ARCHIVED - Vitamin and Mineral Food Supplements and the Codex Alimentarius Commission

Background

The Codex Alimentarius Commission (often simply referred to as Codex) was established in 1963 to implement the Joint World Health Organization/Food and Agriculture Organization of the United Nations Food Standards Program. The primary mandate of Codex is to develop food standards for the protection of the health of consumers and to ensure fair practices in food trade. The standards, guidelines and related texts developed by Codex are intended for voluntary use by governments.

The Codex Alimentarius Commission is referenced in the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) as the relevant standards-setting organization for food safety issues. The WTO Agreements, such as the SPS Agreement and the Agreement on Technical Barriers to Trade (TBT Agreement), encourage WTO members to harmonize their regulations with international standards where possible.

Standards, guidelines and related texts adopted by Codex are elaborated by Committees or Task Forces. International non-governmental organizations may participate in discussions on the development of Codex texts but final decisions are taken only by the Member governments. The Codex Contact Point for Canada, located in the Food Directorate, Health Canada, is responsible for the coordination of Canada's activities in these bodies. Issues related to vitamin and mineral food supplements are addressed by the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU).

Status of the Codex Guidelines for Vitamin and Mineral Food Supplements

The Codex Alimentarius Commission adopted the Draft Guidelines for Vitamin and Mineral Food Supplements at its 28th Session, July 4 - 9, 2005 in Rome. The Guidelines deal only with vitamins and minerals and are not applicable to other natural health products or to alternative medicines.

The Guidelines provide guidance on composition, including criteria for establishing minimum and maximum levels, packaging and labelling, so that vitamin and mineral food supplements will be safe, efficacious and labelled in a clear and non-misleading manner to ensure safe and informed use. The Guidelines do not stipulate any maximum limits on vitamin and mineral levels, the setting of which remains the prerogative of national governments.

Section 1.3 of the Guidelines stipulates that they are for use only in those countries that regulate vitamin and mineral supplements as food. As Canada regulates vitamin and mineral supplements as natural health products, the Guidelines are not applicable to the Canadian regulatory system. The manufacture, importation and sale of vitamin and mineral supplements and other natural health products in Canada will not be affected by the Commission's adoption of the Guidelines. Such products will continue to be regulated in Canada by the Natural Health Products Regulations under the Canadian Food and Drugs Act.

The Guidelines are attached for reference purposes.

As natural health products fall outside of the Codex mandate, information on the regulation of these products in Canada can be obtained by visiting their website, www.healthcanada.ca/nhpd.