G/SPS/N/BRA/1389  
 
16 April 2018  
(18-2286) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member: BRAZIL  
If applicable, name of local government involved:  
2. Agency responsible: The Brazilian Health Regulatory Agency - ANVISA  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable): Pesticides, components, related products and wooden preservatives; 
ICS Code(s): 13, 65  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft Resolution Nº 484, 16 March 2018 - Criteria for 
the evaluation and toxicological classification of pesticides, components, related products 
and wooden preservatives . Language(s): Portuguese.  Number of pages: 29 
http://portal.anvisa.gov.br/documents/10181/2858730/CONSULTA+P%C3%9ABLICA+N%
C2%BA+484+ -+GGTOX/18d3d6d5 -0623-4daf-871b-f6825f92fd32  
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 ANVISA.  
The process of toxicological evaluation of products must be instructed with all the 
documentation established in Decre e No. 4,074  of 4 January  2002, its updates or other 
specific legislation.  
The documentation required for the toxicological evaluation 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 i n 
accordance with current protocols published by the Organization for Economic 
Co-operation and Development (OECD) or other authorities having similarity of 
requirements and validation.  
Without prejudice to the provisions of Decree No. 4,074 of 4 January 2 002, for the studies 
of corrosion/skin irritation and ocular corrosion/irritation, the toxicological profile of a 
technical product is considered equivalent to the profile of the technical reference product, 
when does not fall into a category of greater da nger, in accordance with specific legislation 
and in accordance with the equivalence criteria of the Food and Agriculture Organization 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.  G/SPS/N/BRA/1389  
 
- 2 - 
 
  For pesticides, related and preservatives 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.  
7. Objective and rationale: [  ] food safety, [  ] animal health, [  ] plant protection, 
[X] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and lan guage(s) in which these are available: 
Organization for Economic Co -operation and Development (OECD) applicable standards;  
Food and Agriculture Organization of the United Nations (FAO) equivalence criteria;  
Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria   
10. Proposed date of adoption (dd/mm/yy) : On the date of its publication.  
Proposed date of publication (dd/mm/yy) : To be determined after the end of the 
consultation period.  
11. Proposed date of entry into force: [ ] Six months from date of publication , and/or  
(dd/mm/yy) : 90 days after its publication.  
[ ] Trade facilitating measure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 23 April 2018  
Agency  or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:  
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br