G/SPS/N/BRA/1568  
 
25 September 2019  
(19-6154) 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:  Brazilian Health Regulatory Agency (ANVISA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  HS Code(s): 070320, 071220, 0706, 08071, 2401, 0714900011, 
duboisia; ICS Code(s): 13, 65  
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 number 712, 16 September 2019, 
regarding the active ingredient F70 - FLUENSULFONA (fluensulfone) 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, on the Brazilian Official Gazette 
(DOU - Diário Oficial da União) of 2 September  2003. Language(s):  Portuguese . Number 
of pages:  3 
Draft:  
http://portal.anvisa.gov.br/documents/10181/5635688/CONSULTA+P%C3%9ABLICA+N+
712+GGTOX.pdf/0aaf44ab -cd6e-4e23-8e0d-29d5b1b7c84b  
Comment  form:  
http://portal.anvisa.gov.br/documents/33880/0/Formul%C3%A 1rio+Padr%C3%A3o+Cons
ulta+P%C3%BAblica/34eba1a0 -0f05-46f4-b127-1e7819752234  
6. Description of content:  This Draft resolution incorporates the following changes for the 
active ingredient F70 - FLUENSULFONA  (fluensulfone) from the Relation of Monographies 
of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:  
− includes the garlic and onion cultures with MRL of 0.05 mg/kg and safety security 
period "not determined" in the modality of pre -planting use (application);  
− includes the beetroot, arracacha, melon and watermelon cultures with MRL of 
0.2 mg/kg and safety security period "not determined" in the modality of pre -planting 
use (application);  
− includes the tobacco and duboisia cultures with MRL and safety security per iod of 
"Non-food use" in the modality of soil use (application);  
− - changes the phrase at item "j": "for the purpose of residue definition for conformity 
with MRL, it will be considered the sum of the ingredient Fluensulfona (fluensulfone) 
and its acid meta bolit 3,4,4 - trifluorobut -3-eno-1-sulfônico (synonyms: butene -sulfonic 
acid (BSA) and M -3637), expressed as equivalent of fluensulfone, and for the dietary 
risk assessment it will be considered the ingredient of fluensulfone".  G/SPS/N/BRA/1568  
 
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  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 standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : CAC/MRL 1 Maximum Residue Limits (MRLs) for 
Pesticides  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter nu mber) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The scientific methodology used by Brazil to establish MRLs is 
consistent with international best practice. Countries set MRLs according to the good 
agricultural practice (GAP) applicable to their region. Agricultural chemical use p atterns 
differ between different production regions and countries as pests, diseases and 
environmental factors vary. This means that Brazilian MRLs for agricultural chemicals in 
food may differ from Codex standards.  
9. Other relevant documents and languag e(s) in which these are available:    
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) : 18 November 2019  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax nu mber and e -mail address (if 
available) of other body:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
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:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br