   
  
G/SPS/N/BRA/1689  
 
16 July 2020  
(20-4858) 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:  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): 071010, 09, 1201; ICS Code(s): 13, 65  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All tradi ng partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft resolution number 853, 23 June 2020, regarding 
the active ingredient F69 - FLUPIRADIFURONE  (flupyradifurone) 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/10181/5932181/CONSULTA+P%C3%9ABLICA+
N+853+GGTOX.pdf/5597adb1 -caa2-4683-a7b9-fca538d1ff73  
Comment form:  
http://portal.anvisa.gov.br/documents/111215/0/Formul%C3%A1r io+Padr%C3%A3o+
Consulta+P%C3%BAblica+ -+GGTOX/5faccd95 -356b-4e0e-91d1-9f318e0aa370  
6. Description of content:  This Draft resolution incorporates the following changes for the 
active ingredient F69 – FLUPIRADIFURONE  (flupyradifurone) from the Relation of 
Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood 
Preservers, all in the modality of foliar use (application):  
− changes the safety security period of the potato culture from 7 to 3 days;  
− changes the MRL of the coffee cultu re from 0,5 to 1,5 mg/kg;  
− includes the soya culture with MRL of 0,4 mg/kg and safety security period 14 days;  
− changes the phrase at item "i" from "class III (medium toxic)" to "specific for each 
product, in compliance with article 38 of the Resolution - RDC number 294, 
29 July 2019";  
− changes the phrase at item "j": "for the purpose of residue definition for conformity 
to MRL  and for the dietary risk assessment it will be considered the ingredient 
flupyradifurone and its  metabolite acid difluo roacetic (DFA), expressed as 
flupyradifurone";  
− includes the phrase: "acute reference dose  (ARfD)=0,2  mg/kg p.c. (source: JMPR, 
2015)";  
− includes the phrase: "inclusion of the cultures requested by the Joint Normative 
Instruction number 01, 16 June 2014";  
− includes the phrase: "Joint FAO/WHO Meeting on Pesticide Residues".  G/SPS/N/BRA/1689  
 
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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 pest s.  
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 number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] 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 patterns 
differ between different production regions and countries as pests, diseases and 
environmental factors vary. This means that Brazilian MRLs for agricultu ral chemicals in 
food may differ from Codex standards.  
9. Other relevant documents and language(s) in which these are available:  
Resolution - RDC number 294, 29 July 2019:  
http://portal.anvisa.gov.br/documents/10181/2858730/RDC_294_2019_.pdf/c5e8ab56 -
c13d-4330-a7a4-153bed4c5cda  
Joint Normative Instruction number   01, 16 June 2014:  
https://www.aenda.org.br/wp -content/uploads/2018/02/mapa_inc -1_2014_registro -
por-csfi.pdf  (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) : 29 August 2020  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if ava ilable) of other body:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(5561) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br   G/SPS/N/BRA/1689  
 
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  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 Internacion ais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(5561) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br   
 