. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/BRA/762 
28 July 2011  
 (11-3881) 
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):  Enzymes and enzymatic preparation 
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 Enzymes and Enzymatic Preparation 
Language(s):  Portuguese  Number of pages:  9 
6. Description of content:  This draft technical resolution approves the technical regulation 
on enzymes and enzymatic preparation for food use. 
It applies to all enzymes and enzymatic prep aration used in food preparation for human 
consumption, but it does not applies to enzymes and enzymatic preparation for drug or 
therapeutic proposes. 
The enzymes must follow identity and purity requirements and also other requirements 
established, at least, in one of the following references: 
I - JECFA - Joint FAO/WHO Expert Committee on Food Additives  
II - FCC - Food Chemicals Codex  
III - FDA  - US Food and Drug Administration  
IV - IUB - International Union of Biochemistry  
When this resolution is adopted, it will be gr anted a period of 180 da ys for industries to 
promote the necessary adjustments to follo w the requirements of this resolution. 
Resolution RDC nº 205/2006 and resolu tion RDC nº26/2009 will be revoked. 
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)   G/SPS/N/BRA/762 
Page 2  
 
  [ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] 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) , 7 July 2011; Section 1, page 43.  Draft 
Resolution (Consulta Pública) number 36, 4 July 2011, 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) :  October 2011 
Proposed date of publication (dd/mm/yy) :  October 2011 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  180 days after being adopted. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  7 September 2011 
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, [ ] 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/co nnect/f12ce68047806ba08 24e825c9a854df2/CP_N
_36_GGALI.pdf?MOD=AJPERES "