An overview of regulatory rules for the EU, US, China, and Japan regarding probiotics’ use in foods and their claims.
by Ainhoa Larrañaga and Mathilde Do Chi
Probiotics are live microorganisms, which confer a certain health benefit on the host when administered in adequate amounts. The effect it has is largely dependent on the specific strain. Even though there is a wide range of strains, seven core genera of microbial organisms remain commonly used worldwide, namely Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, Escherichia, and Bacillus.
Either added to regular foods like dairy or made available in food supplements, probiotics have been shown to have health benefits. Examples include improving mild to moderate irritable bowel syndrome or helping to manage symptoms associated with the poor digestion of lactose. Therefore, companies are entitled to make claims on their products containing probiotics, taking into consideration restrictions that may apply in the country where these are sold. However, further limitations have to be considered regarding the target group or even the type of products where the live microorganisms are added, like infant formulas.
Here we give an overview of probiotics regulation in different jurisdictions, namely the EU, US, China, and Japan.
A common regulatory framework governs the claims, registration, and specific requirements on foods for children and infants applicable to the 27 Member States of the EU.
Under Regulation 1924/2006 on nutrition and health claims made on foods, there are no approved claims for probiotics. These claims have been rejected due to insufficient characterization of the strain or insufficient scientific evidence to demonstrate a cause and effect relationship between the food and the claimed effect.
The terms “probiotics” or “contains probiotics” are not permitted, as these are considered health claims and, thus, they cannot qualify as nutrition claims. An application under Article 1(4) of Regulation 1924/2006 was filed in 2014 to recognize the term “probiotics” as a generic descriptor—used to indicate a particularity of a class of foods or beverages that could imply an effect on human health. However, a decision has not yet been reached.
Despite this, some Member States like Italy or the Nether- lands have adopted divergent rules in connection with the composition, labeling, and advertising of probiotics and allow the term “probiotics,” provided their guidelines are met. Moreover, the 2013 Italian guidelines on probiotics allow the use of the claim “contributes to the maintenance of balanced intestinal microflora.”
Even though there are no approved claims for probiotics, there is one claim that has been authorized for live cultures in yogurt, which pertains to lactose digestion for the microorganisms Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus, with the condition these contain at least 10 colony forming units (CFUs) per gram.
Food products containing probiotics do not need to be registered. However, specific restrictions may apply at the national level.
Most Member States accept the use of probiotic strains that have been awarded the status of qualified presumption of safety (QPS), an assessment method established by the European Food Safety Agency (EFSA), which determines the safety of the use of microorganisms in food. All microorganisms that have been awarded QPS status are presumed to be safe and have a confirmed history of use in foods.
However, it shall be noted that if a strain has not been used be- fore May 1997 within the EU, it shall be deemed a novel food and requires a pre-marketing authorization under Regulation 2015/2283 on novel foods.
Foods for Children or Infants
Probiotic claims are not permitted either in children or infant foods, including infant formula and follow-on formula, for which nutrition and health claims have been prohibited since February 22, 2020, pursuant to Regulation 2016/127.
While EFSA has concluded there is no necessity to add probiotics to infant and follow-on formula, their use is not expressly restricted under Regulation 2016/127. It is therefore possible to do so, when proven suitable for infants by generally accept- ed scientific data. In practice, infant formula containing probiotics can be found on the market
This article originally appeared in the Oct/Nov 2020 edition of The World of Food Ingredients. Click here for the full version on page 134.