Accepted Claims about the Nature of Probiotic Microorganisms in Food

April 2009

A limited number of claims or statements about the nature of probiotic microorganisms may be made for food without strain-specific evidence that is generally required in supporting the health effects or benefits of these microorganisms. This is a summary of the guidance on Non-Strain-Specific-Claims that will appear in Chapter 8 (Health Claims) of the CFIA Guide to Food Labelling and Advertising (Guide). This summary outlines the claims that may be made and the microorganisms eligible for such claims, as well as labelling requirements under the Food and Drug Regulations that are applicable to foods that carry probiotic claims.

This summary should be read together with the Guidance Document "The Use of Probiotic Microorganisms in Food" which has been posted on the Health Canada Web site. Manufacturers are also advised to consult the chapter on health claims and the section on probiotic claims when the updated Guide is published on the CFIA website for additional information.

Acceptable Non-Strain-Specific Claims for Probiotics

Probiotic microorganisms generally have been isolated from the gastrointestinal tract of healthy individuals. A limited number of non-strain-specific claims about the nature of probiotics (i.e. that they naturally form part of the gut flora) have been accepted for use on food when the following guidance is followed.

1. Eligible claims and species
   The specified claims can be used only when the product contains one or more of the specific species listed in Table 1.
   
2. Minimum levels in the product
   A serving of stated size of a product should contain a minimum level of 1.0 x 10⁹ cfu of one of the eligible microorganism(s) that is(are) the subject of the claim (Gill and Prasad 2008; Hawrelak 2006; Lenoir-Wijnkoop et al. 2007; Picard et al. 2005; Reid et al. 2003).

In addition, the following general guidance and specific labelling guidelines^{Footnote 1} apply to all products containing probiotic microorganisms.

General guidance

1. When making any probiotic claims, the manufacturer or importer of the product should have documentation supporting the identification, safety and viability, as well as the concentration and stability of the probiotic strain added to the food product.
   
2. The manufacturer or importer should follow all requirements applicable to the food, including those dealing with the use and labelling of ingredients used in novel technology in the delivery of a viable microorganism for food application.
   
3. The food must contain, at a minimum, the amount of the probiotic microorganism(s) required to result in the claimed effect or health benefit throughout the shelf life of the product. Documentation to support the functionality aspects of the product (i.e. stability and viability of the probiotic strain or mixed culture) should be maintained.

Specific labelling guidelines

1. Identification of strain: A probiotic claim should be accompanied by the Latin name of the microorganism (i.e. genus and species), along with the identity of the strain of the microorganism, using acceptable nomenclature (see Table 1 for nomenclature of selected bacterial species). For consistency, it is recommended that the strain be identified by using the number assigned by an internationally recognized culture repository (e.g. American Type Culture Collection).
   
   In the case of advertising, if the probiotic microorganism is identified or referred to in the advertisement, then the identity of the microorganism (genus, species and strain) should be declared using acceptable nomenclature. For example, the claim "contains two probiotics" would trigger the identification of both microorganisms in the advertisement.
   
2. Quantitative declaration: The amount of the probiotic microorganism(s) contained in the product at the end of its shelf life must be declared in colony forming units (cfu) per serving of stated size of the food. This statement should appear adjacent to the Nutrition Facts table, the list of ingredients or in close proximity to the claim.
   
   In mixed culture, if multiple probiotic genera are used, declaration of the quantity of each genus is generally expected. If multiple species or strains of the same genus are added to a food, the need for separate declaration of individual species would be determined case-by-case.
   
3. Ingredient list: Food containing probiotic microorganism(s) must be labelled with a list of ingredients in accordance with Sections B.01.008 - B.01.010 of the Food and Drug Regulations (see section 2.8 of the CFIA Guide. The probiotic microorganism must be identified by its common name or by a class name set out in Section B.01.010. The class name "bacterial culture" may be used to describe all bacterial species added to the food product. Where the class name (i.e. bacterial culture) is used in the list of ingredients, the identity (i.e. the genus, species and strain) of the probiotic bacterial culture(s) should be declared in close proximity to the claim using an acceptable nomenclature.

References

ATCC. 2008. American Type Culture Collection [online]. Manassas (VA): The Global Bioresource Center. Available from: www.atcc.org/ [Accessed 28 May 2008].

EFSA (European Food Safety Authority). Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal 2007;587:1-16; Appendix A: Scientific report on the assessment of gram-positive non-sporulating bacteria. Available from: www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion
/sc_appendixa_qps_en.pdf?ssbinary=true
[Accessed 28 May 2008].

Euzéby JP. 2008. List of bacterial names with standing in nomenclature: a folder available on the Internet. Int J Syst Bacteriol 1997;47(2):590-592. Last full update: May 02, 2008. Available from: www.bacterio.cict.fr/ [Accessed 15 May 2008].

Gill H, Prasad J. Probiotics, immunomodulation, and health benefits. Adv Exp Med Biol 2008;606:423-454.

Gilliland SE. Technological & Commercial Applications of Lactic Acid Bacteria; Health & Nutritional Benefits in Dairy Products [online]. Background paper for the Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria; 2001 October; Rome, Italy. Food and Agriculture Organization of the United Nations (FAO); 2001. Available from: ftp://ftp.fao.org/es/esn/food/Gilli.pdf [Accessed 28 May 2008].

Hawrelak JA. Probiotics. In: Textbook of Natural Medicine, 3rd ed., Vol. 1. Pizzorno JE Jr, Murray MT (eds.), pp 1195-1215. St. Louis (MO): Elsevier Ltd.; 2006.

Lenoir-Wijnkoop I, Sanders ME, Cabana MD, et al. Probiotic and prebiotic influence beyond the intestinal tract. Nutr Rev 2007;65(11):469-489.

Picard C, Fioramonti J, François A, et al. Review article: bifidobacteria as probiotic agents - physiological effects and clinical benefits. Aliment Pharmacol Ther 2005;22(6):495-512.

Reid G. Regulatory and clinical aspects of dairy probiotics [online]. Background paper for the Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria; 2001 October; Rome, Italy. Food and Agriculture Organization of the United Nations (FAO); 2001. Available from: ftp://ftp.fao.org/es/esn/food/Reid.pdf
[Accessed 28 May 2008].

Reid G, Jass J, Sebulsky MT, McCormick JK. Potential uses of probiotics in clinical practice. Clin Microbiol Rev 2003;16(4):658-672.

Skerman VBD, McGowan V, Sneath PHA (eds). 1989. Approved Lists of Bacterial Names, Amended Edition [online]. Washington (DC): American Society of Microbiology Press. Available from: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=bacname [Accessed 28 May 2008].