Notice of Modification to the List of Permitted  Food Enzymes  to Enable the Use of  
Lipase from Ogataea polymorpha  B14-CBS synt in Bread, Flour, Whole Wheat Flour , 
Unstanda rdized Bakery Products, and Pasta   
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 
Ogataea  polymorpha  B14-CBS synt in Bread, 
Flour, Whole Wheat Flour , Unstandardized 
Bakery Products , and Pasta  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0126] 
 
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-01XX] November 19, 2018  Notice of Modification to the List of Permitted  Food Enzymes  to Enable the Use of  
Lipase from Ogataea polymorpha  B14-CBS synt in Bread, Flour, Whole Wheat Flour , 
Unstanda rdized Bakery Products, and Pasta   
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  (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 or a new condition of use fo r 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 und er 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 Ogataea polymorpha  B14-CBS synt in bread , flour , whole wheat flour , 
unstandardized bakery prod ucts (such as buns, cakes, tortillas and sweet goods ), and pasta1. The 
enzyme , which exhibits both lipase and phospholipase activity,  is intended to be used at a level 
consistent with Good Manufacturing Practice (GMP) .   
 
Lipase from other source organisms is already permitted for use  in Canada as a food enzyme in a 
number of foods  including most of those  of interest to the petitioner . 
 
The results of the Food Directorate ’s evaluation of the relevant scientific data support  the safety 
and efficacy of lipase from O. polymorpha  B14-CBSsynt when used as requested by the 
petitioner . Therefore, Health Canada has modified the List of Permitted Food Enzymes  to enable 
the requested uses of lipase from this source by adding the entries shown below to the list . 
 
Organisms currently classified as Ogataea polymorpha  have also been previously identified as 
Hansenula polymorpha  and sometimes as Pichia angusta  (the genera Hansenula  and Pichia  are 
closely related) . As some regulatory authorities and food enzyme manufacturers still refer to 
O. polymorpha  B14-CBSsynt using the taxonomic nomenclature H. polymor pha B14-CBSsynt 
and P. angusta  B14-CBSsynt , these terms have also been included in the listing.    
 
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  Ogataea 
polymorpha  B14-
CBS synt ( also (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
                                              
1 Pasta is considered a synonym for “alimentary paste”, as described in Division 13, Section B, of the Regulations. 
Pasta (alimentary paste) includes noodles , macaroni, spaghetti, etc . 
 Notice of Modification to the List of Permitted  Food Enzymes  to Enable the Use of  
Lipase from Ogataea polymorpha  B14-CBS synt in Bread, Flour, Whole Wheat Flour , 
Unstanda rdized Bakery Products, and Pasta   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    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  
referred to as : 
Hansenula 
polymorpha  B14-
CBSsynt and Pichia 
angusta  B14-
CBSsynt ) (2) 
Pasta  (2) 
Good Manufacturing 
Practice  
(3) 
Unstandardized bakery 
products  (3) 
Good Manufacturing 
Practice  
 
Consequential Modification  
 
To reflect the updated taxonomy for Hansenula polymorpha , the permitted source for hexose 
oxidase in item H.2 of the List of Permitted Food Enzymes  has been changed from Hansenula 
polymorpha  (B13-HOX4 -Mut45 ) to Ogataea polymorpha  B13-HOX4 -Mut45.  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted  Source  
H.2 Hexose oxidase  Ogataea polymorpha  B13-HOX4 -Mut45 ( previous 
name:  Hansenula polymorpha  (B13-HOX4 -
Mut45 )) 
 
Rationale  
 
Health Canada’s Food Directorate completed a pre market safety assessment of the requested 
uses of lipase from O. polymorpha  B14-CBS synt. The assessment considered  chemi cal, 
microbiolog ical, molecular biolog ical, nutrition al, toxicolog ical and technical aspects of 
O. polymorpha  B14-CBSsynt, and found that the requested uses  are acceptable from a food 
safety perspective . Therefore, the Department  has enabled the requested uses of lipase from 
O. polymorpha  B14-CBS synt by modifying  the List of Permitted Food Enzymes  as shown  in the 
first table above . 
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as lipase  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 Comp endium 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 S tates 
Pharmacopeial Convention.  The Combined Compendium of Food A dditive Specifications  and its 
associated  General Specifications and Considerations for Enzyme Preparations  are both Notice of Modification to the List of Permitted  Food Enzymes  to Enable the Use of  
Lipase from Ogataea polymorpha  B14-CBS synt in Bread, Flour, Whole Wheat Flour , 
Unstanda rdized Bakery Products, and Pasta   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)  and published 
by the Food and Agriculture Organization of the United Nations.    
 
Implementation and Enforcement  
 
The above modification s came into force November  19, 2018 , 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 D rugs 
Act and its associated regulations with respect to foods.  
 
Contact Information  
 
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 Ogataea polymorpha B14-CBSsynt .  
Anyone wishing to submit 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 (NOM -0126)" 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: hc.bcs -bipc.sc@canada.ca