Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to Remove “Solid cut meat with or 
without added phosphate salts”, “Solid cut poultry meat” 
and “Solid cut poultry meat that contains  phosphate salts  
or water ” From the List of Food s that are Permitted to 
Contain  Transglutaminase in the List of Permitted Food 
Enzymes  
Notice of Modification – Lists of Permitted Food Additives   
Reference Number: [NOM/ADM -0086] 
 
 
 Febr uary 15 , 2017   
Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
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 th eir 
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.  
 
Transglutaminase is an enzyme that can be used to bind together small pieces of meat into  larger 
“formed” meat products.  It was first approved for such use in 2007. In response to concerns that 
were subsequently raised about the possibility of microbial contamination in the inte rior of 
certain types of formed meat products that look like whole cuts of meat but which are actually 
made from smaller pieces of meat and a binding agent (such as transglutaminase), Health Canada 
revisited its safety evaluation of transglutaminase. The s pecific concern was not with the safety 
of transglutaminase itself, but rather with the possibility of consumers cooking  certain types of  
formed meat products to a medium rare state even though these products are labelled “formed”. 
Cooking to a medium rare  state would not be sufficient to destroy any pathogens at the interior 
of the product.  
 
Health Canada concluded that such concerns were founded and therefore, in July 2016, Health 
Canada posted a notice of a proposal, titled Notice of Health Canada's Proposal to Remove 
"Solid cut meat with or without added phosphate salts" From the List of Foods that are 
Permitted to Contain Transglutaminas e in the List of Permitted Food Enzymes - Reference 
Number: NOP/AVP -0020 . The intended effect of this proposal was to prevent the preparation of 
formed beef, veal, or lamb products that have the appearance of intact cuts of meat. The proposal 
was open for  public comment for 75 days.  Health Canada received three comments expressing 
concerns in response to the proposal, as described further below. No new scientific information 
was submitted that changed the conclusion  of the safety evaluation that the transgl utaminase  is 
itself acceptable for use as a food enzyme .   
 
Upon analysing the comments submitted, Health Canada’s Food Directorate concluded that 
preventing the use of transglutaminase in the preparation of formed beef, veal, or lamb products 
that have th e appearance of intact cuts of meat was not the appropriate risk mitigation measure to 
follow. Rather, the Food Directorate will be exploring, as a separate project, alternative strategies 
such as product labelling for addressing the concerns about possibl e microbial contamination at 
the interior of certain types of formed meat products . As such, the food additive provisions will 
continue to allow the use of transglutaminase in these types of meat products.  
 
In the course of the review of this issue, the D irectorate also determined that the use of 
transglutaminase in formed meat and poultry products is accommodated by the existing  
Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 provisions for its use in “Prepared meat”, “Prepared meat by -product”, “Prepared poultry meat”, 
and “Prepared poultry meat by -product” . Therefore, the provision s for the use of 
transglutaminase in “Solid cut meat  with or without added phosphate salts ”, “Solid cut poultry 
meat”  and “Solid cut poultry meat that contains phosphate salts or water” are  not necessary. 
These food categories have therefore been removed from the List as indicated below. These are 
corrective modifications that have no impact on the foods in which transglutaminase has been 
accepted for use.  
 
Corrective Modifications to the List of Permitted F ood Enzymes  
 
Sub-item T.01(8)  in the List of Permitted Food Enzymes  has been  removed and new sub -items 
T.01(11)  and (12) have been  added . These new sub -items replicate the food categories that were 
previously listed under T.01(8) with the except ion of the three food categories that were 
identified as un necessary : 
 
