G/TBT/N/BRA/588  
 
16 April 2014  
(14-2395)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
 NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  ANVISA - Brazilian Health Surveillance Agency 
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 :   
National Institute of Metrology, Quality and Technology - INMETRO 
Telephone: +(55) 21 2563.2821 
Telefax:  +(55) 21 2502.6542 Email: barreirastecnicas@inmetro.gov.br  
Web-site:  http://www.inmetro.gov. br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=15139   
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):  Dental 
bleaching agents classified as medical devices. 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
No. 14, 11 April 2014, concerning dental bleaching agents control. (3 pages, in Portuguese).     
6. Description of content:  This draft Resolution establishes criteria for packing and 
labelling of dental bleaching agents which are classified as medical devices. 
According to this draft technical regulation, the distribution of medical devices used in 
dental bleaching, containing hydrogen peroxide or carbamide peroxide with 
concentrations of these substances higher th an 3%, alone or in combination, is subject 
to the dental prescription.  
Packaging and labelling of dental bleaching agents containing those substances shall 
include, in red stripe and emphasized, the phrase: "Sale under dental prescription". The leaflets shall include, emphasized and in a larger font, the phrase: "Sale under dental 
prescription".” 
Sale of the products directly to dental surgeons and legal persons that provide dental 
services is allowed. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human health or Safety. G/TBT/N/BRA/588 
 
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  8. Relevant documents:   (1) Brazilian Official Journal (Diário Oficial da União), 4 April 
2014, Section 1, Draft Resolution (Consulta Pública) number 14, 1 April 2014, issued by 
Brazilian Health Surveillance Agency - Anvisa; (2) Not Applicable; (3) Brazilian Official 
Journal; (4) Not Applicable.   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  
On the date of adoption. 
10. Final date for comments:  9 June 2014 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
Agency responsible 
Brazilian Health Regulatory Agency - ANVISA SIA, Trecho 5, Área Especial 57 
Brasília - DF / Brazil 
CEP: 71.205-050 Phone:  55 61 3462-5402 
E-mail:  rel@anvisa.gov.br   
Website: 
http://portal.anvisa.gov.b r/wps/wcm/connect/9277b8804 3841dc1ac70ac493cc3c60f/Cons
ulta+P%C3%BAblica+n%C2%B0+ 14+GGTPS.pdf?MOD=AJPERES