Notice of Modification to the  List of 
Permitted Food Enzymes to Enable the 
Use of Lactase  from Kluyveromyces lactis  
DS 80496 in Lactose -reducing Enzyme 
Preparations and in Certain Dairy Foods  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0179 
February  2, 2022 
 Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase from Kluyveromyces lactis  DS 80496 in  
Lactose -reducing Enzyme Preparations  and Certain Dairy F oods  – Reference Number: NOM/ADM -0179| 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 , a new source  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  β-
galactosidase  (“lactase”; EC 3.2.1.23)  from  Kluyveromyces lactis  DS 80496 in the manufacture of lactose -
reducing enzyme preparations and in certain standardized and unstandardized dairy foods (e.g., flavoured 
milks1, milk for the production of ice cream , sweetened condensed milk, whey, yogurt, and dulce de leche ). 
The food enzyme is intended to be used at a level consistent with Good Manufacturing  Practice2.  
According to the petitioner, β -galactosidase from K. lactis  DS 80496 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 lactos e-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 certain 
milk -derived products such as sweetened condensed milks and dulce  de leche.  
Lactase  from other sources is already permitted for use in Canada in the same foods requested by the 
petitioner. However, the new source organism, K. lactis  DS 80496 , was not a permitted source for any food 
enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of  lactase ( β-
galactosidase ) from K. lactis DS 80496  for its requested use s. Therefore, Health Canada has modified the List 
of Permitted Food Enzymes  to enable  the use of lactase from K. lactis  DS 80496 by adding the  name of this  
source to the entry to Column 2 of item L.1, as  shown in the table below  (bold font not used in 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  
L.1 Lactase  Bacillus licheniformis 
PP3930 ; Kluyveromyces 
lactis  DS 80496  (1)  
Lactose -reducing enzyme 
preparations  (1)  
Good Manufacturing 
Practice  
(2) Milk destined for use 
in ice cream mix   (2)  
                                                             
1 The flavoured milks are ( naming the flavour) Malted Milk [B.08.022 ], (naming the flavour) Milk [B.08.016 ], 
(naming the flavour) Partly (Partially) S kimmed Milk [B.08.018 ], (naming the flavour) Partly (Partially) S kimmed 
Milk with Added Milk Solids  [B.08.026 ], (naming the flavour) Skim Milk [B.08.017 ], and (naming the flavour) Skim 
Milk with Added Milk Solids  [B.08.023 ]. 
2 See the definition of “Good Manufacturing Practice ” in the Marketing Authorization for Food Additives That May 
Be Used as Food Enzymes . Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase from Kluyveromyces lactis  DS 80496 in  
Lactose -reducing Enzyme Preparations  and Certain Dairy F oods  – Reference Number: NOM/ADM -0179| 3 
 Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use 
and Other Conditions  
Good Manufacturing 
Practice  
(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 Food Directorate completed a premarket safety assessment of lactase  from K. lactis DS 
80496  for use as a food enzyme in the foods requested by the petitioner . The Department  conclud ed that 
information related to allergenicity, chemistry, microbiology, molecular b iology, nutrition and toxicology 
supports the safety of lactase  from  K. lactis DS 80496  for its requested uses.  Therefore, the Department has 
enabled the requested us es of lactase from K. lactis DS 80496  by adding the name of this new source to 
Column 2 of item L.1  of the List of Perm itted Food Enzymes , as shown in the table above  (bold font  not used 
in the List ).  
Other Relevant Information  
Food additives , such as lactase  from  K. lactis DS 80496 , 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 . 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. Specifications in the  Combined Compendium of 
Food Additive Specifications  and its associated Gene ral Specifications and Considerations for Enzyme 
Preparations  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 Enfor cement  
Lactase from K. lactis  DS 80496  is being permitted for use in lactose -reducing enzyme preparations, as is 
already permitted for lactase from numerous other sources. Manufacturers interested in using such a 
preparation to make a lactose -reduced or la ctase -free version of a standardized dairy product that is not Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lactase from Kluyveromyces lactis  DS 80496 in  
Lactose -reducing Enzyme Preparations  and Certain Dairy F oods  – Reference Number: NOM/ADM -0179| 4 
 specifically permitted to contain lactase as shown by the List should consult the Canadian Food Inspection 
Agency’s policy on “ Common names for lactose -free dairy products ”. 
The above modification came into force February 2, 2022 the day it was published in  the List of Permitted 
Food Enzymes . 
The Canadian Food Inspection Agenc y is responsible for the enforcement of the Food and Dr ugs 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, including lactase  from K. lactis DS 80496 . Anyone wishing to submit an inquiry 
or new scienti fic information on the use of this additi ve may do so in writing, by regular mail or electronically. 
If you wish to contact the Food Directorate electronically, please use the words " lacta se (NOM -0179)" in the 
subject line of your e -mail.  
Bureau of Chemical Safety, Food Direc torate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: bcs-bipc@hc -sc.gc.ca