Novel Food Notification and Food Additive Submission

Our regulatory experts review your product and determine if the ingredient or product is novel or has a technical effect. We prepare a safety data dossier for and engage with the Food Directorate through the entire process until a final decision is made by Health Canada.

Novel Food Notifications and Food Additive Submissions

When introducing a new food ingredient that is not regulated in the Food and Drug Regulations, Novel Food Notifications must be completed and submitted to Health Canada. The submission of novel food notification is required before selling new food in Canada. Similarly, Food Additive Submissions includes food ingredients that serve a technical effect that are completely new and have never been used before, as well as existing food additives that will be used differently, i.e. in different food.

Our Assistance for Novel Food Notification and for Food Additive Submissions

We have the expertise needed to prepare novel food notification submissions. Similarly, we prepare statutory requirements for submissions on food additives, such as descriptions of the food additive, which include chemical properties, efficacy, purpose, level of use, and proposed maximum level of use. We help:

Conduct a gap analysis and feasibility review of your data
Check whether your product or ingredient is novel
If required, arrange a pre-submission meeting with Health Canada
Communicate with officials about novel food or food additive approval
Respond to government clarification requests
Address information request notices

Preparing Technical Dossier with Supporting Information

Our regulatory experts will write and prepare a technical dossier as required by Health Canada to substantiate safety of the ingredient, including food quality considerations, benefits for consumers, information on approvals, and authorizations of other health authorities. We’ll also prepare a safety data package for notification submission, such as:

History of use
Dietary exposure
Detail of novel process
History of organism(s)
Characterization
Nutritional considerations
Allergen considerations
Chemical considerations
Genetic modification considerations

Frequently Asked Questions

How do I get a new food ingredient approved by Health Canada?

When introducing a new food ingredient that is not regulated in the Food and Drug Regulations, Novel Food Notifications must be completed and submitted to Health Canada. The submission of novel food additive applications is required before selling novel food in Canada. The application includes food additives that are completely new and have never been used before, as well as existing food additives that will be used differently, i.e., in different food.

How do I complete a Novel Food Notification application?

We have the expertise needed to prepare novel food additive applications. We prepare statutory requirements for submissions on food additives, such as descriptions of the food additive, which include chemical properties, efficacy, purpose, level of use, and proposed maximum level of use. We help:

Review your ingredient
Check whether your product or ingredient is novel
Arrange pre-submission meetings
Communicate with officials about novel food approval
Respond to government clarification requests
Address information request notices

What is a novel food in Canada?

This is a food that was manufactured, prepared, preserved or packaged through a process that may cause that food to go through a major change.