G/SPS/N/BRA/1920  
 
26 March 2021  
(21-2530) 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): 52, weeds; 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 1022, 11 March 2021, 
regarding the active ingredient I18 - ISOXAFLUTOL (isoxaflutole) of the Monograph List 
of Active Ingredients for Pesticid es, 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:  4 
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6243462/%281%29CONSULTA+P%C3%
9ABLICA+N+1022+GGTOX.p df/3939c802 -ddeb-42e8-b7a0-0e31264936ba  
Comment  form: 
http://antigo.anvisa.gov.br/documents/111215/0/Formul%C3%A1rio+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 I18 – ISOXAFLUTOL  (isoxaflutole) from the Relation of Monographies of 
Active Ingredients of  Pesticides, Household Cleaning Products and Wood Preservers:  
− includes the cotton culture with safety security period "Not determined due to the 
modality of use (application)", in the modality of pre emergency use (application);  
− includes the weeds culture in the modality of pre emergency use (application);  
− includes the cotton culture tolerant to isoxaflutole in the modality of pre emergency 
use (application);  
− includes the cotton culture tolerant to isoxaflutole in the modality of early post 
emergency use (a pplication);  
− includes the phrase at item "l": Acute Reference Dose (ARfD): Not applicable (source: 
JMPR*, 2013);  
− includes the phrase: "*Joint FAO/WHO Meeting on Pesticide Residues";  
− - includes the phrase at item "m": "for the purpose of residue definition for conformity 
to MRL and dietary risk assessment, it will be considered the sum of the active 
ingredient isoxaflutole and its metabolit diquetonitrila (CAS n. 143701 -75-1), 
expressed as isoxaflutole".  G/SPS/N/BRA/1920  
 
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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 number) :  
[ ] International Plan t 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:  Brazilian MRLs are established based on scientific methodology 
consistent with international best practices. Countries usually 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 agricultural chemicals in 
food may differ from Codex standards. However, when a product differs from Brazilian 
MRLs, bu t is in conformity to Codex standards, it may be imported, provided that the risk 
assessment does not indicate an unacceptable risk to Brazilian consumers.  
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of a doption (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) : 15 May 2021  
Agency o r authority designated to handle comments: [  ] 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  
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