G/TBT/N/BRA/606  
 
16 September 2014  
(14-5165)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: BRAZIL  
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: ANVISA - Brazilian Health Surveillance Agency 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :  
National Institute of Metrology, Quality and Technology-INMETRO  
Telephone: +(55) 21 2563.2821 
Telefax: +(55) 21 2502.6542 Email: barreirastecnicas@inmetro.gov.br   
Website: http://www.inmetro.gov.br/barreirastecnicas  
 
The comments to this Draft Regulation shall be sent to  http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=17171  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Disposable personal 
hygiene products 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution nº 67, August 21th 2014, regarding technical requirements to the regularization 
of disposable personal hygiene products, such as toothbrushes, dental floss and dental 
tapes, sanitary pads and cotton swabs  (14 pages, in Portuguese).     
6. Description of content: Draft Technical Resolution nº 67, 21 August 2014, regarding 
technical requirements to the regularization of disposable personal hygiene products, such 
as toothbrushes, dental floss and dental tapes, sanitary pads and cotton swabs. 
This draft Resolution updates the procedures which are necessary to the regularization of 
disposable personal hygiene products in Anvisa, through the simplification of processes, in 
order to improve the quality of the information and the agility in health surveillance measures. 
Disposable products regularized according to Ordinance n. 1.480/1990, Ordinance n. 
97/1996, Resolution RDC n. 10/1999, Resolution RDC n. 211/2005 and Resolution RDC n. 343/2005, can be manufactured until 24 (twenty-four) months after the publication of this draft Resolution and marketed until the expiration date of the product. 
This draft Resolution revokes the following te chnical resolutions: Ordinance n. 1.480/1990, 
Ordinance n. 97/1996 and RDC n. 10/1999. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human health or Safety G/TBT/N/BRA/606 
 
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  8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 25 August 2014; 
Section 1, p. 67, Draft Resolution (Consulta Pública) number 67, 21 August 2014, issued by Brazilian Health Surveillance Agency – Anvisa . When adopted, it will be published at the 
Brazilian Official Journal. Available in Portuguese. 
9. Proposed date of adoption: To be determined after the end of the consultation period.  
Proposed date of entry into force: To be determined after the end of the consultation 
period.   
10. Final date for comments: 30 October 2014 
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency responsible 
Brazilian Health Surveillance Agency - ANVISA SIA, Trecho 5, Área Especial 57 
Brasília - DF / Brazil 
CEP: 71.205-050 Tel.: 55 61 3462-5402 
E-mail: rel@anvisa.gov.br   
 
Website: 
http://portal.anvisa.gov.br/wps/wcm/conne ct/7a62cd80453ec539bb24fba5af521445/Consult
a+P%C3%BAblica+n+67+GGCOS.pdf?MOD=AJPERES  http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagina=67&data=25/0
8/2014