G/SPS/N/BRA/2074  
 
22 September 2022  
(22-7119) 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):  Food technology (ICS code(s): 67)  
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 1114, 6 September 2022 . 
Language(s):  Portuguese . Number of pages:  11 
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6485886/consulta_publica_1114_2022+GE
REG.pdf/a2f4a70c -5925-4245-9542-c467fea19008  
Comment form: https://pesquisa.anvisa.gov.br/index.php/926683?lang=pt -BR 
6. Description of content:  This draft resolution is regarded to a proposal for a Normative 
Instruction - In that "Establishes the form of regularization of the different categories of 
food and packaging, and the respective documentation that must be presented".  
In workshops held wit h health surveillance, the low effectiveness of current regulatory 
procedures for food regularization was identified, with the following consequences: lack of 
access to information about regularized products; lack of clarity of regulation; difficulties 
with food categorization; lack of definition of how this risk is understood; insufficient 
technical information resulting in inadequate controls, especially for higher risk products; 
insufficient operational capacity of analytical laboratories; forms of regul arization in 
insufficient quantity (market authorization or exemption from market authorization), 
considering the variability of existing foods and their different levels of risk; regulatory 
gaps, among others. Thus, given the whole scenario found in the a nalysis of the problem, 
among other measures, the need for regulatory changes to solve the main problem is 
pointed out.  
This regulation will be also notified to the TBT Committee.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant p rotection, 
[ ] 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) :  G/SPS/N/BRA/2074  
 
- 2 - 
 
  [ ] 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:   
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 peri od. 
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: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 13 December 2022  
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