The use of the term probiotic in France, Italy and Spain: a comparative analysis

Since the beginning of 2023, it is possible to use the word probiotic on food supplements in France. Here follows a comparison with the situation in Italy and in Spain.

With the arrival of 2023, France has opened up to the possibility of using the term probiotic for food supplements that contain probiotics. European guidance with no legal force indicates the word probiotic as a general, non-specific health claim, which must be accompanied by a specific, approved health claim in order to be used. However, more and more countries are opening up to the use of this term, under different justifications and with no need to associate a specific health claim to it. In this article we compare the approach of three of these countries: France, Italy, and Spain.

Use of the term probiotic: official documents and scope

The positions of the three countries are expressed through a position adopted by the AESAN in Spain*, guidelines by the Ministry of Health in Italy, and a DGCCRF letter addressed to Synadiet** in France, respectively. The Italian document is accompanied by its translated version in English.

The scope of the three documents is not the same: while Italy and Spain open to the use of the term probiotic in relation to foods, including food supplements, France restricts the use of the term to the latter category.

Use of the term probiotic: definitions, claims, and rationales

The documents from the three countries are not aligned regarding the definition of probiotic. The Italian guidelines, analyzed in a dedicated article by Orchidali, do not include any definition of the term probiotic. The Spanish document recalls that there is no harmonized definition of the term probiotic in EU legislation, and that the term is used to refer broadly to bacterial species, bacterial strains, or species of live microorganisms. The French authorities choose instead to use the definition of probiotic indicated by FAO and WHO: “Live microorganisms which when administered in adequate amounts confer a health benefit on the host”.

The reasoning behind the authorization of the term probiotic differs between Italy on the one hand, and France and Spain on the other.

Without stating it explicitly, the Italian guidelines assume that probiotics can promote the balance of intestinal flora***. Considering, as stated by EFSA, that increasing the number of any groups of bacteria is not in itself a beneficial health effect, the term probiotic is not an health claim, and is not subject to prior authorization by European authorities.

The justification brought by France and Spain for the use of the term probiotic stems from the fact that, due to the principle of Mutual Recognition, numerous products mentioning the term probiotic, originating from countries where this mention is authorized, are found on the market and might penalize domestic companies. The solution becomes adapting to the market while waiting for common European regulations.

The French letter specifies that the term probiotic is authorized as a category name to characterize the nature of the ingredients.

With regard to statements associated with probiotics, Italy justifies the claims on the support of the microbiota balance with the same logic used for the term probiotic, i.e. by inferring that it is not a health claim. The French position allows referring to the support of the balance of intestinal flora, too. A degree of word flexibility is allowed, provided the meaning of the sentence is left unaltered. The Spanish document does not accept any claim on the action exerted by probiotics.

Use of the term probiotic: characterization, safety, and efficacy of probiotic ingredients

The three documents also cover topics related to the use of probiotics, such as the characterization of the microorganisms used, their safety, and their efficacy.

France and Italy recommend the use of microorganisms that have a history as probiotics (or are approved novel foods), and that are properly characterized: they should be identified to the strain level, named using officially-recognized taxonomic nomenclature, and deposited in a qualified culture collection.

Concerning the safety of the microorganisms used, Spain and France recall that the products in question must comply with the general food law; Italy and Spain cite the QPS list as a reference for ensuring the safety of a certain microorganism, and Italy and France insist that the microorganisms chosen do not carry antibiotic resistance.

France and Italy also address the measures ensuring that the microorganisms perform the claimed action on the balance of the intestinal microbiota. Since this activity is related to the amount of microorganisms ingested, the Italian guidelines require the presence of at least 10⁹ live cells per daily dose for at least one strain in the product; the French authorities, on the other hand, require 10⁷-10⁹ live cells.

Use of the term probiotic: considerations

The positions of the three countries analyzed are similar, and in each country it is possible to use the word probiotic, at least on food supplements. However, the justifications and additional provisions are not identical. The provisions of each country are summarized in the table at the bottom of the article.

Orchidali helps you comply with regulatory requirements.

* Link in Spanish.

** Synadiet is the French national trade association for dietary supplements. Link in French.

*** The Italian guidelines refer to bacterial flora; however, the term microbiota would be preferable.