Health claims on food labels
Additional information

Schedule 1 (subsection 1(1)) - included natural health product substances

1. A plant or an animal material, an alga, a bacterium, a fungus or a non-human animal material
2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
3. Any of the following vitamins:
   1. biotin
   2. folate
   3. niacin
   4. pantothenic acid
   5. riboflavin
   6. thiamine
   7. vitamin A
   8. vitamin B6
   9. vitamin B12
   10. vitamin C
   11. vitamin D
   12. vitamin E
4. An amino acid
5. An essential fatty acid
6. A synthetic duplicate of a substance described in any of the items 2 to 5
7. A mineral
8. A probiotic

Schedule 2 (subsection 1(1)) - excluded natural health product substances

1. A substance set out in Schedule C to the Act
2. A substance set out in Schedule D to the Act, except for the following:
   1. a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
   2. any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
3. A substance regulated under the Tobacco Act
4. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
5. A substance that is administered by puncturing the dermis
6. An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic

Schedule A diseases from the Food and Drugs Act [Section 3]

• Acute alcoholism
• Acute anxiety state
• Acute infectious respiratory syndromes
• Acute, inflammatory and debilitating arthritis
• Acute psychotic conditions
• Addiction (except nicotine addiction)
• Appendicitis
• Arteriosclerosis
• Asthma
• Cancer
• Congestive heart failure
• Convulsions
• Dementia
• Depression
• Diabetes
• Gangrene
• Glaucoma
• Haematologic bleeding disorders
• Hepatitis
• Hypertension
• Nausea and vomiting of pregnancy
• Obesity
• Rheumatic fever
• Septicemia
• Sexually transmitted diseases
• Strangulated hernia
• Thrombotic and Embolic disorders
• Thyroid disease
• Ulcer of the gastro-intestinal tract

Reference list for probiotic claims

• ATCC. 2008. American Type Culture Collection [online]. Manassas (VA): The Global Bioresource Center. Available from: www.atcc.org/ [Accessed 28 May 2008].
• European Food Safety Authority (EFSA). 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: http://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 2, 2008. Available from: www.bacterio.cict.fr/ [Accessed 15 May 2008].
• FAO/WHO. 2001. Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Report of a Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Córdoba, Argentina, October 1-4, 2001. Available from: www.who.int/foodsafety/publications/fs_management/probiotics/en/index.html [Accessed 3 April 2008]
• FAO/WHO. 2002. Guidelines for the Evaluation of Probiotics in Food. Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. London, Ontario, April 30 - May 1, 2002. Available from: www.who.int/foodsafety/publications/fs_management/probiotics2/en/index.html [Accessed 3 April 2008]
• FAO/WHO. 2006. Probiotics in Food: Health and Nutritional Properties and Guidelines for Evaluation. FAO Food and Nutrition Paper 85. Food and Agriculture Organization of the United Nations and World Health Organization, Rome. Available at: ftp://ftp.fao.org/docrep/fao/009/a0512e/a0512e00.pdf [Accessed 3 April 2008]. (This document integrates the 2001 and 2002 FAO/WHO reports listed above).
• Gill H, Prasad J. Probiotics, immunomodulation, and health benefits. Adv Exp Med Biol 2008;606:423-454.
• Gilliland SE. 2001. Technological and Commercial Applications of Lactic Acid Bacteria; Health and 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. Rome, Italy. Food and Agriculture Organization of the United Nations (FAO). Available from: ftp://ftp.fao.org/es/esn/food/Gilli.pdf [Accessed 28 May 2008].
• Hawrelak JA. 2006. Probiotics. In: Textbook of Natural Medicine, 3rd ed., Vol. 1. Pizzorno JE Jr, Murray MT (eds.), pp. 1195-1215. St. Louis (MO): Elsevier Ltd.
• Health Canada. 2009. The Use of Probiotic Microorganisms in Food. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/hpfb-dgpsa/pdf/legislation/probiotics_guidance-orientation_probiotiques-eng.pdf
• 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. 2001. 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. Rome, Italy. Food and Agriculture Organization of the United Nations (FAO). 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].

Information letters/policy updates

Labelling and Composition of Food Containing Probiotic Microorganisms