G/SPS/N/BRA/2144  
21 March 2023  
(23-2019) 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):  Oil seeds and oleaginous fruits; Miscellaneous grains, seeds and fruit; 
Industrial or medicinal plants; Straw and fodder (HS code(s): 12); 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 number 1150, 10 March 2023 . 
Language(s):  Portuguese . Number of pages:  4 
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6565277/consulta_publica_1150_2023+GG
TOX.pdf/2a01010d -3f99-4503-9765-dbe781ec2033  
Comment  form:  https://www.gov.br/anvisa/pt -
br/centraisdeconteudo/publicacoes/agrotoxicos/publicacoes/formu lario-padrao -consulta -
publica -ggtox.docx/view  
6. Description of content:  This draft resolution regards the proposal for the inclusion of 
soybean with an MRL of 0.05 mg/kg and Safety security period of 58 days, in the mode of 
use (application) in the soil;  of the sentence "Definition of residue for compliance with the 
MRL and evaluation of the dietary risk: metaldehyde (Anvisa, 2023)", of the toxicological 
classification table and toxicological reference parameters, in the monograph of the active 
ingredient  M09 - METALDEHYDE, in the List of Monographs of Active Ingredients of 
Pesticides, Sanitizing Disinfectants and Wood Preservatives, published through 
Normative  Instruction - IN No. 103, of 19 October 2021.  
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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : CAC/MRL 1 Maximum Residue Limits (MRLs) for 
Pesticides  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  G/SPS/N/BRA/2144  
 
- 2 - 
 
  [ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international stand ard: Brazilian MRLs are established based on scientific methodology 
consistent with international best practices. Countries usually set MRLs according to the 
Good Agricultural Practice (GAP) applicable to their region. Agricultural chemical use 
patterns di ffer between different production regions and countries as pests, diseases and 
environmental factors vary. This means that Brazilian MRLs for agricultural chemicals in 
food may differ from Codex standards. However, when a product differs from Brazilian 
MRLs, but is in conformity to Codex standards, it may be imported, provided that the risk 
assessment does not indicate an unacceptable risk to Brazilian consumers.  
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: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 20 May 2023  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
availa ble) 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