G/SPS/N/BRA/1415  
 
29 June 2018  
(18-4117) 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): ICS Code(s): 13, 65  
4. Regions or countries likely to be affected, to the extent rele vant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft resolution (Consulta Publica) number 536, 
20 June 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 Resolution - RE n° 165 of 29 August 2003, on the Brazilian 
Official Gazette (DOU - Diário Oficial da União) of September 2nd 2003. Language(s ): 
Portuguese.  Number of pages: 3 
http://portal.anvisa.gov.br/documents/10181/4580043/CON SULTA+P%C3%9ABLICA+N%
C2%BA+536+COPSI+GGTOX.pdf/8d205497 -2397-4df1-8a0d-8afd41413a17  
6. Description of content: Inclusion of IBSBF Strain 323; text correction of the safety 
security period from "Not determined due to the nature of the product" to "Not determined 
due to no need to stipulate Maximum Residue Limit (MRL) for this active ingredient"; text 
correction from "4 hours or until drying of the syrup" to "Not determined due to  no need to 
set the Maximum Residue Limit (MRL) for this active ingredient" ; for the active 
ingredient  B49 - BACILLUS AMYLOLIQUEFACIENS from the Relation of Monographies of 
Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.  
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.  G/SPS/N/BRA/1415  
 
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  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, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed reg ulation 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) : 22 July 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:  
Coordinator of International Liaison and Regulatory Convergence  
International Affairs Office  
Brazilian Health Regulatory Agency - ANVISA  
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:   
Coordinator of International Liaison and Regulatory Convergence  
International Affairs Office  
Brazilian Health Regulatory Agency - ANVISA  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br