Probiotics

PROBIOTICS IN THE EU

In the European Union, there is no EU-wide legal framework defining probiotic bacteria or the food category "probiotics". Nor is there a harmonised EU legal framework establishing the conditions for a strain to be considered as probiotic or a positive list of individual strains which have a probiotic status.

By contrast, probiotics in feed benefit from a comprehensive status as zootechnical - or feed additives, with a positive list of identified strains and clear conditions of use.

Moreover, since 14 December 2012, there is a de facto ban on the use of the term "'probiotic" for food products in the European Union. This prohibition results from the interpretation of the 2007 European Commission Guidance on the implementation of the Nutritional Health Claim Regulation (NHCR), which considered the phrase "contains probiotics" to be a health claim instead of a nutrition claim. The paradox is that the health benefits of probiotics cannot derive from the whole category of probiotics, but only from individual microorganisms. Probiotic effects are strain-specific. Therefore, the term "probiotic" per se could not be the object of an authorisation as a health claim.

Besides, none of the 422 applications for probiotics submitted under the Health Claims Regulation to EFSA received a positive assessment by EFSA. Due to lack of guidance, most of the applications were considered as not sufficiently characterised. This makes of Probiotics one of the categories most negatively impacted by the NHCR.

At national level, some fragmented national measures on probiotics have been adopted which creates discrepancies and difference of treatment between Member States.

One of the key objectives of IPA Europe is to break the deadlock for probiotics in Europe.

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