G/SPS/N/BRA/1007
3 December 2014 
(14-7032)  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): Revision of the toxicological class, with attribution of the 
toxicological classification IV; exclusion of th e indications of the culture, according to the 
Act n. 6/2014 of the Agricultural Defense Secretariat (SDA/MAPA); and exclusion of the 
minimum and maximum concentrations of conidia, and the percentage of active 
ingredient, for not presenting relation with toxicological studies. 
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 M39 
METARHIZIUM ANISOPLIAE of the monograph list of active ingredients for pesticides, household cleaning products and wood preser vers, published by Resolution - RE No. 165 
of 29 August 2003, Brazilian Official Gaze tte (DOU Diário Oficial da União) of 
2 September 2003.  Language(s): Portuguese  Number of pages: 2 
http://portal.anvisa.gov.br/wps/wcm/connect/3e78e500465c1e7dab0dbf99223cd76e/Co
nsulta+P%C3%BAblica+n%C2%B0+105+GGTOX+ATUAL.pdf?MOD=AJPERES  
6. Description of content: Revision of the toxicological class, with attribution of the 
toxicological classification IV; exclusion of th e indications of the culture, according to the 
Act n. 6/2014 of the Agricultural Defense Secretariat (SDA/MAPA); and exclusion of the minimum and maximum concentrations of conidia, and the percentage of active ingredient, for not presenting relation with toxicological studies. 
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 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 G/SPS/N/BRA/1007 
 
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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: The 
Brazilian Official Journal (Diário Oficial da União), 27 November 2014, 230th edition, 
Section 1, p. 48. Draft Resolution (Consulta Pública) number 105, 25 November 2014, issued by the Brazilian Health Surveillance Ag ency (ANVISA). When adopted, it will be 
published in the Brazilian Official Journal (available in Portuguese). 
10. Proposed date of adoption (dd/mm/yy) : To be determined after the end of the 
comment period. 
Proposed date of publication (dd/mm/yy) : To be determined after the end of the 
comment 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 comment period. 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 26 December 2014 
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:  
Ana Paula S. J. da Silveira e Silva 
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br 
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Ana Paula S. J. da Silveira e Silva  
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br