Modification to the List of permitted food enzymes to authorize the use of leucyl aminopeptidase from a new source

Notice of modification - Lists of permitted food additives
Reference number: M-FAA-24-13
October 30, 2024

Background

Food additives are regulated in Canada under marketing authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations (FDR). Authorized food additives and their permitted conditions of use are set out in the Lists of permitted food additives that are incorporated by reference in the MAs. A petitioner can request that Health Canada authorize a new additive or a new source or new condition of use for an already permitted food additive by filing a food additive submission with the Department's Food and Nutrition Directorate. Health Canada uses this premarket authorization process to determine whether scientific information supports the safety of food additives when used under specified conditions in foods sold in Canada.

Issue

Health Canada's Food and Nutrition Directorate received a food additive submission seeking authorization for the use of leucyl aminopeptidase, a type of protease enzyme, from Aspergillus oryzae AT1088 in the manufacture of various breads; Colby cheese; dairy-based flavouring preparations; flour; hydrolyzed animal, milk and vegetable proteins; hydrolyzed yeast; meat tenderizing preparations; pre-cooked (instant) breakfast cereals; spray-dried cheese powder; various bakery products other than bread (including but not limited to biscuits, viennoiseries, pastry, cakes, pancakes, tortillas, pizza crusts, wafers and waffles); whole wheat flour; yeast extract; and various plant-based foods that resemble dairy, egg, meat, fish, seafood, or poultry products. Leucyl aminopeptidase from A. oryzae AT1088 is intended to be used to catalyze the hydrolysis of proteins. The petitioner requested a maximum level of use for this food enzyme of "Good Manufacturing Practice".

At the time of the petitioner's submission, several proteases were permitted for use as food enzymes, and all of the foods of interest to the petitioner, except plant-based foods that resemble fish products and seafood products, are permitted to be made with a protease. However, the source organism A. oryzae AT1088 was not previously a permitted source for any food enzyme in Canada.

Rationale for action

Health Canada's Food and Nutrition Directorate completed a premarket safety assessment of leucyl aminopeptidase from A. oryzae AT1088 for use as a food enzyme in the foods of interest to the petitioner. The Directorate considered allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology in the assessment. The results of the assessment support the safety of leucyl aminopeptidase from A. oryzae AT1088 for its requested use. Therefore, Health Canada has authorized the requested use of leucyl aminopeptidase from A. oryzae AT1088 by adding to the List of permitted food enzymes the new item L.1.1 and its corresponding entries to columns 1, 2, 3 and 4 as shown below. For the definition of "Good Manufacturing Practice" set out in column 4 as a maximum level of use, see the Marketing Authorization for Food Additives That May Be Used as Food Enzymes.

Modification to the List of permitted food enzymes

Item No.	Column 1 Additive	Column 2 Permitted Source	Column 3 Permitted in or Upon	Column 4 Maximum Level of Use and Other Conditions
L.1.1	Leucyl Aminopeptidase	Aspergillus oryzae AT1088	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(2) Colby Cheese	(2) Good Manufacturing Practice
			(3) Dairy-based flavouring preparations	(3) Good Manufacturing Practice
			(4) Hydrolyzed animal, milk and vegetable proteins; Hydrolyzed yeast	(4) Good Manufacturing Practice
			(5) Meat tenderizing preparations	(5) Good Manufacturing Practice
			(6) 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.21.004 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	(6) Good Manufacturing Practice
			(7) Pre-cooked (instant) breakfast cereals	(7) Good Manufacturing Practice
			(8) Spray-dried cheese powder	(8) Good Manufacturing Practice
			(9) Unstandardized bakery products	(9) Good Manufacturing Practice
			(10) Yeast extract	(10) Good Manufacturing Practice

Corrective modification

In the List of permitted food enzymes, the foods listed in column 3 for item C.01(i), carboxypeptidase D from Aspergillus oryzae AT1727, were reorganized to be in alphabetical order. Specifically, "Spray-dried cheese powder", formerly set out in column 3 as subitem C.01(i)(5), was moved to subitem C.01(i)(8). The foods that had been set out in C.01(i)(6) to C.01(i)(8) were moved up accordingly to now be as shown in the table below (i.e. "Meat tenderizing preparations", which was sub-item C.01(i)(6), was moved up to be sub-item C.01(i)(5), etc.).

Also, when the food enzyme carboxypeptidase D from A. oryzae AT1727 was added to the list on May 23, 2023, the requested uses of this food enzyme in plant-based products that resemble fish products and plant-based products that resemble seafood products were unintentionally excluded. To correct this, Health Canada has added the food categories "Plant-based products that resemble fish products" and "Plant-based products that resemble meat (as defined in section B.21.004 of the Food and Drug Regulations) products" to new subitem C.01(i)(6), as shown in the table below (all changes are shown in bold font in this notice only, to illustrate the modification).

Corrective modification to the List of permitted food enzymes

Item No.	Column 1 Additive	Column 2 Permitted Source	Column 3 Permitted in or Upon	Column 4 Maximum Level of Use and Other Conditions
C.01	(i) Carboxypeptidase D	Aspergillus oryzae AT1727	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(…)	(…)
			(5) Meat tenderizing preparations	(5) Good Manufacturing Practice
			(6) 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.21.004 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	(6) Good Manufacturing Practice
			(7) Pre-cooked (instant) breakfast cereals	(7) Good Manufacturing Practice
			(8) Spray-dried cheese powder	(8) Good Manufacturing Practice
			(9) Unstandardized bakery products	(9) Good Manufacturing Practice
			(10) Yeast extract	(10) Good Manufacturing Practice

Other relevant information

Food additives such as leucyl aminopeptidase are required to meet food-grade specifications set out in Part B of the FDR, where such specifications exist, or those set out in the most recent edition of the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications where there are no specifications in Part B. The Food Chemicals Codex is a compendium of food-grade specifications for food ingredients, including food additives, published by the United States Pharmacopeial Convention. Specifications in the Combined Compendium of Food Additive Specifications and its associated General Specifications and Considerations for Enzymes Used in Food Processing, both of which are published by the Food and Agriculture Organization of the United Nations, are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Implementation and enforcement

The above modification came into force October 30, 2024, the day it was published 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

Health Canada's Food and Nutrition Directorate is committed to reviewing new scientific information on the safety in use of any permitted food additive. Anyone wishing to submit an inquiry or new scientific information on the use of a permitted food additive may do so in writing, by regular mail or e-mail. If you wish to contact the Food and Nutrition Directorate by e-mail about leucyl aminopeptidase from A. oryzae AT1088, please use the words "leucyl aminopeptidase(M-FAA-24-13)" in the subject line of your e-mail.

Bureau of Chemical Safety
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2202C
Tunney's Pasture
Ottawa ON K1A 0K9
E-mail: bcs-bipc@hc-sc.gc.ca