Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Pectinase from Aspergillus niger  
in Unstandardized Fruit and Vegetable 
Products  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0157 
January  5, 2021  
  
Notice of M odification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase from Aspergillus ni ger in Unstandardized 
Fruit and Vegetable Products – Reference Number: [NOM/ADM -0157]| 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 
pectinase  from Aspergillus niger  as a food enzyme in unstandardized fruit and vegetable products. The food 
enzyme is intended to be used  at a level consistent w ith Good Manufacturing Practice .    
Pectinase from A. niger  is already permitted for use in Canada as a food enzyme  in several  foods, including 
certain unstandardized fruit and vegetable products  (skins of citrus fruits destined for  jam, marmalade and 
candied fruit production, and vegetable stock for use in soups ). In addition, pectinase from sources other 
than A. niger  is permitted for use in Canada as a food enzyme in all unstandardized fruit and vegetable 
products.  However, pectin ase from A. niger  is not permitted more broadly in this manner in all 
unstandardized fruit and vegetable products.       
The results of the Food Directorate’s evaluation of available scientific data support the safety of  pectinase 
from A. niger  for its req uested use .  Therefore,  Health Canada has modified the List of Permitted Food 
Enzymes  to extend the use of pectinase fr om A. niger  by adding the new entry  subitem (8) , shown below , to 
the List.  The food category “unstandardized fruit and vegetable products” includes “skins of citrus fruits 
destined for jam, marmalade and candied fruit production ” [subitem (5)]  as well as “vegetable stock for use 
in soups ” [subitem (6)]. Therefore, subitems (5) and (6) in column s 3 and 4 for item P.3 of the List were  
removed as s hown  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  
P.3 Pectinase  Aspergillus niger  var. (5) 
[Removed, 2021-01-05, (See NOM/ADM -0157)] 
(6) 
[Removed, 2021-01-05, (See NOM/ADM -0157)] 
. . . . . . 
(8) 
Unstandardized fruit and 
vegetable products  (8) 
Good Manufacturing 
Practice  
  
Notice of M odification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase from Aspergillus ni ger in Unstandardized 
Fruit and Vegetable Products – Reference Number: [NOM/ADM -0157]| 3 
 Consequential Modification  
The previous list entry1 for pectinase from A. niger  var. was grouped with another permitted source of 
pectinase, Rhizopus oryzae  var. In order to extend the use of pectinase from A. niger  var. to unstandardized 
fruit and vegetable products, as indicated in the table above, without modifying the permitted uses of 
pectinase  from R. oryzae  var., a separate entry for pectinase from R. oryzae  var. has been added to Item P.3 
in the List of Permitted Food Enz ymes.    
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of  pectinase from A. niger  for 
use as a food enzyme  in unstandardized fruit and vegetable products .  The assessment concluded that 
information related to allergenicity, chemistry, microbiology, nutrition and toxicology supports the safety of  
pectinase from A. niger  for its requested use .  Therefore, the Department has  enabled the requested use  of 
pectinase from A. niger  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 pectinase  that do not have food -grade 
specifications set out in Part B of the Regulations meet the food -grade specifications set out in the  most 
recent  edition of 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 S tates Pharmacopeial Conve ntion. The Combined 
Compendium of Food Additive Specifications  and its associated General Specifications and Considerations for 
Enzyme Preparations  are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and 
published by the Food and A griculture Orga nization of the United Nations.  
Implementation and Enforcement  
The above modification came into force January 05, 2021 , 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 pectinase from A. niger .  Anyone wishing to submit new scient ific 
information on the use of this additive or to submit any inquiries may do so in writing, by regular mail or 
                                                             
1 The one that appeared in t he List of Permitted Food Enzymes  immediately before the day on which the 
modification for pectinase from A. niger , which is the subject of the present NOM, was made.   
Notice of M odification to the List of Permitted Food Enzymes  to Enable the Use of Pectinase from Aspergillus ni ger in Unstandardized 
Fruit and Vegetable Products – Reference Number: [NOM/ADM -0157]| 4 
 electronically.  If you wish to contact the Food Directorate electronically, please use the wo rds " Pectinase  
(NOM -0157)” 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 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca