Modification to the List of permitted preservatives to extend the use of natamycin

Notice of modification - Lists of permitted food additives
Reference number: M-FAA-24-06
May 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 (Regulations). Approved 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 and published on the Canada.ca website. 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 natamycin as a preservative in unstandardized processed cheese products, standardized cream cheeses, unstandardized cream cheese products, ranch-flavoured dressings for salads and ranch-flavoured dips. The requested maximum level of use for this preservative is 10 or 20 parts per million (ppm), depending on the food.

At the time of the petitioner's submission, natamycin was permitted as a Class 3 (antifungal) preservative on the surface of the following cheeses: (naming the variety) cheese, cheddar cheese, grated or shredded (naming the variety) cheese, and grated or shredded cheddar cheese. However, natamycin was not permitted in the foods of interest to the petitioner.

Rationale for action

Health Canada's Food and Nutrition Directorate completed a premarket safety and efficacy assessment of natamycin for use as a preservative in unstandardized processed cheese products, standardized and unstandardized cream cheese products, ranch-flavoured dressings for salads and ranch-flavoured dips. The Directorate considered allergenicity, chemistry, microbiology, nutrition, efficacy, and toxicology in the assessment. The results of the assessment support the safety and efficacy of natamycin for the purposes and under the conditions of use set out in the table below. Therefore, Health Canada has modified the List of permitted preservatives to extend the use of natamycin by adding the new entries (3) and (4) to columns 2 and 3 of Part 3 of the list, as shown below (in bold in this notice to illustrate the addition).

Modification to the List of permitted preservatives

Item No.	Column 1 Additive	Column 2 Permitted in or upon	Column 3 Maximum level of use and other conditions
N.1	Natamycin	(3) Cream cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); Unstandardized cream cheese products; Ranch-flavoured dips; Ranch-flavoured dressings for salads	(3) 10 p.p.m.
		(4) Unstandardized processed cheese products	(4) 20 p.p.m.

Other relevant information

Food additives such as natamycin are required to meet food-grade specifications set out in Part B of the Regulations, 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 standards for purity and identity for food ingredients, including food additives, published by the United States Pharmacopeial Convention. Specifications in the Combined Compendium of Food Additive Specifications 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 May 30, 2024, the day it was published in the List of permitted preservatives.

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 electronically. If you wish to contact the Food and Nutrition Directorate by email, please use the words "natamycin (M-FAA-24-06)" in the subject line of your email.

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