WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/362 
12 February 2010  
 (10-0811) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance 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, Standa rdization and Industrial Quality-INMETRO 
Tel:  +(55) 21 2563.2821 
Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br Website:  http://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 applicab le, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):  Food products.  
5. Title, number of pages and langu age(s) of the notified document:  Draft Resolution 
nº 95, 21 December 2009 – Food registration and notification procedures (24 pages, Portuguese).  
6. Description of content:  This draft technical regulation updates the list of food that needs 
to be registered before commercialized, establishes the required procedures for food 
registration, and also notification procedur es of food products exempt from registration.  
The draft regulation applies to procedures of registration and notifi cation of food products, 
food additives, food processing aids, packaging.  It applies to domestic and imported food 
products.  
The food products are divided into two cate gories:  products which registration is 
mandatory to be commercialized in Brazil a nd products exempt from registration.  In 
Annexes I and II of the Resolution there are lists containing the categories of each product. 
All food products, whether they have the obligati on to be registered at Anvisa or not, to be 
commercialized in Brazil must: 
I - Be obtained, processed, packaged, stored, transported and stored under conditions that 
do not produce, develop and / or aggregate physical substances, chemical or biological 
weapons that endanger consumer  health a nd must obey current legislation of Good 
Manufacturing Practices.  The Handbook of Go od Manufacturing Practices must be 
available to health authorities at the time of inspection or when requested. G/TBT/N/BRA/362 
Page 2  
 
  II – Follow the requirements of Technical Regul ations of specific products, food additives 
and food processing aids; contaminants; food Labe lling and other relevant legislations.  All 
food products are under health sanitary control.   The registration and notification of food 
products, whether national or im ported products, must follow the same procedures set forth 
in this regulation. 
After the entry into force of this Resolution,  food products, food additives, food processing 
aids and packaging exempt from registration must be notified to ANVISA only electronically.  
The establishments covered by th is resolution will have a period of 12 months from the date 
of its entry into force to promote the necess ary adjustments to the Technical Regulation. 
Since the entry into force of this resolution, new plants and those who wish to restart their 
activities must comply fully with the requirem ents contained therein, prior to operation. 
Companies that hold the registration number in their food products, and that in accordance 
with this resolution are to be exempt from re gistration can use it in their products until the 
expiration date of the registration. 
When adopted, this Resolution will revoke:  
Resolution CNNPA nº. 1, from 8 May 1968;  Resolution CNNPA nº. 18, 22 July 1968;  Item 3 from Resolution CNNPA nº. 38, from 27 December 1977; Adminitrative Act (Portaria) SNVS/MS nº. 47, from 31 October 1986;  Adminitrative Act (Portaria)  DINAL/MS n.º 9, from 23 February 1990;  
Adminitrative Act (Portaria)  SVS/MS 579, from 17 November 1997;  
Resolution ANVISA nº. 23, from 15 March 2000;  Resolution ANVISA nº. 22, from 15 March 2000; and Resolution RDC nº. 278, from 22 September 2005. 
7. Objective and rationale, including the natu re of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 
22 December 2009; Section 1. Draft Resolution (Consulta Pública) number 95, 
21 December 2009, issued by Brazilian Sanita ry Surveillance Agency – Anvisa;  When 
adopted, it will be published at Brazilian Official  Journal.  Available in Portuguese.   
9. Proposed date of adoption:   
 Proposed date of entry into force:    To be determined after the end of the 
consultation period.  On the date of adoption. 
10. Final date for comments:  22 March 2010  G/TBT/N/BRA/362 
 Page 3 
 
 
  11. Text available from: National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:    
Agency responsible 
Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 
Brasília – DF / Brazil 
CEP:  71.205-050 Tel.:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br  Website:  http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br/wps/wcm/connec t/4a7ed00040c2f481afe 1efce64477fe7/Consulta
+Publica+n+95.pdf?MOD=AJPERES