Report published on the assessment of the safety of “probiotics” in food supplements | Food Safety Authority of Ireland

Monday, 08 July 2024

The Food Safety Authority of Ireland (FSAI) today published a report on the assessment of the safety of “probiotics” in food supplements. The purpose of the report is to assist businesses in assessing the safety of the live microorganisms 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”.  According to EU law, the term “probiotic” is currently not authorised as a health claim and therefore, is not allowed on food or  food supplement product labels.  The term, however, 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.

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

Assessment of the Safety of “Probiotics” in Food Supplements