Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Nisin  
as an Antimicrobial Preservative in or on Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Preservatives  to Enable the Use of Nisin a s an 
Antimicrobial Preservative in or on Various 
Foods  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0110] 
February 9 , 2018  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Nisin  
as an Antimicrobial Preservative in or on Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    2 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 Pe rmitted Food Additives  that are 
incorporated by reference in the MAs and published on the Canada.ca  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 foo d 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 submission s that together  sought  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 fo od or beverage , range  from 
2.5 parts per million ( p.p.m.) to 30 p .p.m., depending on the product . 
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of nisin when used as set out in the table below. Since this is a food additive that was 
not previously permitted for use in Canada, Health Canada published  a notice of the 
Department’s intent to enable the use of nisin, titled Health Canada’s Proposal to Enable the 
Use of a New Food Additive, Nisin, as an Antimicrobial Preservative in or on Various Foods  – 
Reference Number: NOP/A DP-0028 . 
 
The proposal was published on September 20, 2017 , and was open for public comment for 
75 days.   No new scientific information was submitted to the Department as a result of this 
publication.   Since the conclusions of the evaluation remain as desc ribed in the publication, 
Health Canada has modified Part 2 of the List of Permitted Preservatives  as indicated below , 
with two minor modifications to the listings in response to comments received. This is further 
described in the section “ Notification – Summary of Comments ”. 
 
Modification to Part 2 of the List of Permitted Preservatives  
 
Item 
No. Colu mn 1  
Additive  Column 2  
Permitted in or Upon Column 3  
Maximum Level of Use 
and Other Conditions  
N.1 Nisin  (1)  
Baking mixes containing egg; Brine for 
hard-boiled egg; Liquid whole egg; Liquid 
whole egg mix  (1)  
15 p.p.m . 
(2)  
Concentrated (naming the fruit) juice; 
(naming the fruit) Juice; (naming the (2) 
2.5 p.p.m . in product s as 
consumed   
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Nisin  
as an Antimicrobial Preservative in or on Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Item 
No. Colu mn 1  
Additive  Column 2  
Permitted in or Upon Column 3  
Maximum Level of Use 
and Other Conditions  
fruits) Juice; Unstandardized beverages 
containing fruit juice ; Unstandardized 
beverage concentrates containing fruit 
juice  
(3)  
Meat Loaf; Ready -to-eat prepared meat 
(Division 14);  Ready -to-eat prepared meat 
by-product ; Ready -to-eat prepared poultry 
meat ; Ready -to-eat prepared poultry meat 
by-product ; Ready -to-eat preserved meat 
(Division 14 ); Ready -to-eat preserved 
meat by -product ; Ready-to-eat preserved 
poultry meat ; Ready -to-eat preserved 
poultry meat by -product ; Ready -to-eat 
smoked fish ; Sausage  (3) 
25 p.p.m.  
(4)  
Refrigerated cooked potato -based products  (4) 
12.5 p.p.m.  
(5)  
Unstandardized heat -treated low -acid 
sauces   (5) 
6.25 p.p.m.  
(6)  
Unstandardized processed cheese products  (6) 
30 p.p.m.  
 
Certain foods identified in sub -item (3) in the table shown above are meat products for which 
there are standards of identity and composition set out in Division 14 of Part B of the 
Regulations . The terminology “prepared meat” and “preserved meat” is used both in Division 14 
(“Meat, Its Preparations and Products”) and in Division 21 (“Marine and Fresh Water Animal 
Products”). Therefore, “Division 14” is indicated afte r these terms in order to be clear that they 
do not refer to marine or freshwater animal products.  
 
Rationale  
 
Health Canada’s Food Directorate completed a premarket safety and efficacy assessment of the 
requested uses of nisin . The assessment considered information related to chemistry, 
microbiolog y, nutrition, and toxicology, as well as the efficacy of nisin as an antimicrobial 
preservative , and found that the available data supported the uses of this preservative as shown in 
the table above. Health Cana da has therefore  enabled the se requested  uses of  nisin  by modifying 
Part 2 of the List of Permitted Preservative s as shown  in the above table . 
 
  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Nisin  
as an Antimicrobial Preservative in or on Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 Other Relevant Information  
 
The 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 c ompendium 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.   
 
Notification – Summary of Comments  
 
During the comment period, Health Canada received comment s from one industry association  
and one member of the food industry . The association expressed support  for the use of nisin in 
beverages ; requested confirmation that the maximum level of use would be applied to 
concentrated juice on an “as consumed” basis ; and reque sted that “Unstandardized beverage 
concentrates containing (naming the fruit/fruits) juice ” be added to sub item  (2). The food 
industry member requested clarification on the definition and scope of products covered by the 
food category “unstandardized proc essed cheese products.”  
 
To ensure clarity  in how the maximum level of use should be applied to juice concentrates  and to 
beverage concentrates containing juice , wording has been added , as shown in the table above , to 
the maximum level of use for sub item  (2) indicating that the concentration is to be applied on an 
“as consumed” basis. With respect to the second request, since  the use of nisin is acceptable in 
“unstandardized beverages containing fruit juice” , it is also acceptable in “unstandardized 
bever age concentrates containing fruit juice” . Therefore , the latter food category has also been 
included in sub item  (2). The term “fruit juice” accommodates the use of both standardized and 
unstandardized fruit juices.  
 
With respect to the question regarding “unstandardized processed cheese products” , this food 
category  covers processed cheese products that : (1) are made by comminuting or mixing one or 
more varieties of cheese into a homogeneous mass with the aid of heat ; and (2) do not meet and 
are not being represented as one of the  various standards for processed cheese products that are 
set out in sections B.08.040(1)[S] through to B.08.041.4(1)[S], Part B, of the Food and Drug 
Regulations .  
 
Implementation and Enforcement  
 
The above modification came into force February 9 , 2018 , the day it was published in  Part 2 of 
the List of Permitted Preservatives . 
  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Nisin  
as an Antimicrobial Preservative in or on Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    5 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 Directorate is committed to reviewing any new scientific info rmation on 
the safety in use of any food additive, including  nisin.  Anyone wishing to submit new scientific 
information on the use of this food additive or to submit any inquiries may do so in writing, by 
regular mail or electronically. If you wish to contact the Food Directorate electronically, please 
use the words "nisin (NOM -0110 )" in the subject line of your e -mail.  
 
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