FSAI Publishes Guidance for Industry on Safe Use of Probiotics in Food Supplements – Food Safety Magazine

In the absence of EU guidance on probiotic food supplements, the Food Safety Authority of Ireland (FSAI) has developed its own guidance document to help food supplement producers and food businesses assess the safety of probiotics used in their products.

According to the guidance, the most commonly used probiotics in food supplements are lactic acid bacteria strains, bifidobacteria, Bacillus sporogenes, and Saccharomyces boulardii. Although the consumption of probiotics can carry some potential risks, reported adverse effects resulting from common probiotic food supplements are few. When adverse effects have been reported, they are usually in patients at an increased risk of infection.

Under current EU law, the term probiotic is currently not authorized as a health claim and is therefore not allowed on food or food supplement product labels. In Ireland, food supplement producers are required to notify FSAI of their products being placed on the market, which is not an approval or authorization procedure; rather, a notification is completed via an online form, which includes submission of the product label to FSAI. Additionally, FSAI references the European Food Safety Authoritys (EFSAs) Qualified Presumption of Safety (QPS) listwhich includes some species-level bacteria and yeaststo assess the safety of microbes or their byproducts in foods.

Furthermore, if a probiotic organism was not used in food in the EU prior to 15 May 1997, its use must be authorized under the novel food Regulation (EU) 2015/2283. If the organism was genetically modified, it must be authorized under Regulation (EC) No. 1829/2003 on genetically modified food and feed, and under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms.

In the guidance document, FSAI describes the most appropriate criteria when assessing the safety of probiotic food supplements, including:

FSAI states that a food supplement producer should be able to demonstrate that the organism(s) used meets the aforementioned criteria. Other food safety evidence that supplement producers should provide to FSAI include:

Other recommendations to food producers in the guidance document suggest that producers document their food safety management systems (FSMS); that the individual microbial strains used should be stored and accessible in the event of a suspected link to human infection; that the product labels include strain types and the number of organisms present, appropriate storage advice, and accurate shelf-life information; and, in the instance that an Enterococcus faecium strain is used, that the label clearly indicates its presence.

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FSAI Publishes Guidance for Industry on Safe Use of Probiotics in Food Supplements - Food Safety Magazine