. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/291 
12 January 2010  
 (10-0088) 
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 Intent — Project  No. 1652 — Schedule F)  
(3 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 listing for l-asparaginase (also 
known as asparaginase) in Part I of Schedule F to the Food and Drug Regulations to maintain 
prescription status for injectable dosage forms while providing an exemption from 
prescription status for other dosage forms.  
L-asparaginase is an enzyme that breaks down the amino acid asparagine in the body and is 
used as an injectable drug to treat some forms of  cancer. L-asparaginase is not given orally to 
treat cancer because it is broken down in the st omach and therefore not absorbed by the body. 
Available information indicates th at l-asparaginase is used therapeutically as an injectable 
drug but not in any other dosage forms. Theref ore prescription status is required only for the 
injectable dosage form. 
The enzyme, asparaginase, can also act on f ood to reduce the amount of the amino acid, 
asparagine. Adding asparaginase to food to reduce the amount of  asparagine can reduce the 
risk of formation of the chemical acrylamide  which occurs during processing. Any residual 
asparaginase in the food would be broken dow n in the stomach and consequently would not 
be absorbed by the body. G/TBT/N/CAN/291 
Page 2  
 
  This proposed amendment to the listing of l-asparaginase in Schedule F would remove 
prescription restrictions from  asparaginase when used or ally. This would then allow 
asparaginase to be proposed for use as a f ood additive under the Food and Drug Regulations 
for the reduction of acrylamide in prepared and packaged foods. 
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. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Canada Gazette, Part I, 19 December 2009, Pages 3717-3719 
(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:  4 March 2010 
11. Text available from: National enquiry point [  ], or addre ss, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:   The electronic version of the 
regulatory text can be downloaded at:  
http://www.gazette.gc.ca/rp-p r/p1/2009/2009-12-19/pdf/g1-14351.pdf  (Canada Gazette) 
or  http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-19/html/notice-avis-eng.html#d103
 
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-19/html/notice- avis-fra.html#d103  (French)