Former - Health Claims
Probiotics (definition) are microorganisms that are beneficial to human health. A probiotic health claim can consist of one of the following examples:
- the term "probiotics" and similar terms or representations;
- "with beneficial probiotic cultures";
- "contains bacteria that are essential to a healthy system"; and
- Latin name of a microbial species modified to suggest a health benefit.
A probiotic health claim can be presented in either text or graphic, on food labels or in advertisements to suggest that a food confers a health benefit.
Due to the special nature of probiotic microorganisms, Health Canada has prepared a guidance document, The Use of Probiotic Microorganisms in Food (Health Canada, 2009), that sets out the conditions under which health claims about probiotics are considered acceptable.
Type of Probiotic Claims
Disease Risk Reduction or Therapeutic Probiotic Claims
Probiotic claims that are therapeutic in nature or that are considered "drug" claims are required to undergo a pre-market assessment by the Food Directorate of Health Canada and a regulatory amendment to the Food and Drug Regulations to allow their use. Refer to Acceptable Disease Risk Reduction Claims and Therapeutic Claims for more information.
Probiotic Function Claims
Most probiotic claims are function claims. Two types can be made on food: strain-specific claims and non-strain-specific claims.
- Strain-specific claims are claims about the health benefits or effects of specific strains of probiotics. At the present time, no strain-specific claims have been accepted by Health Canada. As these claims are reviewed and accepted, Health Canada will create a list of acceptable strain-specific claims that will be available on their website.
- Non-strain-specific claims are statements about the nature of probiotics. A closed list of non-strain-specific probiotic claims that are acceptable without the need for the manufacturer to conduct a detailed review of the scientific basis for the claim is provided in the Table of Acceptable Non-Strain Specific Claims for Probiotics.
See Science Research under Function Claims for more information on the acceptability of new health claims, including new function claims.
Conditions of Use for Probiotic Claims
Health Canada's guidance document, The Use of Probiotic Microorganisms in Food (Health Canada, 2009), sets out the conditions under which health claims about probiotics are considered acceptable. The following is a summary of the guidance; the guidance document should be consulted for specific details.
- The use of "probiotic" and other similar terms and representations (including trade names that suggest a health benefit) should be accompanied by specific, validated statements about the benefits or effects of the probiotic. This will reduce the possibility of these statements being vague, uninformative or misleading.
- Validated health claims about the health benefits or effects of probiotics are statements that are supported by strain-specific evidence.
- When making any probiotic claim, the manufacturer or importer of the product should have documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product.
- The manufacturer or importer must follow all requirements applicable to the sale of food, including those related to the use and labelling of ingredients used in novel technology in the delivery of a viable microorganism for food application.
- The food should 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.
General information about evidence requirements applicable to health claims of all types, including function claims, also apply to probiotic claims (See Science Research under Function Claims).
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 the Table of Acceptable Non-Strain Specific Claims for Probiotics 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; ATCC 2008; see the Reference List for Probiotic Claims).
Language Requirements for Probiotic Claims
While there are no specific language requirements set out in the Food and Drug Regulations for probiotic claims, it is recommended that when a claim is made on the label of a food, it appear in both English and French unless a bilingual labelling exemption applies to the product [B.01.012(3) or (7), FDR].
Quantitative Statements for Probiotic Claims
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 or 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 the separate declaration of individual species would be determined case by case.
Foods containing probiotic microorganism(s) must be labelled with a list of ingredients in accordance with sections B.01.008-B.01.010, FDR (see List of Ingredients). The probiotic microorganism(s) must be identified by its (their) common name(s) or by a class name set out in section B.01.010 of the FDR. The class name "bacterial culture" may be used to describe all bacterial species added to a food product. When the class name (e.g. 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 acceptable nomenclature.
Acceptable Non-Strain Specific Claims
A limited number of non-strain-specific claims about the nature of probiotics (e.g. that they naturally form part of the gut flora) have been accepted for use on food. Any of the statements listed in the Table of Acceptable Non-Strain Specific Claims for Probiotics may be made for one or more of the specific bacterial species included in the table when the conditions specified below are followed.
When making any of the claims listed in the Table of Acceptable Non-Strain Specific Claims for Probiotics below, the manufacturer or importer of the product must follow guidelines outlined under Conditions of Use for Probiotic Claims, regarding documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product, as well as specific conditions.
- Eligible species
These claims can be used only when the product contains one or more of the specific species listed in the Table of Acceptable Non-Strain Specific Claims for Probiotics below.
- 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 or more of the eligible microorganism(s) that is (are) the subject of the claim Footnote 10
|Eligible bacterial species
Table Note 11
Latin name (acceptable nomenclature Table Note 12) and synonym where applicable
|Acceptable Non-Strain Specific Probiotic Claim for Food|
Probiotic that naturally forms part of the gut flora. Table Note 14
Provides live microorganisms that naturally form part of the gut flora. Table Note 14
Probiotic that contributes to healthy gut flora. Table Note 14
Provides live microorganisms that contribute to healthy gut flora. Table Note 14
- Table Note 11
References reviewed for the bacterial species included: EFSA 2007, Gilliland 2001, Reid 2001 (see Reference List of Probiotic Claims).
- Table Note 12
References reviewed for acceptable nomenclature: ATCC 2008, Euzéby 2008, Skerman et al. 1989 (see Reference List of Probiotic Claims).
- Table note 13
In product labelling, Bifidobacterium longum subsp. infantis and Bifidobacterium longum subsp. longum would be considered acceptable nomenclature.
- Table note 14
The word "gut" may be replaced by the expression "digestive tract" in these claims.
Advertisements for Probiotic Claims
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" triggers the identification of both microorganisms in the advertisement. See Identification of Strain for more information.
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