Modification to the List of Permitted Food Enzymes (protease)

Notice of Modification – Lists of Permitted Food Additives
Reference number: MFAA-2612
November 10, 2026

Summary

The purpose of this notice is to announce that Health Canada modified the List of Permitted Food Enzymes to authorize the use of protease from Fusarium venenatum strain WTY939-8-3 as a food enzyme in plant-based products that resemble dairy products and plant-based products that resemble dairy-based products at a maximum level of use of "Good Manufacturing Practice" (GMP) ^{Footnote 1}, as shown in Table 1.

This modification comes into force on November 10, 2026.

Background

The food additives authorized for use in Canada are set out in the Lists of Permitted Food Additives. These lists are incorporated by reference into Division 16 of the Food and Drug Regulations.

A person, company or organization (referred to as the petitioner) may ask Health Canada to authorize a new food additive use by filing a food additive submission.

Issue

Health Canada received a food additive submission requesting that protease from F. venenatum WTY939-8-3 be authorized for use as a food enzyme at a maximum level of use of "Good Manufacturing Practice" in:

• Plant-based beverages derived from various cereals and grains
• Plant-based "cheese" that resembles (naming the variety) cheese
• Plant-based fermented and non-fermented dairy-type foods

At the time the request was filed, protease from F. venenatum WTY939-8-3 was already authorized for use in hydrolyzed animal, milk and vegetable proteins, but not in the requested foods.

Rationale

Health Canada completed a premarket assessment of protease from F. venenatum WTY939-8-3 for its requested use. The assessment considered potential dietary exposure to protease from F. venenatum WTY939-8-3, other food safety aspects (allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology), and technical information pertaining to efficacy.

The outcome of Health Canada's evaluation supports authorizing the use of protease from F. venenatum WTY939-8-3, as set out in Table 1.

Modification to the list

Health Canada has authorized the requested use of protease from F. venenatum WTY939-8-3 by adding the new paragraphs P.11(7)(b) to the List of Permitted Food Enzymes, as shown in bold font in Table 1.

Corrective modification

The entry for the food category "Hydrolyzed animal, milk and vegetable proteins" has been updated to include a subitem designation (i.e., "(a)") to align with the presentation of other entries in the list when there are multiple foods or food categories for an entry. This modification is not intended to alter the authorized use of the food additive.

Other relevant information

Food additive specifications

Food additives authorized for use in Canada must meet the specifications set out in the Table of Food Additive Specifications, if they exist.

Food additives which do not have specifications in this table must meet the specifications, if any, set out in the latest edition of one of the following documents:

• Food Chemicals Codex ^{Footnote 2}
• Combined Compendium of Food Additive Specifications ^{Footnote 3}

Implementation and enforcement

The modification shown in Table 1 comes into force on November 10, 2026, the day of its publication in the List of Permitted Food Enzymes.

You can consult the Notices of Proposal and Notices of Modification web page to stay informed of these modifications. You can also register for Health Canada's Consultation and Stakeholder Information Management System to be automatically notified when they are issued.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact information

If you wish to submit an inquiry or new scientific information about a food additive authorized for use in Canada, please contact Health Canada's Bureau of Chemical Safety.

If your communication is specific to this notice, please write "protease (MFAA-2612)" in the subject line of your message.

Bureau of Chemical Safety
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2202C
Tunney's Pasture
Ottawa ON K1A 0K9
Email: bcs-bipc@hc-sc.gc.ca

Useful links

Health Canada:

• Food Additives: Overview

Canadian Food Inspection Agency:

• Permitted synonyms for food additives