G/SPS/N/BRA/1447  
 
12 October 2018  
(18-6333) 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): ICS Code(s): 01.040.65, 13  
4. Regions or countries likely to be affected, to the exte nt relevant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft Reso lution number 560, 26 September 2018, 
regarding the active ingredient B49 - BACILLUS AMYLOLIQUEFACIENS of the Monograph 
List of Active Ingredients for Pesticides, Household Cleaning Products and Wood 
Preservers, published by Re solution - RE n° 165, 29 August 2003, on the Brazilia n Official 
Gazette, 2 September 2003. Language(s): Portuguese.  Number of pages: 2 
http://portal.anvisa.gov.br/documents/10181/4580043/CONSULTA+P%C3%9ABLICA+
N%C2%BA+560+COPSI+GGTOX.pdf/31105aa3 -a134-4c75-9ce6-795edb0d902e  
6. Description of content: This Draft resolution incorporates the following ch anges for the 
active ingredient B49 - BACILLUS AMYLOLIQUEFACIENS from the Relation of 
Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood 
Preservers:  
 Inclusion of Strain IBSBF 323;  
 Correction of the text of the safety security period from "non determined d ue to the 
product nature", to " non determined in function of the no need to stipulate the MRL 
of this active ingredient";  
 Correction of the text of the safety security period from "4 hours or until the syrup 
drying" to "non determined in function of the no ne ed to stipulate the LMR".  
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:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapte r number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  G/SPS/N/BRA/1447  
 
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  Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
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/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 October 2018  
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:  
Coordination of International Liaison and Regulatory Convergence - CCREG   
Tel: +(55 61) 3462 5402  
 +(55 61) 3462 5404  
 +(55 61)  3462 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:   
Coordination of International Liaison and Regulatory Converge nce - CCREG   
Tel: +(55 61) 3462 5402  
 +(55 61)  3462 5404  
 +(55 61) 3462 5406  
E-mail: rel@anvisa.gov.br