Guidance documents: Infant formula and human milk fortifiers

The following guidance documents aim to assist health and industry stakeholders in the interpretation of policies and regulations, and to assist manufacturers in preparing premarket submissions when seeking approval from Health Canada for infant formulas and human milk fortifiers.

For information on requesting a pre-submission consultation with the Food Directorate, please see the Pre-submission consultation guidance: Pre-market mandatory submissions for the Food Directorate.

• Guide on the sale of human milk fortifiers

This document provides guidance on conditions relating to the sale of human milk fortifiers, such as who can sell human milk fortifiers, how to obtain human milk fortifiers, and who can write orders for human milk fortifiers.

• Guide for the preparation of infant formula and human milk fortifier premarket submissions

The purpose of this document is to assist food manufacturers in the preparation of infant formula or human milk fortifier premarket submissions.

This document elaborates on the submission process and includes sections on the regulatory context, the information requirements and nutritional, clinical, manufacturing, packaging and labelling components that must be addressed as well as administrative considerations.

• Scientific evidence requirements for nutritional adequacy of preterm infant formulas and human milk fortifiers

This document provides guidance to manufacturers on the scientific evidence needed to establish the nutritional adequacy of a new preterm infant formula and new human milk fortifiers or one that has undergone a major change.

• Scientific evidence requirements for nutritional adequacy of term infant formulas

This document provides guidance to manufacturers on the scientific evidence needed to establish the nutritional adequacy of a new infant formula or one that has undergone a major change.

• Growth and tolerance clinical trial protocol - preterm infants

This clinical protocol provides petitioners with guidance on conducting growth and tolerance studies to ensure they support the end goal of safe and nutritionally adequate infant formulas and human milk fortifiers for their intended infant population.

• Growth and tolerance clinical trial protocol - healthy term newborn infants

This clinical protocol provides petitioners with guidance on conducting growth and tolerance studies to ensure they support the end goal of safe and nutritionally adequate infant formula for their intended infant population.

• Good manufacturing practices for infant formula

This document describes good manufacturing practices for the production and quality control of infant formulas marketed in Canada. The information in this document can also apply to human milk fortifiers.

• New manufacturing facility requirements - infant formulas and human milk fortifiers

This document provides guidance to assist food manufacturers and distributors in the preparation of a premarket submission for a new manufacturing facility for infant formulas or human milk fortifiers.