Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of L-Lysine Monohydrochloride in Certain Processed Snack Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Food Additives with Other Accepted Uses  to 
Enable the Use of L-Lysine 
Monohydrochloride  in Certain Processed 
Snack Foods  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0140 
November 6 , 2019 Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of L-Lysine Monohydrochloride in Certain Processed Snack Foods   
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  (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 the Canada.ca  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 f ood 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 ’s Food Directorate  received a food additive submission seeking approval for the 
use of L-lysine monohydrochloride to inhibit acrylamide formation  in processed snack foods 
made from dough where the primary ingredient is either dried potatoes or wheat flour.1  The 
requested maximum level of use is 0.8%  in the finished snack food,  calculated as L-lysine.  
 
The results of the Food Directorate ’s evaluation of available scientific data support the safety and 
efficacy of L-lysine monohydrochloride  when used as requested by the petitioner.  Since this is a 
food additive that was not previously permitted for use in Canada, Health Canada’s Proposal to 
Enable the Use of L-Lysine Monohydrochloride  in Certain Processed Snack Foods  [Reference 
Number: NOP/ADP -0032 ] was published on May 13, 2019 . The proposal  was open to the public 
for comment for 75 days .  No new scientific information was submitted to the Department as a 
result of this Notice of Proposa l.  Since the conclusions of the evaluation remain as described in 
the publication , Health Canada has enable d the requested uses of L-lysine monohydrochloride  by 
adding the entr y shown in the table below to  the List of Permitted Food Additives with Other 
Accepted Uses .  
 
Modification to the List of Permitted Food Addit ives with Other Accepted Uses  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
Upon  Column 3  
Purpose of Use  Column 4  
Maximum Level of 
Use and Other 
Conditions  
L.5 L-Lysine 
Monohydrochloride  Processed snack 
foods  based on 
dried potato dough ; 
Processed snack 
foods  based on 
wheat flour dough  To inhibit 
acrylamide 
formation  0.8% calculated as 
L-Lysine  
 
                                              
1 There is a standard of identity and composition for flour in section B.13.001  of the Food and Drug Regulations  
that prescribes  that flour shall be a food prepared from wheat . Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of L-Lysine Monohydrochloride in Certain Processed Snack Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety and efficacy assessment of L-
lysine monohydrochloride for inhibit ing acrylamide formation  in processed snack foods made 
from either dried potato or flour dough .  The Food Directorate’s assessment concluded that L-
lysine monohydrochloride is effective  for its requested use and that information related to  
chemistry, microbio logy, nutrition,  and toxicolog y supports the safety of  this additive for such 
use.  Therefore, the Department has enabled the requested use of L-lysine monohydrochloride  by 
adding to  the List of Permitted Food Additives with Other Accepted Uses  the new entry  shown  in 
the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as L-lysine monohydrochloride 
that do not have food -grade specifications set out in Part B of the Regulations meet the most 
recent food -grade specifications set out in the Food Chemicals Codex  or the Combined 
Compendium of Food Additive Specifications .  The Food Chemicals Codex  is a co mpendium of 
standards for purity and identity for food ingredients, including food additives, published by the 
United States Pharmacopeial Convention.  The Combined Compendium of Food Additive 
Specifications , which contains specifications prepared by the J oint FAO/WHO Expert 
Committee on Food Additives (JECFA) , is published by the Food and Agriculture Organization 
of the United Nations.  
 
Notification – Summary of Comments  
 
No comments were received in response to  Health Canada’s Proposal to Enable the Use of L-
Lysine Monohydrochloride in  Certain Processed Snack Foods [Reference Number: NOP/ADP -
0032 ], published on May 13, 2019 . 
 
Implementation and Enforcement  
 
The above modification came into force November 6 , 2019, the day it was published in  the List 
of Permitted Food Additives with Other Accepted Uses . 
 
The Canadian Food Inspection Agency is responsibl e 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 in use of any food additive, including L-lysine monohydrochloride .  Anyone wishing 
to submit new scientific information on the use of this additive or t o submit any inquiries may do 
so in writing, by regular mail or electronically.   If you wish to contact the Food Directorate Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of L-Lysine Monohydrochloride in Certain Processed Snack Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 electronically, please use the words "L-lysine monohydrochloride (NOM -0140)" 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: hc.bcs -bipc.sc@canada.ca