For the last few decades, consumption of food supplements has steadily increased. More than 30,000 food supplements are available on the French market. Almost 16% of French adults and 6% of children consumed one of these products in 2012. But some products contain pharmacologically active ingredients which can cause adverse effects. An adverse effect is a harmful reaction occurring under normal conditions of use, or resulting from misuse.

This innovative scheme, unique to Europe, was initially set up in 2009 to monitor food products of special concern that are not covered by other vigilance schemes (ex. medicinal or exotic plants found in food supplements are not covered by drug monitoring). A pilot phase was launched for the scheme in 2010-2011 during which 192 cases of adverse effects were reported. The pilot phase was replaced in 2012 with the full-scale scheme, which is fully operational and more responsive.

This program is led by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES), an independent scientific body whose central role is to assess health risks in order to inform public policy and thus help ensure the safety of consumers.

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Which products are covered by the Nutritional Vigilance Scheme?

The goal of this scheme is to improve consumer safety by quickly 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.)

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How are adverse effects reported?
They can be reported by health professionals such as doctors, pharmacists, and dieticians who have identified them in their patients, or by producers and distributors. The declaration form can be filled quickly and easily on the ANSES website. Private individuals wishing to file a report are encouraged to first contact a healthcare professional.

How are the reports handled?
Reports recorded by ANSES preserve the anonymity of the consumer. They are then analyzed by ANSES’s nutritional vigilance team with the help of medical experts. The results of these analyses are provided to relevant French Ministries so that they may implement appropriate management measures.
Depending on the number of cases reported and their severity, the Agency may decide to conduct an assessment of the risks of consuming certain products or certain ingredients.

For more information, please visit the ANSES web site