Pre-market oversight of certain food products sold in Canada

On this page

• Mandatory pre-market safety assessments
• Scientific safety opinions
• Health claims
• Guidance for stakeholders
• Contact us

Mandatory pre-market safety assessments

As part of our commitment to the safety and nutritional quality of our food supply, we conduct scientific, pre-market safety assessments of certain food products.

Novel foods

We conduct pre-market safety assessments of all novel foods prior to their sale in Canada. Novel foods (NF) are foods:

• with no history of safe use as a food in Canada
• treated with a process not previously used for food and causes a major change in the treated foods or
• derived from a genetically modified organism with a new or altered characteristic

Learn more:

• Novel foods
• Safety assessments of cellular agriculture products

New food additives

We conduct pre-market safety assessments of both new food additives and of new uses of already permitted additives before adding them to the Lists of Permitted Food Additives. These lists show:

• which additives are permitted
• the foods to which they can added
• the maximum amounts that can be used and other conditions of use

In general, the 15 lists are organized according to technical function (for example, food colours are in the List of Permitted Food Colours).

Learn more:

• Food additives

Infant formula and human milk fortifiers

We conduct pre-market safety assessments of any new infant formula or human milk fortifier, or an infant formula or human milk fortifier that has undergone a major change.

A manufacturer of a new ingredient that hasn't been used in an infant formula in Canada must file either a novel food or new infant formula ingredient (NIFI) submission for evaluation. If deemed acceptable as either a NF or NIFI, then the ingredient could be used in an infant formula offered for sale in the Canadian marketplace. An infant formula manufacturer could subsequently file a pre-market major change submission to add this same NF or NIFI to an existing infant formula.

Learn more: Infant formula and human milk fortifiers

New supplemented foods categories and ingredients

The List of permitted supplemented food categories specifies the type of foods than can be supplemented. The List of permitted supplemental ingredients specifies the supplemental ingredients that are allowed and their corresponding conditions of use.

Stakeholders can request a change to these lists by submitting a pre-market request, including:

• adding a new supplemental ingredient or changing a permitted supplemental ingredient in the List of permitted supplemental ingredients
• adding a new category or modifying a category from the List of permitted supplemented food categories

Learn more:

• About supplemented foods

Scientific safety opinions

At the request of stakeholders, Health Canada conducts voluntary pre-market safety assessments of food packaging materials.

If the assessment is favourable, we provide the manufacturer with documentation to demonstrate the product has been found acceptable from a food chemical safety standpoint.

Health claims

We conduct mandatory and voluntary pre-market assessments of health claims on food.

Mandatory pre-market assessment is required for health claims that relate to a disease on Schedule A.1 of the Food and Drugs Act (FDA). Voluntary pre-market assessment may be requested for health claims that don't make reference to a Schedule A.1 disease. Completed pre-market assessments of health claims are available on the Health Claim Assessments website.

Learn more: Health claims

Guidance for stakeholders

We have prepared a number of documents to guide you through the pre-market submission management process for food additives, infant formulas and human milk fortifiers, novel foods, supplemented foods and health claims.

Contact us

If you have any questions about the premarket oversight of food products, please contact the Submission Management and Information Unit (SMIU):smiu-ugdi@hc-sc.gc.ca.