« Probiotic » term can now be used on food supplements in France
Background: in the Guidance on the implementation of Regulation N° 1924/2006 on nutrition and health claims: conclusions of the standing Committee on the food chain and animal health published in 2007, the probiotic term is considered as a health claim because it refers to the implied description or indication of a functionality on health.
France until now strictly followed this interpretation and considered this health claim as a nonspecific health claim that has to be accompanied by an authorized health claim to be used as it is stated in the article 10.3 of the EU regulation 1924/2006. Only one specific health claim related to the health effect of microorganisms has been authorized since the application of the Nutrition and Health claim Regulation. Thus, the use of the probiotic word was rejected on most of food products including food supplements.
On another hand, an increasing number of European countries such as Italy, Spain, The Netherlands, Czech republic, Denmark, Greece, …) broke out the European orientations and the use of the probiotic term on food supplements develops around Europe.
The letter from the French administration addressed to the French food supplement Association:
On December 19, 2022, the French administration issued a letter about the use of the “probiotic” term as a name of category of substances characterizing food supplements. In this letter, the French administration has changed its position and has stated that the use of probiotic term has not to be considered as a nonauthorized health claim when it is used on food supplements under the following conditions:
- Probiotic is used as the name of a substance category for characterizing the nature of the constituents in food supplements according to the requirements of the article 6.3.a of the EC Directive 2002/46 on food supplements.
- Probiotics according to the combined definition of FAO/WHO and of the Larousse dictionary, are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host contributing to the balance of the intestinal microflora.
- In order to fit with the above definition, food supplements bearing probiotic name have to contain at least from 107 to 109 UFC of a strain per daya so that a significant level of live microorganisms can reach the gastrointestinal tract and develop there.
- Without prejudice to health claims that can be allowed in the future according to the validation process defined by the EU regulation, no health claim referring to another benefit than the intestinal microflora balanceb figures on the labelling of food supplement and on the referring commercial communication.
The companies in charge of commercializing food supplements with probiotics have to put on the market food supplements complying with the Food law especially on the food safety aspects. Strains to be used have to belong to species with a significant food consumption history, to be well characterized, and to not bear antibiotic resistance. When no consumption history is available, the compliance to the Novel Food regulation 2015/2283 has to be respected.
UFC: unit forming colony
a: according to the generally recognized data, without prejudice of justification for a lower dose through scientific data;
b: only the wording ”contributes to gut microflora balance” can be used or any wording with the same meaning. In case of reformulation, the health claim wording can only refer to the contribution (support, help, …) of these live microorganisms for a normal constitution of the gut microbiota and not to a reinforcing effect, increasing the gut microflora.
Thanks to the joined work between the French food supplement Association and the French administration, the term “probiotic” can be used on food supplements as the name of a category of substances characterizing the constituents of food supplements.