. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/BRA/118 
27 July 2005 
 (05-3382) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   BRAZIL
 
If applicable, name of local government involved: 
2. Agency responsible:   ANVISA - Brazilian Sanitary Surveillance Agency 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  food in natura 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  All 
countries  
5. Title, language and number of pages of the notified document:   Draft Resolution n.º 43 - 
Technical Regulation on procedures for field trials to establish Maximum Residues Levels (MRL) in food (Available in Portuguese, 35 pages). 
6. Description of content:   
This draft technical regulation establishes procedures for fi eld trials, including minimum 
requirements for the studi es of residues, procedures for sa mpling and for the preparation of 
samples for analysis, and declaration of analytical conformity and of conformity with good 
laboratorial pr actices (GLP). 
The studies made before the date of the entry into force of this regulation and according to 
the rules that prevailed until then remain va lid, as well as the approved uses and MRLs. 
The field analyses installed up to 6 months prior to the date of the entry into force of this 
regulation, as well as the samples and the analytical studies derived from them will be 
considered valid.  The pesticides producers responsible for those analyses must notify 
ANVISA about their studies that apply to this category up to 180 days after the entry into to 
force of this regulation.  
The pesticides producer companies must submit to ANVISA a plan for the implementation of 
field analyses.  Any changes on dates or sites must also be informed to ANVISA.  
ANVISA has the right to inspect the field analyses when considered necessary. 
It revokes the Ministerial Act (Portaria) n.º 03, 16 January 1992 from the Secretaria 
Nacional de Vigilância Sanitária; and the Resolution RDC nº 44 10 May 2000 from 
ANVISA. 
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 G/SPS/N/BRA/118 
Page 2  
 
 8. International standard, guideline or recommendation:  
[ X ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s ) in which thes e are available:  Brazilian Official 
Journal (Diário Oficial da Un ião), 6 June 2005; Draft Resolution (Consulta Pública) 
number 43, dated 2 June 2005, issued by Brazilian Sanitary Surveillance Agency – 
ANVISA;  To be published at Brazilian Offici al Journal.  Available in Portuguese. 
10. Proposed date of adoption:   beginning of September 2005 
11. Proposed date of entry into force:   180 days. 
12. Final date for comments:  2 August 2005 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
Brazilian Sanitary Surveillance Agency - ANVISA 
SEPN 515 - Bloco "B", Edificio Omega CEP 70770-502 Brasilia – DF/Brasil 
Tel.:  (55) 61 448 1078 
Fax:  (55) 61 448 1089 E-mail:  rel@anvisa.gov.br
 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
The full text can be directly accessed through the following link: 
http://www4.anvisa.gov.br/base/visadoc/CP/CP[10559-1-0].PDF