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-24-09
• September 6, 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 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 Rhizopus arrhizus AE-TL in the manufacture of modified fats and oils. 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 was already permitted for use in modified fats and oils. However, R. arrhizus AE-TL was not 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 lipase from R. arrhizus (also known as Rhizopus delemar var. multiplicisporus and Rhizopus oryzae) strain AE-TL, for use as a food enzyme in the manufacture of modified fats and oils. 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 R. arrhizus AE-TL for its requested use. Therefore, Health Canada has authorized the requested use of lipase from R. arrhizus AE-TL by adding to the List of permitted food enzymes the new source organism, R. arrhizus (syn. Rhizopus delemar var. multiplicisporus, Rhizopus oryzae) AE-TL, to immediately follow Aspergillus niger (pCaHj600/MBin118#11) in Column 2 of Item L.2 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

Other relevant information

Food additives such as lipase 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 September 6, 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 lipase from R. arrhizus AE-TL, please use the words "lipase (M-FAA-24-09)" 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