G/TBT/N/CAN/464
4 August 2015 
(15-4017)  Page: 1/2
Committee on Technical Barriers to Trade  Original: English/French
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: CANADA 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Department of Health 
Name and address (including telephon e 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 : 
Canada's Notification Authority and Enquiry Point 
Foreign Affairs, Trade and Development Canada 
Technical Barriers and Regulations Division (TIB) 111 Sussex Drive Ottawa, ON K1A 0G2 
Canada 
Telephone: (343)203-4273 Fax: (613)943-0346 
Email: enquirypoint@international.gc.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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): The salts of the 
following 14 substances: apomorphine, cyprenorphine, narcotine, papaverine, 
carbamethidine, oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan, and cyclazocine (ICS: 11.120) 
5. Title, number of pages and language(s) of the notified document: Notice to 
interested parties – Proposal regarding an order amending the schedules to the Controlled Drugs and Substances Act (CDSA) and regulations amending the regulations under the CDSA 
to exclude the salts of 14 substances that are currently excluded from the CDSA (2 pages, 
available in English and French) 
6. Description of content: This notice provides interested stakeholders with the opportunity 
to provide comments on Health Canada's proposal for the exclusion of the salts of the following 14 substances from the Controlled Drugs and Substances Act (CDSA) and its 
regulations: apomorphine, cyprenorphine, narcotine, papaverine, carbamethidine, 
oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan, and cyclazocine.  
The salts of these 14 substances are not captured within the current exclusions, which 
explicitly capture only the parent substances. Under this regulatory proposal, the scope of 
the exclusions for these 14 substances would be extended to include their salts. 
The salts of these substances are used for a wide variety of purposes and do not pose a 
threat to public health or public safety. For most of these substances, the salt form is the 
most common commercially available form of the substance. Salt forms can often have improved chemical and physical stability (e.g. for storage and transport) and can be easier 
to process (e.g. forming a salt can turn a viscous oil into a free-flowing powder). They are G/TBT/N/CAN/464 
 
- 2 - 
 
  thus used in lieu of the parent substance. The salts of these substances are contained in a 
variety of products currently sold in Canada (e.g. cough syrups commonly contain the salt of dextromethorphan). 
7. Objective and rationale, including the nature of urgent problems where 
applicable: The purpose of these amendments are to exclude specific substances that do 
not pose a threat to public health or public safety from the schedules of the CDSA and its 
regulations and to facilitate legitimate access to specific substances that are currently controlled under the CDSA.  
8. Relevant documents: Canada Gazette , Part I, 25 July 2015, pages 1992-1993 (available 
in English and French 
9. Proposed date of adoption: Anticipated for winter 2016 
Proposed date of entry into force: On the date the regulations are adopted   
10. Final date for comments: 8 October 2015 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
The electronic version of the notice can be downloaded at: http://www.gazette.gc.c a/rp-pr/p1/2015/2015-07 -25/pdf/g1-14930.pdf  
http://www.gazette.gc .ca/rp-pr/p1/2015/201 5-07-25/html/notice -avis-eng.php#nc3   
http://www.gazette.gc .ca/rp-pr/p1/2015/201 5-07-25/html/notice -avis-fra.php#nc3