Notice of Modification to the List of Permitted Preservatives to Enable the Use of Ethyl Lauroyl Arginate as a  
Preservative in Various Standardized and Unstandardized Foods   
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 Ethyl Lauroyl 
Arginate as a Preservative in Various Standardized and 
Unstandardized Food s 
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0032] 
 
 
 August  18, 2014   
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Ethyl Lauroyl Arginate as a  
Preservative in Various Standardized and Unstandardized 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.  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 new additive or a new condition of use for an already 
approved food additive by f iling 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 ethyl lauroyl 
arginate as a preservative in a variety of standardized and unstandardized foods.  
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of ethyl lauroyl arginate when used as proposed.  Since this is a food additive that was 
not previously permitted for use in Canada, Health Canada publis hed a Consultation Document 
on Health Canada's Proposal to Enable the Use of a New Food Additive, Ethyl Lauroyl 
Arginate,  as a Preservative in Various Standardized and Unstandardized Foods  on December 9, 
2013, requesting comments.  The comment period was open for 75 days, during which no new 
scientific information about this additive was submitted to the Department as a resu lt of this 
publication.  Since the conclusions of the evaluation remain as described in the Notice of 
Proposal, Health Canada has modified the List of Permitted Pres ervatives  as indicated below.  
 
Modification to the List of Permitted Preservatives  
 
Part 2 – Class 2 Preservatives  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
upon  Column 3  
Maximum Level of Use and Other 
Conditions  
E.1 Ethyl 
lauroyl 
arginate  (1) 
Unstandardized  
non-alcoholic water - 
based beverages  
 
(2)  
Cheddar cheese;  
Meat by -product 
loaf; Meat loaf; 
(naming the  
variety) Cheese;  (1)  
50 p.p.m. calculated as ethyl -N-alpha -
dodecanoyl -L-arginate hydrochloride  
 
(2)  
200 p.p.m. calculated as ethyl -N-alpha -
dodecanoyl -L-arginate hydrochloride  
  
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Ethyl Lauroyl Arginate as a  
Preservative in Various Standardized and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 (naming the variety)  
Whey cheese;  Pie 
fillings; Potted meat;  
Potted meat by - 
product; Prepared 
fish  
or prepared meat  
(Division 21);  
Prepared meat;  
Prepared meat by - 
product; Prepared  
poultry meat;  
Prepared poultry 
meat  
by-product; 
Preserved  
fish or preserved 
meat  
(Division 21);  
Preserved meat;  
Preserved meat by - 
product; Pr eserved  
poultry meat;  
Preserved poultry  
meat by -product;  
Processed (naming 
the 
variety) cheese;  
Processed (naming 
the 
variety) cheese with  
(naming the added  
ingredients); 
Sausage;  
Soups; Tomato  
catsup;  
Unstandardized dips;   
Unstandardized  
sauces; Whey cheese  
 
 
 
  
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Ethyl Lauroyl Arginate as a  
Preservative in Various Standardized and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety and efficacy assessment of 
ethyl lauroyl arginate for use as a preservative as described above.  The assessment considered 
microbiological, toxicological and technical aspects of the proposal.     
 
No microbiological concerns have been identified with respect to the use of the active ingredient 
and no evidence was found that any of the breakdown products produced following ingestion and 
metabolism of e thyl lauroyl arginate are allergenic or are suspected of causing food intolerance.  
 
Health Canada reviewed the results of a number of toxicological studies, the results of which 
were considered in relation to an estimate of total dietary exposure to ethyl  lauroyl arginate.  No 
toxicological concerns were identified.    
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of ethyl lauroyl arginate when used under the conditions set out in  the 
table above.  The Department has therefore enabled the use of ethyl lauroyl arginate as described 
in that table.  
 
 
Other Relevant Information  
 
As a food additive, ethyl lauroyl arginate  is required to 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 the purity and identity of food ingredients, including food additives, which is 
published by United States Pharmacopeial Convention. A key specification of the FCC 
monograph is that ethyl lauroyl arginate contains not less than 85% of the active ingredient 
(ethyl -N-alpha -dodecanoyl -L-arginate hydrochloride).  
 
