On November 20th, 2025, Health Canada released a new proposal signalling its intention to authorize exo-inulinase from Trichoderma reesei strain AR 577 as a permitted food enzyme in Canada. If the proposal moves forward, the change would be implemented through an update to the List of Permitted Food Enzymes following a public consultation period that closes on February 3rd, 2026.
The List of Permitted Food Enzymes is incorporated by reference into Division 16 of the Food and Drug Regulations, which means any amendment to the list becomes part of Canada’s food additive law once finalized. Exo-inulinase is not currently permitted in the Canadian market, but this proposal outlines a clear pathway for its authorization pending completion of the consultation period.
If approved, the enzyme would be permitted for use in bread, white flour, whole wheat flour, and an extensive range of unstandardized bakery products. Its use would be limited to levels consistent with Good Manufacturing Practice (GMP), ensuring manufacturers apply only the amount required to achieve the intended technological effect.
- Understanding How Food Enzymes Are Regulated in Canada
- What Exo-inulinase Does in Bread and Bakery Processing
- Health Canada’s Safety and Efficacy Findings for Exo-inulinase
- What Good Manufacturing Practice (GMP) Means for Enzyme Use
- Ingredient Specifications and Quality Standards for Exo-inulinase
- Implications for Bakeries, Flour Millers, and Ingredient Suppliers
- Consultation Timeline and What Industry Should Expect Next
- Final Remarks
- FAQ
Understanding How Food Enzymes Are Regulated in Canada
Food enzymes in Canada fall under the country’s broader food additive system. When a company seeks approval for a new enzyme or a new microbial source for an existing enzyme, the process begins with a formal food additive submission. Health Canada then conducts a thorough scientific assessment that examines chemistry, microbiology, allergenicity, molecular biology, nutritional impact, toxicology, and the technological purpose of the enzyme.
Once Health Canada determines that the enzyme is safe, functional, and suitable for the proposed use, the department updates the relevant List of Permitted Food Additives. Only after this amendment is published can manufacturers legally incorporate the enzyme into Canadian-sold food products.
What Exo-inulinase Does in Bread and Bakery Processing
Exo-inulinase plays a very specific and scientifically supported role in flour and bakery systems. Inulin is a naturally occurring carbohydrate found in several plants. When exo-inulinase breaks down inulin, it produces shorter-chain oligosaccharides, fructose, and glucose. These breakdown products increase the availability of fermentable sugars in dough, which promotes consistent yeast fermentation and supports more stable dough development.
As dough behaviour improves, bakeries may see changes in loaf volume, crust colour, fermentation timing, or dough handling characteristics. Health Canada notes that the enzyme can also reduce dough softness, likely due to shifts in water absorption and dough structure. These effects explain why the bakery sector is watching this proposal closely, particularly as manufacturers continue to refine dough performance and production efficiency.
Health Canada’s Safety and Efficacy Findings for Exo-inulinase
The department has completed its scientific review of exo-inulinase from T. reesei AR 577 and concluded that the enzyme is safe and effective for its intended use in bakery products. Instead of setting a numerical limit, Health Canada proposes managing the enzyme under GMP. This approach ensures that manufacturers apply the smallest amount required to achieve the technological effect. It is also consistent with how many other processing enzymes are regulated in Canada.
What Good Manufacturing Practice (GMP) Means for Enzyme Use
GMP requires manufacturers to use exo-inulinase at the lowest level that still provides the intended function. Companies will need to document their reasoning for the selected use level and ensure that the enzyme integrates into their existing quality and food safety programs. As with all processing aids, the enzyme must not compromise product safety, compositional integrity, or regulatory compliance.
Ingredient Specifications and Quality Standards for Exo-inulinase
If the proposal moves forward, exo-inulinase from T. reesei AR 577 must meet the specifications outlined in the Table of Food Additive Specifications whenever applicable. When no Canadian specification exists, manufacturers must reference established international standards such as the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications. Suppliers may need to review their manufacturing controls and quality documentation to ensure alignment with Canadian expectations before commercializing the enzyme in this market.
Implications for Bakeries, Flour Millers, and Ingredient Suppliers
This proposal has practical implications across the bakery supply chain. Bakeries may begin assessing how exo-inulinase could support formulation goals related to fermentation performance, dough stability, or product consistency. Flour processors may evaluate whether the enzyme could help maintain performance across natural variations in wheat quality. Ingredient suppliers, meanwhile, may use this time to prepare technical profiles, use guidelines, and specification sheets, so customers are ready to adopt the enzyme once the authorization becomes official.
Although the approval would not directly change Canadian food labelling rules, manufacturers should verify the accuracy of any nutrient declarations affected by shifts in carbohydrate composition. Since exo-inulinase functions as a processing aid, it generally does not require declaration on retail labels, yet overall compliance with the Food and Drug Regulations must remain intact.
Consultation Timeline and What Industry Should Expect Next
Health Canada is accepting comments on Proposal P-FAA-25-01 until February 3rd, 2026. This consultation period provides an opportunity for companies, industry associations, and technical specialists to offer feedback on the proposed categories, technological considerations, or any anticipated implementation challenges. After reviewing all submissions, Health Canada will determine whether to finalize the amendment. If approved, the department will issue a Notice of Modification confirming the update to the List of Permitted Food Enzymes and the effective date for the regulatory change.
Final Remarks
If Health Canada finalizes the authorization, exo-inulinase from T. reesei AR 577 will offer Canadian bakeries an additional tool for optimizing dough performance and improving fermentation consistency. Once added to the List, its use will be monitored under Canada’s existing compliance and inspection framework, and manufacturers will be expected to demonstrate adherence to GMP at all times.
For bakeries, flour processors, and ingredient suppliers looking to enhance their formulations or scale production with greater predictability, this proposal is an important development to track as 2026 approaches.
How SNI Can Support Your Team
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FAQ
Is exo-inulinase from T. reesei AR-577 already allowed in Canada?
No. At the time of the proposal, this source of exo-inulinase is not yet listed in the List of Permitted Food Enzymes. It can only be used once Health Canada issues a Notice of Modification and updates the List.
Will there be a fixed maximum use level in ppm or mg per kg?
No numerical limit is proposed. Instead, the enzyme would be controlled through the requirement to use it at levels consistent with GMP,which is the same approach applied to many other food enzymes in Canada.
Does this proposal change retail label requirements for finished bakery products?
This proposal focuses on permitting the enzyme as a food additive. It does not directly change front-of-pack or nutrition labelling rules. However, companies will still need to ensure that ingredient declarations and any related claims comply with the Food and Drug Regulations, and that any inulin-related claims remain accurate if the formulation changes.
How does this proposal relate to other recent food enzyme decisions?
P-FAA-25-01 is part of a series of recent updates where Health Canada has either proposed or finalized new food enzyme authorizations, such as pullulanase from Klebsiella pneumoniae AE-PUL for brewing applications. This reflects a broader trend of gradual expansion of enzyme tools within a modernized food additive framework.
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