Proposal to modify the List of Permitted Food Enzymes to authorize the use of exo-inulinase

Notice of Proposal – Lists of Permitted Food Additives
Reference Number: P-FAA-25-01
November 20, 2025

Summary

The purpose of this notice is to publicly announce Health Canada’s intention to permit the use of exo-inulinase from Trichoderma reesei strain AR-577 as a food enzyme in the foods and under the conditions specified in this notice.

Comments on this proposal can be submitted by email to food.ibr-ipr.aliments@hc-sc.gc.ca until February 3, 2026. Please use the words "exo-inulinase (P-FAA-25-01)" in the subject line of your email.

Background

The food additives authorized 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.

There is a premarket authorization process to ask Health Canada to permit a new use of a food additive. The process is started by filing a food additive submission that Health Canada will review to determine if the safety of the food additive is supported for its requested use.

Emerging health risks, new scientific data, or outcomes of health risk assessments may also prompt Health Canada to modify the permitted uses of food additives.

Issue

Health Canada received a food additive submission asking that exo-inulinase from T. reesei AR-577 be permitted for use as a food enzyme in the manufacture of bread, flour, whole wheat flour, unstandardized flours (rye flour), unstandardized bakery products, and unstandardized mixes and batters.

The petitioner requested a maximum level of use for this food enzyme of “Good Manufacturing Practice”.

This food additive is not currently set out in the Lists of Permitted Food Additives and, therefore, is not permitted for use in foods sold in Canada.

Rationale

Health Canada completed a premarket safety and efficacy assessment of exo-inulinase from T. reesei AR-577 for its requested use. The assessment considered allergenicity, chemistry, microbiology, molecular biology, nutrition, technical, and toxicology aspects.

Exo-inulinase hydrolyzes inulin into short-chain oligosaccharides, fructose, and glucose, in order to increase the level of fermentable and reducing sugars in the dough, which increases yeast fermentation. The enzyme can also decrease the softness of dough, which may result from increased water absorption.

The results of the premarket assessment support the safety and efficacy of exo-inulinase from T. reesei AR-577 when used as a food enzyme in bread, white flour, whole wheat flour, and unstandardized bakery products at a level of “Good Manufacturing Practice”. These food categories capture the foods of interest to the petitioner (unstandardized flours and the types of unstandardized batters and mixes of interest to the petitioner are types of unstandardized bakery products).

Proposed modification

Based on the rationale detailed above, Health Canada proposes to permit the requested use of exo-inulinase from T. reesei AR-577 by adding the new item E.1 to the List of Permitted Food Enzymes, as shown in Table 1.

Table 1. Proposed modification to the List of Permitted Food Enzymes

	Column 1	Column 2	Column 3	Column 4	Column 5
Item	Food additive	Source	Food	Purpose of use	Maximum level of use, maximum level of residue and other conditions	Notes
E.1	Exo-inulinase	Trichoderma reesei AR-577	(a) Bread; White flour; Whole wheat flour	(a) Food enzyme	(a) Good Manufacturing Practice	n/a
			(b) Unstandardized bakery products	(b) Food enzyme	(b) Good Manufacturing Practice	n/a

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 1}
• Combined Compendium of Food Additive Specifications^{Footnote 2}

Implementation and enforcement

The proposed modification will come into effect the day on which it is published in the List of Permitted Food Enzymes. This will be announced via a Notice of Modification that will be published on the Notices of Proposal and Notices of Modification web page.

You can register for Health Canada's Consultation and Stakeholder Information Management System (CSIMS) to stay informed of such notices as 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.

Consultation

Please submit your comments on the “Proposal to modify the List of Permitted Food Enzymes to authorize the use of exo-inulinase” directly to Health Canada’s Food Incorporation by Reference Unit (FIRU) at food.ibr-ipr.aliments@hc-sc.gc.ca by February 3, 2026, 75 days from the date of this posting and use the words "exo-inulinase (P-FAA-25-01)" in the subject line of your email.

Endnotes