G/SPS/N/BRA/1191  
 
18 October 2016  
(16-5640) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: 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): Pesticides, its components, related products and wood 
preservers. ICS Code(s): 13, 65, 79  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Draft resolution regarding the criteria and 
requirements for the toxicological evaluation of pesticides, its components (add itives and 
other ingredients), related products and wood preservers . Language(s): Portuguese . 
Number of pages: 27 
http://portal.anvisa.gov.br/documents/10181/2858730/CONSULTA+P%C3%9ABLICA+N
+260+GGTOX.pdf/662743b8 -045b-46b6-bd1c-5a098ac66f4c  
http://members.wto.org/crnattachments/2016/SP S/BRA/16_4366_00_x.pdf  
6. Description of content: Draft Technical Resolution n o. 260, 10 October 2016, to 
establish procedures for the toxicological evaluation (criteria and requirements) of 
pesticides, its components, related products and wood preserver s for authorization and 
post-authorization purposes.  
This Draft Resolution revokes the (DIRETRIZES E EXIGÊNCIAS DO MINISTÉRIO DA 
SAÚDE, REFERENTES À AUTORIZAÇÃO DE REGISTRO, RENOVAÇÃO DE REGISTRO E 
EXTENSÃO DE USO DE AGROTÓXICOS E AFINS ) Guidelines and Ex igencies of the 
Ministry of Health, regarding Register Authorization, Register Renovation and Extension 
of Pesticides Use approved by the Divisions of Products, Human Ecology and 
Environmental Health and Risk Assessment as (DIRETRIZES E EXIGÊNCIAS, 
REFEREN TES À AUTORIZAÇÃO DE REGISTROS, RENOVAÇÃO DE REGISTRO E EXTENSÃO 
DE USO DE PRODUTOS AGROTÓXICOS E AFINS ) Guidelines and Exigencies, regarding 
Register Authorization, Register Renovation and Extension of Pesticides Use – no. 01, 
9 December  1991, published o n Brazilian Official Journal, 13 December 1991 and 
Endorsed by the Ordinance no. 3, 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 pests.   G/SPS/N/BRA/1191  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commiss ion (e.g.  title or serial number of Codex 
standard or related text) :   
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
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 the se are available: 
Official  Journal No. 196, 11 October 1999, Section 1, pages 43 and 44.  
10. Proposed date of adoption (dd/mm/yy) : To be determined 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 (ninety) days after its publication.  
[ ] Trade facilitating measure   
12. Final date for comments: [ ]  Sixty days fr om the date of circulation of the 
notification and/or (dd/mm/yy) : 21 October 2016  
Agency or authority designated to handle comments: [ ]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of o ther 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) o f other body:   
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br