G/SPS/N/BRA/1192  
 
18 October 2016  
(16-5646) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Origin al: English  
 
  NOTIFICATION  
1. Notifying Member: BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible: The Brazilian Health Regulatory Agency - ANVISA  
3. Products covered (provide tariff item number(s) as specifie d in national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable): Labels and leaflets of pesticides, wood preservers and 
others  
4. Regions or countries likely to be affected, to the extent relevant or practicab le: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Draft resolution regarding guidelines for toxicological 
information in labels and leaflets of pesticides and wood preservers . Language(s): 
Portuguese . Number of pages: 13 
http://portal.anvisa.gov.br/documents/10181/2858730/%281%29CONSULTA+P%C3%9
ABLICA+N+261+G GTOX.pdf/0cd3f01e -be40-43b1-83a5-3c0c692f46ec  
6. Description of content: Draft Technical Resolution no. 261, 10 October 2016, 
regarding guidelines for toxicological information in labels and leaflets of pesticides and 
wood preservers.  
This Draft Resolut ion approves the Technical Regulation which establishes the guidelines 
for toxicological information in labels and leaflets of pesticides, wood preservers and 
others.  
This Draft Resolution revokes the Guidelines and Exigencies of the Ministry of Health, 
regarding Register Authorization, Register Renovation and Extension of Pesticides Use 
(DIRETRIZES E EXIGÊNCIAS DO MINISTÉRIO DA SAÚDE, REFERENTES À AUTORIZAÇÃO 
DE REGISTRO, RENOVAÇÃO DE REGISTRO E EXTENSÃO DE USO DE AGROTÓXICOS E 
AFINS ) approved by the Divi sions of Products, Human Ecology and Environmental Health 
and Risk Assessment as Guidelines and Exigencies, regarding Register Authorization, 
Register Renovation and Extension of Pesticides Use (DIRETRIZES E EXIGÊNCIAS, 
REFERENTES À AUTORIZAÇÃO DE REGISTRO S, RENOVAÇÃO DE REGISTRO E EXTENSÃO 
DE USO DE PRODUTOS AGROTÓXICOS E AFINS ) – no. 01, 9  December  1991, published 
on Brazilian Official Journal, 13 December 1991 and Endorsed by the Ordinance no. 03, 
16 January 1992, from the Technical -Normative Department of the Sanitary Surveillance 
Secretariat of the Ministry of Health.  
7. Objective and rationale: [X]  food safety, [ ]  animal health, [ ]  plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ]  protect territory from 
other damage from p ests.   G/SPS/N/BRA/1192  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :   
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or A quatic 
Animal Health Code, chapter number) :   
[ ] International Plant Protection Convention (e.g.  ISPM number) :   
[X] None  
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available: The 
Brazilian Official Journal (Diário Oficial da União), 11 October 2016, 196th edition, 
Section 1, p. 44. Draft Resoluti on (Consulta Pública) number 261, 10 October2016, 
issued by the Brazilian Health Regulatory Agency (ANVISA). When adopted, it will be 
published at the Brazilian Official Journal  (available in Portuguese) . 
10. Proposed date of adoption (dd/mm/yy) : To be de termined after the end of the 
consultation period.  
Proposed date of publication (dd/mm/yy) : To be determined after the end of the 
consultation period.  
11. Proposed date of entry into force: [ ]  Six months from date of publication , 
and/or  (dd/mm/yy) : 90 (n inety) days upon its publication.  
[ ] Trade facilitating measure   
12. Final date for comments: [ ]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 20 October 2016  
Agency or authority designated to handle comments: [ ]  Natio nal Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:  
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Text(s)  available from: [ ]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br