G/TBT/N/BRA/803  
 
3 April 2018  
(18-1983) 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=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): Pesticides, 
components, related products  and wooden preservatives.  
5. Title, number of pages and language(s) of the notified document: Draft resolution 
number 484, 16 March 2018. - criteria for the evaluation and toxicological classification of 
pesticides, components, related products and wooden preservatives. (29 page(s), in 
Portuguese)   
6. Description of content: This Draft Resolution establishes the criteria for the evaluation 
and toxicological classification of pesticides, components, related products and wooden 
preservatives, within A NVISA.  
The process of toxicological evaluation of products must be instructed with all the 
documentation established in Decree No. 4,074, of January 4, 2002, its updates or other 
specific legislation.  
The documentation required for the toxicological evalua tion for product registration and 
post-registration shall be in accordance with specific legislation and standards.  
In order to instruct or justify the granting of registration to third parties, ANVISA may use 
data or information related to the results of studies submitted by another company.  
All toxicological studies submitted to comply with this Resolution shall be carried out in 
accordance with current protocols published by the Organization for Economic 
Co-operation and Development (OECD) or other autho rities having similarity of 
requirements and validation.  
Without prejudice to the provisions of Decree No. 4,074 of 4 January, 2002, for the studies 
of corrosion/skin irritation and ocular corrosion/irritation, the toxicological profile of a G/TBT/N/BRA/803  
 
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  technical prod uct is considered equivalent to the profile of the technical reference product, 
when does not fall into a category of greater danger, in accordance with specific legislation 
and in accordance with the equivalence criteria of the Food and Agriculture Organi zation of 
the United Nations (FAO).  
For purposes of toxicological classification, the criteria based on the Globally Harmonized 
System of Classification and Labelling of Chemicals (GHS) are adopted in this Resolution.  
For pesticides, related and preservati ves of wood already registered, the company must 
evaluate its toxicological dossier and verify the need for toxicological reclassification, 
considering the provisions of this Resolution.  
The company is responsible for evaluating the composition/formulation  of its registered 
products and checking for the presence of unauthorized components.  
It revokes item "l", "m", 1.3 and 1.4 of " Guidelines and Requirements Ministry of Health, 
Regarding the Authorization of Registration and Extension of Use of Agrochemical s and 
Related  ", approved by the Divisions of Human Ecology and Health Environment and Risk 
Assessment as " Guidelines and Requirements of the Ministry of Safety,  
Regarding the Authorization to Register and Extend Use of Agrotóxicos and Afins N °. 01, of 
09 December 1991", published in the Official Gaze tte of the Union on 13 December  1991 
and ratified by Admini strative Rule 03, of 16 January  1992, of the Technical -Normative 
Department of the Health Surveillance Secretariat of the Ministry of Health.  
7. Obje ctive 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 r equirements of the Ministry of Health, 
Regarding the Authorization of Registration and Extension of Use of Agrochemicals and 
Related ; (3) Brazilian Official Journal (Diário Oficial da União); (4) Not stated.   
9. Proposed date of adoption: date of its publication  
Proposed date of entry into force: 90 (ninety) days after 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.go v.br/documents/10181/2858730/CONSULTA+P%C3%9ABLICA+N%
C2%BA+484+ -+GGTOX/18d3d6d5 -0623-4daf-871b-f6825f92fd32