G/SPS/N/BRA/1528  
 
3 July 2019  
(19-4431) 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):  HS Code(s): 30049085 (Veterinary  medicinal preparations, not for 
human use, not elsewhere specified or included); ICS Code(s): 13, 65  
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 (Consulta Publica) number 658, 
24 June 2019, regarding maximum residue limit (MRL) of veterinary drugs in food of 
animal orign. Published on D.O.U., 26 June 2019 . Language(s):  Portuguese . Number 
of pages:  9 
Draft:  
http://portal.anvisa.gov.br/documents/10181/5545276/CONSULTA+P%C3%9ABLICA+
N+658+GGALI.pdf/5078daaf -aa1d-4ad8-a732-7a5fdce6a2a3  
Comment form:  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=48153  
6. Description of content:  This draft resolution establishes t he procedure for risk 
assessment of veterinary drugs to human health and the methods for conformity 
assessment procedures.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or d isease, [  ] 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) : Maximum Residue Limits (MRLs) and Risk 
Management Recommendations (RMRs) for Residues of Veterinary Drugs in Foods  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Conventi on (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/BRA/1528  
 
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  [ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The scientific methodology used by  Brazil to establish MRLs is 
consistent with international best practice. Countries set MRLs according to the good 
agricultural practice (GAP) applicable to their region. Agricultural chemical use patterns 
differ between different production regions and co untries as pests, diseases and 
environmental factors vary. This means that Brazilian MRLs for agricultural chemicals in 
food may differ from Codex standards.  
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) : In the date of its publication.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 2 September 2019  
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:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Naciona l 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