Notice of Intent: Publication of the list of non-novel food products and ingredients

Purpose

The purpose of this notice is to inform Canadians and interested stakeholders of Health Canada’s intention to publish on its website a list of non-novel determinations for foods and ingredients that are not considered to fall within the definition of “novel food”. The primary objective of this initiative is to improve the transparency of Health Canada’s decisions under the Novel Food Program.

Background

Under Division 28 of Part B of the Food and Drug Regulations, a food with no history of safe use, or a food produced using a process that causes a major change, or a food that has been genetically modified to add, remove, or change a trait falls within the definition of “novel food”. Division 28 of Part B of the Food and Drug Regulations prohibits the sale of novel foods unless they have undergone a mandatory pre-market safety assessment and determined to be safe for consumption. Frequently, stakeholders ask Health Canada to determine if their food products or ingredients meet the definition of novel or not in order to understand whether they must submit a novel food pre-market submission for their product (referred to as the novelty determination process).

Health Canada has kept records of non-novel determinations for foods and ingredients and will be publishing a list on its website in order to improve transparency, and to allow other interested businesses the opportunity to verify if their food products and ingredients can be found on the list.

Next Steps

Health Canada will begin publishing a list of non-novel determinations for foods and ingredients on September 30, 2020, using a phased approach.

On September 30, 2020, the majority of past determinations, beginning from 2012, will be published on the list. These determinations have been confirmed to be free of confidential business information and are not associated with any specific health and safety considerations.

A minority of past determinations will require further analysis before they can be included in the list. This analysis will take place over the coming months and be completed by March 2021 with the goal of including as many of the remaining determinations in the list.

All non-novel determinations based on requests received after September 30, 2020 will automatically be included in the list.

The list of non-novel food products and ingredients will contain the following information: the date, the name of the product, a plain language description of the product, and Health Canada’s rationale. The identification of the requestor will not be published.

Any comments regarding the above Notice should be directed to:

Bureau of Microbial Hazards, Food Directorate
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2203B
Ottawa, Ontario K1A 0L2
E-mail: hc.bmh-bdm.sc@canada.ca

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