FRANCE AUTHORIZES THE TERM ‘PROBIOTIC’ ON FOOD SUPPLEMENTS

The French authorities have authorized the term “probiotic” on food supplements.

The approved definition of probiotics is: “Living microorganisms, which, when consumed in adequate quantities, have a beneficial effect on the health of the host by contributing to the balance of the intestinal flora.”

The authorization limits the use of claims on product labeling and marketing communications to the effect of probiotics on the balance of intestinal flora. Some flexibility is allowed, brands may use wording that is considered equivalent, such as “contributing to the maintenance of intestinal flora”, but they may not claim to increase or reinforce the gut flora.

The probiotics used must provide a minimum of 10⁷ to 10⁹ live cells of a strain per day, the strains must be well characterized, and also have a history of safe use. They must not fall within the scope of the novel food regulation.

In the EU at present, there is one health claim approved linking live microorganisms, that is, live cultures in yogurt or fermented milk with improved lactose digestion. However, probiotic strains as such have not received a positive opinion from the European Food Safety Authority (EFSA) based on health benefits claimed as part of submitted applications, therefore no health claim specific to probiotics has been authorized in the EU. As a result, the European Commission has considered the term ‘probiotic’ to be an unauthorized health claim that cannot be used in food labeling.

Italy was the first country to allow the use of the term probiotic on food supplements. In 2012, they stated that, since the EFSA’s assessment was that balance of the microflora was not a health effect, probiotics could be regulated under other provisions with specific conditions of use. Since then a growing number of EU countries have adopted the Italian approach. Now Spain, Denmark, the Czech Republic, and the Netherlands are now tolerating or regulating the term under conditions. Other countries allowing the use of probiotics without publishing a formal position include Bulgaria, Malta, and Poland.