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

Notice of Modification - Lists of permitted food additives
Reference Number: M-FAA-24-04
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). 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 and published on the Canada.ca website. A petitioner can request that Health Canada authorize a new additive 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 nisin as a preservative in egg-white wraps. The requested maximum level of use for this food additive is 20 parts per million (ppm).

At the time of the petitioner's submission, nisin was already permitted for use as a Class 2 (antibacterial) preservative in a number of foods, including liquid whole egg, liquid whole egg mix, and baking mixes containing egg. However, nisin was not permitted in egg-white wraps.

Rationale for Action

Health Canada's Food and Nutrition Directorate completed a pre-market safety and efficacy assessment of nisin for use as a preservative in egg-white wraps. The Directorate considered allergenicity, chemistry, efficacy, microbiology, nutrition, and toxicology in the assessment. The results of the assessment support the safety and efficacy of nisin for use as a preservative in the food 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 nisin by adding the new entry shown in the table below to Part 2 of the list (in bold font in this Notice to illustrate the change).

Modification to Part 2 of 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 Nisin (8)
Egg-white wraps
(8)
20 p.p.m.

Other Relevant Information

Food additives such as nisin 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 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 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 e-mail. If you wish to contact the Food and Nutrition Directorate by e-mail about nisin, please use the words "nisin (M-FAA-24-04)" in the subject line of your e-mail.

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

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