Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  Lactase  from  
Bacillus subtilis  CB108 in Lactose -Reducing Enzyme  Preparations and Certain Dairy Food s 
  
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 Lactase from 
Bacillus subtilis  CB108 in Lactose -Reducing 
Enzyme Preparations and Certain Dairy Food s 
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0118 
June  6, 2018  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  Lactase  from  
Bacillus subtilis  CB108 in Lactose -Reducing Enzyme  Preparations and Certain Dairy Food s 
  
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 Per mitted 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 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 ’s Food Directorate  received a food additive submission seeking approval for the 
use of lactase from Bacillus subtilis  CB108 in lactose -reducing enzyme preparations and certain 
dairy foods  (e.g., standardized flavoured milk s, whey, yogurt and milk for use in the production 
of ice cream)  at a level consistent with Good Manufacturing Practice (GMP) . When  added to 
dairy foods, lactase can  reduce the levels of lactose in the  finished  product s. Lactase from 
B. subtilis  CB108 in particular  would be used not only to reduce lactose but also to form 
galactooligosaccharides (GOS) , a dietary fibre, in situ  within the dairy foods . 
 
With respect to lactose -reducing enzyme preparations, they may be sold directly to consumers 
for personal use , but they may also be used as an ingredient in “lactose -free” dairy products. 
When these preparations are used in dairy products that have a standard of composition that does 
not allow the use of lact ase, the common name on the label of the product must clearly indicate 
how the product deviates from its standard (e.g., “lactose -free milk”).1 
 
Lactase  from other source organisms is already permitted in Canada to be used as a food additive 
in the foods of  interest to the petitioner ; however, B. subtilis  CB108  is not one of the currently 
permitted source organisms .  
 
The results of Health Canada’s evaluation of available scientific data supports the safety of 
lactase from B. subtilis  CB108 when used as desc ribed by the petitioner and as set out in the 
table below . Therefore, Health Canada has modified the List of Permitted Food Enzyme s to 
extend the use of lactase from B. subtilis  CB108 by adding the entry shown below to the list . 
  
  
                                              
1 Canadian Food Inspection Agency ’s Labelling Requirements for Dairy Products 
(http://www.inspection.gc.ca/food/labelling/food -labelling -for-industry/dairy -
products/eng/1393082289862/139 3082368941?chap=0#s1c3 , accessed May 25, 2018)   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  Lactase  from  
Bacillus subtilis  CB108 in Lactose -Reducing Enzyme  Preparations and Certain Dairy Food s 
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3  
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  
L.1 Lactase  Bacillus 
subtilis 
CB108  (1) 
Lactose -reducing enzyme 
preparations  (1) 
Good Manufacturing 
Practice  
(2) 
(naming the flavour) Malted 
milk;  (naming the  flavour) 
Milk; (naming the  flavour) 
Partly skimmed  milk; (naming 
the flavour) Partly skimmed 
milk with added milk solids; 
(naming the flavour) Skim 
milk; (naming the flavour) 
Skimmed milk with added milk 
solids   (2) 
Good Manufacturing 
Practice  
(3) 
Milk destined for use in ice 
cream mix   (3) 
Good Manufacturing 
Practice  
(4) 
Whey    (4) 
Good Manufacturing 
Practice  
(5) 
Yogurt  (5) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of the requested use 
of lactase from B. subtilis  CB108 . The assessment did not identify any chemical, 
microbiological, nutritional or toxicological food safety concerns.  Therefore, the Department  has 
enabled the requested use of lactase from B. subtilis  CB108 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 lactase that do not have 
food-grade specifications set out in Part B of the Regulations meet the most recent food -grade  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  Lactase  from  
Bacillus subtilis  CB108 in Lactose -Reducing Enzyme  Preparations and Certain Dairy Food s 
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 specifications set out in the Food Chemicals Codex  or the Combined Compendium of Food 
Additive Spec ifications . 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  and its 
associated General Specifications and Considerations for Enzyme Preparations  are both  
prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)  and published 
by the Food and Agriculture Organization of the United Nations.   
 
Implement ation and Enforcement  
 
The above modification came into force June  6, 2018 , the day it was published i n 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, inclu ding lactase from B. subtilis  CB108 . Anyone wishing 
to submit new scienti fic information on the use of this additive  or to submit any inquiries may do 
so in writing, b y regular mail or electronically.  If you wish to contact the Food Directorate 
electronically, please use the words " Lactase  (NOM  -0118)" 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: hc.bcs -bipc.sc@canada.ca