Health Canada’s Proposal 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 
  
Health Canada’s Proposal to Enable the Use  of L-
Lysine Monohydrochloride  in Certain Processed  
Snack Foods  
 
Notice of Proposal – Lists of Permitted Food Additives  
Reference Number: NOP/A DP-0032 
May  13, 2019  
Health Canada’s Proposal 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 food additive submission with t he 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 L-lysine 
monohydrochloride to inhibit acrylamide formation  in processed snack foods  made from  dough 
where the primary ingredient  is either dried potato es or wheat flour .  The requested maximum 
level of u se is 0.8% calculated as L-lysine.   
 
Although “ processed snack  foods ” is a term that is intended to refer to multi -ingredient snack 
foods that are comprised of individual bite -sized pieces, such as crackers, hard pretzels, chip -
type products, tortilla chips, etc. , the snack food s of primary interest to the petitioner 
areprocessed dried  potato -dough -based products and p rocessed wheat flour -dough -based 
products . Hence, s nack foods such as p retzels, crackers, tortilla chips, corn chips , and potato 
chips made from sliced potatoes  were not considered as part of this proposal . 
 
Health Canada  has determined that information related to the safety and efficacy of L-lysine 
monohydrochloride  support s the uses of this additive as shown in the table below .  Therefo re, it 
is the intention of Health Canada to modify the List of Permitted Additives with Other Accepted 
Uses  by adding the following entry to the list.  
 
Proposed Modification to the List of Permitted Additives 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 dried 
potato dough -based 
snack foods ; 
Processed wheat 
flour dough -based 
snack foods  To inhibit 
acrylamide 
formation  0.8% calculated as 
L-Lysine  
* As this proposed provision is for a food additive and a technical function each of which have 
not previously appeared in the Lists of Permitted Food Additives , an amendment to the Schedule  
Health Canada’s Proposal 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 in the Marketing Authorization for Food Additives with Other Accepted Uses  is also required . 
The steps for amending this Schedule are being tak en following a sep arate procedure. Further 
details are available in the Notic e of Intent to Issue Food Marketing Authorization .  
 
Rationale  
 
Health Canada’s Food Directorate assessed  L-lysine monohydrochloride  for use to inhibit 
acrylamide  formation as requested by the petitioner . The assessment considered information 
related to chemistry, microbiolog y, nutrition,  and toxicolog y, including the efficacy of L-lysine 
monohydrochloride  in inhibiting acrylamide formation .   
 
 
Test results for L-lysine monohydrochloride demonstrated reduced  acrylamide  formation  in a 
potato -based processed product and a multigrain -based processed product made with this 
additive at a level of 1%1 compared to the same product made without the additive .  
 
Health Canada did not identify any  toxicological or nutritional safety concerns with this use of 
L-lysine monohydrochloride. L-lysine is an essential amino acid as it cannot be synthesized by 
the body and therefore must be obtained from the  diet. The available safety data indicate that  the 
additional lysine from the proposed use  of L-lysine monohydrochloride would be unlikely to lead 
to any nutritional concerns  related to L -lysine . Individuals who need to follow a diet reduced in 
lysine will be able to identify processed snack foods that have been made with L-lysine 
monohydrochloride since the additive  will need to be declared in the list of ingredients in 
accordance with the general food ingredient labelling requirements .  
 
The results of the premarket assessment  support the safety of L-lysine monohydrochloride  when 
used in the foods  at  the level set out in the table above. The Department is therefore proposin g to 
enable the use of this additive  as shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as L-lysine monohydroc hloride  
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 compendium 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 b y the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) , is published by the Food and Agriculture Organization 
of the United Nations.  
 
Implementation and Enforcement  
                                              
1 A level of 1% L-lysine monohydrochloride is equivalent to a level of 0.8% L-lysine.   
Health Canada’s Proposal 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  
The proposed change will be effective the day on which it is published in the List of Permitted 
Additives with Other Accepted Uses .  This will be announced via a Notice of Modification  
(NOM) that will be published on the Canada.ca  website . The publication of th is NOM  will be  
contingent on the publication of the amendment to the Schedule2 of the Marketing Authorization 
for Food Additives with Other Accepted Uses  in the Canada Gazette , Part II.  
 
The Canad ian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect to foods.   
 
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 words “L-lysine monohydrochloride  (NOP -0032)” 
in the subject line of your e -mail.   Health Canad a is able to consider information received by 
July 26, 2019 , 75 days from the date of this posting.  
                                              
2 See the Notice of Intent to Issue Food Marketing Authorization .