G/SPS/N/BRA/1238  
 
10 April 2017  
(17-1922) Page: 1/2 
Committee on Sanitary and Phytosanitary Mea sures  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 i n national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable): ICS Code(s): 13, 65   Pesticides  
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 Technical Resolution N° 313, 23 February 2017.  
Language(s): Portuguese . Number of pages: 6 
http://portal.anvisa.gov.br/documents/10181/2859776/CONSULTA+PUBLICA+N+313+
GGTOX.pdf/673e9056 -2963-4a57-961a-bfab6f07a5cb  
6. Description of content: This Draft Resolution provides the criteria an d procedures for 
toxicological reassesment of active ingredients of pesticides within the scope of the 
Brazilian Health Regulatory Agency (ANVISA). The active ingredients of pesticides that 
show signs of altering risks to human health can be re -evaluated a t any time. 
The toxicological re -evaluation process of active pesticide ingredients includes: indication 
of the active ingredients of pesticides for toxicological re -evaluation; selection and 
definition of the scope of the revaluation; disclosure of the be ginning of the revaluation; 
public consultation; publication of the regulatory decision; elaboration of the final 
technical note. ANVISA will select the active ingredients of pesticides that will be 
submitted to the re -evaluation based on the risk of to hu man health and the list of the 
active ingredients selected to re -evaluation will be shared on Anvisa website. The 
toxicological re -evaluation of active ingredients shall follow the criteria for toxicological 
evaluation of technical and formulated products established by the technical regulation. 
A public consultation will be published with the proposed regulatory decision on the 
active ingredient. The Brazilian Health Regulatory Agency will publish the final decision 
about the revaluation process. This Reso lution re vokes Resolution RDC Nº 48 of 
7 July 2008, published on 8 July 2008 on Brazilian Official Journal nº 129, section 1, 
pages 43 and 44.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from an imal/plant pest or disease, [  ] protect territory from 
other damage from pests.  G/SPS/N/BRA/1238  
 
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  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 internati onal standard?   
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are available:   
10. Proposed date of adoption (dd/mm/yy) : To be de termined after the end of the 
consultation period.  
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) : To be  determined after the end of the consultation period.  
[ ] Trade facilitating measure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 3 May 2017  
Agency or authority designated to handle comme nts: [X]  National Notification 
Authority, [  ] 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)  availabl e 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