. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/381 
3 August 2010  
 (10-4127) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance 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, Standa rdization and Industrial Quality-INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 E-mail:  barreirastecnicas@inmetro.gov.br Website:  http://www.inmetro.gov.br/barreirastecnicas
 
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 applicab le, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):  Sanitizing products.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
N° 45, 13 May 2010 – notification and regi stration procedures for sanitizing products 
(11 pages, in Portuguese).     
6. Description of content:  This technical regulation estab lishes procedures and requirements 
for notification and registration of sanitizi ng products.  This draft Resolution has the 
objective to update, streamline procedures and reduce bureaucracy, to establish definitions, 
general characteristics and technical requi rements for packaging and labelling, for 
notification and registration of products classi fied as sanitizing, with the purpose of better 
health risks management.  This draft Reso lution applies to all products defined as 
sanitizing.  The notification and registration procedures of sanitizing products were done 
taking into account risk assessment and risk management. The sanitizing products are 
classified according to their risk, objectives, sales and use.   
The sanitizing products classified as risk 1sha ll be notified, and must attend to the 
provisions of Resolution RDC 42, 13 August 2009,  in addition to the requirements of this 
Resolution.  The sanitizing products classified as  risk 2 shall be registered.  Anvisa will 
grant a period of 360 days for all products prev iously notified and registered to be adjusted 
to this Resolution, after its entry into for ce.  This resolution will revoke Resolution RDC 
184, 22 October 2001, Resolution RE 3168, 22 September 2006, and items 3.2 and 3.3 of 
the Annex of the Resolution RDC 38, 28 April 2000.  G/TBT/N/BRA/381 
Page 2  
 
  7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 14 May 2010; 
Section 1. Draft Resolution (Consulta Pública) number 45, 14 May 2010, issued by Brazilian Sanitary Surveillance Agency – Anvi sa; when adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese.   
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:  14 July 2010 
11. Text available from: National enquiry po int [ X ], or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:    
National enquiry point 
Agency responsible Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil 
CEP:  71.205-050 
Tel.:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br  Website:  http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br /wps/wcm/connect/241c4880428 400579d72fd01cce3dc94/CP+N
%C2%BA+45+GGSAN.pdf?MOD=AJPERES