G/SPS/N/BRA/1430  
 
19 September 2018  
(18-5780) 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: Food; 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 (C onsulta Pública) number 541, 
17 July 2018, provisions on the microbiological criteria of safety and hygiene for food and 
its application . Language(s): Portuguese.  Number of pages: 7 
http://portal .anvisa.gov.br/documents/10181/4660474/CONSULTA+P%C3%9ABLICA+
N%C2%BA+541+GGALI.pdf/f0de60ad -cd70-44ac-a63d-2e5f217c5f07  
6. Description of content: Proposal of revision of the Collegiate Board of Directors  – 
RDC nº 12 of 2001 that lays down technical regulation about microbiological standards 
for food.  
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 th ere 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 international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it de viates from the 
international standard:  G/SPS/N/BRA/1430  
 
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  9. Other relevant documents and language(s) in which these are available: 
Resolution of the Collegiate Board of  Directors - RDC n° 12 of 2001, which provides for 
the technical regulation on micr obiological standard s for food  
http://portal.anvisa.gov.br/documents/10181/2718376/%281%29RDC_12_2001_COMP
.pdf/b3cb6241 -6d1b-49fc-8a88-b0781a147980  (available in Portuguese)  
10. Proposed date of adoption (dd/mm/yy) : On the date of its publication.  
Proposed date of publication (dd/mm/yy ): One year (365 days) after the date of its 
publication.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : On the date of 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 September 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:  
Coordenação de Articulação Internacacional e Convergência Regulatória - CCREG  
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:   
Coordenação de Articulação Internacacional e Convergência Regulatória - CCREG  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br