Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Pectin esterase from Aspergillus  
oryzae  AR-962 and Polygalacturonase 
from Aspergillus  oryzae  AR-183 in 
Certain Fruit and Vegetable Products  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0208 
September  28, 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin esterase from Aspergillus  oryzae  AR-962 and 
Polygalacturonase from Aspergillus  oryza e AR-183 in Certain Fruit and Vegetable Products 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by th e 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 Permitted 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 sou rce 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 
authorization  process to determine whether the scientific data support the s afety of food additives when 
used under specified conditions in foods sold in Canada.  
Health Canada’s Food Directorate received two food additive submission s, one  seeking authorization fo r the 
use of pectinesterase from Aspergillus  oryzae  AR-962 and the second seeking authorization for  
polygalacturonase from Aspergillus  oryzae  AR-183. They are  to be used as food enzyme s in the processing of 
fruit and vegetable products such as fruit juices  (single -strength and concentrated1), fruit and vegetable 
purées, and in the production of wine . The requested maximum level of use for each food  enzyme  is “Good 
Manufacturing Practice”  (GMP) . 
Pectinesterase and p olygalacturonase (both previously identified under the broader enzyme name 
“pectinase ” in the List of Permitted Food Enzymes ) from other  sources were  already permitted for use in 
Canada in certain fruit and vegetable products a s well as wine at a maximum level of use of Good 
Manufacturing Practice . 2 Prior to this notice , the A. oryzae  strains AR-962 and AR-183 were not permitted 
source s for any food enzyme in Canada.  
The results of the Food Directorate’s evaluation s of available scientific data support the safety of 
pectinesterase from A. oryzae  AR-962 and polygalacturonase from A. oryzae AR-183 when used as set out in 
the table below. Therefore, Health Canada has modified the List of Permitted Food Enzymes  to enable  the use 
of pectinesterase from A. oryzae  AR-962 and polygalacturonase from A. oryzae  AR-183 by adding the new 
entr ies “(ii) Pectinesterase” and  “(iii) Polygalacturonase” to column 1 of item P.3, and by adding the ir 
corresponding entries in columns 2, 3 and 4 , as shown below  (in bold in this Notice to illustrate the addition) . 
For the definition  of “Good Manufacturing Practice” set out in Column 4 as a “Maximum Level of Use ”, see 
the Marketing Authorization for Food Additives That May Be Used as Food Enzymes . 
 
 
 
1 Although “concentrated (naming the fruit) juice ” was among  the foods request ed for both pectinesterase from A. oryzae  AR-
962 and polygalacturonase from A. oryzae  AR-183, the se enzyme s are not intended to be added directly to or have a technical 
function in concentrated  juice s. They are intended to be added in the processing of single -strength fruit juices, that would 
subsequently be used to manufacture “concentrated (naming the fruit) juice ”. The presence of those enzymes in concentrated 
fruit juices would therefore be the result of a permitted carry -over.  
2 See Item P.3 (Pectinase) in the List of Permitted Food Enzymes  which can include pectinesterase , polygalacturonase  and/or 
pectin lyase . Pectinase from Aspergillus niger var is permitted in the same foods as are being permitted for pectinesterase from 
A. oryzae AR -962 and polygalacturonase from A. oryzae AR -183, and pe ctinase  from Rhizopus oryzae var is permitted in some of 
the same foods. In addition, p ectinesterase (as pectinase) from Trichoderma  reesei  RF6201  and A. oryzae , Km-1-1 (pA2PEI)  is 
already permitted in the same foods  as are being permitted for pectinesterase from A. oryzae AR -962, and polygalacturonase 
(as pectinase) from Trichoderma  reesei  RF6197 is already permitted in the same foods as are being permitted for 
polygalacturonase from A. oryzae AR -183.  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin esterase from Aspergillus  oryzae  AR-962 and 
Polygalacturonase from Aspergillus  oryza e AR-183 in Certain Fruit and Vegetable Products 3 
 Consequential Modification  
Pectinase is a broad enzyme ca tegory, encompassing more than one type of pectinolytic enzyme with 
differing substrate specificity and mode of action.  Pectinesterase from “ Aspergillus  oryzae  Km-1-1 (pA2PEI)” 
and “Trichoderma  reesei  RF6201” , and polygalacturonase from “ Trichoderma  reesei  RF6197” were previously 
listed under the more broad term “Pectinase” in item P.3 of the List of Permit ted Food Enzymes .  
To identify these enzymes by their specific names (i.e., the specific type of pectinase) when the source 
organisms only produce one type of pectinase enzyme, the permitted sources “ Aspergillus  oryzae  Km-1-1 
(pA2PEI) ” and “Trichoderma  reesei  RF6201” were moved to column 2 of the new subitem “(ii) 
Pectinesterase” while the permitted source “ Trichoderma  reesei  RF6197 ” was moved to column 2 of the new 
subitem “(iii) Polygalacturonase” as shown in the table below . 
 
