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EU - Postbiotics: The concept and their use in healthy population

European Union

Dec 19, 2022

The term postbiotic was recently defined by an panel of scientists convened by the International Scientific Association of Probiotics and Prebiotics as “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” This definition focused on the progenitor microbial cell or cell fragments, not just metabolites, proteins or carbohydrates they might produce. Although such microbe-produced constituents may be functional ingredients of the preparation, they are not required to be present in a postbiotic according to this definition. In this context, terms previously used such as paraprobiotics, ghostbiotics, heat-inactivated probiotics, non-viable probiotics, cell fragments or cell lysates, among others, align with the term postbiotics as conceived by this definition.

In the European Union, postbiotics, similar to probiotics and prebiotics, face both novel food regulation and health claim regulation. If the microbe, being probiotic or postbiotic, falls into the novel food category, the safety evaluation is more exhaustive and requires toxicological information among other safety requirements. The EFSA guidance document in the case of safety assessment of live microbes is challenging and lacks clear guidelines. Recent experience demonstrates that safety of inanimate bacteria (potential postbiotics) may be easier to achieve than safety of live bacteria. Safety assessment of inanimate bacteria as novel food is now available for three different preparations (Bacteroides xylanisolvens, Akkermansia muciniphila, and Mycobacterium sentence manresensis)

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