. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/388 
8 April 2009  
 (09-1703) 
Committee on Sanitary a nd 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; ICS numbers should be provided in addition, where 
applicable):  Liquid whey and dried whey products (ICS Codes 67.100, 67.220) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ X ] All trading partners, or [   ] Specific regions or countries:    
5. Title of the notified document:  Interim Marketing Authorization regarding the use of 
calcium sulphate as a carrier of benzoyl pe roxide in liquid whey destined for the 
manufacture of dried whey products, other that those for use in infant formula Language:  English and French  Number of pages:  2 
6. Description of content:  Health Canada has received a submission to permit the use of 
calcium sulphate as a carrier of benzoyl pe roxide in liquid whey destined for the 
manufacture of dried whey products, other that  those for use in infant formula, at a 
maximum level of use of 0.3% of dried wh ey products.  Evaluation of available data 
supports the safety and effectiveness of calcium sulphate as a carrier of benzoyl peroxide in 
the production of this food product. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations  be amended to permit the use of calcium sulphate as a carrier of benzoyl 
peroxide in liquid whey destined for the ma nufacture of dried whey products, other than 
those for use in infant formula, at a maximum level of use of 0.3% of dried whey products. 
As a means to improve the responsiveness of the regulatory system, an Interim Marketing 
Authorization is being issued to permit the immediate use of calcium sulphate, as indicated above, while the regulatory process is undertaken to amend the Regulations. 
The proposed regulatory amendments would be  enabling measures to allow the sale of 
additional foods containing calcium sulphate  as a carrier of benzoyl peroxide.  The 
amendments are supported by the safety assessment and would have a low impact on the economy and on the environment.  Consequen tly, the regulatory amendments may proceed 
directly to final approval and publication in the Canada Gazette , Part II. G/SPS/N/CAN/388 
Page 2  
 
  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:  
[   ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)    
[   ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)     
[   ] International Plant Protection Convention (e.g.  ISPM N°)     
[ X ] None Does this proposed regulation conform to the relevant international standard?   
 [   ] Yes   [   ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language (s) in which these are available:  Canada 
Gazette , Part I, 28 March 2009, Pages 766-76 7 (available in English and French) 
10. Proposed date of adoption (dd/mm/yy) :  Immediate for this IMA.  For the final 
regulation, normally within 12-18 months  of publication of the Notice of Interim 
Marketing Authorization in the Canada Gazette , Part I, 28 March 2009.  
Propose date of publication ( dd/mm/yy) :   
11. Proposed date of entry into force:  [   ] Six months from date of publication , and/or  
(dd/mm/yy) :  Immediate for this IMA.  For the final regulation, normally within 12-18 
months of publication of the Notice of Interim Marketing Authorization in the Canada 
Gazette , Part I, 28 March 2009. 
[   ] Trade facilitating measure  
12. Final date for comments: [   ] Sixty days from the date of circulation of the 
notification and/or ( dd/mm/yy ):  11 June 2009 
Agency or authority designated to handle 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 the regulatory text can be downloaded at:  
http://www.gazette.gc.ca/rp-pr/ p1/2009/2009-03-28/p df/g1-14313.pdf  (Canada Gazette ) 
or  http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-03-28/html/notice-avis-eng.html#d111
 
(English) http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-03-28/html/notice-avis-fra.html#d111
 
(French)