Modification to the List of Permitted Food Enzymes (transglutaminase)

Notice of Modification – Lists of Permitted Food Additives
Reference number: MFAA-2602
April 14, 2026

Summary

The purpose of this notice is to announce that Health Canada modified the List of Permitted Food Enzymes to extend the use of transglutaminase from Bacillus licheniformis strain NZYM-TR as food enzyme to various foods of plant and animal origin at a maximum level of use of “Good Manufacturing Practice”^{Footnote 1}, as shown in Table 1.

This modification comes into force on April 14, 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 transglutaminase from B. licheniformis NZYM-TR be authorized for use as a food enzyme at a maximum level of use of “Good Manufacturing Practice” in various foods of plant and animal origin. The foods that are being authorized to be made with transglutaminase are shown in Table 1.

At the time the request was filed, transglutaminase from other sources was already authorized for use in the foods of interest to the petitioner, except in beer, brewer’s mash, and in various standardized cheese and processed cheeses. However, transglutaminase from B. licheniformis NZYM-TR had not yet been authorized for use.

Rationale

Health Canada completed a premarket safety assessment of transglutaminase from B. licheniformis NZYM-TR for its requested use. The assessment considered potential dietary exposure to transglutaminase from B. licheniformis NZYM-TR and other food safety aspects (allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology).

Some of the foods requested by the petitioner are standardized in Canada. The Canadian Food Inspection Agency (CFIA) administers the Canadian Food Compositional Standards and the Canadian Standards of Identity.

The outcome of Health Canada’s evaluation supports authorizing transglutaminase from B. licheniformis NZYM-TR for use as a food enzyme, as set out in Table 1.

Modification to the list

Health Canada has authorized the use of transglutaminase from B. licheniformis NZYM-TR as a food enzyme by adding the new subitem T.2(3) and its corresponding new paragraphs T.2(3)(a) to (r) to the List of Permitted Food Enzymes, as shown in Table 1.

Table 1. Modification to the List of Permitted Food Enzymes

Item	Column 1: Food additive	Column 2: Source	Column 3: Food	Column 4: Purpose of use	Column 5: Maximum level of use, maximum level of residue and other conditions	Notes
T.2	Transglutaminase	(3) Bacillus licheniformis NZYM-TR	(a) Beer	(a) Food enzyme	(a) Good Manufacturing Practice	MFAA-2602
			(b) Blend of prepared fish and prepared meat as set out in paragraph 18.1.3(g) of Volume 18 of the Food Compositional Standards Document	(b) Food enzyme	(b) Good Manufacturing Practice	MFAA-2602
			(c) Brawn; Headcheese; Meat and meat by-product loaf; Meat by-product loaf; Meat loaf; Meat lunch; Meat roll; Prepared meat or prepared meat by-product; Prepared poultry meat or prepared poultry meat by-product; Preserved meat or preserved meat by-product; Preserved poultry meat or preserved poultry meat by-product; Pumping pickle, cover pickle or dry cure used in the curing of preserved meat or preserved meat by-product; Sausage; (Naming the prepared meat or prepared meat by-product) with (naming the non-meat ingredients)	(c) Food enzyme	(c) Good Manufacturing Practice	MFAA-2602
			(d) Bread; White flour; Whole wheat flour	(d) Food enzyme	(d) Good Manufacturing Practice	MFAA-2602
			(e) Brewers’ mash	(e) Food enzyme	(e) Good Manufacturing Practice	MFAA-2602
			(f) Cold-pack (naming the variety) cheese; Cold-pack (naming the variety) cheese with (naming the added ingredients); Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); Cottage cheese; Creamed cottage cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)	(f) Food enzyme	(f) Good Manufacturing Practice	MFAA-2602
			(g) Pasta	(g) Food enzyme	(g) Good Manufacturing Practice	MFAA-2602
			(h) Plant-based products that resemble dairy products; Plant-based products that resemble dairy-based products; Plant-based products that resemble egg products; Plant-based products that resemble fish products; Plant-based products that resemble meat (as defined in section B.21.002 of the Food and Drug Regulations) products; Plant-based products that resemble meat products, including simulated meat products; Plant-based products that resemble poultry meat products, including simulated poultry products	(h) Food enzyme	(h) Good Manufacturing Practice	MFAA-2602
			(i) Plant protein concentrates; Plant protein isolates	(i) Food enzyme	(i) Good Manufacturing Practice	MFAA-2602
			(j) Simulated meat products	(j) Food enzyme	(j) Good Manufacturing Practice	MFAA-2602
			(k) Tempeh; Tofu	(k) Food enzyme	(k) Good Manufacturing Practice	MFAA-2602
			(l) Unstandardized bakery products	(l) Food enzyme	(l) Good Manufacturing Practice	MFAA-2602
			(m) Unstandardized cheese products	(m) Food enzyme	(m) Good Manufacturing Practice	MFAA-2602
			(n) Unstandardized cream cheese products	(n) Food enzyme	(n) Good Manufacturing Practice	MFAA-2602
			(o) Unstandardized frozen dairy desserts	(o) Food enzyme	(o) Good Manufacturing Practice	MFAA-2602
			(p) Unstandardized prepared fish products	(p) Food enzyme	(p) Good Manufacturing Practice	MFAA-2602
			(q) Yogurt	(q) Food enzyme	(q) Good Manufacturing Practice	MFAA-2602

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 April 14, 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 or 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 "Transglutaminase (MFAA-2602)" 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:

Canadian Food Compositional Standards
Permitted synonyms for food additives