G/SPS/N/BRA/1870  
 
14 January 2021  
(21-0463) 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): 07133; 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 981, 15 December 2020, 
regarding the active ingredient B54 - BIXAFEM (bixafen) of the Monograph List of Active 
Ingredients for Pesticides, Household C leaning 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://antigo.anvisa.gov.br/documents/10181/3540586/%283%29CONSULTA+P%C3%
9ABLICA+N+981+GGTOX.pdf /778c8b62 -6303-4311-9eb1-4397f1326280  
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 B54 – BIXAFEM  (bixafen) from the Relation of Monographies of Active 
Ingredients of Pesticid es, Household Cleaning Products and Wood Preservers, all in the 
modality of foliar use (application):  
− includes the bean culture with MRL of 0.07 mg/kg and safety security period of 
14 days;  
− includes the phrase: "Acute Reference Dose (ARfD): 0.025 mg/kg b.w . (source: 
JMPR*, 2013);  
− includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues".  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect terri tory 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  G/SPS/N/BRA/1870  
 
- 2 - 
 
  [ ] 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 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 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, but is in conformity to Codex standards, it may be imported.  
9. Other relevant documents and language(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 int o 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) : 20 February 2021  
Agency or 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