ARCHIVED - Interim Marketing Authorization Addition of Folic Acid to Goat's Milk

Government Notices - Department of Health - Food and Drugs Act / Food and Drug Regulations Amendment

Health Canada has received a submission to permit the optional addition of folic acid to goat's milk to bring the level up that found naturally in cow's milk. Goat's milk is deficient in folic acid, having only about one-tenth of the level of folic acid found in cow's milk. Provision currently exists in the Food and Drug Regulations for the addition of folic acid to evaporated goat's milk at a higher level consistent with its potential use as an infant formula. Health Canada has completed a safety assessment of the new proposal to add folic acid to goat's milk and considers this request to be in the public interest. This nutrient addition is consistent with the General Principles for the Addition of Essential Nutrients to Food published in the Codex Alimentarius, under the Joint Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO) Food Standards Programme.

This amendment will benefit industry by making it possible to render the nutritional value of goat's milk equivalent to cow's milk with respect to folic acid and it will increase the choice and nutritional quality of products available to consumers.

Therefore, it is the intention of Health Canada to recommend the amendment of the Food and Drug Regulations to permit the optional addition of folic acid to fluid or dried whole, skimmed or partly skimmed goat's milk to a minimum level of 5 micrograms and a maximum level of 10 micrograms folate per 100 mL goat's milk when ready-to-serve.

The addition of vitamins to goat's milk continues to be optional. Nevertheless, manufacturers who choose to add folic acid to fluid or dried whole, skimmed or partly skimmed goat's milk are also required to add the vitamins indicated under subsections B.08.029 (1) and (2) and at the prescribed levels.

As a means to improve the responsiveness of the regulatory system while enhancing the nutritional well-being of consumers, an Interim Marketing Authorization(IMA) is being issued to permit the immediate optional addition of folic acid in goat's milk as indicated above while the regulatory process to amend the Regulations formally is undertaken.

April 17, 1998

J.Z. LOSOS, M.D.
Assistant Deputy Minister
Health Protection Branch
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