G/TBT/N/BRA/802  
 
3 April 2018  
(18-1982) 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 (Anvisa)  
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 Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2840  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.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=33294  
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): Pesticides, 
related products and wooden preservatives  
5. Title, number of pages and language(s) of the notified document: Draft Resolution 
N° 483, 16 Marc h 2018. - toxicological information for labels and leaflets of pesticides, 
related products and wooden preservatives. (17 page(s), in Portuguese)   
6. Description of content: This Draft Resolution provides for toxicological information for 
labels and leafle ts of pesticides, related products and wooden preservatives, within Anvisa.  
The guidelines for the preparation of toxicological information for labels and leaflets of 
pesticides, related products and wooden preservatives are approved within Anvisa.  
The pur pose of this Resolution is to establish:  
I - the obligatory information related to the protection of human health that must be 
included in pesticide labels and leaflets, similar products and wooden preservatives; and  
II - the adoption of the labeling guide lines of the Globally Harmonized System of 
Classification and Labeling of Chemicals (GHS).  
The company is responsible for all labeling and package leaflet information, and must 
present it clearly and ensure that it is adequate and sufficient for health pro tection 
purposes.  
ANVISA may, at its discretion and with a reasoned technical justification, require the 
company that holds the record to change the texts of labels and package leaflets.  
The labels and package inserts of biological products and wooden pres ervatives must 
follow the provisions of this Resolution and the determinations provided in other specific G/TBT/N/BRA/802  
 
- 2 - 
 
  devices and norms, and the necessary adaptations must be made to the peculiarities of the 
product.  
For information on appropriate poisoning prevention  or risk minimization measures, the 
pictograms recommended by the Food and Agriculture Organization of the United Nations 
(FAO) should be used on pesticide labels and leaflets, as well as on wood preservatives.  
ANVISA may make available on the ANVISA websi te the latest version of the package 
leaflets and approved labels in relation to health information.  
Companies with already registered models of labels and pesticides, wood preservatives and 
preservatives must comply with this Resolution by means of a noti fication, with protocol 
under a specific subject code, and submit electronically to ANVISA all relevant 
documentation, up to 360 (three hundred and sixty) days after the validity of this 
Resolution, and may implement the labels and package inserts, without  prior authorization 
from ANVISA.  
It revokes item 2 of the " Guidelines and Requirements of the Ministry of Health, 
Registration Authorization, Renewal of Registration and Extension of Use of Agrochemicals 
and Related ", approved by the Product Divisions, Hu man Ecology and Environmental 
Health and Risk Assessment as " Guidelines and Requirements Regarding the  
Authorization of Records, Renewal of Registration and Extension of Use of Agrotóxicos and 
Afins Products – n° 01, 09 December 1991", published in the Fe deral Official Gazette on 
13 December  1991 and Ratified by Administrative Rule 03, 16 January 1992, of the 
Technical Department of Normative of the Health Surveillance Secretariat of the Ministry of 
Health.  
7. Objective and rationale, including the nature  of urgent problems where 
applicable: Protection of human health or safety  
8. Relevant documents:  (1) Brazilian Official Journal, 19 March 2018 (Diário Oficial da 
União de 19 de Março de 2018); (2)  Guidelines and requirements of the ministry of health, 
registration authorization, renewal of registration and extension of use of agrochemicals 
and related published in the Federal Official Gazette on 13 December 1991 and Ratified by 
Administrative Rule 03, 16 January 1992, of the Technical Department of Norm ative of the 
Health Surveillance Secretariat of the Ministry of Health.; (3) Brazilian Official Journal 
(Diário Oficial da União); (4) Not stated.   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry into force: 90 days aft er its publication.  
10. Final date for comments: 24 April 2018  
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 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.anvisa.gov.br/documents/10181/2858730/CONSULTA+P%C3%9ABLICA+N%
C2%BA+483+ -+GGTOX/57e9a676 -19ce-41ea-8c9c-556003533375