G/TBT/N/CAN/539  
 
11 January 2018  
(18-0357) 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 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:   
Canada 's Notification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Telephone: (343) 203 -4273 
Fax: (613) 943 -0346 
E-mail: 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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Drugs and 
Medical Devices (ICS: 11.120; 11.040)  
5. Title, number of pages and language(s) of the notified document: Notice - 
Amendments to the Food and Drug Regulations for Mica (1 page(s), in English; 1 page(s), 
in French)   
6. Description of content: This Notice communicates Health Canada's intent to ame nd the 
Food and Drug Regulations  to permit the use of mica coated with titanium dioxide and/or 
iron oxide as colouring agents in drugs for both internal and external use. The regulatory 
proposal would also establish concentration limits for this inactive i ngredient when it is 
used in different dosage forms.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: This proposal responds to a request and supporting data provided by a 
manufacturer of mica coated with titanium diox ide and/or iron oxide.  
8. Relevant documents:  The Notice of Intent for this regulatory proposal is available from 
the following websites,  in English and French:  
http://www.canada.ca/en/health -canada/services/drugs -health -products/drug -
products/announcements /notice -amendment -food-drug-regulations -mica.html  
https://www.canada.ca/fr/sante -canada/se rvices/medicaments -produits -
sante/medicaments/annonces/avis -modifications -reglement -aliment -drogues -mica.html   G/TBT/N/CAN/539  
 
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  9. Proposed date of adoption:  Not stated  
Proposed date of entry into force:  The regulations will come into force on the day they 
are published i n Canada Gazette Part II.  
10. Final date for comments: 11 March 2018  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
The electronic version of this  notice is available from the following websites, in English and 
French:  
http://ww w.canada.ca/en/health -canada/services/drugs -health -products/drug -
products/announcements/notice -amendment -food-drug-regulations -mica.html  
https://www.canada.ca/fr/sante -canada/services/medicaments -produits -
sante/medicaments/annonces/avis -modifications -reglement -aliment -drogues -mica.html