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Assessment of the safety of “probiotics” in food supplements

Monday, 08 July 2024

The purpose of this scientific report is to assist businesses in assessing the safety of “probiotics” used in food supplements, in the absence of specific legal criteria.

“Probiotics” are defined by FAO/WHO* as “live microorganisms which when administered in adequate amounts confer a health benefit on the host”. The term “probiotic”, however, is currently a non-authorised health claim according to EU law. Applications for health claims on “probiotics” have been submitted for evaluation to the European Food Safety Authority (EFSA) and to date, no application has received a positive opinion and subsequent authorisation. While the term is not allowed on food or food supplement product labels, the term is used in this scientific report because it is widely used by the industry and the scientific community.

This report was produced by the FSAI Scientific Committee. The Committee found that reported adverse events associated with “probiotics” are few and tend to be ad hoc reports of infections, including bacteraemia, sepsis or endocarditis in physiologically at-risk people. 

The Committee made recommendations regarding (i) criteria for the assessment of safety and (ii) the evidence a food supplement producer should use to demonstrate safety of the microorganisms in their products.

Guidance for food business operators, based on this scientific report, can be found on the Food Supplements webpage.

* Food and Agriculture Organization of the United Nations / World Health Organization


Cover page of report showing the report title