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  (8) [Removed, 2017-02-15, (See 
NOM/ADM -0086 )] 
(9) Bread; Flour; 
Whole wheat flour  
 (9) 
Good 
Manufacturing 
Practice  
(10) Unstandardized 
bakery products  
 (10) 
Good 
Manufacturing 
Practice   
Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 (11)  
Brawn; Headcheese; 
Meat by -product loaf; 
Meat loaf; (naming the 
prepared meat or 
prepared meat by -
product) with (naming 
the non -meat 
ingredients); Prepared 
meat  (Division 14) ; 
Prepared meat by -
product; Preserved 
meat  (Division 14) ; 
Preserved meat by -
product ; Pumping 
pickle, cover pickle and 
dry cure employed in 
the curing of preserved 
meat or preserved meat 
by-product; Sausage  (11) 
Good 
Manufacturing 
Practice  
 
(12)  
Prepared  poultry meat; 
Prepared poultry meat 
by-product; Preserved 
poultry meat; Preserved 
poultry meat by -
product  (12) 
Good 
Manufacturing 
Practice  
 
In addition, a corrective modification has been made  to the List of Permitted Food Enzymes  in 
which the food item “prepared poultry meat” had been mistakenly reported as “sous -produits de 
viande de volaille préparée” instead of “viande de v olaille préparée”.  
 
Rationale  
 
Health Canada previously evaluated a food additive submission requesting amendment of the 
Food and Drug Regulations  (FDR) to allow for the use of the enzyme transglutaminase from 
Streptoverticillium mobaraense  S-8112 as a binding agent in certain prepackaged poultry 
products and meat products including “Solid cut meat with or without added phosphate salts”, 
“Solid cut poultry meat” and “Solid cut poultry meat that contains phosphate salts  or water ”.  
 
The resul ts of the evaluation supported the safety of transglutaminase as a food additive at levels 
consistent with Good Manufacturing Practice (GMP) in various prepackaged meat and poultry 
products and an Interim Marketing Authorization (IMA) was issued on Novembe r 24, 2007 ,  
Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 enabling the requested uses of this food enzyme. The provisions reflected in the IMA were later 
added to the List of Permitted Food Enzymes  that is incorporated by reference in the Marketing 
Authorization for Food Additives That May Be Used as Food Enzymes .  
 
Subsequent to the initial safety evaluation, concerns about the possibility of microbial 
contamination  in the interior of formed meat product s that look like whole cuts of meat but 
which are actually made from smaller pieces of meat and a binding agent (such as 
transglutaminase) were raised, on the basis that such products if not properly cooked could pose 
a health risk. There are no concerns a bout the saf ety of transglutaminase itself.  Health Canada’s 
Food Directorate considered, from a microbial perspective, the safety of such food products and 
concluded that formed beef, veal, and lamb products, if cooked medium rare by consumers as 
though th ey were indeed an intact cut of meat, could present microbiological concerns. There is 
not a corresponding concern about other types of formed meat products that may also look like 
an intact piece of meat  (e.g., chicken breast, ham, pork loin ) because the recommended internal 
cooking temperatures for these types of intact products are also appropriate for the corresponding 
formed products.  
 
In July 2016, as a result of these conclusions, Health Canada posted a notice of the Department’s 
proposal, titled Notice of Health Canada's Proposal to Remove "Solid cut meat with or without 
added phosphate salts" From the List of Foods that are Permitted to Contain Transglutaminas e 
in the List of Permitted Food Enzymes - Reference Number: NOP/AVP -0020 . The proposal was 
open f or public comment for 75 days. Health Canada received three comments expressing 
concerns in response to the proposal, as described below. No new scientific inf ormation was 
submitted that changed the outcome of the safety evaluation of the enzyme transglutaminase.   
 
Upon analysing the comments that were submitted, Health Canada’s Food Directorate concluded 
that preventing the use of transglutaminase in such form ed meat products is not an appropriate 
measure for addressing the concerns that were identified. Rather, the Food Directorate will be 
exploring, as a separate project, alternative strategies such as product labelling for addressing the 
concerns about possi ble microbial contamination at the interior of certain types of formed meat 
products. Therefore, the food additive provisions will continue to allow the use of 
transglutaminase in these types of meat products.   
 
