Fact Sheet

Codex and the Availability of Vitamin and Mineral Supplements in Canada

Many Canadians have expressed concerns about the perceived impact that Codex may have on the availability of vitamins and minerals in this country. The main concern expressed by stakeholders and Canadians is that the new Codex Guidelines on Vitamin and Mineral Supplements will severely limit the amount and type of vitamin and mineral supplements available in Canada.

Health Canada wishes to clarify and reassure Canadians that the proposed Codex Guidelines on Vitamin and Mineral Supplements will not apply in Canada and, therefore, will have no impact on the availability of vitamins and mineral supplements in Canada.

What is Codex?

The Codex Alimentarius Commission, or Codex for short, was created in 1963 by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main objective of Codex is to protect the health of consumers, ensure fair trade practices in the food trade, and promote coordination of all food standards work undertaken by international, governmental and non-governmental organizations. Codex currently consists of 172 member governments, including Canada. Standards, guidelines and related texts developed by Codex are intended for voluntary use and there is no obligation for governments to adopt these standards. Individual member countries adapt these recommendations to meet their own specific needs.

What are the proposed Codex Guidelines on Vitamin and Mineral Supplements?

The proposed Codex Guidelines on Vitamin and Mineral Supplements are intended to provide guidance on the composition, including maximum and minimum levels, as well as packaging and labelling, so that vitamin and mineral supplements will be safe, efficacious and labelled in a clear and non-misleading manner to ensure safe and informed use.

Canada will not be adopting these proposed Guidelines for two reasons:

1. The Guidelines on Vitamin and Mineral Supplements specifically state they will only apply in countries that regulate vitamins and minerals as foods. In Canada, vitamin and mineral supplements are regulated as natural health products. The proposed Codex guidelines are therefore not applicable in this country.
2. Under Canada's Natural Health Products Regulations, which came into effect on January 1, 2004, the safety and efficacy of vitamin and mineral supplements sold in Canada is already ensured.

How are vitamin and mineral supplements regulated in Canada?

Health Canada has always supported the right of Canadians to access natural health products that are safe, effective and of high quality, while respecting cultural and philosophical diversity. In Canada, vitamin and mineral supplements are classified as natural health products, not foods. In 1998, following the recommendations of the Standing Committee on Health and broad public consultations, the Natural Health Products Regulations were developed to provide a safe, new and innovative framework for these products¹. These regulations came into force on January 1, 2004 and set out the standards, guidelines, and requirements for the sale of natural health products in Canada.

Regulating vitamins and minerals as natural health products brings several advantages to Canadian consumers. The mandatory pre-market review of all natural health products ensures that what is on the label is what is in the bottle, and that health claims are supported by appropriate levels of evidence. Unlike foods, which are limited under the Food and Drug Regulations to diet-related or nutritional content claims, natural health products can make the full range of health claims that consumers and industry have requested, including risk reduction, structure-function and treatment-prevention claims, where sufficient evidence exists. At the same time, the Regulations increase the safety and efficacy of natural health products by requiring clear labelling information, for example on treatment, dosage and health warnings, as well as pre-market review and assessment, which is not generally required for foods. With this framework in place, Health Canada is helping Canadians have access to natural health products that are safe, effective, and of the highest quality.

More information on Codex and Canada's Position.

¹Further information on the key components of the Natural Health Products Regulations is available under the About the Natural Health Products Regulations section of this Web site.