G/TBT/N/BRA/607  
 
24 September 2014  
(14-5362)  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 2563.2820 
Telefax: +(55) 21 2502.6542 Email: barreirastecnicas@inmetro.gov.br  
Web-site: 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=17388  
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): Labelling of medical 
devices containing natural rubber latex 
5. Title, number of pages and language(s) of the notified document: Draft Technical 
Resolution nº 70, 9 September 2014, Regarding the Standardization of Phrases Stating the Presence of Natural Rubber Latex on Medical Device Labels (3 pages, in Portuguese) 
6. Description of content: Draft Technical Resolution nº 70, 9 September 2014, regarding 
the standardization of phrases stating the pr esence of natural rubber latex on medical 
device labels.  
This draft Technical Resolution applies to the medical devices defined as medical products 
and in vitro  diagnostic products. 
According to this draft resolution, the labelling of medical devices which composition 
contains natural rubber latex must include the following featured warnings: "This product 
contains natural rubber latex. Its use may cause allergic reactions in people sensitive to latex". In case of small packaging, the warning can alternatively be: "Contains natural 
latex. It may cause allergy". 
The labelling of the products must be corrected  in 180 days from the date of publication of 
this resolution. The products which were manufactured before the entry into force of this regulation and during the adequacy period can be marketed until the expiration date. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health or safety G/TBT/N/BRA/607 
 
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  8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), 10 September 
2014; Section 1, p. 70, Draft Resolution (Consulta Pública) number 70, 9 September 2014, issued by Brazilian Health Surveillance Ag ency – 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: 17 November 2014 
11. Texts available from: Nati onal 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 Phone.: 55 61 3462-5402 
E-mail: rel@anvisa.gov.br  
Website: 
http://portal.anvisa.gov.br/ wps/wcm/connect/dec52380456c04aaa0efa40bb3a02a58/Consul
ta+P%C3%BAblica+n%C2%B0+70+GGTPS.pdf?MOD=AJPERES