The country joined a growing movement away from the European Commission’s interpretation on the use of the term. The Directorate General for Competition policy, Consumer Affairs and Fraud Control (DGCCRF) has announced to the French organisations that the use of the word “probiotic” can be allowed on the label of dietary supplements that meet certain conditions, as well as the related health claim “contributes to the balance of the intestinal flora”.
In Europe the term “probiotic” is accepted in some Member States, but not in others. According to the principle of mutual recognition, the product legally produced in a country that allows the use of the term “probiotic” is in free circulation in the European Union.
The European Commission only recognizes the term probiotic as a “health claim”, which can be used if accompanied by a specific health effect.
There is therefore no European regulatory framework to identify probiotic microorganisms and conditions of use in foods and food supplements.
Italy is at the forefront compared to other European countries: since 2005 the use of the term “probiotic” is regulated by national guidelines, updated in 2018, which establish clear indications for the use in foods and food supplements of probiotic microorganisms traditionally used for the balance of intestinal flora.
We discussed this with Rosanna Pecere, Executive Director – IPA Europe.
What is the information on the use of the word ‘probiotic’ in France? Based on the information available so far, France will refer to probiotics as a product category when specific conditions are met. This is a valid approach because it provides the consumer with a guarantee of quality, safety and efficacity of the probiotic food and food supplements. Additionally, a claim referring to the effect of probiotics on the balance of the intestinal flora can be used on the label of a food supplement and in commercial communication.
In addition, a claim referring to an effect of probiotics on the balance of intestinal flora will be allowed on the label of a dietary supplement and in commercial communication. In practice, this is aligned with the Italian wording “favorisce/contribuisce”, which corresponds to the wording French “contribue à l’équilibre de la flore intestinal”. The indication on the label can be flexible – “participation” or “maintien” can also be used.
In what context did the French decision come about?
The lack of a harmonised regulatory framework and the lack of clarity on the definition of probiotic foods at European level has led individual Member States to adopt national rules or practices to allowtheuse of the term ‘probiotic’ on the label. Italy and Czech Republic already implemented National guidances, with specific conditions of use that apply to food and food supplements. Spain has officially permitted the use of the term probiotics on labels for foods and food supplements from November 2020. Since May 2021 Denmark is also allowing the use of probiotic labels for dietary supplements while it waits for the EC to clarify its views, and the Netherlands included probiotics in an updated version of the “Nutrition and Health Claims Handbook.” Other countries allowing the use of the term are Bulgaria, Malta and Poland.
According to the available information, what will the conditions of use and the label of probiotic in France ?
In France, the term is expected to be used to identify the category of probiotic microorganisms. As already stated in the Italian guidelines, food supplements in France can refer to the balance of the gut flora, provided that they contain a minimum amount of living cells per day (which in France would be between 107 and 109), are ‘well characterized’ to ensure the safety of the micro-organism used (with identification of the species and strain) and that they are not carriers of antibiotic resistance. Wording of the associated claim can be flexible for example with equivalent terms for ‘contributes’ such as ‘participates in’ or ‘maintains’ a “normal constitution of the intestinal flora.”
What do you, as IPA Europe, expect in the near future?
Today, all “probiotic” products from European and non-EU countries available and sold by Internet are in free circulation in the European market. The absence of criteria and conditions for use to define the category of probiotics in the European Union creates a serious confusion for the consumer and uncertainty for the industry. The Probiotic Association IPA Europe, has been working on the use of probiotics, as a category, in food and food supplements with defined criteria. The Italian guideline, and now the French approach, should be considered as a ‘benchmark’ for Europe.
What is the European situation with regard to the use of claims or claims on foods under Regulation (EC) No 1924/2006?
Currently in the EU there is one authorized health claim for live probiotic micro-organisms “live cultures of yoghurt improve lactose digestion”. So far, probiotic specific strains have not received a positive opinion from the European Food Safety Authority (EFSA) and cannot claim the specific health benefits that are listed in the requests submitted to EFSA. However, there is scientific evidence to support the role played by probiotic micro-organisms in human health and well-being. In other regions of the world public authorities consider probiotics as an “ad hoc” category of ingredients, recognize their specificity and regulate the use of the term on labels and in the communication to consumers.