Modification to the List of Permitted Food Enzymes to authorize the use of polygalacturonase from a new source
Notice of Modification – Lists of Permitted Food Additives
Reference number: M-FAA-25-08
December 22, 2025
Summary
The purpose of this notice is to announce that Health Canada modified the List of Permitted Food Enzymes to authorize the use of polygalacturonase from Trichoderma reesei strain AR-414 in single-strength fruit juices, wine and fruit wine at a maximum level of use of “Good Manufacturing Practice”Footnote 1, as shown in Table 1.
This modification comes into force on December 22, 2025.
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 (FDR).
A person, company or organization (referred to as the petitioner) can ask Health Canada to authorize a new food additive use by filing a food additive submission.
Issue
Health Canada received a food additive submission asking that polygalacturonase, a type of pectinase enzyme, from Trichoderma reesei strainAR-414 be permitted for use at a maximum level of “Good Manufacturing Practice” in the following foods:
- single-strength fruit juices
- wine
- fruit wine
Polygalacturonase is to be used with other pectinases to increase the efficiency of processing fruits into wine and fruit juices.
At the time the request was filed, polygalacturonase from other sources was already permitted for use in the foods of interest to the petitioner. However, T. reesei AR-414 was not a permitted source for any food enzyme in Canada.
Rationale
Health Canada completed a premarket safety assessment of polygalacturonase from T. reesei AR-414 for its requested use. The assessment considered potential dietary exposure to the enzyme and other food safety aspects (allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology).
The outcome of Health Canada's evaluation supports authorizing polygalacturonase from T. reesei AR-414, as set out in Table 1.
Modification to the List
Health Canada has authorized the use of polygalacturonase from T. reesei AR-414 as requested by the petitioner by adding a new subitem for this source to item P.10 already set out for polygalacturonase in the List of Permitted Food Enzymes.
As a result, Aspergillus oryzae AR-183 and Trichoderma reesei RF6197 that were already permitted sources for polygalacturonase are now set out in subitem (1).
The new source T. reesei AR-414 and its corresponding entries are set out in subitem (2), as shown in Table 1 (new entries to columns 2, 3, 4, and 5 in bold font to illustrate the change).
| 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 |
|---|---|---|---|---|---|---|
| P.10 | Polygalacturonase |
(2) Trichoderma reesei AR-414 |
(a) Fruit wine; Wine |
(a) Food enzyme |
(a) Good Manufacturing Practice |
M-FAA-25-08 |
(b) Single-strength fruit juices |
(b) Food enzyme |
(b) Good Manufacturing Practice |
M-FAA-25-08 |
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:
Implementation and enforcement
The modification shown in Table 1 comes into force on December 22, 2025, the day of its publication in the List of Permitted Food Enzymes.
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 "polygalacturonase (M-FAA-25-08)" 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