. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/BRA/790 
9 February 2012  
 (12-0779) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  BRAZIL 
If applicable, name of local government involved:    
2. Agency responsible:  ANVISA - Brazilian Health Surveillance Agency 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where applicable):  Enteral nutrition 
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 on Enteral Nutrition  Language(s):  
Portuguese  Number of pages:  6 
6. Description of content:  This draft technical resolution establishes nutrient compounds and 
substances for enteral nutrition. 
This draft resolution aims to establish nutrient  compounds and other substances that can be 
used in formulas for enteral nutrition. 
It is not included in this draft resolution the modified formulas for enteral nutrition for 
children under three-years old, which nutrien ts and other substances are specified in 
specific technical regulation. 
It will be granted a period of 18 (eighteen ) months, from the date of adoption of this 
Resolution, for the establishments to make  the necessary adjustments to attend this 
technical regulation. 
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 stan dard?  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/790 
Page 2  
 
  [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:  Brazilian 
Official Journal (Diário Oficial da União), 19 January 2012; Section 1, page 36.  Draft 
Resolution (Consulta Pública) number 1, 12 January 2012, issued by Brazilian Health 
Surveillance Agency - ANVISA; to be published at Brazilian Official Journal (available in 
Portuguese) 
10. Proposed date of adoption (dd/mm/yy) :  April 2012 
Proposed date of publication (dd/mm/yy) :  April 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  April 2012 
[X] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  19 March 2012 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
Brazilian Health Surveillance Agency - ANVISA 
SIA, Trecho 5, Área Especial 57 CEP: 71.205-050  Brasilia - DF/Brazil 
Tel:  +(55) 61 3462 5402 
Fax:  +(55) 61 3462 5414 E-mail:  rel@anvisa.gov.br 
13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
The full text can be directly accessed through the following link:  
"http://portal.anvisa.gov.br/wps/wcm/conn ect/1ed6408049d99a1dab6da f6dcbd9c63c/Consu
lta+P%C3%BAlblica+N%C2%B0+1+GPESP.pdf?MOD=AJPERES "