Request a Demo1. Definition
As per Food and Drug Regulations, infant formula is the common name of a human milk substitute, which refers to any food that is represented
(a) for use as a partial or total replacement for human milk and intended for consumption by infants, or
(b) for use as an ingredient in a food referred to in (a).
2. Competent authority
Competent authority | Responsibility |
Health Canada (HC) | HC is responsible for establishing national health policies and regulations related to food safety and nutrition. It ensures that food products sold in Canada are safe for consumption and meet high standards of public health. It is also responsible for setting standards for food additives, contaminants, and food labeling, ensuring that Canadians have access to safe and nutritious food. |
Canadian Food Inspection Agency (CFIA) | CFIA is the federal body tasked with enforcing food safety, animal health, and plant protection laws. CFIA ensures that food products meet Canada's rigorous safety and labeling standards through inspections, compliance monitoring, and enforcement activities. It plays a critical role in verifying that both domestically produced and imported food products are safe, properly labeled, and compliant to regulatory requirements, from farm to table. |
Canada Border Services Agency (CBSA) | CBSA regulates the entry of food products into the country, ensuring their compliance with Canadian laws at the border. CBSA works in conjunction with CFIA and Health Canada to ensure that imported food products meet Canada's safety and quality standards. It monitors and enforces regulations related to food imports, including preventing the entry of non-compliant and unsafe products, while facilitating legitimate trade and protecting Canadian consumers. |
3. Market access approval
3.1 Premarket submission
According to Food and Drug Regulations, manufacturers must submit a premarket submission at least 90 days prior to selling or advertising any new infant formula or infant formula that has undergone a major change. The premarket submission must contain detailed information on the composition and manufacturing of the infant formula as well as its packaging and labelling. Besides, evidence should be provided to prove that the new or changed infant formula is safe and nutritionally adequate to promote acceptable growth and development in infants for whom it is intended. In cases where only minor changes are made, a voluntary submission may be considered appropriate.
4. Product compliance
4.1 Product requirements
The Good Manufacturing Practices (GMPs) for Infant Formula establish general requirements for effective control of ingredients, formulations, processes, facilities and equipment used for the production of all infant formulas to be sold, distributed or marketed in Canada, regardless of whether the infant formula is manufactured in Canada or in another country whose manufacturing regulations may differ from those of Canada.
The nutritional composition requirements for infant formula are specified in Division 25 of Food and Drug Regulations, particularly in B.25.054, B.25.055, and B.25.056. However, the nutritional level may exceed the level specified in regulations to overcome the nutritional loss caused over time. Besides, the use of food additives in infant formula must comply with the List of Permitted Food Additives.
Manufacturer of a new ingredient that has never been used in an infant formula or human milk fortifier in Canada should submit either a novel food or a new infant food ingredient (NIFI) submission for evaluation. The manufacturer should receive approval of the ingredient as either a novel food or an NIFI, before the premarket submission is made for the infant formula or human milk fortifier containing the ingredient. For more details about the premarket submission or NIFI, please refer to Guide for the Preparation of Infant Formula and Human Milk Fortifier Premarket Submissions.
4.2 Label
The labeling of infant formula products shall meet the general food labeling requirements stated in Safe Food for Canadians Regulations and Food and Drug Regulations, as well the specific labeling requirements for infant formula in Division 25 of Food and Drug Regulations.
Notably, "Nutrition Facts Table" and "Front-of-Package (FOP) Nutrition Symbol" are prohibited on infant formula labels. Instead, other appropriate headings such as "Nutrition Information" can be used. Nutrients that must be disclosed include energy, protein, fat, carbohydrates, ash, minerals, vitamins, and choline. For more information about the labeling and claims of infant formula, please refer to Labelling Requirements for Infant Foods, Infant Formula and Human Milk.
In addition, the Division 23 of Food and Drug Regulations provides guidance on the requirements on safe packaging of foods, including infant formula. In general, the packaging must not absorb nutrients from the infant formula into the packaging or leach unacceptable amounts of chemicals from the packaging into the infant formula. A Letter of No Objection (LONO) from Health Canada is required for all infant formula packaging materials. In particular, some constituent packaging materials (e.g., vinyl chloride, polyvinyl chloride formulations containing octyltin chemicals, and acrylonitrile based materials) are deemed inappropriate for infant formulas.
* Global Food Compliance Service
We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.
Covered Countries
China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.
Our Services
Food Ingredient Review
Label Review
Product Registration
Regulatory Consultation
Monitoring, Training and Customized Report
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