G/TBT/N/BRA/592  
 
23 June 2014  
(14-3637)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: BRAZIL 
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible:  Brazilian Health Surveillance Agency - ANVISA 
Name and address (including telephon e 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, Quality and Technology - INMETRO 
Telephone: +55 (21) 2563.2840 
Telefax: +55 (21) 2563.5637 Email: barreirastecnicas@inmetro.gov.br  
Website: 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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Recognized sources of 
food allergies or food intolerances in sensitive persons 
5. Title, number of pages and langua ge(s) of the notified document: Draft Resolution nº 
29, 5 June 2014, that adopts provisions on the mandatory declaration in the label of 
packaged food, of recognized sources of food allergies or food intolerances in sensitive 
persons (6 pages, in Portuguese) 
6. Description of content: Draft resolution that adopts provisions on the mandatory 
declaration in the label of packaged food, of recognized sources of food allergies or food 
intolerances in sensitive persons.  
This resolution applies to food, ingredients, food additives, technological coadjuvants and 
raw materials which are packaged in the absence of consumers, including those intended 
to be used exclusively for industrial processing and at food establishments. 
This resolution is complementary to the Resolution number 259, of 20 September 2002, 
which approves the technical regulation fo r labelling packaged food, and to the Law 
10.674, of 16 May 2003, which establishes mandatory providing information on the presence of gluten in marketed food products. 
The following are recognized sources of food allergies or food intolerances in sensitive 
persons: 
I. Cereals containing gluten, namely wheat, ry e, barley, oats and their hybridised strains; 
II. Crustaceans; III. Eggs; IV. Fish; V. Peanut ; VI. Soy; VII. Milk; VIII. Almond (Prunus 
dulcis); IX. Hazelnut (Corylus spp.); X. Cashew nut (Anacardium occidentale); XI. Brazil 
nuts (Bertholletia excelsa); XII. Macadamia (M acadamia spp.); XIII. Nut (Juglans spp.); 
XIV. Pecan (Carya illinoensis); XV. Pistachio (Pistacia vera L.); XVI. Sulphites (sulphur 
dioxide and its salts) in concentration equal to or greater than 10 (ten) parts per million 
(ppm), expressed in sulphur dioxide. G/TBT/N/BRA/592 
 
- 2 - 
 
  Alterations in the list provided here within can be made upon updates on Codex 
Alimentarius guidelines or scientific eviden ces showing the cause-effect of the food 
consumption and adverse events, its epidemiological magnitude and its severity. 
The food, ingredients, additives, technological coadjuvants and raw materials which are 
packaged in absence of consumers, including those intended to be used for manufacturing 
and for food establishments must contain the declaration: Contains Gluten or Gluten Free, 
as appropriate. 
Food that are, derives from or have been inte ntionally added of ingredients, food additives, 
technological coadjuvants or raw materiasl from recognized sources of food allergies or 
food intolerances described in sections II to XVI of article 4, in any quantity, must bring 
the declaration: Allergic: Contains (source names), or Allergic: Contains derivatives of (source names), as appropriate. 
In cases that food, ingredients, food additives, technological coadjuvants or raw materials 
have risks of causing incidental contamination from recognized sources of food allergies or 
food intolerances described in sections II to XV of article 4 , must inform in its label the declaration: Allergic: May Contain (source names). 
Declarations required at articles 6, 7 and 8 of this Resolution must be grouped near the 
ingredients list on the label, in a white background frame and in black characters of the same type, complying with height requirements established in the annex of this 
Resolution. 
This Resolution revokes Resolution RDC number 40 of February 8 2002 which approves the 
technical regulation on labelling of packed food and beverage that contain gluten. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human Health  
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União),9 June 2014; 
Section 1, p. 76, Draft Resolution (Consulta Pública) number 29, 5 June 2014, issued by Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at the 
Brazilian Official Journal. Available in Portuguese. 
9. Proposed date of adoption: To be determined after the end of the consultation period 
Proposed date of entry into force: To be determined after the end of the consultation 
period 
10. Final date for comments: 18 August 2014 
11. Texts available from: Nati onal enquiry point [ ] or address, telephone and fax 
numbers email and website addresses,  if available, of other body: 
Brazilian Health Surveillance Agency ANVISA 
SIA, Trecho 5 Área Especial 57 
Brasília DF / Brazil 
CEP: 71.205-050 Phone.: 55 61 3462-5402 E-mail: rel@anvisa.gov.br  
Website:  www.anvisa.gov.br 
http://portal.anvisa.gov.b r/wps/wcm/connect/48e9d400445246c4a670ae7f5a7b924e/Consul
ta+P%C3%BAblica+n+29+GGALI.pdf?MOD=AJPERES