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

Notice of Proposal - Lists of Permitted Food Additives

Reference Number: [NOP/AVP-0020]

July 05, 2016

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 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.

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 meat, which is a standardized food under Division 14 of the FDR, includes both whole cut meat or a product consisting of pieces of meat of which at least 80 percent weigh at least 25 g each.

Since the results of the evaluation at that time supported the safety of transglutaminase as a food additive when used as proposed, an Interim Marketing Authorization (IMA) was issued on November 24, 2007, enabling the use of transglutaminase at levels consistent with Good Manufacturing Practice (GMP) in various prepackaged meat and poultry products, including solid cut meat with or without added phosphate salts. The provisions in the IMA are now in 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, Health Canada received a number of inquiries related to meat products containing transglutaminase. The possibility of microbial contamination in the interior of meat products that are formed from smaller pieces of meat into a single piece using transglutaminase was raised, the concern being that such foods, if not properly cooked, could pose a microbiological health risk.

Although the transglutaminase enzyme itself was found to be safe for use as a food additive in these foods, the safety evaluation did not originally consider the cooking practices that consumers might choose depending on the appearance of the transglutaminase-treated meat product. Consequently, Health Canada revisited the safety assessment by considering the manner in which meat and poultry products that could be made using transglutaminase are presented at retail, and how consumers might reasonably be expected to prepare these foods for consumption.

Scientists in Health Canada's Food Directorate concluded that consumers might prepare formed or reformed meat that has the appearance of a whole cut of meat such as steak (products that could fall under the category of "solid cut meat") in a manner that could present a potential health risk. For example, individuals who typically consume a whole cut of meat (such as a steak) cooked "rare" or "medium-rare" might do the same with a formed or reformed meat product made with transglutaminase if the product has the same appearance as the whole cut of meat. Although such products are labelled "formed" or "reformed", consumers may not recognize that they should be cooked through to the center.

Consequently, it is the intention of Health Canada to modify the List of Permitted Food Enzymes by removing the food category "Solid cut meat with or without added phosphate salts" from column 3 in the entry for sub-item T.01(8). The other foods listed under sub-item T.01(8) would remain unchanged.

It is important to note that this proposal addresses a food safety risk related to a potential microbiological hazard if formed or reformed solid cut meat products made with transglutaminase are under-cooked, a hazard that does not come from the transglutaminase enzyme itself. The transglutaminase enzyme is a safe food additive regardless of the manner in which a meat product to which it has been added is cooked.

Rationale

Bacterial contamination of whole cuts of meat is generally found on the surface of the meat, not in its interior (i.e. inside the muscle). For this reason, intact whole cuts of meat that have not been mechanically tenderized may be consumed after cooking "medium-rare". However, the interior of formed or reformed meat products prepared using transglutaminase contains surfaces of the smaller pieces of meat that have been bound together using the enzyme. Consequently, any bacterial load that was present on the former exterior surfaces of the smaller pieces may be in the interior of the formed or reformed piece of meat. While this may not present a health risk when the foods are products such as poultry products, comminuted poultry products, and comminuted meat products, all of which are generally understood to require thorough cooking to the center before consuming, there is a potential microbiological health risk with formed or reformed meat products that appear to be a whole cut of meat if they are cooked to a "medium-rare" state.

Health Canada's recommended practice for preparing "medium-rare" beef, veal and lamb (i.e., heating to an internal temperature of 145°F (63°C) are not intended to apply to reformed or formed products. However, if they are inappropriately applied, the internal temperature would possibly not be sufficiently high to inactivate all of the potential microbiological pathogens in a formed or reformed meat product.

Therefore, Health Canada is proposing to remove the broader provision for the use of the enzyme in "solid cut meat with or without added phosphate salts" from the List of Permitted Food Enzymes. The same food safety concern does not exist for the other existing provisions for use of the enzyme.

Implementation and enforcement

The proposed changes will be effective the day on which they are published in the List of Permitted Food Enzymes. These changes, and the date on which the List of Permitted Food Enzymes is to be amended, will be announced via a Notice of Modification (NOM) which will be published on Health Canada's website after the 75-day notification period for the current posting has passed. Health Canada plans to implement the changes to the list three months after publication of the NOM.

The Canadian Food Inspection Agency is responsible for the enforcement of the food-related aspects of the Food and Drugs Act and its associated regulations.

Contact Information

For additional information or to submit comments related to this proposal, please contact:

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

If communicating by e-mail, please use the word "transglutaminase" in the subject line of your e-mail. Health Canada is able to consider information received by September 17, 2016, 75 days from the date of this posting.

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