Health Canada’s Proposal to Enable the Use of Leuconostoc carnosum  4010 as an Antimicrobial Preservative in Certain  
Vacuum -Packed Non -Shelf -Stable Meat and Poultry Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  Health Canada’s Proposal to Enable the Use of 
Leuconostoc carnosum  4010 as an Antimicrobial 
Preservative in Certain Vacuum -Packed Non -Shelf -Stable 
Meat and Poultry Products  
Notice of Proposal  – Lists of Permitted Food Additives  
Reference Number: [NO P/AVP -0016 ] 
 
April  12, 2016   
Health Canada’s Proposal to Enable the Use of Leuconostoc carnosum  4010 as an Antimicrobial Preservative in Certain  
Vacuum -Packed Non -Shelf -Stable Meat and Poultry 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 Per mitted 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 new additive or a new condition of use for an already 
approved food additive by filing a foo d 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 the bacterium 
Leuconostoc carnosum  4010 as an antimicrobial preservative at a maximum level of use 
consistent with Good Manufacturing Practice in certain vacuum -packed non -shelf -stable meat 
and poultry products, namely: bologna, cervelat, frankfurters, mortadella, and wieners.  
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of L. carnosum  4010 when used as described. Therefore, it is the intention of Health 
Canada to modify Part 2 of the List of Permitted Preservatives  by adding the following entry to 
the list.    
Proposed Modification to Part 2 of the List of Permitted Preservatives  
Item 
No. Column 1  
Additive  Column 2  
Permitted in or upon  Column 3  
Maximum Level of Use and 
Other Conditions  
L.1 Leuconostoc 
carnosum  4010  Vacuum -packed 
bologna; Vacuum -
packed cervalat ; 
Vacuum -packed 
frankfurters; Vacuum -
packed mortadella; 
Vacuum -packed wieners  Good Manufacturing Practice  
All of the above -mentioned products, except when made with poultry, are subject to the 
compositional standard for “Sausage or Sausage Meat” set out in section B.14.032 of the Food 
and Drug Regulations . Although this standard permits lactic acid -producing s tarter culture in 
sausage, Leuconostoc carnosum  4010, which is a lactic acid producing bacterium, is added to 
prevent the growth of Listeria monocytogenes , not to function as a starter culture.  True starter 
cultures are used to initiate product fermentati on and to achieve consistency in fermentation 
results.   
Health Canada’s Proposal to Enable the Use of Leuconostoc carnosum  4010 as an Antimicrobial Preservative in Certain  
Vacuum -Packed Non -Shelf -Stable Meat and Poultry Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Rationale  
Health Canada’s Food Directorate has completed its pre -market safety and efficacy assessment 
of Leuconostoc carnosum strain 4010.  The assessment considered microbiological and 
toxicological  aspects of L. carnosum 4010 when used as described above. It was noted that the 
application of L. carnosum 4010 affects neither the nutritional nor the organoleptic quality of the 
treated food products.   
L. carnosum has been found to occur naturally in w iener sausages and cooked ham, and had 
historically been associated only with its potential to cause spoilage of vacuum -packed meat.  
However, research conducted in the late 1990s identified strains of L. carnosum  that were not 
associated with spoilage and which produced bacteriocins, which  are ribosomally synthesized 
antimicrobial peptides produced by one bacterium that are specifically active against other 
bacteria.  The bacteriocins produced by  L. carnosum  4010  (formerly known as L. carnosum  
1043) are small heat -stable peptides that act against Listeria  monocytogenes  by inhibiting cell 
wall synthesis or by producing small holes in the cell membrane resulting in the death of this 
spoilage and pathogenic microorga nism.  
The L. carnosum 4010 culture would be applied as part as of a freeze -dried preparation to 
emulsion -type meat and poultry products at a rate of 1 x 106 to 1 x 107 colony forming units per 
gram of the meat/poultry product. The bacterium would remain ac tive throughout the shelf -life 
of treated sausage products.  
