Interim policy statement on the nutrition labelling of prepackaged human milk

October 6, 2023

On this page:

• Introduction
• Background
• Interim Policy statement
• Scope
• Contact us

Introduction

Health Canada is responsible for setting standards and providing advice and information on the safety and nutritional value of foods, including prepackaged human milk. Prepackaged human milk sold in Canada is subject to the provisions of the Safe Food for Canadians Act and the Safe Food for Canadians Regulations, as well as those of the Food and Drugs Act and the Food and Drug Regulations (FDR). These provisions include a requirement for prepackaged foods to carry a Nutrition Facts table (NFt), which could pose a barrier to the distribution of prepackaged human milk.

Background

Prepackaged human milk is most often used in a clinical setting for preterm infants who cannot obtain sufficient breastmilk, for a variety of reasons (e.g., immaturity of mammary glands, illness, etc.).^{Footnote 1} Prepackaged human milk is pooled from several donors. The composition of donor milk varies widely due to individual factors such as stage of lactation, and food and supplement intake. Because of this variability, it would be difficult to derive accurate nutrient values for prepackaged human milk for the purposes of nutritional labelling.

The FDR require most prepackaged foods sold in Canada to carry an NFt. However, the regulations specify certain foods or categories of foods that are exempted or prohibited from carrying an NFt on their label. For example, prepackaged fresh fruits and vegetables were exempted from the requirement to carry an NFt because representative values were not available for these foods, while infant formula is prohibited from carrying an NFt because there are already specific labelling requirements for these foods in the FDR. The FDR neither prohibit nor exempt prepackaged human milk from the requirement to carry an NFt.

Interim Policy Statement

Health Canada has determined that NFts for prepackaged human milk could be inaccurate due to the natural variation in the nutritional composition of human milk.

This interim policy statement signals Health Canada's intention for prepackaged human milk without an NFt to remain available until regulatory changes can be implemented as part of future regulatory amendments.

Scope

This interim policy statement applies to prepackaged human milk and its prepackaged components (e.g., human milk cream) distributed in Canada.

Note: This policy statement does not apply to the following foods: human milk substitutes or human milk fortifiers intended for infants (up to one year of age) for which pre-market notification is required under Division 25 of Part B of the FDR or foods containing human milk or its components as an ingredient.

Contact Us

Bureau of Nutritional Sciences

Food Directorate
Health Products and Food Branch
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2203E
Tunney's Pasture
Ottawa, Ontario K1A 0K9
E-mail: bns-bsn@hc-sc.gc.ca
Telephone: 613-948-8476
Facsimile: 613-948-8470