WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/293 
18 January 2010  
 (10-0214) 
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):  Prescription status of 
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 (Notice of In tent — Project  No. 1577 — Schedule F)  5 
pages available in English and French 
6. Description of content:  The purpose of this Notice of Intent (NOI) is to provide an 
opportunity for comment on the proposal to amend the current listings in  Parts I and II of 
Schedule F to the Food and Drug Regulations by  removing the listings for four medicinal 
ingredients, thus allowing them to have non-prescription status.  
Since the coming into force of the Natural Heal th Products Regulations in 2004, all naturally 
sourced substances meeting the definition of a natural health product are governed by these 
Regulations. However, products containing subs tances listed in Schedule F to the Food and 
Drug Regulations are explicitly excluded from the Natural Health Products Regulations. 
Health Canada has undertaken a review of the naturally source d medicinal ingr edients listed 
in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee 
(“the Committee”) has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these me dicinal ingredients could be regulated (in 
whole or in part) as non-prescription natura l health products under the  Natural Health 
Products Regulations. 
Health Canada is proposing that the followi ng four medicinal ingredients be removed from 
Schedule F to the Food and Drug Regulations as none of the factors for listing in Schedule F 
were found to apply. This would mean that products containing these medicinal ingredients 
would not require a prescription to be sold in Canada and that manufacturers could apply for G/TBT/N/CAN/293 
Page 2  
 
  market authorization for these me dicinal ingredients as natural health products pursuant to the 
Natural Health Product Regulations. 
Description of the medicinal ingredients: Apiol, oil of — Apiol oil is found in the essent ial oils of parsley seed, dill seed, and, to a 
lesser extent, in fennel seed, sassafras root bark  and other plant species. Apiol oil is currently 
regulated as a prescription dr ug although there are presently no known marketed prescription 
products that contain apiol oil. A review of the available scientif ic literature indicates that 
there is a wide margin of safety between the th erapeutic and toxic doses of apiol oil. It has 
toxic effects in humans exposed to doses of  approximately 1 g/day; however, the common 
presence of apiol oil in foods indicates a lack of toxicity at doses likely to be found in herbal 
medicines. No health hazards or side effe cts are known in conjunc tion with appropriate 
therapeutic dosages of parsley seed, whose medicinal properties are largely attributed to the apiol volatile oil content, and there are no reports of serious health risks associated with 
normal dietary ingestion or recommended medicinal use of parsley seed. 
Centella asiatica extract and active principles thereof — Centella asiatica extract is derived 
from a small plant commonly known as gotukola. Ce ntella asiatica extract is a concentrated 
preparation. An active principle is the part of the drug upon which the therapeutic action of 
the drug depends. Centella asia tica extract and active principles thereof have prescription 
status in Canada although ther e are presently no known marketed prescription products that 
contain Centella asiatica extract and active princi ples thereof. Centella asiatica crude herb 
does not have prescription status  and is regulated as a natura l health product. It is also 
available as a vegetable in South Asian markets. A review of the available scientific literature 
indicates that there is a wide margin of safe ty between the therapeu tic and toxic doses of 
Centella asiatica extract. Centella asiatica extract and active principles thereof pose a low risk of undesirable or severe side ef fects. There is a very low pe rcentage of adverse reactions 
compared to its length and frequency of use both in food and medicine. 
Deanol and its salts and derivatives — Deanol , also known as dimethylaminoethanol or 
DMAE, is a naturally sourced chemical found in salmon roe, shellfish a nd fish oils. Deanol 
and its salts and derivatives have  prescription status in Canada although there are presently no 
known marketed prescription products  containing deanol. Deanol is a precursor to choline, a 
chemical in the body used to make acetylcholin e, a chemical that is found in the brain and 
other areas of the body. A review of the available scientific lite rature indicate s that deanol 
does not have a narrow margin of safety between the therapeutic and toxic doses. 
Theobromine and its salts — Theobromine is a naturally occurring chemical substance that is 
found in cocoa and chocolate and is also pr epared synthetically for commercial purposes. 
Theobromine and its salts have prescription status in Canada although there are presently no 
known marketed prescription products that co ntain theobromine. Theobromine affects 
humans similarly to caffeine, but to a lesser degree. Toxicity from the use of theobromine is 
very rare and is only seen at very high doses in humans; therefore, it does not possess a high 
level of risk relative to expected benefits . As well, theobromine has no known severe side 
effects at normal therapeutic dosage levels. Due to theobromine’s low potency as a drug and the availability of more effective treatments , it is rarely used therapeutically anymore. 
Schedule F is a list of medicinal ingredients, th e sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulatio ns. Part I of Schedule F lists ingredients 
that require a prescription for human use and fo r veterinary use. Part II of Schedule F lists 
ingredients that require a prescription for hu man use, but do not require a prescription for 
veterinary use if so labelled or if  in a form unsuitable for human use. 
  G/TBT/N/CAN/293 
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  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Canada Gazette, Part I, 26 December 2009, Pages 3843-3847 
(available in English and French)   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 6 to 8 months of publication in 
the Canada Gazette, Part I. 
On the date the measure is adopted 
10. Final date for comments:  11 March 2010 
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/p1/2009/2009-12-26/pdf/g1-14352.pdf  (Canada Gazette) 
or  
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-26/html/notice-avis-eng.html#d113  
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-26/html/notice- avis-fra.html#d113  (French)