Infant formula and human milk fortifiers

Infant foods are foods that are represented for consumption by infants (persons who are under the age of one year). Health Canada assesses safety and nutritional adequacy of the following two types of infant foods: (1) infant formulas (human milk substitutes) and (2) human milk fortifiers, before they enter the Canadian market.

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Infant formula

Breast milk is the best food for newborn babies. Health Canada promotes breastfeeding - exclusively for the first six months, and sustained for up to two years or longer with appropriate complementary feeding - for the nutrition, immunologic protection, growth, and development of infants and toddlers. When breastfeeding is not possible for personal, medical, or social reasons, infant formula can be used in place of human milk.

Human milk fortifiers

Human milk fortifiers (HMFs) are infant foods which are added to human milk to increase its nutritional value. HMFs provide necessary nutrients for infants who are born prematurely or have certain medical conditions. These nutrients include added vitamins, mineral nutrients, and amino acids, as well as protein, fat, and carbohydrates, which are essential for these infants to develop and grow properly. HMFs should not be used on their own as they are not nutritionally adequate unless they are added to human milk.

HMFs should only be used under the direction of a qualified medical professional. They are most commonly used in hospital neonatal intensive care units, however, some infants may benefit from their continued use at home for a short period of time. Medical professionals determine if HMFs are necessary for home use and whether proper follow-up is in place to facilitate their use at home. In order to obtain HMFs outside of a hospital, a written order from a physician, nurse practitioner or dietitian (who is authorized to do so in their province or territory) is required.

Bringing infant foods to the Canadian market

Infant foods are regulated under Division 25, Part B of the Food and Drug Regulations. A regulatory framework for HMFs was finalized in April 2021 as part of the 2019 Agri-food and Aquaculture Regulatory Review Roadmap. A transition period was applied to the HMFs marketed in Canada before the new regulations were in place, which can be found in the List of Human Milk Fortifiers Sold in Canada as of March 25, 2021.

Manufacturers are required to provide detailed information on infant formulas and HMFs for review by Health Canada. Health Canada reviews the information submitted by manufacturers to determine whether the product is safe and nutritionally adequate to promote acceptable growth and development in infants. The required information for Health Canada's review includes the evidence for the nutritional adequacy of the product, as well as information on composition, manufacturing, packaging, and labelling.

The Food and Drug Regulations set conditions on the sale of infant formulas and HMFs, including: labelling requirements for these products and stopping the sale and advertising if evidence shows that the infant formula or the HMF is not nutritionally adequate or that the expiration date is not valid.

Additional guidance for health and industry stakeholders to assist them in the interpretation of policies and regulations, and to assist infant formula and human milk fortifier manufacturers in preparing premarket submissions for infant formulas and human milk fortifiers can be found on Guidance documents: Infant formula and human milk fortifiers.

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