Table 1.

Overview of the status of viability acceptance across different regulations and guidelines.

No.	Country	Comments	References
1	Italy	The recommended product serving for daily consumption shall contain a quantity of 109 live cells of at least one of the strains. It is pointed out that the most suitable analysis methods to quantify live micro-organisms may vary according to each species.	Ministero-Della-Salute-Italy (2018)
2	France	The recommended product serving for daily consumption shall be between 107 and 109 viable cell per day from one strain.	DGCCRF (2023)
3	Australia	The quantity (potency) of each strain must be expressed in CFU/g, CFU/mL or CFU per metric unit or dose; or as the number of viable cells per mL based on a viable-cell assay.	TGA (2023)
4	Europe	For live biotherapeutics, the potency of each strain expressed in CFU/mL, CFU/g, CFU/unit or viable cells/mL. For food or food supplements, there is no specific legislation that regulates the use of probiotics in human nutrition, therefore the EU legislation does not specify any specific labeling provisions for probiotic enumeration reporting other than for the approved claim which must be reported in CFU.	EDQM (2019) and IPA (2022)
5	Codex alimentarius	From a labeling side, the product label should contain the amount of viable cells of total probiotic microorganisms (CFU/g). Although, from an enumeration side, traditionally, plating has been used and endorsed as the “standard way” to evaluate microbial viability and it has been determined through counting “colony-forming units,” CFU. The plate count method is based on the premise that a single bacterium can grow and divide to give an entire colony. This method is historically and currently, the most broadly used method to demonstrate the activity of the microorganisms. Now, other methods such as flow cytometry (ISO 19344 IDF 232) are coming to be used widely and a standardized method has been developed and used as a way to evaluate total probiotic microorganisms. All work will be coordinated with the applicable general subject Codex Committee to ensure the appropriate application of Codex. Expertise and resources.	CCNFSDU (2019)
6	Norway	The number of viable probiotic bacterial cells in the product within the time frame of its shelf life should be clearly given including a proviso that recommended storage conditions have been upheld. The numbers may be expressed as log Colony Forming Units (CFU) per gram of product or per serving of a specified size.	Yazdankhah et al. (2014)
7	USA	For dietary supplements, it is mandatory to declare the quantitative amount of live microbial ingredients in terms of weight in the Supplement Facts label. The concentration can be declared in CFU as long as it is done in a manner that clearly separates and readily distinguishable from the weight. However, the FDA believes that CFUs provide a useful description of the quantity of live microbial dietary ingredients and is aware that researchers are currently evaluating other methods and units of measure for live microbial dietary ingredients and that such alternative methods have the potential to more accurately and more efficiently quantify the number of viable cells. For food containing microorganisms, such as yogurt, the product label may be indicate “contains live and active cultures” or another appropriate descriptor if the food contains a minimum level of live and active cultures of 107 colony forming units per gram (CFU/g) at the time of manufacture with a reasonable expectation of 106 CFU/g through the manufacturer’s assigned shelf life of the product.	FDA (2018) and FDA (1977)
8	Brazil	The product must be labeled with the quantity to be consumed in CFU/day to obtain the desired effect.	ANVISA (2021)
9	India	Minimum viable number of added probiotic organisms in food shall be ≥108 CFU in the recommended serving size per day.	FSSAI (2022)
10	Canada	All individual strain quantities of live microorganisms must be indicated in Colony Forming Units (CFU) per dosage unit.	Health-Canada (2023)
11	Colombia	The food should contain a number of viable cells ≥1 × 106 CFU/g in the finished product until end of shelf life	Ministry-of-Health-and-Social-Protection-of-Colombia (2011)
12	IPA	The quantitative amount(s) of probiotics in a product should be expressed in Colony Forming Units (CFUs).	CRN-IPA (2017)