. /.WORLD TRADE
ORGANIZATIONG/SPS/N/BRA/75
22 January 2003
(03-0362)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:   BRAZIL
If applicable, name of local government involved:
2. Agency responsible:  Brazilian Sanitary Surveillance Agency - ANVISA
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):
Tissues or fluids from animals (bovine, ovine, caprine and wild ruminants species) which
are raw materials for drugs, cosmetics and medical devices.
Food products containing in their composition ingredients from bovine, ovine, caprine and
wild ruminant.
Pulmonary surfactants, by-products of milk and live animal wool are hereby excluded from
the restrictions provisioned for in this Resolution.
4. Regions or countries likely to be affected, to the extent relevant or practicable:   All
countries
5. Title, language and number of pages of the notified document:  Resolution RDC Nº 306,
dated 14 November 2002 (5 pages), published in the Federal Official Journal (Diário
Oficial da União) on 18 November 2002.  Available in Portuguese.
6. Description of content:   This regulation (Resolution RDC Nº 306) establishes the
documents and information required to export products that may cause the human variant
of Bovine Spongiform Encephalopathy to Br azil, in conformity with Resolution RDC
Nº 305.  The requirements vary according to the exporter’s geographic risk and the
product's level of infectivity.
For certain categories of products, the Brazilian Sanitary Authority accepts both the
International Veterinary Certificate and the Conformity Certificate from European
Pharmacopoeia.  Furthermore, certain forms can be filled in Portuguese, English or
Spanish.
The Resolution RDC Nº 306 revokes the Resolution RDC Nº 214 previously notified as
G/SPS/N/BRA/71.
7. Objective and rationale:  [    ] food safety, [   ] animal health, [   ] plant protection,
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other
damage from pestsG/SPS/N/BRA/75
Page 2
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s ) in which these are available:   Resolution RDC
Nº 305, published in the Federal Official Journal (Diário Oficial da União) on
14 November  2002.  (Available in Portuguese, 8 pages)
10. Proposed date of adoption:   Not stated
11. Proposed date of entry into force:   18 March 2003
12. Final date for comments:   Not stated
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:
13. Texts available from:  [   ] 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) 21 2502 6542
E-mail:  rel@anvisa.gov.br
Or at the website: http://www.anvisa.gov.br/legis/resol/2002/306_02rdc.htm