G/TBT/N/BRA/1446  
14 September 2022  
(22-6804) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Brazilian Health Regulatory Agency (ANVISA)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br  
Web-site: www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  FOOD 
TECHNOLOGY (ICS code(s): 67)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
number 1114, 06 September 2022;; (11 page(s), in Portuguese)  
6. Description of content:  This Draft Resolut ion contains provisions on a proposed 
Normative Instruction that "Establishes the form of regularization of the different 
categories of food and packaging, and the respective documentation that must be 
presented"  
This regulation will be also notified to the SPS Committee.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In workshops held with 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 resultin g in inadequate controls, especially 
for higher risk products; insufficient operational capacity of analytical laboratories; forms 
of regularization in insufficient quantity (market authorization or exemption from market 
authorization), considering the var iability of existing foods and their different levels of 
risk; regulatory gaps, among others. Thus, given the whole scenario found in the analysis 
of the problem, among other measures, the need for regulatory changes to solve the 
main problem is pointed ou t.; Protection of human health or safety  G/TBT/N/BRA/1446  
 
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  8. Relevant documents:   
- 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  13 December 2022  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
The final text is available only in Portuguese and can be downloaded at:  
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6485886/consulta_publica_1114_2022+
GEREG.pdf/a2f4a70c -5925-4245-9542-c467fea19008  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/926683?lang=pt -BR