Managing Health Claims for Foods in Canada:
Towards a Modernized Framework

Discussion Paper

Appendix G - References: Health Claims for Foods in Selected Jurisdictions

Canada

CFIA (Canadian Food Inspection Agency) (2003). Guide to Food Labelling and Advertising. Available at
http://www.inspection.gc.ca/english/fssa/labeti/guide/toce.shtml.

Government of Canada. (2003). Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Nutrient Content Claims and Health Claims) Canada Gazette Part II: 137(1):154-403. Available at
http://canadagazette.gc.ca/partII/2003/20030101/
html/sor11-e.html.

Health Canada. (1998, November 2). Policy Paper: Nutraceuticals/Functional Foods and Health Claims on Foods. Government of Canada: Therapeutic Products Program and the Food Directorate from the Health Protection Branch. Available at
http://www.hc-sc.gc.ca/fn-an/label-etiquet/nutrition/
claims-reclam /nutra-funct_foods-nutra-fonct_aliment-eng.php.

Health Canada. (2001, October). Product-Specific Authorization for Health Claims on Foods, a Proposed Regulatory Framework. Government of Canada: Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch. Available at
http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/
pdf/label-etiquet
/final_proposal-proposition_final_e.pdf.

Health Canada. (2002). Interim Guidance Document - Preparing a Submission for Foods with Health Claims: Incorporating Standards of Evidence for Evaluating Foods with Health Claims. Government of Canada: Bureau of Nutritional Sciences Food Directorate Health Products, Food Branch Health Canada. Available at
http://www.hc-sc.gc.ca/fn-an/label-etiquet/nutrition/ claims-reclam
/abstract_guidance-orientation_resume-eng.php.

Codex

Codex Alimentarius Commission. (2004). Guidelines for Use of Nutrition and Health Claims. CAC/GL 23-1997, Rev. 1-2004. Available at
http://www.codexalimentarius.net/web/standard_list.do.

Codex Alimentarius Commission. (2006). Proposed Draft Annex to the Codex Guidelines for Use of Nutrition and Health Claims: Recommendations on the Scientific Basis of Health Claims. CX/NFSDU 06/28/7. Available at
ftp://ftp.fao.org/codex/ccnfsdu28/nf28_07e.pdf.

Australia and New Zealand

FSANZ (Food Standards Australia New Zealand). (2005, December). Regulatory Framework for Nutrition, Health and Related Claims - Generic Application. Proposal P293 - Nutrition, Health and Related Claims. Draft Assessment Report.

Food Standards Australia New Zealand (FSANZ). (2007, March). Nutrition, Health and Related Claims - A guide to the development of a food standard for Australia and New Zealand. Available at
http://www.foodstandards.gov.au/standardsdevelopment/proposals
/proposalp293nutritionhealthandrelatedclaims/index.cfm.

Food Standards Australia New Zealand (FSANZ). (2007, April). Proposal P293 - Nutrition, Health and Related Claims. Preliminary Final Assessment Report. Available at
http://www.foodstandards.gov.au/standardsdevelopment/proposals
/proposalp293nutritionhealthandrelatedclaims/index.cfm.

European Union

Commission of the European Communities. (2003). Proposal for a Regulation of the European Parliament and the Council on Nutrition and Health Claims made on foods. 2003/0165(COD). Available at
http://europa.eu/eur-lex/en/com/pdf/2003/com2003_0424en01.pdf.

Council of the European Union. (2005, November 15). Common Position adopted by the Council with a view to the adoption of a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods. 2003/0165 (COD). Available at
http://www.europarl.europa.eu/oeil/FindByProcnum.do
?lang=2&procnum=COD/2003/0165.

European Parliament. (2006, May 16). Legislative resolution on the Council common position for adopting a regulation of the European Parliament and of the Council on nutrition and health claims made on foods (9858/3/2005 - C6-0018/2006 - 2003/0165(COD). Available at
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=
-//EP//TEXT+TA+P6-TA-2006-0198+0+DOC+XML+V0//EN.

European Parliament and the Council of the European Union. (2006, December 20). Regulation (EC) No 1924/2006 on Nutrition and health claims made on foods. Available at
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=
CELEX:32006R1924R(01):EN:NOT.

European Safety Authority (EFSA). (2007). Scientific and Technical Guidance for the Preparation of the Application for Authorization of a Health Claim. Available at
http://www.efsa.europa.eu/en/science/nda/nda_consultation/
health_claim.html.

Japan

Ohama, H., Ikeda, H. and Moriyama, H. (2006). Health foods and foods with health claims in Japan. Toxicology 221(1): 95-111.

Tanaka, H., Kaneda, F., Suguro. R. and Baba, H. (2004). Current system for regulation of health foods in Japan. Journal of the Japan Medical Association 27(9): 436-450.

United States

Rowlands, J.C. and Hoadley, J.E. (2006). FDA perspectives on health claims for food labels. Toxicology 221: 35-43.

US Food and Drug Administration (FDA). (1998, June 11). Guidance for Industry. Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. Available at
http://www.cfsan.fda.gov/~dms/hclmguid.html.

US Food and Drug Administration (FDA). (1999, November 2). Guidance for Industry. Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. Rockville, MD: Center for Food Safety and Applied Nutrition (CFSAN), Office of Special Nutritionals. Available at
http://www.cfsan.fda.gov/~dms/ssaguide.html.

US Food and Drug Administration (FDA). (2003, July 10). Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplement and Interim Evidence-based Ranking System for Scientific Data, CFSAN, Consumer Health Information for Better Nutrition Initiative Task Force Final Report. Available at
http://www.cfsan.fda.gov/~dms/nuttf-b.html.

US Food and Drug Administration (FDA). (2003, September). Claims that Can Be Made for Conventional Foods and Dietary Supplements. College Park, MD: CFSAN/Office of Nutritional Products, Labelling and Dietary Supplements. Available at
http://www.cfsan.fda.gov/~dms/hclaims.html.

US Food and Drug Administration (FDA). (2006). Guidance for Industry. FDA's Implementation of "Qualified Health Claims": Questions and Answers. College Park, MD: CFSAN. Available at
http://www.cfsan.fda.gov/~dms/qhcqagui.html.

US Food and Drug Administration (FDA). (2007, July). Guidance for Industry. Evidence-Based Review System for the Scientific Evaluation of Health Claims. Available at
http://www.cfsan.fda.gov/~dms/hclmgui5.html.

Global perspectives in general

Arvanitoyannis, I. and van Houwelingen-Koukaliaroglou, M. (2005). Functional foods: a survey of health claims. Pros, cons, and current legislation. Critical Reviews in Food Science and Nutrition 45: 385-404.

Hasler, C.M. (ed.). (2005). Regulation of Functional Foods and Nutraceuticals: A Global Perspective. Ames, Iowa: Blackwell Publishing.

Hawkes, C. (2004). Nutrition Labels and Health Claims: The Global Regulatory Environment. World Health Organization: Geneva, Switzerland. Available at
http://whqlibdoc.who.int/publications/2004/9241591714.pdf.