G/SPS/N/BRA/1010  
 
18 December 2014  
(14-7344)  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: ANVISA - The Brazilian Health Surveillance Agency 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Food additives to 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 Technical Resolution nº 108, 8 December 2014, 
regarding the authorized food additives to use in formulas to enteral nutrition.  
Language(s): Portuguese  Number of pages: 9 
http://portal.anvisa.gov.br/wps/wcm/connect/12bd6b004683e18a8cdc9c99223cd76e/Co
nsulta+publica+n%C2%B0+108+GPESP.pdf?MOD=AJPERES  
6. Description of content: Draft Technical Resolution nº 108, 8 December 2014, 
regarding the authorized food additives to use in formulas to enteral nutrition. 
This draft Technical Resolution establishes the approved lists of food additives with its 
respective functions, which are authorized to use in formulas to enteral nutrition. 
According to this draft technical resolution, the formulas to enteral nutrition are 
classified as: ready-to-feed formulas to enteral nutrition; and powder to preparation of formulas to enteral nutrition.  
The companies will have a period of 12 (twelve) months from the date of publication of 
this resolution to make the necessary adjustments to comply therewith. The products manufactured until this deadline can be marketed until its expiration date.  
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 st andard? 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)    
[X] None G/SPS/N/BRA/1010 
 
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  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), 10 December 2014; Section 1, p. 99, 
Draft Resolution (Consulta Pública) number 108, 8 December 2014, issued by Brazilian 
Health Surveillance Agency ANVISA. When adop ted, it will be published at the Brazilian 
Official Journal (available in Portuguese). 
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 period. 
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) : 16 February 2015 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
Patricia Oliveira Pereira 
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br 
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Patricia Oliveira Pereira  
Tel: +(55 61) 3462 5402/5404/5406 
E-mail: rel@anvisa.gov.br