G/SPS/N/BRA/1968  
 
1 October 2021  
(21-7348) 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:  The 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):  Products for agricultural use  
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 1057, 16 September 2021, 
regarding the proposal for the inclusion of the active ingredient B56 - Bacillus velezensis 
the Monograph List of Active Ingredients for Pe sticides, 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:  5 
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6328585/CONSULTA+P%C3%9ABLICA+N+
1057+GGTOX.pdf/ea 71b465 -e577-4508-bb94-513d5c50d574  
Comment  form:  https://www.gov.br/anvisa/pt -
br/centraisdeconteudo/publicacoes/agrotoxicos/formulario -padrao -consulta -publica -
ggtox. docx/view  
6. Description of content:  This resolution is regarded the proposal for the inclusion of the 
active ingredient B56 - Bacillus velezensis the Monograph List of Active Ingredients for 
Pesticides, Household Cleaning Products and Wood Preservers, pu blished by Resolution - 
RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da 
União) of 2 September 2003.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from anima l/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 Plant Protection Convention (e.g.  ISPM number) :  G/SPS/N/BRA/1968  
 
- 2 - 
 
  [ ] 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 
consisten t 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 an d 
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, 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 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/y y): 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) : 5 November 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