Notice to industry – Implementation for Health Canada's new guidance for novel food regulations focused on plant breeding

May 18, 2022

Introduction

As part of a regulatory review commitment to provide greater clarity, predictability, and transparency to Canada's approach to the regulation of products derived from new technologies, Health Canada has published new guidance that relates to the Novel Food Regulations (Division 28, Part B of the Food and Drug Regulations (FDR)):

• Guidance on the novelty interpretation of products of plant breeding
• Guidance on the Pre-Market Assessment of Foods Derived from Retransformants

These new guidance documents were added to the existing 2006 Guidelines for the Safety Assessment of Novel Foods as appendices.

This page summarizes the Canadian Food Inspection Agency's (CFIA) approach to the implementation of this new guidance.

Overview

Health Canada's new guidance accounts for the health and safety objectives of the regulations, making use of the regulator's experience as this field of science has evolved since the regulations were published. This new guidance facilitates a risk-based approach where oversight is applied based on the level of risk posed by a product. It focuses on foods derived from products of plant breeding and describes:

• the specific criteria (for example, characteristics [Guidance on the novelty interpretation of products of plant breeding]) by which a food derived from a product of plant breeding would (or would not) meet the definition of a 'novel food' such that a developer will be able to confirm whether or not their product is novel (for example, require pre-market notification).
• a Transparency Initiative (TI) process where developers will voluntarily submit information about their products derived from gene-edited plants which do not meet the definition of a 'novel food' to Health Canada for publication on the Health Canada website.
• what information is required by Health Canada for a tiered pre-market assessment of products of plant breeding that are still 'novel foods', but closely resemble products that have previously been assessed by Health Canada (defined as 'retransformants' [Guidance on the Pre-Market Assessment of Foods Derived from Retransformants]), as well as an expedited service standard for these assessments.

For more information, refer to Health Canada's webpage on Genetically modified foods and other novel foods.

The new guidance represents the first phase of a broader, multi-year effort to modernize guidance for all novel foods as defined under the Novel Food Regulations. Based on the outcome of this phase, Health Canada has published a Notice of Intent regarding the development of proposed regulatory changes. Regulated parties should refer to Health Canada's new guidance until amendments are made to the FDR.

CFIA approach to implementation of Health Canada guidance

For purposes of compliance and enforcement, and in consideration of Health Canada's new guidance for these novel foods, the CFIA will continue to apply its risk-based oversight using the Standard Regulatory Response Process (SRRP).

Inspection resources will continue to be focused in high-risk areas, including food safety investigations, recall verifications, and export certifications. The CFIA will also prioritize cases where false or misleading labelling information is identified.

Health Canada will continue to conduct health risk assessments in support of CFIA's compliance activities and continue to provide input on the application of the guidance.

Contact

For questions or concerns regarding the Health Canada guidance, including related specific complaints, please contact Health Canada at bmh-bdm@hc-sc.gc.ca.

For questions related to compliance with food regulations, please contact the CFIA through the contact us form.

Related links

• CFIA's Industry Labelling Tool