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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 09/11/2018

What is nutrivigilance?

Keywords : Nutrivigilance, Food supplements, Adverse effects

Food supplements, fortified foods and beverages -  these products can cause adverse effects when consumed. To identify them and better protect consumer health, ANSES has set up a vigilance scheme for food known as nutrivigilance.

The purpose of the nutrivigilance scheme is to improve consumer safety by rapidly identifying any possible adverse effects related to the consumption of:

  • food supplements
  • foods or beverages fortified with substances for nutritional or physiological purposes (vitamins, minerals, amino acids, plant extracts, etc.) such as energy drinks,
  • novel foods and novel ingredients  such as phytosterols, guar gum and noni juice, 
  • products intended as food for specific categories of the population (infants, athletes, patients suffering from food allergies, etc.)

Implementation of the national nutrivigilance scheme was entrusted to the Agency in July 2009 by the French Act on Regional Health Governance (HPST). 

 

Who can report adverse effects?

To ensure the accuracy of the information provided, healthcare professionals (doctors, pharmacists, dieticians, etc.) are responsible for reporting adverse effects to the scheme.

If you, as a private individual, wish to report any adverse effects, you should preferably do so through a healthcare professional.

ANSES points out that healthcare professionals are the key to a dynamic and effective system. It recommends that they consider asking their patients about their consumption of food supplements and other products during consultations.


Where should reports be made?

Adverse effects can be reported on the Adverse Health Event Reporting Portal (in French) of the Ministry of Social Affairs and Health, or directly on the ANSES website by filling in the online form (in French).

When reports are recorded, the patient's anonymity is always preserved.

 

How are the reports used?

Reports of adverse effects received by ANSES are analysed by a group of medical experts who assess the severity of the adverse effect and the probability of a link between consumption of the product and the occurrence of this effect (causality).

Depending on the effects observed, the number of cases received and their causality, the Agency may act on its own initiative to conduct an assessment of the risks associated with consumption of these products or ingredients.

These assessments lead to the publication of scientific opinions and recommendations intended for healthcare professionals and consumers.

The case analyses and the resulting scientific opinions enable risk managers to define, if necessary, appropriate management measures to be implemented.

 

Some examples include: