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Infant Foods and Infant Formula

Food and Drug Regulations Division 25

No person shall sell or advertise for sale an infant formula that, as normally consumed, does not comply with the compositional requirements set out in the Food and Drug Regulations (FDR) for infant formula.

It is also not permitted to sell or advertise for sale an infant formula that, when prepared according to directions, requires the addition of a nutritive substance other than water, a source of carbohydrates, or both.

Other than identifying the quantity of iron on the label, no one can make any claim with respect to the iron content of an infant formula unless it contains at least 1 mg of iron per 100 available Calories.

Infant formulas (human milk substitutes) and foods that are represented as containing infant formula, also have detailed and explicit labelling requirements, including nutrition labelling requirements, set out in Division 25 of the FDR. The labels for these products are prohibited from using the Nutrition Facts table heading (i.e. "Nutrition Facts", "valeur nutritive" or "valeurs nutritives"), but they may voluntarily use the Nutrition Facts table format with respect to order of presentation, naming of nutrients, fonts, layout, etc. provided the applicable requirements of Divisions 25 are met [B.01.401(4) & (5)].

All new infant formula and infant formula which have undergone minor changes in composition, manufacturing or packaging is subject to pre-market notification. Labels must be submitted to Health Canada for review as part of the pre-market notification, at the following address:

Assistant Deputy Minister
Health Products and Food Branch
Health Canada
1st Floor, Health Protection Building
Tunney's Pasture, A.L. 0701A1
Ottawa, Ontario
K1A 0L2

The use of food additives in infant formula and infant foods is strictly controlled under the FDR.

Infant foods are subject to specific maximum sodium levels. It is an offence to sell or advertise for sale an infant food that contains more sodium than that provided for in the FDR.

Note that there are specific nutrition labelling requirements, including formats, Nutrition Facts table information, and nutrient content claims, for foods solely for children under two years of age (but not infant formulas). These are discussed in the Nutrition Labelling section under Foods Intended Solely for Children Under Two Years of Age.

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