. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/BRA/569 
18 August 2009  
 (09-3905) 
Committee on Sanitary a nd 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):  Food additives 
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 food additives to be used according 
to Good Manufacturing Practices  Language:  Portuguese  Number of pages:  16   
6. Description of content:  This draft technical regulation approves food additives to be used 
according to Good Manufacturing Practices (GMP).  The Annex is part of this Resolution.  
When adopted, the resolution will revoke: 
• Resolution nº 386,  5 August 1999;  
• Resolution RDC nº 234, 19 August 2002;  and  
• Resolution RDC 43, 1 May 2005.  
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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) This Draft Technical Resolution only considered the functions 
assessed by the Joint FAO/WHO Expert  Committee on Food Additives – JECFA, 
except for enzymes, ascorb ic acid (INS 300), calcium alginate (INS 404) and 
mono- and di-glycerides of fatty acids (INS 471). For enzymes, ascorbic acid (INS 300), calcium alginate (INS 404) and mono-  and di-glycerides of fatty acids (INS 
471) were considered the functions set by  the General Standard of Food Additives 
– GSFA / Codex Alimentarius. 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    G/SPS/N/BRA/569 
Page 2  
 
  [ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [X] 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), 16 July 2009; Section 1, page 47.  Draft 
Resolution (Consulta Pública) number 51, 15  July 2009, 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) :  February 2010 
Proposed date of publication (dd/mm/yy) :  February 2010 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  February 2010 
[X] Trade facilitating measure 
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  27 September 2009 
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:  naint@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://www4.anvisa.gov.br/base/visadoc/CP/CP[27128-1-0].PDF