G/SPS/N/BRA/2152  
3 May 2023  
(23-3097) 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):  Organic chemicals (HS code(s): 29); Environment. Health protection. 
Safety (ICS code(s): 13)  
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 1153, 6 April 2023 . Language(s):  
Portuguese . Number of pages:  3 
Draft:  http://antigo.anvisa.gov.br/documents/10181/6576374/CONSULTA+P%C3%9ABLIC
A+N+1153+GGTOX.pdf/1be172d1 -e02a-4220-9605-869e0be0309d  
Comment  form:  https://www.gov.br/anvisa/pt -
br/centraisdeconteudo/publicacoes/agrotoxicos/publicacoes/formulario -padrao -consulta -
publica -ggtox.docx/view  
6. Description of content:  This draft resolution regards the proposal to include item A58.2 - 
HYDROALCOHOLIC EXTRACT OF NEEM in the monograph of the active ingredient A58 – 
AZADIRACHTA INDICA on the Monograph List of Acti ve Ingredients for Pesticides, 
Sanitizing Disinfectants and Wood Preservers, published by Normative Instruction 103, 
19 October 2021, in the Brazilian Official Gazette (DOU - Diário Oficial da União).  
7. Objective and rationale: [X]  food safety, [  ] anima l 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, 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:   G/SPS/N/BRA/2152  
 
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  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: [X]  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) : 10 June 2023  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
avail able) 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