G/SPS/N/BRA/904  
 
29 October 2013  
(13-5959)  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: ANVISA - The Brazilian Health Surveillance Agency 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Foliar application in cultures of onion (MLR not 
determined; safety security period not dete rmined), carrot (MLR not determined; safety 
security period not determined), tobacco (M LR not determined; safety security period 
not determined), apple (MLR not determined; safety security period not determined), 
strawberry (MLR not determined; safety secu rity period not determined), soybean (MLR 
not determined; safety security period not determined) and grape (MLR not determined; 
safety security period not determined) 
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 regarding the active ingredient 
BACILLUS SUBTILIS  to be included in the monograph list of active ingredients for 
pesticides, household cleaning products and wood preservers, published by Resolution - RE n° 165 of 29 August 2003, Brazilian Official  Gazette (DOU-Diário Oficial da União) of 
2 September 2003  Language(s): Portuguese  Number of pages: 2 
http://portal.anvisa.gov.br/wps/wcm/connect/b8576000418f39a188129cde61db78cc/CP
+N%C2%B0+43+GGTOX.pdf?MOD=AJPERES  
6. Description of content: Draft Resolution regarding the active ingredient Bacillus 
subtilis to be included in the monograph list of active ingredients of pesticides, 
household cleaning products and wood preservers, including the use in foliar application 
in cultures of onion (MLR not determined; sa fety security period not determined), carrot 
(MLR not determined; safety security pe riod not determined), tobacco (MLR not 
determined; safety security period not dete rmined), apple (MLR not determined; safety 
security period not determined), strawberry (MLR not determined; safety security period 
not determined), soybean (MLR not determined ; safety security period not determined) 
and grape (MLR not determined; safety security period not determined). 
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/904 
 
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  8. Is there a relevant international st andard? 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 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: 
The Brazilian Official Journal (Diário Oficial da União), 23 October 2013, 95th edition, 
Section 1, p. 58. Draft Resolution (Consulta Pública) number 43, 22 October 2013, issued by the Brazilian Health Surveillance Ag ency (ANVISA). When adopted, it will be 
published at the Brazilian Official Journal (available in Portuguese). 
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) : 21 November 2013 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
Patrícia Oliveira Pereira 
E-mail: gresi@anvisa.gov.br Tel: +(55 61) 3462 5402/5404/5406 
13. Texts available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Patrícia Oliveira Pereira  
E-mail: gresi@anvisa.gov.br 
Tel: +(55 61) 3462 5402/5404/5406