National Nutrivigilance Scheme
The nutritional vigilance scheme is a health monitoring system which aims to improve consumer safety by rapidly identifying potential adverse effects associated with, primarily, the consumption of food supplements or novel foods. This programme is unique in Europe and was established in 2009.
The national nutritional vigilance scheme was established by the French Act on Regional Health (loi Hôpital, Patients, Santé et Territoires) and placed under ANSES’s responsibility in July 2009.
The goal of this scheme is to improve consumer safety by rapidly identifying potential adverse effects related to consumption of:
- food supplements
- food or drinks fortified with substances for nutritional or physiological purposes (vitamins, minerals, amino acids, or plant extracts) such as energy drinks
- novel foods and novel food ingredients such as phytosterols, guar gum, and noni juice
- products intended for specific population groups (infants, athletes, patients with food intolerances, etc.)
Several factors prompted the creation of this nutritional vigilance scheme:
- the steady increase in the consumption of food supplements in recent years
- the presence of pharmacologically active ingredients in some products
- reports of adverse effects registered with other vigilance systems not specifically dedicated to food (pharmacological or toxicological vigilance, for example)
- the declaration required before placing food supplements on the market.
After a pilot phase of vigilance targeting food supplements in 2009 and 2010, ANSES has now extended this scheme to all products.
How to file a report?
Who can file a report?
- Health professionals (doctors, pharmacists, dieticians, etc.) who have identified adverse effects in their patients.
- Producers and distributors, within the framework of the provisions of Article L.221-1-3 of the French Consumer Code.
- Private individuals wishing to file a report are encouraged to contact a healthcare professional.
Where to file?
On the Nutrivigilance website, by filling in the online form. E-filing is a quick and reliable way to make a nutrivigilance report.
It is also possible to download the report form, fill it out, and return it to ANSES by email, fax or post.
What is an adverse effect related to food?
It is a harmful reaction occurring under normal conditions of use or resulting from misuse.
It is best to fill in the declaration form as precisely as possible in order to better characterise the reported adverse effect.
How are the reports handled?
Reports are recorded by ANSES while preserving the anonymity of the consumer.
They are then analysed by ANSES’s nutrivigilance team with the help of medical experts.
After consulting the Expert Committee on Human Nutrition, with the support of the Nutrivigilance Working Group, the results of these analyses are provided to the relevant French Ministries so that they may implement appropriate management measures.
Depending on the number of cases reported, their severity, and causality, the Agency may decide to conduct an assessment of the risks of consuming certain products or certain ingredients. These assessments result in ANSES opinions which can be consulted below.