES relies on online reports submitted by healthcare professionals (doctors, pharmacists, etc.) and manufacturers or distributors. Individuals can also declare adverse effects; however, they are advised to ask healthcare professionals to submit reports on their behalf.

A new more user-friendly site to facilitate reporting

The electronic submission site's new user-friendly interface makes it quicker and easier to enter precise information on the products consumed or the adverse effects observed. Reports containing sufficient information are then analysed by a group of doctors who assess the severity of the adverse effect and the probability of a link between consumption of the product and occurrence of this effect, known as the causality

Using reporting data to alert the public authorities and inform producers and consumers

In the event of strong causality and high severity, the Agency alerts the public authorities so that measures can be taken, such as inspecting products, changing their labelling, amending regulations or even withdrawing products from the market. ANSES has issued publications on 12 cases of strong causality and high severity since 2009.

Depending on the reported effects, the number of cases received and their causality, the Agency conducts risk assessments that lead to scientific opinions for the relevant ministries, to enable them to take appropriate management action. These are accompanied by recommendations for healthcare professionals, consumers and manufacturers. The scientific opinions and recommendations are published on our website in the section on Nutrivigilance.

ANSES has now published fifteen opinions on a wide range of products monitored by nutrivigilance, in particular on the risks associated with the consumption of certain substances in food supplements (spirulina, lutein, zeaxanthin, synephrine, red yeast rice, glucosamine and chondroitin, melatonin, etc.), food supplements intended for athletes or for pregnant women, so-called energy drinks, and beverages other than breast milk and its substitutes in the diet of infants under one year of age.

Healthcare professionals, manufacturers and individuals, by reporting adverse effects to this scheme, you are helping to improve product and consumer safety!

Important reminders about the consumption of food supplements:

Healthcare professionals: during consultations, consider asking your patients if they are taking food supplements.

Individuals: food supplements are not harmless products. For more advice on the consumption of food supplements, take a look at our information sheet.