G/SPS/N/BRA/2205  
23 August 2023  
(23-5663) 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):  Pharmaceutical products (HS code(s): 30)  
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:  Normative Instruction 241, 3 August 2023 . 
Language(s):  Portuguese . Number of pages:  14 
http://antigo.anvisa.gov.br/documents/10181/6637201/IN_241_2023_.pdf/dd2c2335 -
48ad-4bfb-b807-cb69ea5b9e94  
https://members.wto.org/crnattachments/2023/SPS/BRA/23_11934_00_x.pdf  
6. Description of content:  This normative instruction establishes daily intakeacceptable 
(ADI), the acute reference dose (ADR) and the maximum residue limits (MRL) foractive 
pharmaceutical ingredients (API) of veterinar y drugs in food of animal origin.  
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 inte rnational standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : CXM 2 , Maximum Residue Limits (MRLs) and Risk 
Management Recommendations (RMRs)  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] 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:    G/SPS/N/BRA/2205  
 
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  10. Proposed date of adoption (dd/mm/yy) : 1 September 2023  
Proposed date of publication (dd/mm/yy) : 1 September 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 1 September 2023  
[ ] Trade facilitating mea sure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
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 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 ava ilable) 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