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Editor's note: This article was originally published on October 28, 2024, and was updated on November 21, 2024, as per the latest developments.
On November 20, 2024, Health Canada announced to extend the public consultation on proposed compositional requirements for infant foods and foods currently regulated as FSDU by 30 days. The consultation period will now close on January 22, 2025.
On October 23, 2024, Health Canada announced to seek comments on its proposal for compositional requirements for infant foods and foods currently regulated as foods for special dietary use (FSDU). The proposal is anticipated to be published in the Canada Gazette in spring 2026. Public comments can be sent to [email protected] by December 23.
Background
Currently, compositional requirements for these products are regulated under Divisions 24 and 25 of the Food and Drug Regulations (FDR). Due to the outdated and inflexible regulatory framework of FDR, in November 2023, Health Canada consulted on a proposal to modernize the framework, which would newly integrate some infant foods and FSDU into food for special dietary purpose (FSDP) and specify limited information regarding product composition. Therefore, this proposal focuses on the compositional requirements, in consideration of international criteria and feedback from the last public consultation.
Proposed compositional requirements for FSDP
This proposal establishes updated compositional requirements for FSDU products, covering infant formula, medical foods for ages one or more, and medical foods represented as a total diet replacement for weight reduction.
Take infant formula for example, the proposed requirements apply to term infant formulas made from cow's milk, goat's milk or soy. An energy density range of 60 to 70 kcal/100 mL is required. Besides, the requirements must be prescribed per 100 kcal, with maximum values being inclusive of overages.
Compared to the current requirements in the FDR, the proposed requirements mandate the inclusion of alpha-linolenic acid, selenium, inositol and carnitine. For term infant formula (0-12 months), the proposed requirements mainly align with the Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Standard 72-1981). For protein, iron, docosahexaenoic acid and nucleotides, the proposed requirements make deviations. For infant formula intended for older infants (6 to 12 months), the proposal considers Codex Standard for Follow-up Formula (Codex 156-1987) and Codex Standard 72-1981.
Proposed Compositional Requirements for Infant Formula
Nutrient | Minimum (per 100 kcal) | Maximum (per 100 kcal) |
Macronutrients | ||
Protein (intact and hydrolyzed) (g) | 1.8 (cow's or goat's milk) 2.25 (soy) | 3 |
Protein quality | Equivalent to casein (measured by PER) or For an equivalent energy value, at least the same amount of each essential and semi-essential amino acid as found in the reference protein (human milk). The amounts of amino acids shall be adjusted for protein digestibility. | |
Amino acids (only L-forms) | N/A | Amount needed to meet protein quality requirements |
Taurine (mg) | 0 | 12 |
Carbohydrate (g) | 9 | 14 |
Fat (g) | 4.4 | 6 |
Linoleic acid (g) | 0.3 | 1.4 |
Alpha-linolenic acid (g) | 0.05 | N/A |
Ratio linoleic acid: alpha-linolenic acid | 5:1 | 15:1 |
Docosahexaenoic acid (g) | 0 | 0.05 |
Micronutrients | ||
Biotin (µg) | 1.5 | 10 |
Choline (mg) | 7 | 50 |
Folic acid (µg) | 10 | 50 |
Niacin (mg) | 0.3 | 1.5 |
Pantothenic acid (mg) | 0.4 | 2 |
Riboflavin (mg) | 0.08 | 0.5 |
Thiamine (mg) | 0.06 | 0.3 |
Vitamin A (µg RE) | 60 | 180 |
Vitamin B6 (mg) | 0.035 | 0.175 |
Vitamin B12 (µg) | 0.1 | 1.5 |
Vitamin C (mg) | 10 | 70 |
Vitamin D (µg) | 1 | 2.5/3 |
Vitamin E (mg α-TE) | 0.5 | 5 |
Vitamin K (µg) | 4 | 27 |
Calcium (mg) | 50 | 140/180 |
Chloride (mg) | 50 | 160 |
Copper (mg) | 0.035 | 0.12 |
Iodine (µg) | 10 | 60 |
Iron (mg) | 0.6 (cow's or goat's milk) 0.9 (soy) | 2 |
Magnesium (mg) | 5 | 15 |
Manganese (mg) | 0.001 | 0.1 |
Phosphorus (mg) | 25 | 100 |
Ratio calcium: phosphorus | 1:1 | 2:1 |
Potassium (mg) | 60 | 180 |
Selenium (µg) | 1 | 9 |
Sodium (mg) | 20 | 60 |
Zinc (mg) | 0.5 | 1.5 |
Ratio | ||
Ratio vitamin E to polyunsaturated fatty acids (mg:g) | 0.5:1 | N/A |
Other substances | ||
L-Carnitine (mg) | 1.2 | N/A |
Inositol (mg) | 4 | 40 |
Nucleotides (mg) | 0 | 16 |
Proposed compositional requirements for non-FSDP
For some products that currently regulated by the FDR but not belong to FSDP under the proposed modernized framework, this proposal also sets updated compositional requirements, such as conventional infant foods, gluten-free food, and formulated nutritional foods.
Take gluten-free food for example, in the proposed modernized framework, gluten-free foods would no longer be considered FSDU and would be regulated under the general food framework. Enterprises are necessary to specify the types of gluten-free foods that can be nutritional-fortified as well as the allowed nutrients and limits.
Proposed vitamin and mineral nutrient requirements for fortified gluten-free flour
Vitamin or mineral nutrient | Amount per 100g |
Mandatory | |
Folic acid (µg) | 150 |
Niacin (NE) | 5.30 |
Riboflavin (mg) | 0.40 |
Thiamine (mg) | 0.64 |
Iron (mg) | 4.4 |
Voluntary | |
Pantothenic acid (mg) | 1.3 |
Vitamin B6 (mg) | 0.31 |
Calcium (mg) | 140 |
Magnesium (mg) | 190 |
Selenium (µg) | 52 |
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