G/SPS/N/BRA/2090  
 
2 November 2022  
(22-8202) 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):  Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) 
consisting of two or more constituents which have been mixed together for therapeutic o r 
prophylactic uses, not put up in measured doses or in forms or packings for retail sale 
(HS code: 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) 
consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up i n 
measured doses (including those in the form of transdermal administration systems) or in 
forms or packings for retail sale (HS code: 3004)  
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:  Resolution - RDC number 730, 1 July 2022 . 
Language(s):  Portuguese . Number of pages:  10 
http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_730_2022_.pdf/0dfa65ac -
4176-414b-a130-564dac564e44  
6. Description of content:  This resolution contains provisions on the human health risk 
assessment of veterinary medicinal products, maximum residue limits (MRLs) of veterinary 
medicinal products in foods of animal origin and methods of analysis for conformit y 
assessment purposes.  
This resolution is the result of the consolidation of previous regulations, which the content 
has not been changed.  
This regulation will also be notified in the TBT Committee.  
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:  
[ ] 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) :  G/SPS/N/BRA/2090  
 
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  [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:   
9. Other relevant documents and language(s) in which these are av ailable:    
10. Proposed date of adoption (dd/mm/yy) : 1 September 2022  
Proposed date of publication (dd/mm/yy) : 1 September 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 1 September 2022  
[ ] Trade facilitating measure   
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 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