G/TBT/N/BRA/ 726 
 
25 July 2017  
(17-4082) 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:  Brazilian Health Regulatory Agency (A nvisa)  
Name and address (including telephone 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 Metr ology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: 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=32938  
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):  HS 33  
5. Title, number of pages  and language(s)  of the notified document:  Draft Resolution 
RDC n. 366, 13 July 201 7 (4 page(s), in Portuguese)    
6. Description of content:  This Draft Resolution provides for amendment and inclusion of 
labelling for personal hygiene products, cosmetics and perfumes, and establishes the rules 
for coexistence of more than one final art ( label) for the same product.  
The coexistence of more than one final approved labelling art is permitted in a single 
product registration or registration -free product notification, provided that the 
requirements of this Resolution are met. All final arts ( labels) that the company intends to 
market must be in the product registration petition or registration -free product notification.  
The labelling elements that may differ in more than one final art for the same product or 
which may be changed with immediate  implementation are:  
I - colours;  
II - figures and images that do not have technical purpose, suggestion of way of use or 
suggestion of properties of the product;  
III - references to commemorative dates;  
IV - other names that do not change the name of the  product;  
V - promotional statements;  
VI - manufacturer information and the technical responsible; and  G/TBT/N/BRA/726  
 
- 2 - 
 
  VII - final arts that specifically meet the programs of the Ministry of Health.  
This draft resolution also establishes other provisions about procedures regarding labelling 
changes for cosmetics, perfumes and personal hygiene products.  
This Resolution revokes the Resolution RDC nº 131, 5 December 2016.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of Huma n Health  
8. Relevant documents:  1) Brazilian Official Journal (Diário Oficial da União), 134, 
14 July 2017; Section 1, p. 48; 2) Resolution RDC 16, 1 April 2014 (Resolução RDC Nº 16, 
de 1 de Abril de 2014); Law 6437, 20  August 1977;  3) Brazilian Official Journal; 4) Not 
stated.   
9. Proposed date of adoption: To be determined after the end of the consultation period.  
Proposed date of entry into force: On the date of publication.  
10. Final date for comments:  19 August 2017  
11. Texts available from : Nation al enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília – DF/Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://portal.a nvisa.gov.br/documents/10181/3178095/Corpo+ -+CP+366+ -
+Atera%C3%A7%C3%A3o+de+rotulagem+de+cosm%C3%A9ticos.pdf/4f92a7d9 -8f07-
4bf2-bee9-259309ce2350