Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Carnobacterium divergens  M35 as an  
Antimicrobial Preservative in Sliced Ready -to-Eat Cold -Smoked Salmon and Sliced Ready -to-Eat Cold -Smoked Trout  
- Reference Number: [NOM/ADM -0079]   
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 Carnobacterium 
divergens  M35 as an Antimicrobial Preservative in 
Sliced Ready -to-Eat Cold -Smoked Salmon and Sliced 
Ready -to-Eat Cold -Smoked Trout  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0079] 
 
 
 Octo ber 13, 2016   
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Carnobacterium divergens  M35 as an  
Antimicrobial Preservative in Sliced Ready -to-Eat Cold -Smoked Salmon and Sliced Ready -to-Eat Cold -Smoked Trout  
- Reference Number: [NOM/ADM -0079]   
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.  
 
Health Canada received a food additive submission seeking approval for the use of a live culture 
preparation of the bacterium Carnobacterium divergens  M35 to limit or inhibit the growth of the 
foodborne pathogen Listeria monocytogenes  on sliced ready -to-eat cold -smoked salmon an d 
sliced ready -to-eat cold -smoked trout .  
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of C. divergens  M35 when used a s requested by the petitioner. Since this is a food 
additive that was not previ ously permitted for use in Canada, Health Canada published a notice 
of the Depa rtment’s proposal to enable th e use of this antimicrobial preservative, titled Notice of 
Health Canada's Proposal to Enable the Use of a New Food Additive, Carnobacterium 
divergens M35, as an Antimicrobial Preservative in Sliced Ready -to-Eat Cold -Smoked Salmon 
and Sliced Ready -to-Eat Cold -Smoked Trout - Reference Number: NOP/AVP -0018 .   
 
The proposal was published on June 7, 2016, and was open for public comment for 75 days.  
Health Canada received one comment in response to the proposal (see below), but no new 
scientific information was submitted that changed the outcome of the safety eva luation. Since the 
conclusion of the evaluation remains as described in the proposal, Health Canada has modified 
the List of Permitted Preservatives  as indicated below.  
 
Modifications 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  
C.1A  Carnobacterium 
divergens  M35  Sliced ready -to-eat cold - 
smoked salmon; Sliced 
ready -to-eat cold -smoked 
trout   Good Manufacturing Practice  
 
 
 
  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Carnobacterium divergens  M35 as an  
Antimicrobial Preservative in Sliced Ready -to-Eat Cold -Smoked Salmon and Sliced Ready -to-Eat Cold -Smoked Trout  
- Reference Number: [NOM/ADM -0079]   
Bureau of Chemical Safety, Food Directorate, Health  Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate assessed the safety and efficacy of C. divergens  M35 for its 
proposed use as an antimicrobial preservative to limit or inhibit the growth of the foodborne 
pathogen Listeria monocytogenes  on sliced ready -to-eat cold -smoked salmon and sliced ready -
to-eat cold -smoked trout . The assessment focused on toxicological and microbiologica l aspects 
related to the proposed use of the live bacterial culture of this microorganism.  
 
Overall, the data that were assessed support the safety and efficacy of C. divergens  M35 when 
used under the conditions of use set out in the table above. Therefore , Health Canada has enabled 
the requested use of Carnobacterium divergens  M35  by modifying the List of Permitted 
Preservatives  as described in the above table.  
 
Notification – Summary of Comments  
 
One comment was submitted to Health Canada in response to the Notice of Health Canada's 
Proposal to Enable the Use of a New Food Additive, Carnobacterium divergens M35, as an 
Antimicrobial Preservative in Sliced Ready -to-Eat Cold -Smoked Salmon and Sliced Ready -to-
Eat Cold -Smoked Trout - Reference Number: NOP/AVP -0018 . The comment expressed concerns 
about the potential health impact of the pro posed use of C. divergens  M35 for individuals with 
weakened immune systems citing a case report in the scientific literature.  
 
Health Canada reviewed the case report, which was about a hospitalised individual with multiple 
health concerns who also had an infection with C. divergens . The route of exposure was not 
confirmed but was presumed to be contamination of a solution in a feeding tube or colonization 
of the feeding tube itself. Other studies cited in the case report were also considered. These 
describ ed the isolation of Carnobacterium  species either in human blood or exudate . The 
individuals were thought to have been exposed to naturally -occurring bacteria, including 
Carnobacterium  species, not from the consumption of food but rather through ski n lesions or 
traumatic wounds. The reports were not considered to  present any information that would 
indicate that the use of C. divergens  M35 on cold -smoked fish poses a health risk for the general 
population.   
 
It is recognised that persons with weakene d immune systems are more vulnerable to pathogenic 
microorganisms than the general population. This is reflected in advice that Health Canada has 
already issued on food safety for persons with weakened immune systems, who may be more 
vulnerable to food poi soning than others.1 One of Health Canada’s recommendations is that 
persons with this condition not consume certain foods, including refrigerated, smoked seafood. 
This advice is based on the potential for exposure to pathogenic microorganisms, such as Listeria 
                                              
1 Food safety for people with a weakened immune system  : (http://healthycanadians.gc.ca/eating -nutrition/healthy -
eating -saine -alimentation/safety -salubrite/vulnerable -populations/immune -immunitaire -
eng.php?_ga=1.266830536.778844979.1465568688 )  
Notice of Modification to the List of Permitted Preservatives  to Enable the Use of Carnobacterium divergens  M35 as an  
Antimicrobial Preservative in Sliced Ready -to-Eat Cold -Smoked Salmon and Sliced Ready -to-Eat Cold -Smoked Trout  
- Reference Number: [NOM/ADM -0079]   
Bureau of Chemical Safety, Food Directorate, Health  Products and Food Branch     4 monocytogenes , as opposed to such microorganisms as  C. divergens  M35 which is recognised as 
non-pathogenic.   
 
The use of  C. divergens  M35 will be an other  option for manufacturers of sliced ready -to-eat 
cold-smoked salmon and sliced ready -to-eat cold -smoked trout to implement in order to  reduce 
contamination of these foods by the pathogen Listeria monocytogenes . Overall, the available 
scientific data supports enabling the use of C. divergens  M35 as Health Canada proposed.  
 
Implementation and Enforcement  
 
The above modification came into force Octo ber 13, 2016 , the day it was 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 info rmation on 
the safety in use of any food additive, including Carnobacterium divergens  M35 . 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 words " Carnobacterium divergens  M35 " 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