Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase  
from Candida c ylindracea  AE-LAYH in B read, Flour, Whole Wheat Flour, Unstandardized  
Bakery Products, Dairy -based Flavouring Preparations and Modified Fats and Oils   
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 from Candida 
cylindracea  AE-LAYH in Bread, Flour, Whole Wheat 
Flour, Unstandardized Bakery Products, Dairy -based 
Flavouring Preparations and Modified Fats and Oils  
 
Notice of Modification –  Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0100] 
August 18, 2017  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase  
from Candida c ylindracea  AE-LAYH in B read, Flour, Whole Wheat Flour, Unstandardized  
Bakery Products, Dairy -based Flavouring Preparations and Modified Fats and Oils   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    2 Summary  
 
Food additives are regulated in Canada under Marketing Authorizati ons (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 Health Canada’s 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 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 us ed under specified conditions in foods 
sold in Canada. 
 Health Canada received a food additive submission seeking approval for the use of lipase from the yeast Candida cylindracea AE -LAYH  at a maximum level of use consistent with Good 
Manufacturing Practice (GMP) in
 bread , flour, whole wheat flour, unstandardized bakery 
products , dairy -based flavouring preparations  and modified fats and oils.  This enzyme is 
intended to function as a dough conditioner in bakery applications; to help in the development of flavour in  enzyme -modified cheese paste and enzyme- modified dairy paste  which are in turn 
used to flavour certain foods ; and it  would also be used in the manufacture of modified fats and 
oils, in particular, docosahexaenoic acid  (DHA) -eicosapentaenoic acid ( EPA) fish oil 
concentrates . 
 The List of Permitted Food Enzymes
 already permits the use of  lipase from other source 
organisms  in the manufacture of the foods of interest to the petitioner . Lipase from Candida 
rugosa in particular is permitted in “dairy -based flavouring preparations”, a food category that 
include s enzyme -modified cheese paste and enzyme- modified dairy paste .  
 The results of Health Canada’s evaluation of available sci entific data support the safety of lipase 
from C. cylindracea  AE-LAYH for use as requested by the petitioner . Therefore, Heal th Canada 
has enabled  the requested use s of lipase from C. cylindracea AE -LAYH by adding the entries 
shown below to Columns 2, 3 and 4 of item L.2 in the List of Permitted Food Enzymes . 
 
Modification to the List of Permitted Food Enzymes  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted 
Source  Column 3  
Permitted in or U pon Column 4  
Maximum Level of Use 
and Other Conditions  
L.2 Lipase  Candida 
cylindracea 
AE-LAYH  (1) 
Bread; Flour; Whole wheat 
flour  (1) 
Good Manufacturing 
Practice  
(2) 
Dairy -based flavouring 
preparations  (2) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase  
from Candida c ylindracea  AE-LAYH in B read, Flour, Whole Wheat Flour, Unstandardized  
Bakery Products, Dairy -based Flavouring Preparations and Modified Fats and Oils   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 (3) 
Modified fats and oils  (3) 
Good Manufacturing 
Practice  
(4) 
Unstandardized bakery 
products  (4) 
Good Manufacturing 
Practice  
 
A corrective modification has also been made to address a duplicative entr y for the use of lipase 
from “ Mucor circinelloides  f. circinelloides  (previous name: Mucor javanicus )” in “Dairy -based 
flavouring preparations”.   
  
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of the requested 
uses of lipase from  the yeast  Candida cylindracea  AE-LAYH. The assess ment did not identify 
any microbiological, toxicological, chemical or nutritional concerns with the se uses of  this 
enzyme  from  this source organism . Therefore, Health Canada has enabled the use of lipase from 
C. cylindracea  AE-LAYH by modifying the List of Permitted Food Enzymes  as shown in the 
above table.  
 
Other Relevant Information  
 The Food and Drug Regulations  requi re that food additives such as lipase from C . cylindracea  
AE-LAYH that do not have food- grade specifications set out in Part B of the Regulations meet 
the most recent food -grade specifications set out in the Food Chemicals Codex  or the Combined 
Compendium of Food Additive Specifications .  The Food Chemicals Codex  is a co mpendium of 
standards for purity and identity for food ingredients, including food additives, published by the 
United States Pharmacopeial Convention. The Combined Compendium of Food Additive Specifications , which contains specifications prepared by the Jo int FAO/WHO Expert 
Committee on Food Additives (JECFA)  and includes JECFA’s  General Specifications and 
Considerations for Enzyme Preparations , is published by the Food and Agriculture Organization 
of the United Nations.  
  
Implementation and Enforcement  
 
The above modification came into force on A ugust 1 8, 2017, 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  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Lipase  
from Candida c ylindracea  AE-LAYH in B read, Flour, Whole Wheat Flour, Unstandardized  
Bakery Products, Dairy -based Flavouring Preparations and Modified Fats and Oils   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4  
Health Canada's Food Directorate is committed to reviewing any new scientific information on 
the safety in use of any food additive, including lipase  from C . cylindracea  AE-LAYH. Anyone 
wishing to submit new scientific informatio n on the use of this additi ve 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 word " lipase " 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