Reporting adverse effects of supplements made easier with Nutrivigilance upgrade

By Will Chu

- Last updated on GMT

©ANSES
©ANSES

Related tags: Adverse event, ANSES, Supplements, spirulina

French food authorities have introduced a new online resource that is hoped to streamline the process of reporting adverse effects of supplements and other food products.

The French Agency for Food, Environmental and Occupational Health & Safety’s (ANSES) Nutrivigilance scheme​simplifies the reporting process into six steps that allows users to anonymously report any unwanted effects as a result of consuming certain foods.

According to ANSES, the process has been speeded up to allow electronically submitted details to undergo evaluation by the relevant authority.

“The Nutrivigilance system aims to harvest the undesirable effects of certain types of food products such as supplements, fortified drinks or so-called energy drinks,”​ explains Gwenn Vo Van Regnault, Nutrivigilance Officer for ANSES.

“This also includes new foods or ingredients such as guar gum and also products intended for particular populations such as infant foods.

Severity and accountability

“The Nutrivigilance system is based on statements that are made directly online on the site to the agency, where all declarations are then processed.

“Those that are sufficiently documented are analysed by a group of experts, who look at the severity of the side effects but also accountability. i.e. the probability that the effect is linked to the consumption of the product.

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.

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.

According to Van Regnault, these assessments lead to scientific opinions that are submitted to the relevant ministries, to enable them to take appropriate management action.

These opinions are accompanied by recommendations intended for healthcare professionals, consumers and manufacturers.

Spirulina et al

ANSES has recently had to deal with a spate of cases concerning food supplements that may have played a role in its upgrade of its nutrivigilance reporting procedures.

To date, ANSES has published fifteen opinions on products monitored by nutrivigilance, including those with risks linked to the consumption of food supplement ingredients (spirulina​, lutein, zeaxanthin, synephrine, red yeast rice, glucosamine and chondroitin, melatonin).

The authority has also published its opinions on food supplements for athletes​ or pregnant women, energy drinks​ and beverages and breast milk substitutes for infants under one year of age.

The agency has been responsible for the national nutrivigilance system’s implementation since 2009, where around 5,000 declarations have been recorded since then with around 1,000 declarations per year noted in recent years.

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