WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/490 
23 November 2010  
 (10-6277) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  CANADA
 
If applicable, name of local government involved:    
2. Agency responsible:  Health Canada 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Infant formula for special medical purposes (ICS Codes:  67.230, 11.120) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Information Document on Health Canada's Proposal to 
Amend the Food and Drug Regulations  to Permit the use of Citric Acid Esters of Mono- 
and Diglycerides (1) as a Food Additive in Infa nt Formula For Special Medical Purposes; 
and (2) in those Foods that are Currently Permitted to Contain Monoglyceride Citrate 
Language:  English and French  Number of pages:  9 and 12   
6. Description of content:  This document provides informati on on Health Canada's proposal 
to amend the Food and Drug Regulations  ("Regulations") to permit the use of citric acid 
esters of mono- and di-glycerides (synonymous names citric and fatty acid esters of glycerol, CAEM, CITREM) as a food additive in the following foods, including in infant 
formula for special medical purposes.  The pr oposed amendments would permit the use of 
citric acid esters of mono- and di-glycerides as an emulsifying agent in infant formula based on crystalline amino acids or protein hy drolysates, or both, and in unstandardized 
foods.  The proposed amendments would also pe rmit the use of citric acid esters of mono- 
and di-glycerides as a class IV  preservative in fats and oils, lard, monoglycerides and 
diglycerides, shortening, in uns tandardized foods (except unstanda rdized preparations of (a) 
meat and meat by-product (Divisions 14 and 21), (b) fish, and (c) poultry meat and poultry 
meat by-product), and in margarine.  Citric acid esters of mono- and di-glycerides would 
also be used as a carrier or solvent agent in natural extractives, spice extracts and in 
unstandardized flavouring preparations. 
Health Canada received a submis sion requesting that the Regula tions be amended to permit 
the addition of citric acid esters of mono- a nd di-glycerides in infant formula for special 
medical purposes.  Specialized formulas are re quired for infants with impaired metabolism, 
e.g.: infants suffering from certain food alle rgies and intolerances where whole protein 
cannot be tolerated; inborn error of metabolis m - when the offending amino acid must be 
excluded (e.g.:  phenylketonuria); or, conditions  where the absorptive surface of the gut is 
damaged or impaired.  Specialized infant form ulas composed of mixtures of amino acids or G/SPS/N/CAN/490 
Page 2  
 
  hydrolyzed proteins, fat, carbohydrates and other nutritional elements are manufactured for 
infants with these types of conditions. 
Health Canada's Food Directorate has completed a safety assessment of citric acid esters of 
mono- and di-glycerides when used as describ ed in the submission through which it has 
determined that there are no health or safety concerns with its addition to infant formula 
that are based on protein hydrolysates or crysta lline amino acids or both.  Such specialized 
formulas are required for infants with impaired  metabolism.  Therefor e, the department is 
proposing amendments to the Regulations to allow citric acid esters of mono- and di-glycerides to be added to infant formula based on crystalline amino acids or protein 
hydrolysates or both. 
In addition, citric acid esters of mono- and di-glycerides would also be added to the tables 
in the Regulations where monoglyceride citr ate is currently permitted.  Monoglyceride 
citrate is a Class IV preservative (synergist anti oxidant) used in a variety of food products 
including margarine, shortening, lard and some  unstandardized foods;  also, it is permitted 
as a carrier or extraction solvent in spice ex tracts, natural extractives, and unstandardized 
flavouring preparations. Since a compositional standard for margarine is outlined in the 
Regulations, it would be amended accordingly by  inclusion of citric acid esters of mono- 
and di-glycerides 
7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, 
[  ] protect humans from animal/plant pest or disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) Codex General Standard for Food Additives (GSFA), CODEX 
STAN 192-1995, citric acid esters of mono- and di-glycerides is listed in Table III 
of the Standard - among additives that can  be used in processed foods generally 
(except in foods listed in Annex to ta ble III) at a level consistent with good 
manufacturing practices. 
Available in English and French: 
http://www.codexalimentarius.net/ download/standards/4/CXS_192e.pdf  (English) 
http://www.codexalimentarius.net/ download/standards/4/CXS_192f.pdf  (French) 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None 
Does this proposed regulation conform to the relevant international standard?   
 [X] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:     G/SPS/N/CAN/490 
 Page 3 
 
 
  9. Other relevant documents and language(s) in which these are available:  Health 
Canada's Food and Nutrition – "Public Invol vement and Partners hips" Website, posted 
18 November 2010 (available in English and French):  
English:  http://www.hc-sc.gc.ca/fn -an/consult/index-eng.php   
French:  http://www.hc-sc.gc.ca/fn -an/consult/index-fra.php  
10. Proposed date of adoption (dd/mm/yy) :  Normally within four to five months from the 
posting of the Information Document  on the Health Canada website. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  The Regulations come into force on the day on which they are adopted in the 
Canada Gazette , Part II. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  31 January 2011 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    
13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
The electronic version of "Information Document on Health Canada's Proposal to Amend 
the Food and Drug Regulations  to Permit the use of Citric Acid Esters of Mono- and 
Diglycerides (1) as a Food Additive in Infant Formula For Special Medical Purposes;  and 
(2) in those Foods that are Currently Permitte d to Contain Monoglyceride Citrate" can be 
downloaded at:  
"http://www.hc-sc.gc.ca/fn-an/consult/techni cal-consultation-technique/citrem-consult-
eng.php " (English) 
"http://www.hc-sc.gc.ca/fn-an/consult/techni cal-consultation-technique/citrem-consult-
fra.php " (English)