Ethyl lauroyl arginate is listed under  the synonym lauric arginate ethyl ester (INS 243) in the 
Codex General Standard for Food Additives (GSFA). The GSFA contains provisions for its use 
in a wide range of food categories at a maximum level of use of 200 mg/kg (p.p.m.), e xcept for 
carbonated and non -carbonated water -based flavoured drinks (food categories 14.1.4.1 and 
14.1.4.2) and concentrates for water -based flavoured drinks (food category 14.1.4.3) for which 
the maximum level of use is 50 mg/kg. However, there are no pr ovisions in the GSFA for the use 
of ethyl lauroyl arginate in meat, poultry and fish products.  
 
In the European Union, ethyl lauroyl arginate has been enabled1 for use in heat treated processed 
meat except for emulsified sausages, smoked sausages and liver paste.  
 
In the United States, one Generally Recognized as Safe (GRAS) notice (GRN000164) for 
lauramide arginine ethyl ester (i.e., ethyl  lauroyl arginate), comprised of 89 -95% ethyl -N-alpha -
                                              
1 Commission Regulation (EU) No 506/2014 of 15 May 2014   
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Ethyl Lauroyl Arginate as a  
Preservative in Various Standardized and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 lauroyl -L-arginate hydrochloride (dehydrated), had been submitted in 2005 to the US Food and 
Drug Administration (FDA) for review.  The US FDA had no further questions regarding the 
petitioner’s determi nation that the use of lauramide arginine ethyl ester as an antimicrobial in a 
wide range of foods at levels up to 200 mg/kg (p.p.m.) ethyl -N-alpha -lauroyl -L-arginate 
hydrochloride was GRAS.   
 
Australia and New Zealand permit the use of ethyl lauroyl argi nate in a wide variety of food 
categories, many of which have a maximum level of use of 200 p.p.m. (calculated as ethyl -N-
alpha -lauroyl -L-arginate hydrochloride).  However, it is permitted in beverages (i.e., wat er-based 
flavoured drinks; fruit and vegetable juices; and fruit and vegetable juice products) up to a level 
of 50 p.p.m.; processed comminuted meat and poultry products up to a level of 315 p.p.m.; and 
in semi -preserved fish and fish products, cheese (sof t/cream/ processed and mozzarella), dairy 
and fat based desserts, dips and snacks at a level up to 400 p.p.m.  All of these maximum use 
levels are calculated as ethyl -N-alpha -lauroyl -L-arginate hydrochloride.  
 
Notification – Summary of Comments   
 
In response to the Consultation Document on Health Canada's Proposal to Enable the Use of a 
New Food Additive, Ethyl Lauroyl Arginate, as a Preservative in Various Standardized and 
Unstandardized Foods , published on December 9, 2013, Health Canada received one comment.  
The comment was received from a domestic industry association.  
 
This association requested that modifications to the listing be made to allow for broader use of 
this food additive. In response, Health Canada has indicated that the permitted foods and the 
maxi mum levels of use are based on the results of the safety evaluation of the requested 
maximum levels of use and the requested foods set out in the food additive submission, and that 
the Department can consider a new food additive submission requesting an ex tension of use for 
this preservative to include a new food or a different maximum level of use.  
 
Implementation and Enforcement  
 
The above modification came into force August  18, 2014 , 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 information on 
the safety in use of any permitted food additive, including ethyl lauroyl arginate . Anyone 
wishing to submit new scientific information on the use of this food additive or to submit any 
inquiries may do so in writing, by regular mail or electronically. If you wish to contact the Food  
Notice of Modification to the List of Permitted Preservatives to Enable the Use of Ethyl Lauroyl Arginate as a  
Preservative in Various Standardized and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     6 Directorate electronically, please use the words " ethyl lauroyl arginate " 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