G/SPS/N/BRA/937  
 
6 June 2014  
(14-3323)  Page: 1/3  
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): Foliar application in cultures of cotton (0.1mg/kg safety 
security period of 21 days), oat (0.3mg/kg sa fety security period of 14 days), potato 
(0.1mg/kg safety security period of 14 days),  banana (0.1mg/kg safety security period 
of 3 days), coffee (0.05mg/kg safety security  period of 30 days), bean (0.1mg/kg safety 
security period of 14 days), apple (0.06mg/kg safety security period of 14 days), papaya 
(0.5mg/kg safety security period of 7 days),  melon (0.5mg/kg safety  security period of 
10 days), corn (0.05mg/kg safety security period of 42 days), soy (0.1mg/kg safety 
security period of 28 days), tomato (0.1mg/kg safety security period of 7 days), wheat (0.1mg/kg safety security period of 20 days). Seeds application in cultures of cotton (0.1mg/kg safety security period not determined due to the mode of use), oat 
(0.3mg/kg safety security period not dete rmined due to the mode of use), barley 
(0.1mg/kg safety security period not dete rmined due to the mode of use), bean 
(0.1mg/kg safety security period not determined due to the mode of use), soy 
(0.1mg/kg safety security period not dete rmined due to the mode of use), wheat 
(0.1mg/kg safety security period not determ ined due to the mode of use). Localized 
application in cultures of banana (0.1mg/kg safety security period of 60 days). Soil 
application in cultures of coffee (0.05mg/kg safety security period of 120 days, apple 
(0.06mg/kg safety security period of 50 days). 
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 active ingredient 
FLUTRIAFOL of the monograph list of active ingredients for pesticides, household cleaning products and wood preservers, published by Resolution - RE n° 165 of 
29 August 2003, Brazilian Official Gazette (DOU Diário Oficial da União) of 2 September 
2003 
Inclusion of the culture of sugarcane (MRL 0.3mg/kg and safety security period of 
30 days), corn (MRL 0.05mg/kg and safety s e c u r i t y  p e r i o d  o f  4 2  d a y s ) ,  i n  f o l i a r  
application, apple (MRL 0.06mg/kg and safety security period of 14 days, foliar 
application), (MRL 0.06mg/kg and safety security period of 50 days, soil application). 
Language(s): Portuguese  Number of pages: 3 
http://portal.anvisa.gov.br/wps/wcm/connect/c3fb10004429d73eb88cbc7061a58ae2/Co
nsulta+P%C3%BAblica+n%C2%B0+25+GGTOX.pdf?MOD=AJPERES G/SPS/N/BRA/937 
 
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  6. Description of content: Draft resolution regarding the active ingredient FLUTRIAFOL of 
the monograph list of active ingredients for pesticides, household cleaning products and wood preservers (inclusion of the cultur e of sugarcane MRL 0.3mg/kg and safety 
security period of 30 days; corn MRL 0.05mg/ kg and safety security period of 42 days, 
in foliar application; apple MRL 0.06mg/kg an d safety security period of 14 days, foliar 
application, MRL 0.06mg/kg and safety security period of 50 days, soil application, to 
this active ingredient), including foliar application in cultures of cotton (0.1mg/kg safety 
security period of 21 days), oat (0.3mg/kg sa fety security period of 14 days), potato 
(0.1mg/kg safety security period of 14 days),  banana (0.1mg/kg safety security period 
of 3 days), coffee (0.05mg/kg safety security  period of 30 days), bean (0.1mg/kg safety 
security period of 14 days), apple (0.06mg/kg safety security period of 14 days), papaya 
(0.5mg/kg safety security period of 7 days),  melon (0.5mg/kg safety  security period of 
10 days), corn (0.05mg/kg safety security period of 42 days), soy (0.1mg/kg safety 
security period of 28 days), tomato (0.1mg/kg safety security period of 7 days), wheat 
(0.1mg/kg safety security period of 20 days). Seeds application in cultures of cotton (0.1mg/kg safety security period not determined due to the mode of use), oat 
(0.3mg/kg safety security period not dete rmined due to the mode of use), barley 
(0.1mg/kg safety security period not dete rmined due to the mode of use), bean 
(0.1mg/kg safety security period not determined due to the mode of use), soy 
(0.1mg/kg safety security period not dete rmined due to the mode of use), wheat 
(0.1mg/kg safety security period not determ ined due to the mode of use). Localized 
a p p l i c a t i o n  i n  c u l t u r e s  o f  b a n a n a  ( 0 . 1 m g / k g  s a f e t y  s e c u r i t y  p e r i o d  o f  6 0  d a y s ) .  S o i l  application in cultures of coffee (0.05mg/kg safety security period of 120 days, apple 
(0.06mg/kg safety security period of 50 days). 
This public consultation is exceptionally open for comments of the public for 5 (five) 
days, due to a judicial decision that establishes the deadline for ANVISAs final decision 
regarding this product. 
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:   
9. Other relevant documents and language (s) in which these are available: The 
Brazilian Official Journal (Diário Oficial da União), 28 May 2014, 100th edition, Section 1, 
p. 101. Draft Resolution (Consulta Públic a) number 25, 26 May 2014, issued by the 
Brazilian Health Surveillance 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 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. G/SPS/N/BRA/937 
 
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  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) : 2 June 2014 
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:  
Ana Paula S. J. da Silveira e Silva 
Tel: +(55 61) 3462 5402/5404/5406 E-mail: rel@anvisa.gov.br 
13. Texts available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Ana Paula S. J. da Silveira e Silva  
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br