Modification to the List of Permitted Food Enzymes to authorize the use of lipase from a new source

Notice of Modification – Lists of Permitted Food Additives
Reference number: M-FAA-25-01
February 18, 2025

Background

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 Food and Drug Regulations (FDR). A petitioner can request that Health Canada authorize a new food additive, or a new source or a 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 the scientific data support 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 lipase from Komagataella phaffii LALL-LI2 in bread, white flour, whole wheat flour and unstandardized bakery products. The petitioner requested a maximum level of use for this food enzyme of "Good Manufacturing Practice". At the time of the petitioner's submission, lipase from other sources was already permitted for use in the foods of interest to the petitioner. However, K. phaffii LALL-LI2 was not a permitted source for any food enzyme in Canada.

Rationale

Health Canada's Food and Nutrition Directorate completed a premarket safety assessment of lipase from K. phaffii LALL-LI2 for use as a food enzyme in bread, white flour, whole wheat flour, and unstandardized bakery products. The Directorate considered allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology in the assessment. The results of the assessment support the safety of lipase from K. phaffii LALL-LI2 for its requested use.

Modification to the List of Permitted Food Enzymes

Based on the rationale detailed above, Health Canada has authorized the requested use of lipase from K. phaffii LALL-LI2 by adding to subitem L.3(2) of the List of Permitted Food Enzymes the new source organism K. phaffii LALL-LI2, as shown below (in bold font in this notice to illustrate the change).^{Footnote 1}

Other relevant information

Food additives such as lipase are required to meet specifications set out in the Table of Food Additive Specifications, where such specifications exist, or those set out, if any, in the most recent edition of the Food Chemicals Codex, published by the United States Pharmacopeial Convention, or the most recent edition of the Combined Compendium of Food Additive Specifications and its associated General Specifications and Considerations for Enzymes Used in Food Processing, both of which 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.

Implementation and enforcement

The above modification came into force February 18, 2025, 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 contact the Directorate's Bureau of Chemical Safety. For all electronic correspondences about lipase from K. phaffii LALL-LI2, please use the words "lipase (M-FAA-25-01)" 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
E-mail: bcs-bipc@hc-sc.gc.ca