G/SPS/N/CAN/597/Add.2  
 
28 May 2013  
(13-2780)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English/French  
 
NOTIFICATION 
Addendum 
The following communication, received on 24 May 2013, is being circulated at the request 
of the Delegation of Canada. 
 
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  Marketing Authorization for Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods 
Recent updates to the Food and Drugs Act  that were introduced in section 30.1 to 30.5 as part of 
the Jobs, Growth and Long-term Prosperity Act, 2012  (Bill C-38, 
http://parl.gc.ca/HousePublications/Publicat ion.aspx?Language=E&Mode=1&DocId=5697420 ) give 
the Minister of Health the authority to issue Marketing Authorizations and incorporate documents 
by reference. Pursuant to subsection 30.3(2)(b) of the Food and Drugs Act , the Department of 
Health is publishing a Marketing Authorization (MA) for veterinary drug maximum residue limits 
(MRL) in order to realize the efficiencies from this legislation and improve current processes.  
Under this legislation, the Department has recently streamlined the regulatory process for food 
additives, and this MA makes the same improvem ents for efficiencies and burden reduction for 
veterinary drug maximum residue limits (MRLs) in food. 
A Maximum Residue Limit (MRL) is an amount of drug  residue that - if present in the tissue of a 
food animal or a food product derived from a food -producing animal that has been treated with a 
veterinary drug - will not pose an unacceptable risk to the safety of the food. This residue, at this 
level, is considered to pose no adverse health effects if ingested daily by humans over a lifetime. 
Currently, when Health Canada reviews and authorizes a veterinary drug for sale in Canada, an 
MRL for the drug residue is determined at the sa me time; however, the MRL then has to be added 
to the regulations, which can take many years af ter the scientific decision and consultation have 
already taken place. 
As a result of this new legislation, an MA has been prepared to modernize this process in Canada 
in a way that maintains the scientific rigor and consultation process, but removes the step of making a regulatory amendment for each new or updated MRL. Health Canada's new MA process for veterinary drug MRLs will continue to protect the health and safety of Canadians while also 
reducing unnecessary red tape. The new process will be several steps shorter and less labour 
intensive because the regulations do not need to be changed every time an MRL is established or updated.  Instead, the "List of Maximum Residue Limits for Veterinary Drugs in Foods" will be 
incorporated by reference (i.e. have the force of law) pursuant to section 30.5 of the Food and 
Drugs Act , and will be maintained on Health Canada's website; any proposed changes will be the 
subject of consultation, public and international notification and the list will then be updated 
administratively. Associated Governor in Council regulations are being developed for pre-
publication at a later date in order to repeal the existing "Table III" in Part B, Division 15 of the 
Food and Drug Regulations , as the list of MRLs will now be published and maintained online. 
The Marketing Authorization comes into force on the day it is registered.  No delay in coming into 
force is required, as this is a reset of existing rules for veterinary drug MRLs that have already 
been subject to scientific review and public consulta tion. In addition, this proposal was published in 
a Notice of Intent (2 February 2013) to interested parties; no comments were received, and this proposal is anticipated by stakeholders. G/SPS/N/CAN/597/Add.2 
 
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  This addendum concerns a: 
[ ] Modification of final date for comments 
[X] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:    
Comment period:  (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days.  Under 
other circumstances, such as extension of or iginally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  Not applicable 
Agency or authority designated to handle comme nts:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax number and e-mail address (if available) of 
other body: 
   
Text available from:  [ ] National Notificati on Authority, [X] National Enquiry Point.  
Address, fax number and e-mail addre ss (if available) of other body: 
The electronic version of the regulatory text can be downloaded at:   
Marketing Authorization published in Canada Gazette , Part II:  
http://www.gazette.gc.ca/rp-pr/p2/ 2013/2013-05-22/pd f/g2-14711.pdf  (Canada Gazette ) 
or 
http://www.gazette.gc.ca/rp-pr/p2/2013/ 2013-05-22/html/sor-dors87-eng.html  (English) 
http://www.gazette.gc.ca/rp-pr/p2/2013/ 2013-05-22/html/sor-dors87-fra.html  (French) 
 
For electronic versions of the List please visit Health Canada's website:  
http://www.hc-sc.gc.ca/dhp-mp s/vet/mrl-lmr/mrl-lmr_ve rsus_new-nouveau-eng.php  (English) 
http://www.hc-sc.gc.ca/dhp-mp s/vet/mrl-lmr/mrl-lmr_ve rsus_new-nouveau-fra.php  (French)  
 
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