Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Lipase from Trichoderma reesei RF10625 i n Bread, Flour, Whole Wheat Flour and  
Unstandardized Bakery  
Products   
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 
Trichoderma reesei RF10625 in Bread, Flour, 
Whole Wheat Flour and Unstandardized Bakery 
Products  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0123] 
September  6, 2018 Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Lipase from Trichoderma reesei RF10625 i n Bread, Flour, Whole Wheat Flour and  
Unstandardized Bakery  
Products   
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 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  the enzyme  lipase from Trichoderma reesei RF10625 in bread, flour, whole wheat flour 
and unstandardized bakery products . The enzyme 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 
bread, flour, whole wheat flour and unstandardized bakery prod ucts.   
 
The Food Directorate concluded  that information related to the safety of lipase from T. reesei 
RF10625  support s enabling its use in the foods of interest .  Therefore, Health Canada has 
modified the List of Permitted Food Enzymes  to enable the requested uses of lipase from this 
source by adding to the list the entries shown in columns 2, 3 and 4 in the table below . 
 
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  Trichoderma 
reesei  RF10625  (1)  
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Unstandardized bakery 
products  (2) 
Good Manufacturing 
Practice  
 
Rationale  
 
The Food Directorate completed a pre market safety assessment of the requested uses of lipase 
from Trichoderma reesei  RF10625 .  The assessment concluded that information related to 
chemistry, microbiology, molecular biology, nutrition, and toxicology  support the safety of Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Lipase from Trichoderma reesei RF10625 i n Bread, Flour, Whole Wheat Flour and  
Unstandardized Bakery  
Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 lipase  from this sou rce for its requested uses . Therefore, Health Canada  has enabled the 
requested uses of lipase from T. reesei RF10625  by modifying the List of Permitted Food 
Enzymes  as shown  in the above table.  
 
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 Compendium of Food 
Additive Specifications .  The Food Chemicals Codex  is a c ompendium 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  and its 
associated  General Specifications and Co nsiderations for Enzyme Preparations  are both 
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 came into force September  6, 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 Drugs 
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 Trichoderma reesei RF10625 .  
Anyone wishing to submit new scienti fic 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 electro nically, please use the words " Lipase (NOM -0123)" 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