G/SPS/N/CAN/912
20 February 2015 
(15-1023)  Page: 1/2
Committee on Sanitary and Phytosanitary Measures  Original: English/French
 
  NOTIFICATION 
1. Notifying Member: CANADA 
If applicable, name of local government involved:   
2. Agency responsible: Health Canada 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Lecithin in infant formula (ICS Codes: 67.220.20, 
67.230) 
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: 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  Language(s): English and French  
Number of pages: 3 and 4 
http://members.wto.org/crnattachments/2015/SPS/CAN/15_0871_00_e.pdf  
http://members.wto.org/crnattachments/2015/SPS/CAN/15_0871_00_f.pdf  
6. Description of content: 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 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 use as well as the consultation document supporting the regulatory amendments. However, subsequent regulatory amendments changed the maximum level of use from 0.3% to 0.03%. 
Consequently, Health Canada has modified 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, effective 13 February 2015. 
The purpose of this communication is to publically announce the Department's decision 
in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food 
additive. 
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.   G/SPS/N/CAN/912 
 
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  8. Is there a relevant international st andard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) 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. 
[ ] 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?   
[ ] Yes   [X] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard: The Codex GSFA provides for the use of lecithin in infant 
formula at 5,000 mg/kg (or 0.5%), while Health Canada has enabled its use at a maximum level of 3,000 mg/kg (or 0.3%). 
9. Other relevant documents and language (s) in which these are available: 
Health Canada's Food and Nutrition - Public Involvement and Partnerships website, 
posted 13 February 2015 (available in English and French):  
http://www.hc-sc.gc.ca/fn-an/consult/index-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/consult/index-fra.php  (French) 
10. Proposed date of adoption (dd/mm/yy) : The proposed food additive use will be 
legally enabled once it is published in Health Canada's List of Permitted Emulsifying, 
Gelling, Stabilizing or Thickening Agents.  
Proposed date of publication (dd/mm/yy) : 13 February 2015 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : The food additive use noted in this document comes into force 
the day on which the modifications are made to the List of Permitted Emulsifying, 
Gelling, Stabilizing or Thickening Agents . 
[X] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:   
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
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 is available through the following weblink:  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0044/index-eng.php  (English)  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0044/index-fra.php  (French)