Summary
The purpose of this notice is to publicly announce Health Canada's decision to permit pullulanase from Klebsiella pneumoniae AE-PUL to be used as a food enzyme in brewers’ mash and beer at a maximum level of use of “Good Manufacturing Practice”.Footnote1 This modification will come into force on October 20, 2025, the date on which theList of Permitted Food Enzymes is modified, which is 5 weeks from the date of publication of this notice.
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).
There is a premarket authorization process to ask Health Canada to permit the use of a new food additive or to modify the use of an already permitted food additive. The process is started by filing a food additive submission that contains scientific information that Health Canada will review to determine if the safety of the food additive is supported for its requested use.
Issue
Health Canada received a food additive submission asking that pullulanase from Klebsiella pneumoniae AE-PUL be permitted for use in ale, beer, brewers’ mash, light beer, malt liquor, porter and stout at a maximum level of use of “Good Manufacturing Practice”.
At the time of the petitioner’s submission, pullulanase from other sources was already permitted for use in brewer’s mash but pullulanase from the source organism K. pneumoniae strain AE-PUL was not permitted for use as a food enzyme in any food sold in Canada.
Rationale
Health Canada completed a premarket safety assessment of pullulanase from K. pneumoniae strain AE-PUL for its requested use. The assessment considered allergenicity, chemistry, microbiology, nutrition, and toxicology aspects.
The results of the assessment support the safety of pullulanase from K. pneumoniae strain AE-PUL for its requested use.
Modification to the List of Permitted Food Enzymes
Health Canada will permit the use of pullulanase from Klebsiella pneumoniae strain AE-PUL as requested by the petitioner by adding a new subitem (5) Klebsiella pneumoniae strain AE-PUL to Item P.13 of the List of Permitted Food Enzymes, as shown in the table below (in bold font in this notice to illustrate the change). The food “Beer” in Column 3 includes ale, light beer, malt liquor, porter and stout as these are all types of beer that are subject to the standard for beer set out in Volume 2 of the Canadian Food Compositional Standards.
List of Permitted Food Enzymes
| Item | Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Notes |
| Food additive | Source | Food | Purpose of use | Maximum level of use, maximum level of residue and other conditions | ||
| P.13 | Pullulanase | -5 | (a) | (a) | (a) | FAA-25-05 |
| Klebsiella pneumoniae AE-PUL | Beer | Food enzyme | Good Manufacturing Practice | |||
| (b) | (b) | (b) | FAA-25-05 | |||
| Brewers’ mash | Food enzyme | Good Manufacturing Practice |
Other relevant information
Food additive specifications
Food additives 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 Footnote2
Combined Compendium of Food Additive Specifications
Implementation and enforcement
The modification described in this notice will come into force on October 20, 2025, the day it is published in the List of Permitted Food Enzymes, which is 5 weeks from the date of publication of this notice.
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 permitted for use in Canada please contact Health Canada’s Bureau of Chemical Safety (BCS). If your communication is specific to this notice, please use the words "pullulanase (M-FAA-25-05)" 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: Regulation of food additives
Canadian Food Inspection Agency: Permitted synonyms for food additives
Endnotes
Footnote 1
When the words "Good Manufacturing Practice" are set out in column 5 of the Lists of Permitted Food Additives, they mean that the amount of the food additive in the food does not exceed the amount required to accomplish the purpose for which it is added.
Return to footnote1referrer
Footnote 2
The Food Chemicals Codex is published by the United States Pharmacopeial Convention.
Return to footnote2referrer
Footnote 3
The Combined Compendium of Food Additive Specifications and its associated General Specifications and Considerations for Enzymes Used in Food Processing are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization of the United Nations.