Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase  from Bacillus licheniformis  PP3930  
in Lactose -Reducing Enzyme Preparations and Certain Standardized and Unstandardized 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 Lactase  from Bacillus 
licheniformis  PP3930 in Lactose -Reducing Enzyme 
Preparations and Certain Standardized and 
Unstandardized Dairy Foods  
Notice of Modification – Lists of Permitted Food Additives   
Reference Number: [NOM/ADM -0090] 
 
 
 April  5, 2017   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase  from Bacillus licheniformis  PP3930  
in Lactose -Reducing Enzyme Preparations and Certain Standardized and Unstandardized 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 th eir 
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 petiti oner 
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 d etermine 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 lactase from 
Bacillus licheniformis PP3930 in certain standardized and unstandardized dairy foods.  Lactase is 
an enzyme that breaks down the disaccharide lactose into two monosaccharides, glucose and 
galactose.  Treatment of dairy foods with lactase results in decreased concentrations of la ctose.  
 
Lactase from other source organisms is already permitted for use in Canada as a food enzyme in 
lactose -reducing enzyme preparations and a number of standardized and unstandardised dairy 
products.  The lactose -reducing enzyme preparations from thes e permitted sources may, in turn, 
be used to make lactose -reduced dairy foods, such as lactose -reduced fluid milk.  However, 
B. licheniformis  PP3930 has not previously been permitted as a source organism for any enzyme 
in the List of Permitted Food Enzymes . 
 
The results of Health Canada’s evaluation of available scientific data support the safety of lactase 
from B. licheniformis  PP3930 for use as requested by the petitioner.  Therefore, to enable the 
requested use of this enzyme from this new source organis m, Health Canada has modified the 
List of Permitted Food Enzymes  by adding Bacillus  licheniformis  PP3930 to the list of permitted 
sources of lactase as shown in the table below.  
 
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 
licheniformis  
PP3930  (1) 
Lactose -reducing enzyme 
preparations  (1) 
Good Manufacturing 
Practice  
(2) 
Milk destined for use in ice 
cream mix  (2) 
Good Manufacturing 
Practice   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase  from Bacillus licheniformis  PP3930  
in Lactose -Reducing Enzyme Preparations and Certain Standardized and Unstandardized Dairy Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 (3) 
(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  (3) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a premarket  safety assessment of the requested 
uses of lactase from B. licheniformis  PP3930.  The assessment did not identify any toxicological, 
nutritional, microbiological, molecular biological or chemical food safety concerns with respect 
to the requested uses of lactase from B. licheniformis  PP3930.  Therefore, Health Canada has 
enabl ed the requested 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 lactase from B. licheniformis  
PP3930 , which do not have specifications set out in the Regulations, meet the most recent food -
grade specifications set out in the Food Chemicals Codex (FCC) or the  Combined Compendium 
of Food Additive Specifications .  The FCC is a compendium of standards for purity and identity 
for food ingredients, including food additives, which is published by the United States 
Pharmacopeial Convention.  The Combined Compendium o f Food 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 United Nations.  
 
Implementation and Enforcement  
 
The above modification came into force April  5, 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.  
 
 
  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase  from Bacillus licheniformis  PP3930  
in Lactose -Reducing Enzyme Preparations and Certain Standardized and Unstandardized Dairy Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 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 lactase. 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 t o contact the Food Directorate elec tronically, please 
use the word  "lactase"  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