Notice of Modification to the List of 
Permitted Food Enzymes to Enable the 
Use of Lipase from Mucor circinelloides 
f. circinelloides  AE-LM in Certain 
Cheeses  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0182 
April  14, 2022 
 Notice of Modification to the List of Permitted Food Enzym es to Enable the Use of  Lipase from Mucor circinelloides f. circinelloides  AE-
LM in Certa in Cheeses – Reference Number: NOM/ADM -0182| 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 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 reviewed a food additive submission requesting the authorization for the 
use of lipase from Mucor circinelloides f. circinelloides  AE-LM in cheddar cheese  and (naming the variety)  
cheese , the latter which includ es many other standardized varieties of cheese . 
This  food enzyme is intended to be used at a level consistent w ith Good Manufacturing Practice (GMP) . The 
petitioner stated that lipase helps to enhance the flavours of various cheeses, therefore shortening t he 
ripening process . According to the petitioner, lipase from M. circinelloides f. circinelloides  AE-LM has a high 
affinity towards triglycerides with short chain fatty acids, preferentially releasing specific acids , which confer 
buttery, cheesy flavour  notes. The petitioner also noted that the use of lipase from this source produces 
methyl ketones at higher levels compared to other lipases permitted in Canada  and which are important 
flavour components of blue cheese . 
Lipase from other sources is already  permitted for use in Canada in cheddar cheese and a variety of  cheeses 
subject to the standard for (naming the variety) cheese1 at a maximum level of use consistent with GMP. In 
addition, lipase from Mucor circinelloides f. circinelloides  (previous name: Mucor javanicus ) is permitted for 
use in dairy -based flavouring preparations.2 However, M. circinelloides f. circinelloides  AE-LM is a strain of 
this microorganism that 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 lipase from 
M. circinelloides f. circinelloides  AE-LM when used as set out in the table below .  Therefore, Health Canada 
has modified the List of Permitted Food Enzymes  to enable  the use of lipase from  M. circinelloides f. 
circinelloides  AE-LM by adding the entry shown below  to the L ist.  
 
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  AE-LM Cheddar cheese; (naming 
the variety) Cheese  Good Manufacturing 
Practice  
                                                             
1 The standard s for Cheddar  cheese and (naming the variety) Cheese are set out in section s B.08.034  and B.08.033  
of the Regulations, respectively.  
2 See item L.2 in the List of Permitted Food Enzymes  Notice of Modification to the List of Permitted Food Enzym es to Enable the Use of  Lipase from Mucor circinelloides f. circinelloides  AE-
LM in Certa in Cheeses – Reference Number: NOM/ADM -0182| 3 
 Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of lipase from M. circinelloides f. 
circinelloides  AE-LM for use as a food enzyme in cheddar cheese and (naming the variety) cheese . The 
Department  conclud ed that information related to allergenicity, chemistry, microbiology, molecular b iology, 
and toxicology supports the safety of  lipase from M. circinelloides f. circinelloides  AE-LM for its requested 
uses . It also concluded that, in view of the existing provisions for the use of this enzyme, efficacy data were 
not necessary  to support these uses . Therefore, the Department has  enabled the requested uses of lipase 
from M. circinelloide s f. circinelloides  AE-LM by adding to the List of Permitted Food Enzymes  the new entry 
shown in the above table.  
Other  Relevant Information  
Because lipase from M. circinelloides f. circinelloides  AE-LM was requested for use in standardized dairy 
foods, Health Canada sought comments from industry associations who have an interest in these dairy 
standards as well as the Can adian Food Inspection Agency. No objections based on a food safety concern 
were received.  
Food additives such as lipase 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 General 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 Enforcement  
The above modification came into force April 14, 2022, 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 from M. circinelloides  f. circinelloides  AE-LM.  Anyone wishing to 
submit an inquiry or new scienti fic information on the use of this additive  may do so in writing, by regular 
mail or electronically.  If you wish to contact the Food Directorate electro nically, please use the wo rds " lipase  
(NOM -0182)" 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