Health Canada’s Proposal to Enable the Use of a New Food Additive, Nisin, as an Antimicrobial Preservative in or on Various Foods

Notice of Proposal - Lists of Permitted Food Additives
Reference Number: [NOP/ADP-0028]
September 20, 2017

Summary

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 Health Canada's website.  A petitioner can request that Health Canada approve a new additive or a new condition of use for an already approved food additive by filing a food additive submission with the Department's Food Directorate.  Health Canada uses this premarket approval process to determine whether the scientific data support the safety of food additives when used under specified conditions in foods sold in Canada.

Health Canada received two food additive submissions seeking approval for the use of nisin as an antimicrobial preservative in assorted standardized and unstandardized foods.  The proposed maximum levels of use on the basis of the finished food or beverage ranges from 2.5 ppm to 30 ppm.

The results of Health Canada's evaluation of available scientific data support the safety and efficacy of nisin as an antimicrobial preservative.  Therefore, it is the intention of Health Canada to modify the List of Permitted Preservatives by adding the following entries to the List:

Rationale

Health Canada's Food Directorate assessed nisin for use as an antimicrobial preservative.  The assessment considered information related to chemistry, microbiology, nutrition, and toxicology, as well as the efficacy of nisin as an antimicrobial preservative.

Nisin is a mixture of structurally-related bacteriocin peptides with antimicrobial activity and are isolated from certain strains of Lactococcus lactis subsp. lactis. Commercial preparations are comprised of a blend of concentrated nisin and sodium chloride, standardized for nisin activity.

Nisin is a normal dietary constituent since many lactic acid bacteria, including Lactococcus lactis subsp. lactis., are found in fermented dairy and meat products.^{Footnote 1} When consumed as part of these foods, nisin is inactivated by digestive enzymes and then hydrolyzed to small peptides in the small intestine which, in turn, are further broken down into to their constituent amino acids.  Like other amino acids in the diet, they will be absorbed into the bloodstream and then enter normal metabolic pathways.  Any small peptides not totally degraded to individual amino acids in the small intestine are expected to pass into the colon where they will either be metabolized by gut bacteria or excreted.  There have been no known cases where nisin was identified as the trigger for an allergic reaction.

Nisin can be effective in controlling certain microorganisms, particularly when used in combination with other antimicrobial technologies.  Food manufacturers who use nisin or any other antimicrobial technologies are responsible for ensuring that the food products they offer for sale are microbiologically safe.

The results of the premarket assessment support the safety of nisin when used under the conditions set out in the table above.  The Department is therefore proposing to enable the uses of nisin as shown in the table.

Other Relevant Information

Nisin is permitted for use as a food preservative in Australia and New Zealand, Europe, and the United States, and it has international recognition for use as a food additive under the Codex General Standard for Food Additives.

The Canadian Food and Drug Regulations require that food additives, such as nisin, that do not have food-grade specifications set out in Part B of the Regulations meet the most recent food-grade specifications set out in the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications.  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.  The Combined Compendium of Food Additive Specifications, which contains specifications prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture Organization of the United Nations.

Implementation and Enforcement

The proposed change will be effective the day on which it is published in Part 2 of the List of Permitted Preservatives.  This will be announced via a Notice of Modification and will be published on the Government of Canada's Website.

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

For additional information or to submit comments related to this proposal, please contact:

Bureau of Chemical Safety, Food Directorate
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2202C
Ottawa, Ontario K1A 0L2
E-mail: bcs-bipc@hc-sc.gc.ca

If communicating by e-mail, please use the word "nisin" in the subject line of your e-mail.  Health Canada is able to consider information received by December 3, 2017, 75 days from the date of this posting.