. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/423 
18 February 2011  
 (11-0839) 
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 governme nt involved (Article 3.2 and 7.2):    
2. Agency responsible:  Brazilian Health Surv eillance 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, Standard ization and Industrial Quality-INMETRO 
Tel.:  +(55) 21 2563.2821 Fax:  +(55) 21 2502.6542 Email:  mailto:barreirastecn icas@inmetro.gov.br
 
Web-site:  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 applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Pesticides.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution nº 2, 
25 January 2011 – Criteria and re quirements for toxico logical evaluation of pesticides and 
their components (26 pages, in Portuguese). 
6. Description of content:  This draft resolution establishes th e criteria and requirements for 
toxicological evaluation and cl assification of pesticides and their components, pesticide 
labeling and the procedure for po st registration alterations.  
It establishes:  
- Research and information to be presented in  the toxicological evaluation of pesticides 
and their active components. 
- Toxicological evaluation. 
- The criteria for toxicological classification.  
- Pesticide labeling and leaflets. 
- Post registrati on alterations. 
- Pesticide risk evaluation. 
This draft Technical Regulati on is based on the methodologies published by the Organization 
for Economic Cooperation a nd Development (OECD).  
This draft resolution revokes "Directives and requirements of the Health Ministry for 
registration authorization and extension of pe sticide use" approved by the Human Ecology G/TBT/N/BRA/423 
Page 2  
 
  Division and Environmental Health and Risk Ev aluation as "Directives and requirements of 
the Health Ministry for registration authoriza tion and extension of pesticide use nº.01, 9 
December 1991" published in the Brazilian Official Journal on 13 December 1991 and 
ratified by the Normative Act (Portaria)  nº.03, 16 January 1992, from the Technical 
Normative Department of the Health Surveillance Secretary of the Health Ministry.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health.  
8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da  União), 28 January 2011; 
Section 1 page 80. Draft Resolution (Consulta Pública) number 2, 25 January 2011, issued by 
Brazilian Sanitary Surv eillance Agency - Anvisa; When adopted, it will be published at 
Brazilian Offici al Journal. Available in Portuguese 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:  28 March 2011 
11. Text available from: National enquiry point [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 Health Regulatory Agency – ANVISA 
SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil CEP: 71.205-050 
Phone.:  55 61 3462-5402 
E-mail:  rel@anvisa.gov.br 
 
Website:  http://www.anvisa.gov.br  
"http://portal.anvisa.gov.br/wps/wc m/connect/dd060f804592dcb8bab0bb7a281c7538/CP+N
%C2%BA+2+GGTOX.pdf?MOD=AJPERES"