G/SPS/N/BRA/1107  
 
8 March 2016  
(16-1348)  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 Regulatory 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 avocado (0.5mg/kg 
safety security period of 7 days), pineapple (0.5mg/kg safety security period of 7 days), 
pumpkin (0.1mg/kg safety security period of 7 days), zucchini (0.1mg/kg safety security 
period of 7 days), on cotton leaves (0.1mg/k g safety security period of 21 days), garlic 
(0.1mg/kg safety security period of 14 days ), annonnaceae (0.5mg/kg safety security 
period of 7 days), oat (0.3mg/kg safety secu rity period of 14 days), banana (0.1mg/kg 
safety security period of 3 days), potato (0.1mg/kg safety security period of 14 days), 
sweet potato (0.1mg/kg safety security pe riod of 14 days), yacon potato (0.1mg/kg 
safety security period of 14 days), beet (0.1mg/kg safety security period of 14 days), eggplant (0.1mg/kg safety secu rity period of 7 days), cocoa (0.5mg/kg safety security 
period of 7 days), coffee (0.05mg/kg safety security period of 30 days), sugarcane 
(0.3mg/kg safety security period of 30 days),  canola (0.1mg/kg safety security period of 
14 days), cará yam (0.1mg/kg safety securi ty period of 14 days), onion (0.1mg/kg 
safety security period of 14 days), shallot (0 .1mg/kg safety security period of 14 days), 
chayote (0.1mg/kg safety security period of 7 days), cupuacu (0.5mg/kg safety security period of 7 days), pea (0.1mg/kg safety security period of 14 days), eucalyptus (non-
food use), bean (0.1mg/kg safety security period of 14 days), caupi bean (0.1mg/kg 
safety security period of 14 days), ginger (0 .1mg/kg safety security period of 14 days), 
sesame (0.1mg/kg safety security period of 14 days), sunflower (0.1mg/kg safety 
security period of 14 days), chickpea (0.1 mg/kg safety security period of 14 days), 
guarana (0.5mg/kg safety security period of  7 days), yam (0.1mg/kg safety security 
period of 14 days), scarlet eggplant (0.1mg/kg safety security period of 7 days), kiwi fruit (0.5mg/kg safety security period of 7 da ys), lentil (0.1mg/kg safety security period 
of 14 days), linseed (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), 
cassava (0.1mg/kg safety security period of 14 days), arracacia (0.1mg/kg safety 
security period of 14 days), mango (0.5mg/kg safety security period of 7 days), passion 
fruit (0.5mg/kg safety security period of 7 days), Indian gherkin (0.1mg/kg safety security period of 7 days), watermelon (0.5 mg/kg safety security period of 10 days), 
melon (0.5mg/kg safety security period of 10 days), corn (0.05mg/kg safety security 
p e r i o d  o f  4 2  d a y s ) ,  t u r n i p  ( 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  1 4  d a y s ) ,  c u c u m b e r  
(0.1mg/kg safety security period of 7 days),  pepper (0.1mg/kg safety  security period of 
7 days), green pepper (0.1mg/kg safety security period of 7 days), okra (0.1mg/kg 
safety security period of 7 days), radish (0 .1mg/kg safety security period of 14 days), 
pomegranate (0.5mg/kg safety security period of 7 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 da ys). Seeds application on cotton seeds 
(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 G/SPS/N/BRA/1107 
 
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  (0.1mg/kg safety security period not dete rmined due to the mode of use), wheat 
(0.1mg/kg safety security period not dete rmined due to the mode of use). Located 
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 
F36 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  Language(s): Portuguese  Number of pages: 4 
http://portal.anvisa.gov.br/wps/wcm/connect/6c3426004be0209a9897b8f0de6cc761/CO
NSULTA+P%C3%9ABLICA+N+134+GGTOX+2016.pdf?MOD=AJPERES 
6. Description of content: Foliar application in cultures of avocado (0.5mg/kg safety 
security period of 7 days), pineapple (0.5 mg/kg safety security period of 7 days), 
pumpkin (0.1mg/kg safety security period of 7 days), zucchini (0.1mg/kg safety security 
period of 7 days), on cotton leaves (0.1mg/k g safety security period of 21 days), garlic 
(0.1mg/kg safety security period of 14 days ), annonnaceae (0.5mg/kg safety security 
period of 7 days), oat (0.3mg/kg safety secu rity period of 14 days), banana (0.1mg/kg 
safety security period of 3 days), potato (0.1mg/kg safety security period of 14 days), sweet potato (0.1mg/kg safety security pe riod of 14 days), yacon potato (0.1mg/kg 
safety security period of 14 days), beet (0.1mg/kg safety security period of 14 days), 
eggplant (0.1mg/kg safety secu rity period of 7 days), cocoa (0.5mg/kg safety security 
period of 7 days), coffee (0.05mg/kg safety security period of 30 days), sugarcane 
(0.3mg/kg safety security period of 30 days),  canola (0.1mg/kg safety security period of 
14 days), cará yam (0.1mg/kg safety securi ty period of 14 days), onion (0.1mg/kg 
safety security period of 14 days), shallot (0 .1mg/kg safety security period of 14 days), 
chayote (0.1mg/kg safety security period of 7 days), cupuacu (0.5mg/kg safety security 
period of 7 days), pea (0.1mg/kg safety security period of 14 days), eucalyptus (non-food use), bean (0.1mg/kg safety security period of 14 days), caupi bean (0.1mg/kg safety security period of 14 days), ginger (0 .1mg/kg safety security period of 14 days), 
sesame (0.1mg/kg safety security period of 14 days), sunflower (0.1mg/kg safety 
security period of 14 days), chickpea (0.1 mg/kg safety security period of 14 days), 
guarana (0.5mg/kg safety security period of  7 days), yam (0.1mg/kg safety security 
period of 14 days), scarlet eggplant (0.1mg/kg safety security period of 7 days), kiwi 
fruit (0.5mg/kg safety security period of 7 da ys), lentil (0.1mg/kg safety security period 
of 14 days), linseed (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), 
cassava (0.1mg/kg safety security period of 14 days), arracacia (0.1mg/kg safety security period of 14 days), mango (0.5mg/kg safety security period of 7 days), passion 
fruit (0.5mg/kg safety security period of 7 days), Indian gherkin (0.1mg/kg safety 
security period of 7 days), watermelon (0.5 mg/kg safety security period of 10 days), 
melon (0.5mg/kg safety security period of 10 days), corn (0.05mg/kg safety security 
p e r i o d  o f  4 2  d a y s ) ,  t u r n i p  ( 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  1 4  d a y s ) ,  c u c u m b e r  
(0.1mg/kg safety security period of 7 days),  pepper (0.1mg/kg safety  security period of 
7 days), green pepper (0.1mg/kg safety security period of 7 days), okra (0.1mg/kg safety security period of 7 days), radish (0 .1mg/kg safety security period of 14 days), 
pomegranate (0.5mg/kg safety security period of 7 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 da ys). Seeds application on cotton seeds 
(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 G/SPS/N/BRA/1107 
 
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  (0.1mg/kg safety security period not dete rmined due to the mode of use). Located 
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). 
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  n u m b e r  o f  C o d e x  
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), 1st March 2016, 40th edition, 
Section 1, p. 47. Draft Resolution (Consulta Pública) number 134, 29 February 2016, i s s u e d  b y  t h e  B r a z i l i a n  H e a l t h  R e g u l a t o r y  A g e n c y  ( A N V I S A ) .  W h e n  a d o p te 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) : 30 March 2016 
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 Tagliari 
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br 
13. Text(s) 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 Tagliari  
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br