G/SPS/N/BRA/1487  
 
13 March 2019  
(19-1525) 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): HS Code(s): 52, 0809, 1006, 0803, 18, 09, 1212, 0805, 08011, 24, 
0808, 080720, 071040,  1201, 1001, 0806; 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 number 613, 28 February  2019, 
regarding the active ingredient G01 - GLYPHOSATE of the Monograph List of Active 
Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published 
by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official  Gazette (DOU - 
Diário Oficial da União) of 2 September 2003 . Language(s): Portuguese.  Number of 
pages: 5 
Draft:  
http://portal.anvisa.gov.br/documents/10181/5344168/Consulta+Pu%C2%B4blica+613
-2019.pdf/f2e6adfb -e12a-4285-b3c3-e8aeb17d6e91  
Comment form:  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=45725  
6. Description of content: This Draft resolution is the result of the risk assessment for the 
active ingredient  G01 - GLYPHOSATE ofthe Relation of Monographies of Active Ingredients 
of Pesticides, Household Cleaning Products and Wood Preservers, and proposes the 
following changes:  
- Rural workers and the population near the farming fields:  
• Prohibition of EW formulation (oil -in-water emulsion);  
• Rotation between workers for aplication activities with tractors (mixing, filling and 
applying);  
• Personal protective equipment  (PPE)  and period for reentry of the worker into the 
treated area;  
• Drift reduction technology;  
• Safe zone of 10 meters when there is population 550 meters way from farming  
fields;  
• Definition of exposure and tolerance limits for rural workers.  
- Urban use and food consuming:  
• Adjustment for cronic exposure tolerance limits;  
• Definition of acute exposure limits;  
• Prohibition of the concentraded product for amateur gardening;  
• Prohibition of POEA (polyoxyethyleneamine)  above 20% in glyphosate products.  G/SPS/N/BRA/1487  
 
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  7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] 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:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : CAC/MRL 1 Maximum Residue Lim its (MRLs) for 
Pesticides  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard: The scientific methodology used by Brazil to establish MRLs is 
consistent with international best practice. Countries set MRLs according to the good 
agricultural practice (GAP) applicable to their region. Agricultural chemical use patterns 
differ between d ifferent production regions and countries as pests, diseases and 
environmental factors vary. This means that Brazilian MRLs for agricultural chemicals in 
food may differ from Codex standards.  
9. Other relevant documents and language(s) in which these are  available:   
10. Proposed date of adoption (dd/mm/yy) : To be determined 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) : 6 June 2019  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [  ] National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:  
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
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:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(55(6 1) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br