The European Ombudsman has concluded an investigation into a complaint from a probiotic producers’ association regarding the European Commission’s (EC) classification of the term “probiotic” as a health claim.[1]
The association argued that the negative evaluations of probiotics’ health benefits and the EC’s rejection of related health claim applications effectively ban the term “probiotic.” They contended that “probiotic” should be viewed merely as a descriptor, not implying specific health benefits, and thus should qualify as a nutrition claim. Furthermore, they noted that several EU Member States have guidelines permitting the use of “probiotic”.
None of the applications for authorisation of health claims concerning live microorganisms, ‘probiotics’ and similar terms submitted to date received a favourable scientific opinion of EFSA. This is mainly due to the absence of scientific evidence on the effects of probiotics on a healthy population, insufficient characterisation of the strains of microorganisms used in the relevant foods, the poor quality of studies, and undefined claims.
As regards the complainant’s proposal to consider the term ‘probiotics’ as a ‘nutrition claim’ rather than a ‘health claim’, the Commission argued that there is no link between probiotics and the nutritional qualities of foods. In any case, the Claims Regulation requires scientific evidence to substantiate any claims, including nutrition claims, which is currently lacking.
The Ombudsman upheld the EC’s interpretation, asserting that “probiotic” suggests a positive health benefit according to the World Health Organization’s definition acknowledged by EU Member States. The WHO defines probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host”. The Ombudsman deemed this interpretation reasonable and protective of consumers against misleading claims, given the current insufficient scientific evidence. Additionally, it was noted that Member States allowing the term’s use are in violation of EU law, which is a matter for the EC to address.
[1] https://www.ombudsman.europa.eu/en/decision/en/197581#_ftn1
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