G/TBT/N/BRA/710  
 
18 April 2017  
(17-2099) 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=30775  
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):  Tobacco Products  
5. Title, number of pages  and language(s)  of the notified document:  Draft Technical 
Resolution n.  314, 17 March 2017 (18 pages, in Portuguese)  
6. Description of content:  This Draft Resolution provides the technical requirements and 
procedures to be observed in the market authorization of tobacco processed and in the 
procedures for smoking products de rived from tobacco.  
It applies to all tobacco processed in the country and to all smoking products derived from 
tobacco, processed, manufactured, stored in the national territory, imported, exported or 
marketed in the country.  
It is considered tobacco pr ocessed all types of tobacco that have passed through any 
process step at the national company intended for use as raw material for obtaining 
smoking products derived from tobacco. Smoking products shall mean any manufactured 
product containing tobacco in its composition.  
All tobacco smoke products must be registered in order to: manufacturing and marketing 
in the national territory; import and marketing in the national territory; and manufacture 
in the national territory exclusively for export. Different i mporting companies will be able 
to obtain from ANVISA the market authorization for the same smoking tobacco product 
manufactured outside the country. The importing company must request the authorization 
for the tobacco smoking product to be imported, even if the product has already been 
registered by another importing company.  
Every year, national manufacturing companies and companies importing smoking products 
derived from tobacco must electronically submit a secondary application for Renewal of G/TBT/N/BRA/710  
 
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  Smoking P roduct Authorization, through the online procedure, available in the ANVISA's 
Electronic Petition System.  
Tobacco companies must petition annually to register all the tobacco they have processed 
in the previous year through the Electronic Petitioning Syste m of ANVISA. Disclosure and 
commercialization of the requested authorization for smoking product may only be initiated 
after the corresponding petition has been granted and published in the Official Gazette.  
The registration of smoking product has validit y of 1 (one) year, counted from the date of 
publication in the Official Gazette, and must have its validity annually renewed.  
The import, export and marketing in the national territory of any smoking product that is 
not properly authorized under the terms  of this Resolution shall be prohibited. The 
commercialization, in the Brazilian market, of smoke products authorized exclusively for 
export is not allowed.  
This Resolution revokes Resolution nº 90 of 27 December 2007, Resolution nº 32 of 29 
May 2008 and R esolution nº 44 of 18 June 2008.  
This resolution comes into force on the date of its publication.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of Human Health  
8. Relevant documents:  (1) Brazilian Offici al Journal (Diário Oficial da União), 20 March 
2017; Section 1 page 63; (2) Technical Resolution RDC n° 90, de 27 December 2007; 
(3) Brazilian Official Journal; (4) Not stated.  
9. Proposed date of adoption: To be determined after the end of the consultati on period.  
Proposed date of entry into force: To be determined after the end of the consultation 
period.  
10. Final date for comments:  27 April 2017  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and w ebsite address es, if available , of 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 
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/2821970/CONSULTA+PUBLICA+N+314+GG
TAB.pdf/d833eaa9 -f36f-42be-af9b-872007959c9a