On October 1, 2024, Canada published a Notice of Intent to Establish a Ministerial Interim Exemption Order for the Special importation of Foods for Special Dietary Purposes (FSDP) for public comment, with a feedback period ending November 15, 2024, Key elements:

(1) Scope of products to be exempted: breast milk substitutes (infant formula) and breast milk fortifiers, as defined in section B.25.001 of the Food and Drug Regulations (FDR), and formulated fluid foods, as defined in section B.24.001 of the FDR, with the exception of dietary products (i.e., metabolizable products) that are applicable to individuals over the age of one year who suffer from hereditary metabolic disorders;

(2) Labeling exemptions. Exemption from the format, location, and/or other specifications in Parts A and B (Item 1) of the FDR regarding the type of information that must be presented (e.g., ingredient lists, batch numbers, allergen and gluten claims, etc.) on food labels, subject to basic labeling information (including the name of the manufacturer and its address and contact information, the product's common name, the ingredient list, etc.). For example, the proposed order would not exempt from the requirement to carry an allergen statement (if applicable), but would exempt FSDPs from the requirement on how to present an allergen statement on the label; exempt from the bilingual labeling requirement, except that when the product is marketed in Canada, certain core information about the special import FSDP must be provided in both English and French; exempt from labeling requirements for products proposed to be exempted in Items 24 and 25; exempt from FDR D Part 1 and 2 from the labeling requirements relating to labeling representations of the actions or effects of vitamins and mineral nutrients in foods;

(3) Ingredient exemptions. Exempts FDR Items 24 and 25 from the ingredient requirements for products to be exempted; Part D, Items 1 through 3, relating to the addition of vitamins, mineral nutrients, and amino acids to foods; and provisions relating to the use or presence in foods of food additives, nutrients used as ingredients in foods, agrochemicals, food packaging materials, and the composition of such materials. There will be no exemptions from the provisions of Item 15 on the presence of contaminants and other adulterating substances in food, and the existing provisions of Item 23 on the presence of vinyl chloride and acrylonitrile in food;

(4) Pre-market review exemption. Exempts from premarket notification for new infant formula and infant formula that has undergone a significant change, and premarket approval for new breast milk fortification and breast milk fortification that has undergone a significant change. There will be no waiver of the "discontinuance of marketing" provisions in B.25.018 and B.25.060 for breastmilk fortifiers and infant formula;

(5) Other conditions. The Minister of Health must be notified in writing of shipments of FSDPs received at least five days prior to the arrival of the product in Canada; the Minister of Health must be notified immediately in writing of any health and/or safety concerns with respect to the FSDPs subject to the Order, and the Minister of Health must be notified in writing of any significant changes to the FSDPs subject to the Order. The proposed order would be effective through December 31, 2025.

Learn more: https://www.canada.ca/en/health-canada/services/food-nutrition/public-involvement-partnerships/notice-of-intent-for-exceptional-importation-certain-foods-to-mitigate-shortage.html