In the course of the review of this issue, the Directorate also determined that the use of 
transglutaminase in formed meat and poultry products is accommodated by the existing 
provisions for its use in “Prepared meat”, “Prepared meat by -product”, “Prepared poultry meat”, 
and “Prep ared poultry meat by-product”. Therefore, the provisions for the use of 
transglutaminase in “Solid cut meat  with or without added phosphate salts ”, “Solid cut poultry 
meat” , and “Solid cut poultry meat that contains phosphate salts or water”  are not necessary. As 
a consequence , the provisions for the use of transglutaminase in these foods have been removed 
from the List as shown in the table above. These are corrective modifications that have no impact 
on the foods in which transglutaminase h as been accepted for use.  
 
  
Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     6 Notification – Summary of Comments   
 
Three comments were received in response to the Notice of Health Canada's Proposal to 
Remove "Solid cut meat with or without added phosphate salts" From the List of Foods that are 
Permitted to Contain Transglutaminase in the List of Permitted Food Enzymes - Reference 
Number: NOP/AVP -0020 .  
 
Comments were submitted in response to the proposal by three stakeholders: the company that 
originally sought approval for the use of transglutaminase in meat manufacturing, an industry 
organization, and the United States Government. The industry stakeholders expressed the 
opinion that preventing the use of the enzy me transglutaminase to manufacture certain types of 
formed meat products would be discriminatory because there are other binders that are available 
for producing formed meat. The scientific rationale for the proposal was questioned based on the 
claim that to date, there have been no reported cases of contamination in meat formed with the 
transglutaminase enzyme. It was also suggested that the reduction of microbial contamination at 
the interior of the product or of cross -contamination could be achieved thro ugh the application of 
HACCP1 in meat processing establishments. It was further suggested that it would be appropriate 
to focus on proper handling and processing of raw meat products, work on consumer education, 
and implement “enhanced labelling requiremen ts” that provide proper cooking instructions for 
formed meat products made with solid cut meat. Finally, the United States Government asked if 
Canada would consider other means of achieving the same level of protection, drawing attention 
to the possibility  of using labels that display a safe handling statement instructing the end user 
how to properly cook the product.  
 
Health Canada responded that it has decided to continue to allow the use of transglutaminase in 
formed meat products, recognising that ther e are other binders available to prepare the same 
products, but that it would be exploring other measures for addressing the concerns about 
possible microbial contamination at the interior of formed products that have the appearance of 
intact cuts of beef,  veal, or lamb. The provisions for the use of the enzyme transglutaminase in 
formed meat products will remain in the List of Permitted Food Enzymes , and are accommodated 
under the existing provisions for its use in “Prepared meat”, “Prepared meat by -produc t”, 
“Prepared poultry meat”, and “Prepared poultry meat by -product”. Consequently for house -
keeping purposes, corrective modifications have been  made to the List to remove the food 
categories “Solid cut meat with or without added phosphate salts”, “Solid c ut poultry meat”, and 
“Solid cut poultry meat that contains phosphate salts or water” from the transglutaminase listing 
(item T.01 of the List of Permitted Food Enzymes ), as these food categories are considered 
redundant.  
 
 
 
 
                                              
1 HACCP stands for Hazard Analysis and Critical Control Points .  
Notice of Modification to Remove “Solid cut meat with or without added phosphate salts”, “Solid cut poultry meat” and “Solid cut poultry 
meat that contains  phosphate salts  or water ” From the List of Foods that are Permitted to Contain Transglutaminase in t he List of Permitted 
Food Enzymes   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     7 Implementation and Enforcement  
 
The above modifications came into force on February 15, 2017 , the day they were 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 infor mation on 
the safety of any permitted food additive, including transglutaminase . 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 word s “transglutaminase as a binding agent ” in the subject line  of 
your e -mail.  
 
Bureau of Chemical Safety, Foo d Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2E -mail: bcs-bipc@hc -sc.gc.ca