Brazilian Health Surveillance Agency (ANVISA)  
www.anvisa.gov.br  
Public Consultation No 42, of 18 August 2008.   
D.O.U of 19/08/08  
The Board of the National Health Surveillance Agency , in the exercise of the powers 
granted by Item IV of Article 11 and Articl e 35 of ANVISA’s Regulations, approved by Decree No. 
3029 of 16 April 1999, and having regard to the provisions of Item V and points 1 and 3 of Article 
54 of the Internal Regulations approved in accordance with Appendix I of ANVISA Administrative 
Ruling No . 354 of 11 August 2006, republished in the DOU of 21 August 2006, at a meeting held 
on 14 August 2008,  
hereby adopts the following Public Consultation, and I, the Director -President, order its 
publication:  
Art. 1 - A period of thirty days from the date of  publication of this Public Consultation is 
hereby declared open for the submission of criticisms and suggestions concerning the draft 
Resolution laying down general rules for personal hygiene products, cosmetics and perfumes that 
are manufactured in Brazi l and intended exclusively for export, annexed to this document.  
Art. 2 - The full text of the draft Resolution will be available throughout the entire 
consultation period on the following web -site: 
http://www.anvisa.gov.br/divulga/consulta/index.htm. Sugg estions should be submitted in writing 
to the following address:  Agência Nacional de Vigilância Sanitária/Gerência Geral de Cosméticos 
SIA, Trecho 5, Área Especial 57, Lote 200 - Brasília (DF) - CEP 71205 -050; or by fax to:  (61) 
3462 -5897;  or by email to:  ggcos@anvisa.gov.br . 
Article 3 - During and after the period referred to in Article 1, the National Health 
Surveillance Agency may contact the bodies and entities involved and others who have expressed 
interest so t hat they may designate representatives for discussions aimed at the consolidation of the 
final text.  
DIRCEU RAPOSO DE MELLO  
ANNEX  
RESOLUTION OF THE BOARD (RDC) No      ,  
Laying down general rules for personal hygiene products, 
cosmetics and perfumes that a re manufactured in Brazil and 
intended exclusively for export.  
The Board of the National Health Surveillance Agency, in the exercise of the powers granted 
by Item IV of Article 11 and Article 35 of the Regulation approved by Decree No. 3029 of 16 April 
1999, and having regard to the provisions of Item II and points 1 and 3 of Article 54 of the Internal Regulations approved in accordance with Appendix I of ANVISA Administrative Ruling No. 354 
of 11 August 2006, republished in the DOU of 21 August 2006, at a meeting held on 22 April 2008, 
and having regard to Article 41 of Law 9782/99, in combination with Provisional Measure No 
2.190 -34, which enables ANVISA to lay down specific regulations for the registration of products 
intended exclusively for external mar kets, hereby adopts the following Resolution of the Board and 
I, the Presiding Director, order its publication:  
Article 1. Personal hygiene products, cosmetics and perfumes manufactured in Brazil and 
intended exclusively for export do not need to be regist ered with ANVISA.  
(1) Personal hygiene products, cosmetics and perfumes are preparations made of natural or 
synthetic substances for external use on various parts of the human body: skin, hair, nails. lips, 
external genitals, teeth, the mucous membranes in  the mouth, with the sole and main aim of 
cleaning, perfuming, changing the appearance and/or combating body odour and/or protecting the 
said parts or keeping them in good condition, in accordance with RDC No 211 of 14 July 2005.  
(2) ANVISA will not issue certificates for products that are intended exclusively for export.  
Article 2. The companies covered by this Resolution are required to hold a Health Licence or 
Permit issued by the competent authority and an Operating Authorisation, issued by ANVISA,  for 
manufacturing and exporting activities . 
Article 3. Companies are required to keep in their records information relating to products 
intended exclusively for export, including their identification from the start of the manufacturing 
process, for any inspect ion of the manufacturing facility by the health authorities.  
(1) The nature of the information and the length of time for which it is to be kept are as 
applicable and provided for in the health legislation in force.  
(2) Companies are required to provide im mediately all information relating to health products 
intended exclusively for export when this is requested by the health authority.  
Article 4. The prohibitions and restrictions on the marketing of products and supplies laid 
down in the Federal Constituti on, in Ordinary Laws and in specific health legislation texts also apply 
to the manufacture of personal hygiene products, cosmetics and perfumes intended exclusively for 
export . 
Article 5. Failure to fulfil the terms of this Resolution constitutes a health  infraction subject to 
the penalties set out in Law No 6437 of 20 August 1977 and to any other applicable measures.  
Article 6. This Resolution shall enter into force on the date of its publication.  
DIRCEU RAPOSO DE MELLO