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Guidance on assessment of safety of microorganisms (“probiotics”) used in food supplements

“Probiotics” are defined by the Food and Agriculture Organization of the United Nations / the World Health Organization 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 widely used by the industry and the scientific community and because of this, it is used in the FSAI Scientific Committee report on assessment of the safety of “probiotics” in food supplements.

The FSAI Scientific Committee report recommends:

(i) criteria for the assessment of safety;

(ii) the evidence a food supplement producer should use to demonstrate safety; and

(iii) makes additional recommendations.


The FSAI Scientific Committee report considers the most appropriate safety criteria for live microorganisms (“probiotics”) used in food supplements to be that:

  • There is long experience of use of the organism(s) in food or food supplements without substantiated report of harm in otherwise healthy people.
  • Credible reports of infection or intoxication associated with the organism are isolated or rare and limited to those people at highest risk of infection.
  • The organism(s) is readily identifiable to at least species level. 
  • There is an antimicrobial agent available for treatment of infection with the organism(s).
  • The organism(s) has no known association with environmental harm.
  • If the organism(s) was not used in food in the EU prior to 15 May 1997, its use has been authorised under the novel food Regulation (EU) 2015/2283.
  • If the organism(s) was genetically modified, it has been authorised 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.

The organism(s) has been rigorously characterised as follows:

  • The definition of species and strain level is adequate to facilitate comparison in the event of suspected link to human infection.
  • There is evidence of the absence of properties associated with increased potential to cause infection.
  • There is evidence of the absence of acquired (transferable) antimicrobial resistance genes.
  • There is evidence of the absence of capacity for biogenic amine production.


The FSAI Scientific Committee report considers that a food supplement producer should be able to demonstrate that:

  • The organism(s) used meets the recommended safety criteria .
  • The culture has been deposited in a recognised and accessible culture collection if not obtained from a culture collection.
  • If cultures are stored, they are stored at -80 °C to ensure that they remain stable in storage.
  • If cultures are propagated, the characterisation of the organism should be repeated at defined intervals to ensure that the organism has not significantly altered or been inadvertently displaced by, or contaminated with, another organism.
  • The production process does not result in substantial change to the properties of the microorganism(s) between start of production and the end product.
  • The production systems have adequate quality management systems to ensure consistent properties of the organism(s) in the final product. 

The FSAI Scientific Committee recommends that an evidence-based risk assessment of the microbes be performed for each “probiotic” food supplement product and that the linked forms, or forms similar in content, be completed as part of the risk assessment providing details of:

  • The food supplement product
  • The identification of the microbial strains
  • The characterisation of each microbial strain
  • Evidence of strain manufacturing safety.

Download blank forms for evidence of safety.

Additional Recommendations

The FSAI Scientific Committee report makes the following additional recommendations:

  • Food supplement producers should document the food safety management system adopted to ensure consistent safe manufacture of the food supplement.
  • The individual microbial strains used should be stored and accessible (either from the food supplement producer or from a culture collection) in the event of a suspected link to human infection. 
  • In line with the requirements of the Regulation on the provision of food information to consumers (Regulation (EU) No. 1169/2011), accurate information should be provided to the consumer on the label. It is recommended that this information includes the type and number of organisms present as well as appropriate storage advice. In addition, the viability of the organism(s) throughout the shelf life of the product should be determined to ensure that the information on the product label is accurate throughout the shelf life. Furthermore, where it is known that there are groups of people for whom the strain or strains used may not be suitable, this should be indicated on the label.
  • If an Enterococcus faecium strain is included as a “probiotic” in a food supplement, the label should clearly indicate the presence of Enterococcus faecium in the food supplement.