Notice of Modification to the List of 
Permitted Food Enzymes  to Extend the Use 
of Lipase from Candida cylindracea  
(previous name : Candida rugosa ) to 
Certain Cheeses  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0177  
January 11 , 202 2 
  
Notice of Modification to the List of Permitted Food Enzymes  to Extend the Use of Lipase from Candida cylindracea  (previous name : 
Candida rugosa ) in Certa in Cheeses – Reference Number: NOM/ADM -0177| 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 Pe rmitted 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 or a new condition of use for an already approved food additive by filing a foo d 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 lipase 
from Candida rugosa  as a food enzyme  in various standardized cheeses, namely cheddar, camembert, feta, 
gouda, mozzarella, provolone , processed (naming the variety) cheese and processed (naming the variety) 
cheese with (naming the added ingredients) .1  This food enzyme is intended to be used at a level consistent 
with Good Manufacturing Practice  (GMP) .  The petitioner  indicated  that lipase from C. rugos a has a high 
affinity towards triglycerides with short chain fatty acids, preferentially releasing butyric acid (C4) and 
isovaleric acid (C5), which confers buttery, cheesy flavour notes , and that lipase from this source  helps create 
a mor e concentrated flavo ured product in less time, thus shortening the ripening period of cheese s. 
Lipase from  C. rugosa  is already permitted for use in Canada in dairy -based flavouring preparations. L ipase 
from ot her microbial sources is also  permitted  in the same standardized cheeses of interest  to the petitioner , 
other than processed (naming the variety) cheese  (with the exception of the cheddar variety , for which it is  
permitted) and processed (naming the variety) cheese with (naming the added ingredi ents) , at a maximum 
level of use consistent with GMP .2 
The results of the Food Directorate’s evaluation of available scie ntific data support the safety of lipase from 
C. rugosa  when used as set out in the table below .  Therefore, Health Canada has modified  the List of 
Permitted Food Enzymes  to extend the use of  lipase from C. rugosa  by adding the entry shown below to the 
List. In addition, the name of the yeast source has been  updated from “ Candida rugosa ” to “ Candida 
cylindracea ” to reflect its latest taxonomic identification . Therefore , this Notice describes lipase from C. 
cylindracea (previous name: C. rugosa ). 
 
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  Candida 
cylindracea  
(previous name : 
Candida rugosa ) Cheddar cheese; Dairy -based 
flavouring preparations; (naming 
the variety) Cheese ; Processed 
(naming the variety) cheese; Good Manufacturing 
Practice  
                                                                 
1 Cheddar cheese has its own standard set out in section B.08.034  of the Regulations.  Camembert, feta, gouda, 
mozzarella and provolone are varietal c heeses under the standard for ( Naming the variety) Cheese  (section 
B.08.033 ).  Processed (naming the variety) Cheese and Processed (naming the variety) Cheese with (naming the 
added ingredients) each have their own standards set out in section s B.08.040  and B.08.041 , respectively.  
2 See item L.2 in the List of Permitted Food Enzymes .  
Notice of Modification to the List of Permitted Food Enzymes  to Extend the Use of Lipase from Candida cylindracea  (previous name : 
Candida rugosa ) in Certa in Cheeses – Reference Number: NOM/ADM -0177| 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  
Processed (naming the variety) 
cheese with (naming the added 
ingredients)  
 
Consequential Modification  
The previous list entry3 for lipase from C. rugosa  was grouped with two other permitted sources of lipase, 
Mucor  circinelloides f. circinelloides (previous name:  Mucor javanicus ) and Penicillium roquefortii . In order to 
extend the use of lipase from C. rugosa  to various standardized cheese products, as indicated in the table 
above, without modifying the permitted us es of lipase  from  M. circinelloides f. circinelloides and P. 
roquefortii , lipase from C. rugosa  has been removed from this entry of Item L.2 in the List of Permitted Food 
Enzymes  and a new, separate entry (as shown above) for C. cylindracea  (previous name: C. rugosa ) has been 
added.  
Rationale  
Health Canada’s Food Directorate comple ted a premarket safety  assessment of  lipase from C. cylindracea  
(previous name: C. rugosa ) for use a s a food enzyme in the standardized cheeses of interest  to the petitioner .  
The assessment conclud ed that information related to allergenicity, chemistry, microbiology, nutrition and  
toxicology  supports the safety  of lipase from C. cylindracea  (previous name : C. rugosa ) for its requested uses.  
There fore, the Department has extended  the requested uses of  lipase from C. cylindracea  (previous name : C. 
rugosa ) by adding to the  List of Permitted Food Enzymes  the new entr y shown in the above table.  
Other Relevant Information  
Food additives such as lipase are required to meet food -grade specifications set out in Part B of the 
Regulations 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.  
 
                                                                 
3 The one that appeared in the List of Permitted Food Enzymes  immediately before the day on which the 
modification for lipase from C. rugosa , which is the subject of the present NOM, was made .  
Notice of Modification to the List of Permitted Food Enzymes  to Extend the Use of Lipase from Candida cylindracea  (previous name : 
Candida rugosa ) in Certa in Cheeses – Reference Number: NOM/ADM -0177| 4 
 Implementation and Enfo rcement  
The above modification came into force January 11 , 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 C. cylindracea  (previous name : C. rugosa ).  Anyone wishing 
to submit new scienti fic information on the use of this additive or to submit  inquiries  may do  so in writing, by 
regular mail or electronically.  If you wish to contact the Food Directorate electro nically, please use the words 
"Lipase  (NOM -0177 )" 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