Research – Evaluation of the safety of microorganisms (“probiotics”) used in food supplements

ACSA

The Food Safety Authority of Ireland (FSAI) Scientific Committee has published a scientific report on the safety assessment of micro-organisms (“probiotics”) used in food supplements which aims to help companies assess the safety of “probiotics” , in the absence of specific legal criteria.

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

The Committee found that reported adverse events associated with “probiotics” are few and tend to be ad hoc reports of infections, including bacteremia, sepsis, or endocarditis in people with belonging to different risk groups. 

The report makes recommendations on the criteria for safety assessment and the evidence that a producer of food supplements should use to demonstrate the micro-organism safety of their products.

FSAI

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