 
  
Notice of Modification to the List of 
Permitted Food Enzymes  to Enable  the 
Use of Transglutaminase from 
Streptomyces mobaraensis  M2020197 
in Various F oods  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NO M/ADM-0196  
March  2, 2022 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from Streptomyces mobaraensis 
M2020197 in Various Foods | 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 authorize  a 
new additive , or a new source  or a new condition of use for an already permitt ed 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 condit ions in foods sold in Canada.  
Health Canada’s Food Directorate received a food additive submission s eeking authorization  for the use of 
transglutaminase from Streptomyces mobaraensis  M2020197 in various  dairy, fish, grain, meat , poultry , and 
plant -based fo ods. The requested maximum level of use for this  food enzyme is Good Manufacturing 
Practice . Transglutaminase  from  another strain of this source  organism ( S. mobaraensis  S-8112) is already 
permitted for use in Canada in  a number of the food s requested by the petitioner. Prior to this Notice, t he 
source organism, S. mobaraensis  M2020197 , was not a permitted source for any food enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the safety  of 
transglutaminase from S. mobaraensis  M2020197 when used  as requested by the petitioner. Therefore, 
Health Canada has modified the  List of Permitted Food Enzymes  to enable  the use transglutaminase from S. 
mobaraensis  M2020197  by adding the  text shown below to the list. 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 . 
 
Modification to the List of Permitted Food Enzymes  
The following text was added 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  
T.01  Transglutaminase  Streptomyces 
mobaraensis  
M2020197  
 (1) 
Blend of prepared fish 
and prepared meat 
referred to in paragraph 
B.21.006(n)  (1)  
Good Manufacturing 
Practice  
(2)  
Brawn; Headcheese; 
Meat loaf or meat by -
product loaf; Meat 
lunch; Meat roll; 
Prepared meat or 
prepared meat by -
product (Division 14); 
Preserved meat or 
preserved meat by -
product (Division 14); (2)  
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from Streptomyces mobaraensis 
M2020197 in Various Foods | 3 
 Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use 
and Other Conditions  
Pumping pickle, cover 
pickle and dry cure 
employed in the curin g 
of preserved meat or 
preserved meat by -
product; Sausage; 
(naming the prepared 
meat or prepared meat 
by-product) with 
(naming the non -meat 
ingredients)  
(3) 
Bread, Flour; Whole 
wheat flour  (3)  
Good Manufacturing 
Practi ce 
(4)  
Pasta  (4)  
Good Manufacturing 
Practice  
(5) 
Plant -based products 
that resemble dairy 
products; Plant -based 
products that resemble 
egg products; Plant -
based products that 
resemble meat 
products, including 
simulated meat 
products; Plant -based 
products that resemble 
poultry meat products, 
including simulated 
poultry products  (5)  
Good Manufacturing 
Practice  
 
(6) 
Plant protein 
concentrates; Plant 
protein isolates  (6)  
Good Manufacturing 
Practice  
(7)  
Prepared poultry meat 
or prepared poultry 
meat by -product; (7)  
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from Streptomyces mobaraensis 
M2020197 in Various Foods | 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  
Preserved poultry meat 
or preserved poultry 
meat by -product   
(8) 
Tofu; Tempeh  (8)  
Good Manufacturing 
Practice  
(9)  
Unstandardized bakery 
products  (9)  
Good Manufacturing 
Practice  
(10)  
Unstandardized cheese 
products  (10)  
Good Manufacturing 
Practice  
(11)  
Unstandardized cream 
cheese products  (11)  
Good Manufacturing 
Practice  
(12)  
Unstandardized frozen 
dairy desserts  (12)  
Good Manufacturing 
Practice  
(13)  
Unstandardized 
prepared fish products  (13)  
Good Manufacturing 
Practice  
(14)  
Unstandardized 
processed cheese 
products  (14)  
Good Manufacturing 
Practice  
(15)  
Yogurt  (15)  
Good Manufacturing 
Practice  
 
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of transglutaminase from S. 
mobaraensis  M2020197 for use as a food  enzyme  in a variety of foods .  The Directorate  considered 
allergenicity, chemistry, microbiology, molecular b iology, nutrition, and toxicology in the assessment. The 
results of the assessment support the safety of  transglutaminase from S. mobaraensis  M2020197 for its 
requested use  and based on technica l information the enzyme is expected to be effective for its intended 
purposes . Therefore, the Department has enabled the requested use of transglutaminase  from S. 
mobaraensis  M2020197 by adding to the List of Permitted Food Enzymes  the new text shown in the above 
table.  
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from Streptomyces mobaraensis 
M2020197 in Various Foods | 5 
 Other Relevant Information  
Food additives such as transglutaminase  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 th e Combined Compendium 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 Prepa rations  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 s came into force March  2, 2022, the day they were  published in 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 informati on 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 additive may do so in writing, by regular mail or electronically.  If you wish to contact the Food 
Director ate electro nically  about transglutaminase from S. mobaraensis  M2020197 , please use the words 
"transglutaminase  (NOM -0196 )" 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   
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