. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/247 
7 July 2005 
 (05-3007) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
 
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):  Formulated liquid diets (ICS: 67.040) 
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 Regarding Formulated Liquid Diets for Special Dietary Use (Available in English and French; pages 2358-2359). 
6. Description of content:   
The Food and Drug Regulations set out nutritional requirements for formulated liquid 
diets. These requirements include minimum levels for 18 vitamins and mineral nutrients 
and, in the case of vitamins A and D, maximum levels.  
Health Canada has received a submission to exempt formulated liquid diets formulated 
specifically for patients with renal failure from the application of the minimum requirements of vitamins A and D and the mineral nutrients phosphorus and magnesium. 
The dietary management of vitamins A and D and the mineral nutrients phosphorus and 
magnesium must be individualized for patient s with renal failure based on the specific 
condition of the patient. Optimal intake levels of these vitamins and mineral nutrients will 
vary depending on the age and body weight of  the patient and the severity of the renal 
failure.  
Health Canada has completed a safety assessment of the proposal to exempt formulated 
liquid diets for patients with renal failure from the application of the current minimum 
requirements for the nutrients named above. Ev aluation of the available data supports the 
safety of the exemption of formulated liquid diets for patients with renal failure from the minimum levels for vitamins A and D and for the mineral nutrients phosphorus and 
magnesium.  
Health Canada therefore intends to recommend that section B.24.102 of the Food and Drug 
Regulations be amended to exem pt liquid diets formulated specifically for patients with 
renal failure from the application of the minimu m requirements of vitamins A and D and of 
the mineral nutrients phosphorus and magnesium to  meet the specific dietary needs of these 
patients.  G/SPS/N/CAN/247 
Page 2  
 
  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 liquid diets formulated 
specifically for patients with renal failure and exempted from the application of the 
minimum requirements of vitamins and mine ral nutrients, as indicated above, 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 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s) in which these are available:  Canada Gazette, Part 
I, 2 July 2005 (available in English and French). 
10. Proposed date of adoption:   Immediate for this IMA.  For the final regulation, the proposed 
date of adoption will be stated in subseque nt Revision or Addendum to this notification. 
11. Proposed date of entry into force:   Immediate for this IMA.  For the final regulation, the 
proposed date of entry into forc e 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 regulat ory text can be downloaded at:  
http://canadagazette.gc.ca/partI/2005/20050702/pdf/g1-13927.pdf