No microbiological concerns were identified with respect to the proposed use of L. carnosum  
4010.  Data was provided demonstrating that vacuum -packed cooked emulsion -type sausages 
(e.g., wiener sa usages, and sliced cervelat) treated with a preparation containing L. carnosum 
4010 would not support the growth of Listeria monocytogenes  during the sausage’s intended 
shelf -life, whereas growth of Listeria monocytogenes  increased during the shelf -life of  untreated 
sausages.  
Health Canada assessed the toxicological safety of the bacterium itself ( L. carnosum  4010), the 
bacteriocins it produces, and the potential for this microorganism to produce biogenic amines. 
Lactic acid bacteria, including L. carnosum 4010, have a long history of use in fermented foods 
and are commonly present in food and the human digestive tract.  In general, they are not 
considered to pose a health concern to the general population.  
While there have been reports in the scientific lit erature of rare cases of L. carnosum strains 
being opportunistic pathogens, these instances are not relevant to the proposed food additive use 
of this organism. In the context of its use in food, L. carnosum 4010 is not considered a 
pathogen.    
Health Canada’s Proposal to Enable the Use of Leuconostoc carnosum  4010 as an Antimicrobial Preservative in Certain  
Vacuum -Packed Non -Shelf -Stable Meat and Poultry Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 No safety c oncerns about exposure to bacteriocins were identified from a toxicological 
perspective.  Bacteriocins produced  by lactic acid bacteria are likely already consumed as part of  
a normal diet. Bacteriocins produced by lactic acid bacteria can be considered t o be safe 
biopreservatives as they are easily broken down by proteolytic enzymes in the human 
gastrointestinal tract and the resulting single amino acids would be normal dietary constituents.  
Leuconostoc species are generally known to produce biogenic ami nes, such as histamine and 
tyramine.  Due to their toxicological effects, histamine and tyramine are probably the two most 
important biogenic amines of bacterial origin in food.  A commercial batch of the live culture 
L. carnosum 4010 was analysed for both  of these biogenic amines and neither were found at a 
level above a limit of detection of 5  mg/L (5 ppm).  It was also taken into consideration that L. 
carnosum is commonly found in meat products and it is not expected that this strain ( L. 
carnosum  4010) would produce biogenic amines at levels any greater than naturally found on 
these types of meat products.  
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of L. carnosum 4010 when used under the conditions of use set out in 
the table above. The Department is therefore proposing to enable the use of L. carnosum 4010 as 
described in the above table.  
Other Relevant Information  
The petitioner indicated that products containing L. carnosum 4010 have been successfully 
introduced to the European meat industry, in particul ar for processed meat products.  Health 
Canada is not aware of its regulatory status in other jurisdictions.  
The Canadian Food and Drug Regulations require that food ad ditives such as L. carnosum  4010, 
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 iden tity for food ingredients, including food additives, 
which is published by the United States Pharmacopeial Convention. The FCC contains an 
appendix with information about food uses of live microbial cultures, but currently there are no 
monographs with requ irements for these cultures. The petitioner did however provide 
specifications used to control the purity of the commercial product containing L. carnosum  4010. 
These specifications are considered acceptable from a microbiological perspective .  
Implementation and Enforcement  
The proposed change will be effective the day on which it is published in  the List of Permitted 
Preservatives .  This will be announced via  a Notice of Modification which will be published on 
Health Canada's Website .  
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect to foods.    
Health Canada’s Proposal to Enable the Use of Leuconostoc carnosum  4010 as an Antimicrobial Preservative in Certain  
Vacuum -Packed Non -Shelf -Stable Meat and Poultry Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 Contact Information  
For additional information or to submit comments related to this proposal, please contact:   
Bureau of Chemic al 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 words “ Leuconostoc carnos um 4010 ” in the subject 
line of your e -mail.   Health Canada is able to consider information received by June 24, 2016 , 
75 days from the date of this posting.