G/TBT/N/BRA/778  
 
11 January 2018  
(18-0276) 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@inmet ro.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): Goods and 
Products  
5. Title, number of pages and language(s) of the notified document: Draft Resolution 
Nº 455, December 28th, 2017. (4 page(s), in Portuguese)    
6. Description of content: This Draft Resolution establishes the sanitary risk management 
applied to control and inspection activities, the importation of goods and products under 
sanitary surveillance, and other measures.  
It establishes the application of sanitary risk management to control and inspection 
activities and incidents in the importation of goods and prod ucts under the responsibility of 
Anvisa.  
Specific programs and differentiated control and inspection regimes, established by Anvisa, 
will be taken into account in the application of the health risk management dealt with in 
this Resolution.  
This Resolution establishes the sanitary risk management criteria to be applied on the 
control and inspection activities, in the importation of goods and products under sanitary 
surveillance.  
Anvisa will submit procedures for the importation of goods or products under san itary 
surveillance into the risk analysis, in accordance with the criteria established in Article 2 of 
this Resolution, in order to select one of the following inspection channels:  
I. Green, simplified granting channel applicable to import processes of com panies and 
products regularized at Anvisa by exemption of documentary analysis and inspection of G/TBT/N/BRA/778  
 
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  cargo;  
II. Yellow, a surveillance channel that performs documentary analysis of the import 
process with the possibility of approval, by exemption of the inspec tion of the cargo, in the 
absence of documentary irregularity;  
III. Red, surveillance channel that performs documentary analysis, inspection of cargo and 
other applicable sanitary procedures established in specific norm; and  
IV. Gray, a surveillance channe l that performs special investigation procedure.  
Regardless of the surveillance channel selected, according to the list above, the 
identification of evidence of irregularity, by the sanitary authority, may lead to the 
establishment of a Special Investigati on Procedure.  
This Resolution revokes the Item 8 of Chapter III of the Resolution of the Board of 
Directors - RDC nº 81, dated 5 November 2008.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Resolution of the Board of Directors - RDC nº 81, dated 
5 November 2008.   
9. Proposed date of adoption: On the date of its publication.  
Proposed date of entry into force: On the date of its publication.  
10. Final date for comments: 30 days from notification  
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  
Website: www.anvisa.gov.br    
http://portal.anvisa.gov.br/documents/10181/2957335/CONSULTA+PUBLICA+N+455+GG
PAF.pdf/a7bbbe9d -3fd1-4c4b-b6d3-8b72f199c80f