G/TBT/N/BRA/781  
 
11 January 2018  
(18-0279) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas   
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=32938  
3. Notified  under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Food 
supplements and labelling.  
5. Title, number of pages and language(s) of the notified document: Draft resolution 
(Consulta Publica) number 457, December 28th 2017 (41 page(s), in Portuguese)    
6. Description of content: This Normative Instruction establishes the lists of nutrients, 
bioactive substances, enzymes and probiotics, limits of use, claims and supplementary 
labelling of food supplements.  
Annex I defines the list of probiotics and source ingredients of nutrients, bioactive 
substances and enzymes authorized for use in food sup plements.  
Annex II sets out the list of minimum levels of nutrients, bioactive substances, enzymes 
and probiotics to be provided by dietary supplements in the daily recommendation for 
consumption and by the population group indicated by the manufacturer.  
Annex III sets out the list of maximum levels of nutrients, bioactive substances, enzymes 
and probiotics which cannot be exceeded by food supplements in the daily 
recommendation for consumption and by the population group indicated by the 
manufacturer.  
Annex IV sets out the list of claims authorized for use on the labelling of food supplements 
and their composition and labelling requirements.  
Annex V sets out the list of supplementary labelling requirements for food supplements.  
Annex VI defines the list of essential amino acid quantities of the reference protein.  G/TBT/N/BRA/781  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº.  249, 
29 December 2017, section 1, page 119; (2) Law nº 9.782, 26 January 1999; (3) Brazilian 
Official Journal; (4) Not applicable   
9. Proposed date of adoption: On the date of its publication.  
Proposed date of entry into force: On the date of its public ation.  
10. Final date for comments: 9 April 2018  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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   
http://portal.anvisa.gov.br/documents/10181/3898888/CONSULTA+PUBLICA+N+457+GG
ALI.pdf/33b58cec -33cd-4295-867c-4ff44e01ca88