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French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 01/12/2017

Nutrivigilance scheme: objective and main results

Surveillance of adverse effects linked to the consumption of food supplements, fortified foods and beverages, and novel ingredients and foods

Keywords : Nutrivigilance, Food supplements, Adverse effects

The consumption habits, market offer and distribution channels for food supplements, novel foods, fortified foods and beverages and foodstuffs for people with specific needs are constantly changing. Yet these products, often perceived by consumers as harmless, can under certain conditions expose them to risks. In order to identify the possible adverse effects of these foods and to reinforce consumer safety, ANSES has been tasked since 2010 with a nutritional vigilance mission. Since the Nutrivigilance scheme was set up, ANSES has issued recommendations on nine different products. So-called energy drinks, food supplements containing alcoholic extracts of yam, red yeast rice and p-synephrine, an instant almond-based beverage for 12-month-old infants, etc., have all been the subject of opinions by the Agency, and three other types of food supplements are currently under examination. Since each opinion launched is based on the declarations of adverse effects received by ANSES, healthcare professionals are an essential link in making the Nutrivigilance scheme work.

For several years now, there has been a rise in the consumption of food supplements, foods and beverages fortified with substances for nutritional or physiological purposes (vitamins, minerals, amino acids, plant extracts, etc.), as well as novel ingredients and foods and products intended for consumption by specific populations. The market offer and distribution channels are also evolving. While these products are often perceived by consumers as without danger, under certain conditions they may expose them to risks.

It is within this framework that in July 2009 the French Act on Regional Health Governance (Loi Hôpital, Patients, Santé et Territoires) entrusted ANSES with the implementation of a nutritional vigilance scheme. Its goal is to monitor the safety of these products under real-life conditions of use by collecting and analysing any adverse effects that may be linked to their consumption.

Four years in operation, 1565 declarations, nine opinions issued

Since ANSES's Nutrivigilance scheme was initiated, it has received 1565 reports of adverse effects. 76% of reported cases involved food supplements while 24% concerned fortified foods or foodstuffs for special uses (including 16% on so-called energy drinks). With regard to food supplements, over one-third of the valid declarations received involved weight-loss, hair health or cholesterol-lowering products. In addition, the main adverse effects reported involved the liver, digestive system and allergies.

Report processing 

Each adverse effect declaration received by the Agency is analysed by a group of experts (doctors and pharmacists). The report, the composition of the product consumed and the probability of a link between the consumption of a given product and the onset of a given adverse effect are analysed. Depending on the results of the analysis, the Agency can decide to launch an internal request in order to conduct a risk assessment of the consumption of certain products or ingredients.

Nine specific scientific opinions were issued by the Agency in this way: so-called energy drinks, food supplements containing alcoholic extracts of yam, lutein, zeaxanthin, red yeast rice, p-synephrine, an instant almond-based beverage for 12-month-old infants, etc. have all undergone health risk assessments. 

Three additional assessments are currently in progress, on food supplements for pregnant women, for athletes, and supplements containing spirulina (results expected in the first quarter of 2015).

The involvement of healthcare professionals is essential to making the Nutrivigilance scheme work.

To ensure that the information supplied is sufficiently precise, healthcare professionals (doctors, pharmacists, dietitians, etc.) are in charge of filing the adverse effects reports. For this, a dedicated website has been created so that they may either file an online declaration or download a declaration form to fill in and send to ANSES. 

All individuals who wish to file an adverse effects report must therefore contact a healthcare professional in order to do so. 

ANSES also emphasises that healthcare professionals are key players in the scheme and that their cooperation is necessary in order to maintain its dynamism and effectiveness. We also recommend that they take the time during visits by their patients to ask them about their consumption habits regarding the types of products involved in the Nutrivigilance scheme. 

We also wish to stress that pregnant or breastfeeding women, children and people taking medical treatments should always seek the advice of a healthcare professional before taking food supplements, and that they should always comply with the instructions for use set by the manufacturer and avoid taking these products for prolonged, repeated or regular periods throughout the year without any specific reason.