Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Peroxidase from Aspergillus niger  MOX -54  
in Liquid Whey Destined for the Manufacture of Dried Whey 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 Peroxidase from 
Aspergillus niger  MOX -54 in Liquid Whey Destined for 
the Manufacture of Dried Whey Products  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0076] 
 
 
 July 13, 2016   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Peroxidase from Aspergillus niger  MOX -54  
in Liquid Whey Destined for the Manufacture of Dried Whey 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.  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 used under specified conditions in foods 
sold in Canada.  
 
Health Canada received a food additive submission seeking approval for the use of peroxidase 
from Aspergillus niger  MOX 54 in liquid whey treated with hydrogen peroxide, where the liquid 
whey is destined for the manufacture of dried whey products, at a lev el of use consistent with 
Good Manufacturing Practice (GMP).  
  
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of peroxidase when used as requested by the petitioner.  Since this is a food additive tha t 
was not previously permitted for use in Canada, Health Canada published a notice of the 
Department’s proposal to enable this use of this food enzyme, titled Notice of Health Canada's 
Proposal to Enable the Use of Peroxidase from Aspergillus niger MOX -54 in Liquid Whey 
Destined for the Manufacture of Dried Whey Products - Reference Number: NOP/AVP -0014 , on 
March 31, 2016.  The proposal was open for public comment for 75 days. N o new scientific 
information was submitted to the Department in response to the proposal. Since the conclusions 
of the evaluation remain as described in the proposal, Health Canada has modified the List of 
Permitted Food Enzymes  as indicated below.  
 
Modifications to the List of Permitted Food Additives  
 
The following new entry has been added 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  
P.5.1  Peroxidase  Aspergillus 
niger  MOX -54 Liquid whey treated with 
hydrogen peroxide in 
accordance with item H.1 
of the List of Permitted 
Food Additives With Other 
Generally Accepted Uses  
 Good Manufacturing 
Practice  
 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Peroxidase from Aspergillus niger  MOX -54  
in Liquid Whey Destined for the Manufacture of Dried Whey Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 In addition, the following modification, shown in bold, to item H.1 of the List of Permitted Food 
Additives with Other  Generally Accepted Uses , was made as a consequence of the new item 
P.5.1 in the List of Permitted Food Enzymes  : 
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
Upon  Column 3  
Purpose of Use  Column 4  
Maximum Level of Use 
and Other Conditions  
H.1 Hydrogen 
Peroxide  (2) 
Liquid whey 
destined for the 
manufacture of 
dried whey 
products  (2) 
To decolourize and 
maintain pH  
 (2) 
100 p.p.m. (see also 
subitem C.1(3) and item 
P.5.1 of the List of 
Permitted Food Enzymes ) 
 
 
Rationale  
 
Health Canada’s Food Directorate assessed the safety and efficacy of peroxidase from 
Aspergillus niger MOX -54 for its proposed use in decolourizing whey that is to be used to make 
dried whey products. The assessment considered microbiology, molecular biology, chemistry, 
toxicology, allergy, and nutrition aspects related to the proposed use of this enzyme.  
 
 
Overall, the data that were assessed support the safety of the production organism as well as the 
safety and efficacy of the peroxidase when used under the conditions of use set out in the table 
above. In addition, no nutritional concerns with the treatmen t of liquid whey as proposed were 
identified. Therefore, Health Canada has enabled the requested use of peroxidase from A. niger  
MOX -54 by modifying the List of Permitted Foo d Enzymes  as described in the above table.  
 
Notification – Summary of Comments  
 
No comments were submitted to Health Canada in response to the Notice of Health Canada's 
Propos al to Enable the Use of Peroxidase from Aspergillus niger MOX -54 in Liquid Whey 
Destined for the Manufacture of Dried Whey Products - Reference Number: NOP/AVP -0014 , 
published on March 31, 2016.  
 
Implementation and Enforcement  
 
The above modification came into force July 13, 2016 , 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.  
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Peroxidase from Aspergillus niger  MOX -54  
in Liquid Whey Destined for the Manufacture of Dried Whey Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 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 peroxidase from Aspergillus niger  MOX -54. 
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 " peroxidase from Aspergillus niger  MOX -54" 
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