Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase Obtained from Mucor javanicus  
as a Food Enzyme in Dairy Based Flavouring Preparations   
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 Lipase Obtained from 
Mucor javanicus as a Food Enzyme in Dairy Based 
Flavouring Preparations  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0024] 
 
 
 March  20, 201 4  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase Obtained from Mucor javanicus  
as a Food Enzyme in Dairy Based Flavouring Preparations   
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 Additives  that are 
incorporated by reference in the MAs.  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 t he 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 lipase 
enzyme obtained from Mucor javanicus  at a maximum level of use in accordance with good 
manufacturing practice in cheese flavouring preparations and butter flavouring p reparations. The 
purpose of using lipase in these products is to modify milk fat in a manner that enhances the 
flavour of cheese and butter flavouring preparations.  
 
Lipase, from various sources, is already permitted for use in Canada as a food enzyme in d airy 
based flavouring preparations and other foods.  The flavouring preparations that were the subject 
of this food additive submission contain dairy ingredients, and are therefore considered dairy 
based flavouring preparations.  
 
The results of Health Cana da’s evaluation of available scientific data support the safety of lipase 
obtained from Mucor javanicus when used as requested by the petitioner. Therefore, Health 
Canada has modified the List of Permitted Food Enzymes  to include the use of lipase from that 
source by adding the entry shown below to the List.  In the scientific literature, the source 
organism has been identified in more recent years as Mucor circinelloides  f. circinelloides.  
Health Canada has listed both names for the source organism.  
 
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.2 Lipase  Mucor 
circinelloides f. 
circinelloides 
(previous name: 
Mucor javanicus)  (1) Dairy based 
flavouring 
preparations  (1) Good Manufacturing 
Practice  
 
 
  
 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase Obtained from Mucor javanicus  
as a Food Enzyme in Dairy Based Flavouring Preparations   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of lipase obtained 
from Mucor javanicus .  The assessment considered chemical, microbiological and toxicological 
aspects of lipase obtained from Mucor javanicus  when used as requested  in the food additive 
submission.  The ability of lipase enzyme to modify flavour in dairy based products is already 
well established.  
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safe ty of lipase obtained from Mucor javanicus  when used under the 
conditions evaluated.  The Department has therefore enabled the use of lipase obtained from 
Mucor javanicus  as described in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regu lations require that all food enzymes, including lipase, used as food 
additives meet the specifications for enzyme preparations set out in the most recent edition of the 
Food Chemicals Codex (FCC). The FCC is a compendium of standards for purity and identi ty of 
food ingredients, including food additives, which is  published by the United States 
Pharmacopeial Convention.  
 
Implementation and Enforcement  
 
The above modification ca me into force March  20, 2014,  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 new scientific information on the 
safety in use of any permitted food additive, including lipase . Anyone wishing to subm it new 
scientific information on the use of this additive or to submit any inquiries may do so in writing, 
by regular mail or electronically. If you wish to contact the Food Directorate electronically, 
please use the words " lipase from Mucor javanicus " 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