. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/BRA/92 
8 April 2004 
 (04-1618) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   BRAZIL
 
If applicable, name of local government involved: 
2. Agency responsible:   ANVISA - Brazilian Sanitary 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):  Drugs, cosmetics, medical devices and food for human consumption 
containing tissues or fluids from bovine, ovine, caprine and wild ruminants species 
Pulmonary surfactants, by-products of milk and live animal wool are excluded from the 
restrictions provisioned for in the notified Resolution. 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any 
country that can be classified  as a region of risk, according to the notified Resolution. 
5. Title, language and number of pages of the notified document:   Draft Resolution Nº 10, 
published in the Federal Official Journal (D iário Oficial da União) on 2 March 2004.  
(available in Portuguese, 14 pages) 
6. Description of content:  This resolution defines the requi rements for countries exporting the 
above-mentioned products to Brazil, according to  their geographical risk  and to the tissue 
infectivity level of the exported product.  It al so bans the import of high risk products.  This 
Resolution does not apply for In Vitro Dia gnostic Products.  For these products, the 
Resolution RDC Nº 305 determines that they should advertise about the risks inherent to the products made of ruminant’s tissues/fluids. 
This measure also defines the importing procedur es of the products cont aining tissues derived 
from ruminants. 
This rule reinforces the prohibition, throughout the Brazilian territory, of the entrance, trade 
and display of the above-mentioned products th at come from countries of certain regions, 
according the classification specified  in the notified Resolution. 
When entering into force, this measure wi ll revoke Resolution RDC Nº 305 (notified as 
G/SPS/N/BRA/305) and Re solution RDC Nº 68. 
7. Objective and rationale:  [  X] food safety, [   ] animal health, [   ] plant protection, 
[ X ] protect humans from anima l/plant pest or disease,  [   ]  protect territory from 
other damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [ X ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   Terrestrial Animal Health Code 2.3.13.1 G/SPS/N/BRA/92 
Page 2  
 
 9. Relevant documents and language(s ) in which these are available:  None 
10. Proposed date of adoption:   Not stated 
11. Proposed date of entry into force:   Not stated 
12. Final date for comments:  1 June 2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
Brazilian Sanitary Surveillance Agency - ANVISA 
SEPN 515 - Bloco "B", Edificio Omega 
CEP 70770-502 
Brasilia – DF/Brasil Tel.:  (55) 61 448 1078 Fax:  (55) 61 448 1089 E-mail:  rel@anvisa.gov.br
 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
Brazilian Sanitary Surveillance Agency - ANVISA 
SEPN 515 - Bloco "B", Edificio Omega CEP 70770-502 Brasilia – DF/Brasil Tel.:  (55) 61 448 1078 
Fax:  (55) 61 448 1089 
E-mail:  rel@anvisa.gov.br
 
 
The full text can be directly accessed through the following link: 
 http://www4.anvisa.gov.br/base/visadoc/CP/CP[6606-2-0].PDF