. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/271 
25 June 2009  
 (09-3109) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  CANADA   
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Department of Health 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :  Canadian Enquiry 
Point, 200-270 Albert Street, Ottawa, Ontari o, Canada, K1P 6N7 Tel.:  +1 613 238 3222, 
Fax.: +1 613 569 7808, E-mail: enquirypoint@scc.ca 
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Non-medicinal ingredients 
for human use (ICS : 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (743 — Non-Medi cinal Ingredients) (Available in English 
and French, 11 pages)     
6. Description of content:  Certain non-medicina l ingredients (NMIs) present in 
nonprescription drugs can cause adve rse reactions in individuals wi th sensitivities or allergies 
and consequently, individuals may wish to avoi d consuming certain NMIs for this and other 
reasons of personal preference. This regulato ry amendment proposes to require the labelling 
of NMIs on the labels of non-prescription drugs  for human use (with some exceptions). This 
may result in a positive impact on consumer health and safety, by allowing individuals to avoid life-threateni ng allergens and agents for which they have a history of adverse reactions. 
Furthermore, this enables consumers to make informed choices when purchasing 
nonprescription medications. Whil e some manufacturers voluntarily list NMIs on the outer 
labels of non-prescription drugs, not all do so , and currently, it is not a legal requirement.  
In Canada, the Natural Health Products Regul ations and the Cosmetic Regulations have 
required the mandatory listing of all NM Is since January 2004 and November 2006 
respectively. This has created a difference in regulatory requirements in Canada, especially in 
light of the knowledge that dr ug NMIs can pose a health risk. 
Health Canada proposes to amend the Food and Drug Regulations (Regulations) to require 
that all NMIs be listed on the outer labels of drugs for human use. The proposed amendment 
does not apply to G/TBT/N/CAN/271 
Page 2  
 
  (i) prescription drugs;  
(ii) non-prescription drugs that are only admini stered under the superv ision of a practitioner; 
(iii) drugs that are represented as being sole ly for use as disinfectants on hard non-porous 
surfaces; nor 
(iv) drugs for veterinary use. 
This proposed regulatory amendmen t to require the listing of NM Is on the outer labels of non-
prescription drugs for human use will assist indi viduals in avoiding life-threatening allergens 
and agents for which they have a history of adverse reactions. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety  
8. Relevant documents:   Canada Gazette, Part I, 6 Ju ne 2009, Pages 1665-1675 (available in 
English and French). A letter to stakeholders was sent and posted on the Health Canada Web 
site 14 August 2006. The letter wa s notified as G/ TBT/N/CAN/171. 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 5 to 8 months of publication in 
the Canada Gazette, Part I. 
Two years after the date the measure is adopted. 
10. Final date for comments:  20 August 2009 
11. Text available from: National enquiry po int [ X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
The electronic version of the regulat ory text can be downloaded at:  
http://www.gazette.gc.ca/rp-p r/p1/2009/2009-06-06/pdf/g1-14323.pdf  (Canada Gazette) 
or  http://www.gazette.gc.ca/rp-pr/ p1/2009/2009-06-06/html/reg3-eng.html
 (English) 
http://www.gazette.gc.ca/rp-pr/ p1/2009/2009-06-06/html/reg3-fra.html  (French)