. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/230 
18 November 2004 
 (04-4995) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   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 Formulas (ICS:  67.230) 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Not 
stated. 
5. Title, language and number of pages of the notified document:   Interim Marketing 
Authorization to Increase the Maximum Level of Vitamin D in Infant Formula (English 
and French; pages 3111-3112) 
6. Description of content:  Health Canada has received a submission to increase the 
maximum level of vitamin D in infant form ula from the current permitted level of 80 
International Units (IU) per 100 kilocalories (kcal) to 100 IU per 100 kcal. This maximum level includes any overage that may be require d to assure that the amount of the vitamin 
indicated on the label is present in the food throughout its shelf life.  
Health Canada completed a safety assessment  of the proposal to increase the maximum 
level of vitamin D in infant formula to the level stated above. Evaluation of the available 
data supports the safety of this maximum level of vitamin D in infant formula.   
Therefore, Health Canada intends to recommend that section B.25.054 of the Food and 
Drug Regulations  be amended to provide that a hu man milk substitute may contain a 
maximum amount, including overage, of 100 IU of vitamin D per 100 available 
kilocalories.  
As a means to improve the responsiveness of the regulatory system, an Interim Marketing 
Authorization (IMA) is being issued to permit the immediate sale of infant formula with a 
maximum level of vitamin D as indicated a bove while the regulatory process is undertaken 
to formally amend the Regulations.  A revision to this notification will be published at the 
start of the amendment process and Members will be given the opportunity at that time to submit comments on this proposed measure. 
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/230 
Page 2  
 
 8. International standard, guideline or recommendation:  
[ X ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   The Codex Standard for Infant Formula 
(CODEX STAN 72-1981) establishes a minimum and maximum level of vitamin D per 100 
kcal of 40 IU and 100 IU, respectively.  The new maximum level of vitamin D proposed by 
Health Canada is consistent with Codex.   
The Codex Standard for Infant Formula can be downloaded at: 
http://www.codexalimentarius.ne t/web/standard_list.do?lang=en
 
9. Relevant documents and language(s ) in which these are available:  Canada Gazette, 
Part I, 6 November 2004 (avail able in English and French) 
10. Proposed date of adoption:   Immediate for this IMA. For the final regulation, will be stated 
in subsequent Revision or A ddendum to this notification. 
11. Proposed date of entry into force:   Immediate for this IMA. For the final regulation, will be 
stated in subsequent Revision or Addendum to this notification. 
12. Final date for comments:  This document is not for comment at this time.  A comment 
period will be provided in a Re vision of this notification. 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
The electronic version of the regul atory text can be  downloaded at:  
http://canadagazette.gc.ca/partI/2004/20041106/pdf/g1-13845.pdf