Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to  
Modify the Level of Use of  Lecithin as an Emulsifying Agent in Infant Formula   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening Agents  to 
Modify the Level of Use of Lecithin as an Emulsifying 
Agent in Infant Formula  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0044] 
 
 
 February  13, 2015   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to  
Modify the Level of Use of  Lecithin as an Emulsifying Agent in Infant Formula   
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 MA’s 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’s Food Directorate received a query regarding the maximum level of use for 
lecithin in infant formula which led to a review of the regulatory history of this particular food 
additive provision.  
 
In both official languages, Item L.2 of the List of Permitted Emulsifying, Gelling, Stabilizing or 
Thickening Agents  on Health Canada’s website indicates that lecithin is permitted for use in 
infant formula at a maximum level of 0.03%.  The same listing occurs in Table IV of Division 16 
of the offic ial version of the Food and Drug Regulations  (FDR) on the website of the 
Department of Justice.1  
 
In the course of the review, the Food Directorate found that the intended maximum level of use 
for lecithin in infant formula had been 0.3% as consumed, not 0.03% as consumed.  This was 
reflected in the English version of the initial amendments to permit this additive use2 as well as 
the consultation document supporting the regulatory amendments3.  However, subsequent 
regulatory amendments changed  the maximum level of use from 0.3% to 0.03%.  
 
Consequently, Health Canada is modifying the List of Permitted Emulsifying, Gelling, Stabilizing 
or Thickening Agents  to enable the use of lecithin, in infant formula, at a level of 0.3% as 
consumed.  
 
 
 
 
 
                                              
1  The Food Additive Tables in Division 16 of the Food and Drug Regulations  will be rescinded as a result of the 
creation, in 2012, of the Lists of Permitted Food Additives.  These lists are published on Health Canada’s website 
and have the force of law as they are incorporated by reference into Marketing Authorizations.  
 
2 Canada Gazette Part II , Vol. 110, No. 22, SOR /1976 -751 
 
3 Health Protection Branch, Information Letter  No. 414, Principles of Proposed Infant Formula Regulations , 
February 22, 1974   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to  
Modify the Level of Use of  Lecithin as an Emulsifying Agent in Infant Formula   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
upon  Column 3  
Maximum Level of Use and Other 
Conditions  
L.2 Lecithin  (3) Infant formula  (3) 0.3% as consumed  
 
Rationale  
 
Health Canada’s Food Directorate reviewed the regulatory history of Item L.2  of the List of 
Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  and determined that the level of 
use of lecithin should be 0.3% as consumed, as was originally intended.    
 
The Department has therefore modified the use of lecithin as described in the above table.  
 
Other Relevant Information  
 
The Codex General Standard for Food Additives (GSFA) provides for the use of lecithin (INS 
322 i) in a wide variety of foods, including food category 13.1.1 Infant formulae, at a maximum 
level of use of 5,000 mg/kg (or 0.5%), on the ready -to-eat basis.  
 
Implementation and Enforcement  
 
The above modification came into force February  13, 2015 , the day it was published in the  List 
of Permitted Emulsifying, Gelling, Stabilizing or  Thickening Agents . 
 
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 lecithin . 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 elect ronically.  If you wish to contact the Food Directorate 
electronically, please use the words “ Lecithin " 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