Notice of Modification to the List of Permitted Preservatives  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 
  
Notice of Modification to the List of Permitted Preservatives  
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 Modification –  Lists of Permitted Food Additives   
Reference Number: [NOM/ADM -0084] 
 
 
 December 14 , 2016   
Notice of Modification to the List of Permitted Preservatives  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 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 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 for the use of a live culture of the bacterium 
Leuconostoc carnosum 4010. The purpose for using the preparation is to limit or inhibit the growth 
of the foodborne pathogen Listeria monocytogenes  in certain non-shelf -stable foods that are vacuum -
packed and that require refrigeration.  
 
The results of Health Canada’s evaluat ion of available scientific data support the safety and efficacy 
of L. carnosum  4010 when used as set out in the table below. Since this is a food additive that was 
not previously permitted for use in Canada, Health Canada published a notice of the Departm ent’s 
proposal to enable the use of this antimicrobial preservative, titled 
Notice of 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 - Reference Number: NOP/AVP -
0016 .  
 The proposal was published on April 12, 2016, and was open for public comment for 75 days. Health 
Canada received one inquiry in response  to the proposal (see below), but no new scientific 
information about this additive was submitted. Since the conclusion of the evaluation remains as 
described in the proposal, Health Canada has modified Part 2 of the List of Permitted Preservatives
 
as indicated in the table below.   
 
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 cervelat; 
Vacuum -packed frankfurters; 
Vacuum -packed mortadella; 
Vacuum -packed wieners  Good Manufacturing Practice  
  
 
  
Notice of Modification to the List of Permitted Preservatives  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 evaluated the safety and efficacy of L . carnosum  4010 for use as 
an antimicrobial preservative to limit or inhibit the growth of the foodborne pathogen Listeria 
monocytogenes  in the vacuum -packed, non-shelf -stable foods identified in the table above. 
Additional details about the evaluation were provided in the notice of propos al published on April 
12, 2016. Based on the outcome of the evaluation, Health Canada has enabled the use of L . carnosum  
4010 in these foods by modifying the List of Permitted Preservatives  as shown in the above table.  
 
Notification – Summary of Comments  
 During the 75 day comment period Health Canada received one inquiry in response to the proposal. The inquiry was from a public interest group that asked whether L . carnosum  4010 is the first pure -
strain bacterial preservative for foods  and requested that H ealth Canada share the scientific 
information on impacts of L . carnosum 4010 on the gut microbiome.  
 In response to the first question, Health Canada answered that Carnobacterium maltaromaticum CB1 
was the first pure -strain bacterial preservative added to the List of Permitted Preservatives . In 
response to the request for scientific information, Health Canada provided a list of references that 
were considered in the microbiological assessment as well as references for information relevant to 
the history of  exposure to lactic acid bacteria such as L . carnosum  4010. Health Canada noted that 
lactic acid bacteria have a long history of use in fermented foods and that strains of naturally occurring L . carnosum  in particular have been isolated from certain types of meat products such as 
vacuum -packed beef, pork, bacon, cooked ham, and luncheon meat. Researchers have also reported 
L. carnosum  is the dominant lactic acid bacterium in the human intestinal tract.  
 
Implementation and Enforcement  
 The above modifications came into force on D ecember 14 , 2016, the day they were published in the 
List of Permitted Preservatives . 
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 of any permitted food additive, including Leuconostoc carnosum  4010. 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 elec tronically, 
please use the word  “Leuconostoc carnosum  4010” 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 0L2E -mail: bcs -bipc@hc -sc.gc.ca