ARCHIVED - Notice to Stakeholders - New Guidance Document - The Use of Probiotic Microorganisms in Food

April 16, 2009

Health Canada has developed a guidance document, "The Use of Probiotic Microorganisms in Food", to help industry comply with Subsection 5(1) of the Food and Drugs Act with respect to the acceptable use of health claims about microorganisms represented as "probiotics" on food labels and in advertising. Subsection 5(1) of the Food and Drugs Act states: "No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety".

All health claims made for food are subject to Subsection 5(1) of the Food and Drugs Act. Industry is responsible for compliance with the Act and should have acceptable scientific evidence that validates the health claims prior to their use. The term "probiotics" and similar terms or representations that suggest a food confers a health benefit are examples of health claims.

The Guidance Document applies to products that are manufactured, sold, or represented for use as food as defined in Section 2 of the Food and Drugs Act. It outlines the types of health claim that may be made for food, including function claims about the physiological effects of probiotic microorganisms in foods. The Guidance Document does not apply to natural health products (NHPs) containing probiotic microorganisms, whether or not the product is in a food format. For information on the criteria used by Health Canada in making classification decisions as to whether a product in food format is a food or an NHP, stakeholders should consult a separate guidance document "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats".

The Guidance Document on the use of probiotic microorganisms in food will be used by the Canadian Food Inspection Agency (CFIA) to administer and assess compliance of food products containing probiotic microorganisms with the Food and Drugs Act and with the food provisions of the Food and Drug Regulations. The CFIA will issue a separate letter to major food industry stakeholders outlining their plan regarding compliance and enforcement. The CFIA will also update their Guide to Food Labelling and Advertising (Guide) that will complement Health Canada's Guidance Document on probiotics. The updated CFIA Guide will provide additional information, including labelling requirements, that are applicable to foods that make probiotic claims, including four claims about the nature of probiotics that may be made for food without the need for further substantiation when guidance for their use is followed.

Yours truly,

Samuel Godefroy, Ph.D.
Director General
Food Directorate

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