. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/518 
10 March 2011  
 (11-1211) 
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 numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Veterinary drugs (ICS Codes:  11.220, 67.040, 67.120) 
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:  Proposed Amendment to the Food and Drug Regulations 
(1347 - Sulfonamides)  Language(s):  English and French  Number of pages:  8 
6. Description of content:  Under the Canadian Food and Drug Regulations  (the 
Regulations), all veterinary drugs must be aut horized by Health Canada prior to their sale 
and administration to prevent and treat diseases in animals.  Some drugs are only permitted 
in certain species not intended to  be used for foods while others  are used in food-producing 
animals.  These amendments to the Regulations establish safe limits for residues of various sulfonamides in foods originating from animals treated with these par ticular drugs.  These 
veterinary drugs are an important tool in the production of healthy animals which are 
destined for use as food. 
Acceptable limits of residues of veterinary drugs in food commodities are called maximum 
residue limits (MRLs).  MRLs are the maximum concentrations of residues, expressed in parts per million (p.p.m.) on a fresh weight basis, in edible tissues of food-producing 
animals as a result of the treatment of those an imals with veterinary drugs.  An MRL is 
based on the type and amount of residue consid ered to pose no adverse health effects if 
ingested daily by humans over a lifetime.  
The proposed amendments would list the following new individual MRLs for authorized 
sulfonamide compounds to be used in food-producing animals: sulfabenzamide, sulfacetamide, sulfachlorpyridazine, sulf adiazine, sulfadimethoxine, sulfadoxine, 
sulfaethoxypyridazine, sulfaguanidine, sulfam erazine, sulfamethazine, sulfanilamide, 
sulfanitran, sulfapyridine, sulfaquinoxa line and sulfathiazole. In addition, these 
amendments propose that sulfonamides may be used singly or in combination.  In cases 
where more than one sulfonamide drug residue is being detected, the combined residues of 
all sulfonamides listed in the amendments s hould not exceed 0.1 p.p.m. in edible tissues 
and 0.01 p.p.m. in milk. G/SPS/N/CAN/518 
Page 2  
 
  Extensive studies have determined that th e food commodities containing residues of 
sulfonamides at levels up to the MRLs listed in  the amendments are safe for consumption.  
These MRLs apply to foods produced dom estically or imported into Canada. 
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 number)    
[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, 26 February 2011, Pages 780- 787 (available in English and French) 
10. Proposed date of adoption (dd/mm/yy) :  Normally within five to eight months of 
publication in the Canada Gazette , Part I 
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) :  On the date the measure is adopted. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  12 May 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 the regulatory text can be downloaded at:   
http://www.gazette.gc.ca/rp-pr/ p1/2011/2011-02-26/p df/g1-14509.pdf  (Canada Gazette ) 
or  http://www.gazette.gc.ca/rp-pr/p1/ 2011/2011-02-26/html/reg6-eng.html
 (English) 
http://www.gazette.gc.ca/rp-pr/p1/ 2011/2011-02-26/html/reg6-fra.html  (French)