G/SPS/N/BRA/891  
 
11 September 2013  
(13-4779)  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: ANVISA - The Brazilian Health Surveillance Agency 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Pesticides in general 
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: Procedure for the notification to ANVISA of technical 
alterations in the registration of pesticides, their components and the related, among other provisions  Language(s): Portuguese  Number of pages: 3 
"http://portal.anvisa.gov.br/wps/wcm/conne ct/f65bca8040f2de17b6e3b79cca79f4cf/Con
sulta+P%C3%BAblica+n%C2%B0+38+GGTOX.pdf?MOD=AJPERES " 
6. Description of content: This draft resolution approves the technical regulation, which 
establishes that technical alterations in the registration of pesticides, their components 
and the related are subject to notification to ANVISA, according to article 4 of this resolution proposal. It applies to toxicological evaluation processes for the purpose of 
changing the packaging, and including or excluding formula/manipulation. It also 
establishes the procedures for the notification of technical alterations in the registration of pesticides, their components and the related, according to paragraph 2 of Article 22 of 
Decree No. 4,074, from 4 January 2002. 
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.   
8. Is there a relevant international st andard? 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 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:   G/SPS/N/BRA/891 
 
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  9. Other relevant documents and language (s) in which these are available: 
The Brazilian Official Journal (Diário Oficial da União), 2 September 2013, 95th edition, 
Section 1, p. 58. Draft Resolution (Consult a Pública) number 38, 30 August 2013, issued 
by the Brazilian Health Surveillance Agen c y  ( A N V I S A ) .  W h e n  a d o p t e d ,  i t  w i l l  b e  
published at the Brazilian Official Journal (available in Portuguese). 
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) : To be determined after the end of the consultation period. 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 8 October 2013 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
Patrícia Oliveira Pereira 
E-mail: gresi@anvisa.gov.br  
Tel: +(55 61) 3462 5402/5404/5406 
13. Texts available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Patrícia Oliveira Pereira  
E-mail: gresi@anvisa.gov.br  
Tel: +(55 61) 3462 5402/5404/5406