G/TBT/N/BRA/769  
 
5 January  2018 
(18-0072) 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 (Anvisa)  
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 Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetr o.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=33294  
 
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): HS 24  
5. Title, number of pages and language(s) of the notified document: RDC Nº 195, 14 
December 2017. (16 pages, in Portuguese). Republished on 18 December, 2017, (DOU 
241, 142/146) and republished on 19 December 2017 (DOU 242, 154/156).    
6. Description of cont ent: This Resolution provides for packaging requirements and health 
warnings for smoking tobacco products.  
This Resolution applies to all smoking products marketed domestically, domestically 
manufactured and imported. The primary and secondary packaging o f all smoking products 
derived from tobacco should contain health warnings about the harm arising from the use 
of these products and the message prohibiting the sale for children under the age of 
eighteen, as provided in this Resolution. All health warning s and the prohibition message 
for the sale for children younger than eighteen years old must be printed on the outside of 
the packaging in high resolution, legibly and ostensibly highlighted, according to the 
models in the Annexes of this Resolution, witho ut changing the proportionality between its 
elements, as well as its graphic parameters.  
The provisions of this Resolution comply with the WHO FCTC, adopted by the Member 
States of the World Health Organization on May 21, 2003 and signed by Brazil on June 16, 
2003, promulgated by Decree 5,658, of January 2, 2006, and follow the guidelines for its 
implementation, approved by the Conference of the Parties.  
This Resolution revokes the Resolutions RDC 335, of November 21, 2003; RDC 168 of July G/TBT/N/BRA/769  
 
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  07, 2004; RDC 10 of February 15, 2007; RDC 30, of May 23, 2013; RDC 43, of September 
3, 2013 and RDC 14, April 10, 2015.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety; Protection of Human Health  
8. Relevant documents:   
(1) Brazilian Official Journal (Diário Oficial da União) n° 240, 15 November 2017, section 1, 
pages 172/181; (2)Law nº 9.782, de 26 January 1999; Law nº 9.294/96; Decree nº 
2.018/96 (3) Brazilian Official Journal; (4) Not applicable   
9. Proposed date of adoption:  On the date of its publication.  
Proposed date of entry into force:  25 May, 2018  
10. Final date for comments: No final date for comments  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, 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  
Websit e: www.anvisa.gov.br   
 
http://portal.anvisa.gov.br/documents/10181/3119516/RDC_195_2017_.pdf/f165638d -
15e9-4b9d-99c6-f6ebe20063ad