G/TBT/N/BRA/1119  
18 January 2021  
(21-0521) 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 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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 Code(s): 38089910 (pesticides)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
number 987, 15 December 2020. (6 page(s), in Portuguese)  
Comment form: http://fo rmsus.datasus.gov.br/site/formulario.php?id_aplicacao=60954  
6. Description of content:  This draft resolution establishes the guidelines for the risk 
assessment of exposure of operators, workers, residents, and bystanders to pesticides 
for the purpose of market authorization, post -market authorization alterations, 
reassessment, monitoring, and inspection procedures.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In the past, the guidelines for toxicological evaluation of pesticides were 
published through Ordinance SNVS/MS No. 03 of 16 January 1992. Since then, scientific 
knowledge has made significant progress, which has generated the need to review its 
criteria and requirements in order to update and align the evaluation process with the 
best practices adopted internationally. This ordinance did not establish criteria for risk 
assessment to individuals exposed to pesticides due to work activities, that is, 
occupa tional risk assessment. It is necessary to assess the health risks of rural workers 
who handle and/or apply pesticides, including those who only enter the agricultural area 
where the application was made (e.g., to harvest food treated with pesticides). In 
addition, people who live nearby or those who may be sporadically close to the treated 
areas should have the risk assessed. As a consequence of these evaluations, necessary 
measures can be adopted for the purpose of protecting the health of these populatio ns.; 
Protection of human health or safety  G/TBT/N/BRA/1119  
 
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  8. Relevant documents:  1) Brazilian Official Gazette 245 on 23 December 2020, section  1, 
page 140; 2) Justification for resolution draft; 3) Assessment guide of the exposure of 
operators, workers, residents, and b ystanders for the assessment risk to pesticides  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-987-de-15-de-dezembro -de-2020-
295784698  
http://antigo.anvisa.gov.br/documents/10181/6164954/Justificativa+ -+CP+987 -
2020.pdf/18452488 -c17d-449a-a24f-7148c825ae6e  
http://antigo.anvisa.gov.br/documents/10181/6164954/Guia+de+Avalia%C3%A7%C3
%A3o+da+exposi%C3%A7%C3%A3o+de+operadores%2C+trabalhadores%2C+reside
ntes+e+transeuntes+para+a+avalia%C3%A7%C3%A3o+do+risco+aos+agrot%C3%B
3xicos.pdf/fb5f5657 -e2f1-452c-8a6f-19e0125ec66f  
9. Proposed date of adoption:  To be defined  
Proposed date of entry into force:  To be defined  
10. Final date for comments:  29 March 2021  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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://antigo.anvisa.gov.br/documents/10181/6164954/CONSULTA+P%C3%9ABLICA+
N+987+GEMAR.pdf/522fe146 -03a6-4111-9318-c4f6fe297875