Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from  
Streptoverticillium mobaraense  S-8112 in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery 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 Transglutaminase from 
Streptoverticillium mobaraense  S-8112 in Bread, Flour, 
Whole Wheat Flour, and Unstandardized Bakery Products  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0071] 
 
April  11, 2016   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from  
Streptoverticillium mobaraense  S-8112 in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery 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 publis hed on Health Canada’s website.  A petitioner 
can request that Health Canada approve a ne w 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 
transglutaminase from Streptoverticillium mobaraense  S-8112 as a food enzyme in bread, flour, 
whole wheat flour, and unstandardized bakery products  at a maximum level of use of consistent 
with Good Manufacturing Practice.  
 
Transglutaminase from Streptoverticillium mobaraense  S-8112 is already permitted for use in 
Canada as a food enzyme in unstandardized prepared fish products, simulated meat products, 
certain unstandardized dairy products, and certain standardized meat and poultry products .   
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of t ransglutaminase from Streptoverticillium mobaraense  S-8112 when used as 
requested by the petitioner.  Therefore, Health Canada has modified the List of Permitted Foo d 
Enzymes  to extend the use of t ransglutaminase from Streptoverticillium mobaraense  S-8112  by 
adding the entries 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  
T.01 Transglutaminase  Streptoverticillium 
mobaraense   
S-8112  (9)  
Bread; Flour; 
Whole wheat 
flour  
(10) 
Unstandardized 
bakery products  (9)  
Good Manufacturing 
Practice  
 
(10) 
Good Manufacturing 
Practice  
 
 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from  
Streptoverticillium mobaraense  S-8112 in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of t ransglutaminase from Streptoverticillium mobaraense  S-8112 .  The assessment 
considered microbiological, toxicological,  nutritional, chemical and technical aspects of this 
additive, and found that the requested uses are acceptable from a food safety perspective. 
Therefore, the Department has enabled the requested uses of t ransglutaminase from 
Streptoverticillium mobaraense  S-8112 by modifying the List of Permitted Food Enzymes  as 
described in the above table.  
 
Other Relevant Information  
 
The Codex General Standard for Food Additives (GSFA) contain s few provisions for food 
enzymes, none of which are for transglutaminase. Similarly, the Codex General Standard for 
Wheat Flour (CODEX STAN 152 -1985) provides for the use of some enzymes, but not 
transglutaminase. However, transglutaminase from Streptomyces mobaraensis  (synonym for 
Streptoverticillium mobaraense ) is listed in the “IPA Database by CCFA”1 (listed as “Protein -
glutamine γ-glutamyltransferase”; IUBMB 2.3.2.13).  
 
In Australia and New Zealand , food enzymes are regulated as processing ai ds under Standard 
1.3.3 of the Australia New Zealand Food Standards Code . Transglutaminase (EC 2.3.2.13) from 
Streptomyces mobaraensis (synonym for Streptoverticillium mobaraense ) may be used  in the 
course of manufacturing any food.  
 
In Europe, the use of food enzymes is subject to national legislation. T ransglutaminase from 
Streptoverticillium mobaraense  S-8112  is specifically permitted for use in France.  
 
In the United States of America, there are standards2 for bread, rolls, and buns; and whole wheat 
bread, rolls, and buns, which permit the use of “enzyme active preparations”. Also, the U.S. 
Food and Drug Administration (FDA) has no questions about “self -affirmed” GRAS 
determinations that have been issued for the use of transglutaminase from Streptovertic illium 
mobaraense  in pasta, bread, and pastry products, and in foods in general including flour and 
bakery products (GRN Nos. 55, 95).  
 
The Food and Drug Regulations require that food additives such as t ransglutaminase from 
Streptoverticillium mobaraense  S-8112 , 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 additives, which is published by the United States Pharmacopeial 
Convention.   
 
                                              
1 See http://ipa.ccfa.cc/substance?task=detail&substance_id=866  
2 The standards are in Title 21 of the Code of Federal Regulations, Part 136 (21 CFR 136).   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Transglutaminase from  
Streptoverticillium mobaraense  S-8112 in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Implementation and Enforcement  
 
The above modification came into force April  11, 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.  
 
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 Transglutaminase . Anyone wishing to submit 
new scientifi c information on the use of this food  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 word “ Transglutaminase ” 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