 
  
Notice of M odification to the List of 
Permitted Food Enzymes  to Enable the 
Use of L actase from Bacillus subtilis  
DH617  in Lactose -reducing Enzyme 
Preparations and Certain Dairy F oods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0193 
February  6, 2023 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Lactase from Bacillus subtilis  DH617 in Lactose -
reducing Enzyme Preparations and Certain Dairy Foods | 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 Permitted Food Additives  that are incorporated by reference in 
the MAs and published on the Canada.ca website. A petitioner  can request that Health Canada authorize  a 
new additive , or a new source  or a new condition of use for an already  permitted  food additive , by filing a 
food additive submission with the Department's Food Directorate. Health Canada uses this premarket 
autho rization  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 a uthorization  for the use of 
lactase from Bacillus s ubtilis DH617 to reduce lactose in milk and dairy products. Examples of foods of 
interest  are cheese, condensed milk and sweet condensed milk, evaporated milk, flavoured milk s, frozen 
dairy desserts,  milk, milk shake, whe y, yogurt  and sweetened yogurt . The requested maximum level of use is 
“Good Manufacturing Practice ”.  
According to the petitioner, lactase serves to catalyze the breakdown of the milk sugar lactose to its 
respective monosaccharides, glucose and galactose, and that its use would allow for the production of 
lactose -reduced and lactose -free dairy products. The petitioner also noted that the use of this enzyme could 
also increase the sweetness of dairy products as well as improve the texture of c ertain milk -derived products 
such as sweetened condensed milks and  ice cream.  
Most of the se examples of dairy products of interest are standardized foods. Lactase from other sources is 
already permitted for use in flavoured milks , milk destined for use in ice cream mix  and whey , which are all 
standardized food s. Lactase from other sources is also permitted in lactose -reducing enzyme preparations . 
Lactose -reducing enzyme  preparations may, in turn, be used in unstandardized dairy products, including  milk 
shake,  yogurt and sweetened yogurt,  and unstandardized frozen dairy desserts . Lactose -reducing enzyme 
preparations may also be used in dairy product s that deviate from standardized dairy products  by virtue of 
being lactose -reduced or lactose -free provided the common name reflects the deviation (e.g. “lactose -free 
milk”) .1  
Prior to this notice, B. subtilis  DH617 was not a permitted source for any foo d enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of lactase from  
B. subtilis DH617 for use as requested by the petitioner . Therefore, Health Canada has  modified the  List of 
Permitted Food Enzymes  to enable  the use of lactase from this source by adding the text shown below to the 
list.  For the definition of “Good Manufacturing Practice” set out in Column 4 as a Maximum Level of Use, see 
the Marketing Authorization for Food Additives That May Be Used as Food Enzymes . 
 
 
 
1 See the Canadian Food Inspection Agency ’s website  Labelling requirements for dairy products  and the 
Implementation and Enforcement section of this Not ice of Modification.   
Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Lactase from Bacillus subtilis  DH617 in Lactose -
reducing Enzyme Preparations and Certain Dairy Foods | 3 
  
 
Modification to the List of Permitted Food Enzymes   
The f ollowing text was added to the List of Permitted Food Enzymes (bold font not used in the list) : 
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 s ubtilis  
DH617  (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  
Rationale  
Health Canada’s Food Directorat e completed a premarket safety assessment of lactase from B. subtilis DH617 
for use as a food enzyme to reduce lactose in  foods as requested by the petitioner .  The D irectorate  
considered allergenicity, chemistry, microbiology, molecular biology, nutrition, and toxicology in the 
assessment. The results of the assessment supports the safety of lactase from B. subtilis DH617  for its 
requested use .  Therefore, the Departm ent has enabled the requested use of lactase from B. subtilis DH617 
by adding to the List of Permitted Food Enzymes  the new  text shown in the above table.  
Other Relevant Information  
Food additives such as lactase are required to meet food -grade specifications set out in Part B of the 
Regulations , where such specifications exist,  or those set out in the  most recent  edition of the  Food 
Chemicals Codex  or the Combined Compendium of Food Additive Specifications  where there are no  
specifications set out in Part B . The Food Chemicals Codex  is a compendium of food grade specifications for  
Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Lactase from Bacillus subtilis  DH617 in Lactose -
reducing Enzyme Preparations and Certain Dairy Foods | 4 
 food ingredients, including food additives, published by the United States Pharmacopeial Convention. 
Specifications in the  Combined Compendium of Food Additive Specifications  and its associated General 
Specifications and Considerations for Enzyme Prepara tions  are prepared by the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) , both of which are  published by the Food and Agriculture Orga nization 
of the United Nations.  
Implementation and Enforcement  
Lactase from B. subtilis DH617 is being permitted  for use in lactose -reducing enzyme preparations, as is 
already permitted for lactase from other sources. Manufacturers interested in using a lactose -reducing 
enzyme preparation to make a lactose -reduced or lactase -free version of a standardized dairy product that is 
not specifically permitted to contain lactase as shown by the List of Permitted Food Enzymes  should consult 
the Canadian Food Inspection Agency’s guidance  on “Common names for lactose -free dairy products” at the 
Agency’s website “ Labelling requirements for dairy products ”. 
The above modification came into force February 6 , 2023, the day it was published in the List o f 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 new scientific information on the safety in use of 
any permitted  food additive .  Anyone wishing to submit an inquiry or new scien tific information on the use of 
a permitted food additive  may do so in writing, by regular mail or electronically.  If you wish to contact the 
Food Directorate electronically  about lactase from B.subtilis  DH617 , please use the words " lactase  (NOM -
0193)" 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 0K9  
E-mail: bcs-bipc@hc -sc.gc.ca  
 