Table 4.

Comparison of probiotic regulations between countries and regions.

Country/region	Accreditation body	Regulation	References
Canada	Health Canada	Validating health claims on strain-specific evidence, clear and specific statements on the probiotic benefits, and documentation on the strain added to the food product.	Health Canada, 2009
United States	U.S. Food & Drug Administration (FDA)	Regulated as dietary supplements, foods, or drugs depending on the product’s intended use. Products containing probiotics are subject to additional regulations based on their classification (i.e., supplements or foods).	U.S. Food and Drug Administration, 2006
European Union	European Food Safety Authority	Based on Regulation N° 1924/2006, probiotics are classified as a health claim to imply a health benefit once ingested.	European Commission, 2007
Australia/New Zealand	Food Standards Australia and New Zealand (FSANZ)	Products containing probiotics are assessed on a case-by-case basis based on Standards 1.2.7 regulation. Information required for risk assessment includes composition, safety, health claim, and history of use in other countries.	Food Standards Australia and New Zealand, 2013; Food Standards Australia and New Zealand, 2021
Asia-Pacific	Ministry of Health, Labor and Welfare (Japan) and State Administration for Public Regulation (China)	In Japan, food products containing probiotics must include health claims such as improving GI health. Probiotics included in foods sold in China require live microbes as the main functional ingredient and must provide information on the strain and its associated health benefits.	Chemical Inspection and Regulation Service, 2019; Iwatani and Yamamoto, 2019
Brazil	Agência Nacional de Vigilância Sanitária	Strains are approved on a case-by-case basis and must demonstrate safety and health benefits based on Resolution N° 18/1999.	International Probiotics Association, 2017