. /.WORLD TRADE
ORGANIZATIONG/TBT/N/BRA/102
20 February 2003
(03-1079)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   BRAZIL
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   National Institute of Metrology, Standardization and Industrial
Quality-INMETRO
Telephone: +(55) 21 2563.2821
Telefax: +(55) 21 2502.6542Email: barreirastecnicas@inmetro.gov.br
Web-site: www.inmetro.gov.br/barreirastecnicas
Agency rsponsible:  Brazilian Sanitary Surveillance Agency – ANVISA
Telephone: +(55) 61 448.1078
Fax: +(55)61 448.1089
E-mail: rel@anvisa.gov.br
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Any product subject to
sanitary surveillance
5. Title, number of pages and language(s) of the notified document:   Resolution number 1,
January 6th 2003, (Resolução RDC no. 1 de 6 de janeiro de 2003) issued by the Brazilian
Sanitary Surveillance Agency, on the sanitary surveillance of imported products (149 pages,
in Portuguese).
6. Description of content:   This Resolution updates the legislation on sanitary surveillance of
imported products. It establishes labelling requirements for ready-to-use products as well as
external packaging requirements for bulk products.
It adds to the previous requirements on what c oncerns the obligation to identify in the external
package the lot’s number or code, the manufacturer name as well as specific aspects relative
to product storage, where applicable. The importers have 60 days to comply with these
specific requirements, after their entry into force.
This Resolution revokes the following documents:G/TBT/N/BRA/102
Page 2
• Ministerial Act number 772, October 2nd 1998 (Portaria SVS/MS no. 772 de 2 de outubro
de 1998)
• Resolution number 19, January 18th  2002 (Resolução RDC no. 19 de 18 de janeiro de
2002)
• Ministerial Act SVS, nº 1, 16 December 1996 (Instrução Normativa SVS no. 1 de 16 de
dezembro de 1996)
• Ministerial Act number 331, May 6th 1998 (Portaria MS/SVS no. 331 de 6 de maio de
1998)
• Ministerial Act number 996, December 10th 1998. (Portaria MS/SVS no. 996 de 10 de
dezembro de 1998)
Resolution number 20, January 30th 2003 (Resolução RDC no. 20 de 30 de janeiro de 2003)
postponed the entry into force of the present resolution to March 31st 2003.
Obs.:  Also notified under SPS Agreement
7. Objective and rationale, including the na ture of urgent problems where applicable:
Labelling and packaging requirements, consumer’s health and safety.
8. Relevant documents:   Law number 6,360, September 23rd 1976 (Lei no. 6.360 de 23 de
setembro de 1976); Decree number 986,  October 21st 1969 (Decreto no.986 de 21 de
outubro de 1969); Resolution number 20, January 30th 2003 (Resolução RDC no. 20 de 30 de
janeiro de 2003)
9. Proposed date of adoption:  10 January 2003
Proposed date of entry into force:  31 March 2003
10. Final date for comments:   20 March 2003
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
http://www.inmetro.gov.br/barreirastecnicas
http://www.anvisa.gov.br/legis/resol/2003/rdc/01_03rdc.pdf