Modification to the List of Permitted Food Enzymes  (bold font not used in  the List ) 
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 (ii) 
Pectinesterase  Aspergillus  oryzae  
AR-962; 
Trichoderma  reesei  
RF6201  (1) 
Single -strength fruit 
juices  (1) 
Good Manufacturing 
Practice  
(2) 
Unstandardized fruit and 
vegetable products  (2) 
Good Manufacturing 
Practice  
(3) 
Wine  (3) 
Good Manufacturing 
Practice  
Aspergillus  oryzae  
Km-1-1 (pA2PEI)  (1) 
Cider; Wine  (1) 
Good Manufacturing 
Practice  
(2) 
Single -strength fruit 
juices  (2) 
Good Manufacturing 
Practice  
(3) 
Unstandardized fruit and 
vegetable products  (3) 
Good Manufacturing 
Practice  
(iii) 
Polygalacturonase  Aspergillus  oryzae  
AR-183; 
Trichoderma  reesei  
RF6197  (1) 
Single -strength fruit 
juices  (1) 
Good Manufacturing 
Practice  
(2) 
Unstandardized fruit and 
vegetable products  (2) 
Good Manufacturing 
Practice  
(3) 
Wine  (3) Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin esterase from Aspergillus  oryzae  AR-962 and 
Polygalacturonase from Aspergillus  oryza e AR-183 in Certain Fruit and Vegetable Products 4 
 Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of 
Use and Other 
Conditions  
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of  pectinesterase from A. oryzae  
AR-962 and  of polygalacturonase from A. oryzae  AR-183 for use as  food enzyme s in fruit juices, fruit and 
vegetable purees and wine . The Directorate considered allergenicity, chemistry, microbiology, molecular 
biology, nutrition , and toxicology in the assessment s. The results of the assessment s support the safety of 
pectinesterase from A. oryzae  AR-962 and polygalacturonase from A. oryzae  AR-183 for their  requested use s. 
Therefore, Health Canada has enabled the requested use s of pectinesterase from A. oryzae  AR-962 and 
polygalacturonase from A.  oryzae  AR-183 by addin g to the List of Permitted Food Enzymes  the new entr ies 
corresponding to  these enzymes  from these sources shown in the above table.  
Other Relevant Information  
Food additives such as  pectinesterase from A. oryzae  AR-962 and  polygalacturonase from A.  oryzae  AR-183 
are required to meet food -grade specifications set out in Part B of the Regulations , where such specifications 
exist,  or those set out in the most recent edition of the Food Chemicals Codex  or the Combined Compendiu m 
of Food Additive Specifications  where there are no specifications in Part B . The Food Chemicals Codex  is a 
compendium of food -grade specifications  for food ingredients, including food additives, published by the 
United States Pharmacopeial Convention. Specifications in the Combined Compendium of Food Additive 
Specifications  and its  associated General Specifications and Considerations for Enzyme Prep arations  are 
prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) , both of which are  published 
by the Food and Agriculture Orga nization of the United Nations.  
Implementation and Enforcement  
The above modification came into force Septe mber  28, 2023, 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 new scientific information on the safety in use of 
any permitted food additive . Anyone wishing to submit an inquiry or new scientific information on the use of 
a permitted food additive  may do so in writing, by regular mail or electr onically . If you wish to contact the 
Food Directorate electronically about  pectinesterase from A. oryzae  AR-962 or  polygalacturonase from A. Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Pectin esterase from Aspergillus  oryzae  AR-962 and 
Polygalacturonase from Aspergillus  oryza e AR-183 in Certain Fruit and Vegetable Products 5 
 oryzae  AR-183, or both, please use the words  "pectinesterase or polygalacturonase (NOM -0208)" 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: bcs-bipc@hc -sc.gc.ca