Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Chymosin B  
from Kluyveromyces lactis  CIN in Certain Dairy Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted Food 
Enzymes to Enable the Use of Chymosin B from 
Kluyveromyces lactis  CIN in Certain Dairy Foods  
Notice of Modification – Lists of Permitted Food Additives   
Reference Number: [NOM/ADM -0091] 
 
 
 
April  19, 2017   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Chymosin B  
from Kluyveromyces lactis  CIN in Certain Dairy 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.   Approved food additives and their 
permitted conditions of use are set out in the Lists of Permitted Food A dditives  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 s ubmission 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 a food additive submission seeking approval for the use of chymosin  B 
from the yeast Kluyveromyces lactis  CIN in dairy products such as cheese, quark (a type of fresh 
cheese), and fermented milk products such as yogurt, kefir and sou r cream. This enzyme 
hydrolyses a protein in milk, which causes the milk to clot. Clotting of milk is essential in the 
manufacture of some dairy products, including those of interest to the petitioner.  
 
Chymosin B from other source organisms, including Kluyveromyces marxianus  var. lactis  
(DS1182) (pKS105), is already permitted for use in Canada as a food enzyme in the manufacture 
of various dairy products. However, K. lactis  CIN has not previously been permitted as a source 
organism for any enzyme on the  List of Permitted Food Enzymes . 
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
chymosin B from K. lactis  CIN for use as requested by the petitioner . Therefore, to enable the 
requested use of this enzyme from thi s source organism, Health Canada has modified the List of 
Permitted Food Enzymes  by adding the entry shown in the table below to the List.  
 
Modification to the List of Permitted Food Enzymes  
 
Item 
No. Column 1 
Additive  Column 2  
Permitted 
Source  Column 3  
Permitted in or Upon  Column 4 Maximum 
Level of Use and 
Other Conditions  
C.3 (ii) Chymosin B  Kluyveromyces 
lactis CIN  (1) 
Cheddar cheese; (naming 
the variety) Cheese; 
Cottage cheese; Cream 
cheese; Cream cheese 
with (naming the added 
ingredients); Cream 
cheese spread; Cream 
cheese spread with 
(naming the added 
ingredients); Sour cream   (1) 
Good Manufacturing 
Practice   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Chymosin B  
from Kluyveromyces lactis  CIN in Certain Dairy Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 (2) 
Unstandardized milk -
based dessert preparations  (2) 
Good Manufacturing 
Practice  
(3) 
Kefir; Quark; Yogurt  (3) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a premarket  safety assessment of the requested 
uses of chymosin B obtained from K. lactis  CIN. The assessment did not identify any 
toxicological, nutritional, microbiological, molecular biological or chemical food safety concerns 
with respect to the requested uses of chymosin B from this source organism . Therefore, Health 
Canada has enabled the req uested uses of this enzyme from this source by modifying the List of 
Permitted Food Enzymes  as shown in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as chymosin B from K. lactis  
CIN 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 F ood Additive 
Specifications , which includes the  General Specifications and Considerations for Enzyme 
Preparations , is prepared by the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA) and published by the Food and Agriculture Organization of the Uni ted Nations.  
 
Implementation and Enforcement  
 
The above modification came into force April 19 , 2017 , 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 Directorate is committed to reviewing any new scientific information on 
the safety in use of any food additive, including chymosin B from K. lactis  CIN. Anyone wishing 
to submit new scientific information on the use of this food additi ve or to submit any inquiries  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Chymosin B  
from Kluyveromyces lactis  CIN in Certain Dairy Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 may do so in writing, by regular mail or electronically. If you wish to contact the Food 
Directorate electronically, please use the words "chymosin B"  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