Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylanase from Bacillus subtilis  Gizα3508  
in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Prod ucts  
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 Xylanase from Bacillus 
subtilis  Gizα3508 in Bread, Flour, Whole Wheat Flour 
and Unstandardized Bakery Products  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0062] 
 
 
 Octo ber 14, 201 5  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylanase from Bacillus subtilis  Gizα3508  
in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Prod ucts  
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.  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 n ew 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 th e safety of food additives when used under specified conditions in foods 
sold in Canada.  
Health Canada received a food additive submission seeking approval for the use of the enzyme 
xylanase from Bacillus subtilis  Gizα3508, in bread, flour, whole wheat flour and unstandardized 
bakery products. The Bacillus subtilis  Gizα3508 source organism  carries a gene encoding 
xylanase from the bacterium Pseudoalteromonas haloplanktis . 
 
Xylanase from certain other strains of B. subtilis  is already permitted for use in the manufacture 
of bread, flour, whole wheat flour and unstandardized bakery products.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
xylanase obtained from B. subtili s Gizα3508 when used as requested by the petitioner . 
Therefore, Health Canada has modified the List of Permitted Food Enzymes  to extend the use of 
xylanase by adding the entr y shown below to the List.   
 
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  Bacillus 
subtilis 
Gizα3508  (1) Bread; Flour; 
Whole wheat 
flour  (1) Good Manufacturing 
Practice  
 
(2) Unstandardized 
bakery products  
 (2) Good Manufacturing 
Practice  
 
 
 
 
 
Rationale   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Xylanase from Bacillus subtilis  Gizα3508  
in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Prod ucts  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Health Canada’s Food Directorate completed a pre -market safety assessment of xylanase  
obtained from B. subtilis  Gizα3508.  The assessm ent considered microbiological, toxicological, 
nutritional and technical aspects of xylanase obtained from B. subtilis  Gizα3508 when used as 
requested in the food additive submission.     
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of xylanase obtained from B. subtilis  Gizα3508 when used as 
requested by the petitioner.  The Department has therefore enabled the us e of xylanase obtained 
from B. subtilis  Gizα3508 under the conditions described in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives such as xylanase from B. subtilis  
Gizα3508, which do not have specifications set out in the Regulations, meet the food -grade 
specifications set out in the most recent edition of the Food Chemicals Codex (FCC). The FCC is 
a compendium of standards for purity and identity for food ingredients, including food enzymes 
and other food additives, which is published by the United States Pharmacopeial Convention.   
 
Implementation and Enforcement  
 
The above modification came into force Octo ber 14, 2015 , 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 xylanase . Anyone wishing to submit n ew 
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 " xylanase " 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