G/SPS/N/BRA/1388  
 
16 April 2018  
(18-2285) 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): 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 483, 16 March 2018 - Toxicological 
information for labels and leaflets of pesticides, related products and wooden  
preservatives . Language(s): Portuguese.  Number of pages: 17 
http://portal.anvisa.gov.br/document s/10181/2858730/CONSULTA+P%C3%9ABLICA+N%
C2%BA+483+ -+GGTOX/57e9a676 -19ce-41ea-8c9c-556003533375  
6. Description of content: This Draft Resolution provides for toxicological information for 
labels and leaflets of pesticides, related products and wooden preservatives, within 
ANVISA . 
The guidelines for the preparation of toxicological information for labels and leaflets of 
pestici des, related products and wooden preservatives are approved within ANVISA . 
The purpose of this Resolution is to establish:  
I. the obligatory information related to the protection of human health that must be 
included in pesticide labels and leaflets, similar products and wooden preservatives; 
and 
II. the adoption of the labeling guidelines of the Globally Harmonized System of 
Classification and Labeling of Chemicals (GHS).  
The company is responsible for all labeling and package leaflet information, and must 
presen t it clearly and ensure that it is adequate and sufficient for health protection 
purposes.  
ANVISA may, at its discretion and with a reasoned technical justification, require the 
company that holds the record to change the texts of labels and package leafle ts. 
The labels and package inserts of biological products and wooden preservatives must 
follow the provisions of this Resolution and the determinations provided in other specific 
devices and norms, and the necessary adaptations must be made to the peculiar ities of 
the product.  
For information on appropriate poisoning prevention or risk minimization measures, the 
pictograms recommended by the Food and Agriculture Organization of the United Nations 
(FAO) should be used on pesticide labels and leaflets, as wel l as on wood preservatives.  G/SPS/N/BRA/1388  
 
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  ANVISA may make available on the ANVISA website the latest version of the package 
leaflets and approved labels in relation to health information.  
Companies with already registered models of labels and pesticides, wood preservati ves 
and preservatives must comply with this Resolution by means of a notification, with 
protocol under a specific subject code, and submit electronically to ANVISA all relevant 
documentation, up to 360 days after the validity of this Resolution, and may im plement 
the labels and package inserts, without prior authorization from ANVISA.  
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 A nimal 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 language(s) in which these are available: Food and 
Agriculture Organization of the United Nations (FAO) pictograms recommenda tion on 
labelling and leaflets of pesticides; Globally Harmonized System (GHS) labelling guidelines   
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) : 24 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