Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Xylanase from  
Trichoderma reesei  (LOVxlnA#568.4) in Bread, Flour, Whole Wheat Flour and  Unstandardized  
Bakery P roducts  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the  List of Permitted 
Food Enzymes  to E nable  the Use of Xylanase 
from Trichoderma reesei  (LOVxlnA#568.4) in 
Bread , Flour, Whole W heat F lour and 
Unstandardized B akery P roducts  
 
Notice of Modification  – Lists of Permitted Food Enzymes  
Reference Number: NO M/ADM-0141 
November 21 , 2019 Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Xylanase from  
Trichoderma reesei  (LOVxlnA#568.4) in Bread, Flour, Whole Wheat Flour and  Unstandardized  
Bakery P roducts  
  
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 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  received a food additive submission seeking approval for the 
use of  xylanase from Trichoderma reesei  (LOVxlnA#568.4)  as a food enzyme  in bread, flour, 
whole wheat flour and unstandardized bakery products. The food enzyme is  intended to be used 
at a l evel consistent w ith Good Manufacturing Practice (GMP) .  
 
Xylanase from various sources, including a nother strain of  T. reesei  (T. reesei  A83) , is already 
permitted for use in Canada as a food enzyme in the same foods  as those of interest to the 
petitioner .   
 
The results of the Food Directorate ’s evaluation of available scientific data support the safety of 
xylanase from T. reesei  (LOVxlnA#568.4)  when used as requested by the petitioner .  Therefore, 
Health Canada has modified the  List of Permitted Food Enzymes  to enable the requested  use of 
xylanase from  this source  by adding the entr ies 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  
X.1 Xylanase  Trichoderma 
reesei  
(LOVxlnA#568.4)  (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Unstandardized 
bakery products  (2) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of  xylanase from 
Trichoderma reesei  (LOVxlnA#568.4)  for use as  a food enzyme . The assessment concluded that 
information related to  chemi stry, microbiolog y, nutrition, and toxicolog y supports the safety of  Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Xylanase from  
Trichoderma reesei  (LOVxlnA#568.4) in Bread, Flour, Whole Wheat Flour and  Unstandardized  
Bakery P roducts  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 xylanase from T.  reesei  (LOVxlnA#568.4)  for its  requested uses.  Therefore, the Department has 
enabled the requested uses of xylanase fr om T. reesei  (LOVxlnA#568.4) by adding the new 
entries  shown in the above table  to the  List of Permitted Food Enzymes . 
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as  xylanase from T. reesei  
(LOVxlnA#568.4)  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 
compendium of standards for purity and identity for food ingredients, including food additives, 
published by the United States Pharmacopeial Convention. The Combined Compendium of F ood 
Additive Specifications  and its associated  General Specifications and Considerations 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 N ovember 21 , 2019, 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 xylanase from T.  reesei  (LOVxlnA#568.4) .  
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 electro nically, please use the words " xylanase  (NOM -0141) " in the subject line of 
your e -mail.  
 
Bureau of C hemical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca