G/TBT/N/BRA/712  
 
18 April 2017  
(17-2103) 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:  Brazilian Health Regulatory Agency (A nvisa)  
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 :  
National Institute of Metr ology, Quality and Technology (INMETRO)  
Telephone:+(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: 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=30795  
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 products  
5. Title, number of pages  and language(s)  of the notified document:  Draft Technical 
Resolution n. 324, 21 March 2017 (2 pages, in Portuguese)  
6. Description of content:  This Draft Resolution establishes the prohibition of the mercury 
and amalgam non -encapsulated indicated for use in dentistry (odontology).  
The manufacture, importation and marketing, a s well as the use in health services, of 
mercury and amalgam in its non -encapsulated form indicated for use in odontology are 
prohibited throughout the national territory.  
Failure to comply with the provisions contained in this Resolution constitutes a he alth 
infraction, pursuant to Law No. 6.437, of 20 August 1977, without prejudice to the 
applicable civil, administrative and criminal responsibilities.  
This Resolution shall enter into force on 1 January 2019.  
7. Objective and rationale , including the nat ure of urgent problems where applicable: 
Protection of Human Health  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 22 March 2017; 
Section 1 page 72. Draft Resolution (Consulta Pública) number 324, 21 March 2017, issued 
by the  Brazilian Health Regulatory Agency – Anvisa; When adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese  G/TBT/N/BRA/712  
 
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  9. Proposed date of adoption: To be determined after the end of the consultation period.  
Proposed date of entry into fo rce: 1 January 2019  
10. Final date for comments:  29 May 2017  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
Agency Responsible  
Brazilian Health Reg ulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF/Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br   
http://portal.anvisa.gov.br/documents/10181/3113092/CONSULTA+P%C3%9ABLICA+N+
324+GGTPS.pdf/b720b65c -cda5-4a36-8e2c-5aacd43c8b7b