G/SPS/N/BRA/939  
 
18 June 2014   
(14-3523) Page: 1/3 
Committee on Sanitary and Phytosanitary Meas ures  Original: English  
 
  NOTIFICATION  
1. Notifying Member: BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible: ANVISA - The Brazilian Health Surveillance Agency  
3. Products covered (provide tariff item number(s) as specif ied in national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable):  
I. Cereals containing gluten, namely wheat, rye, 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 ( Macadamia  spp.);  
XIII.  Nut (Juglans  spp.);  
XIV.  Pecan ( Carya illinoensis ); 
XV. Pistachio ( Pistacia vera  L.); and  
XVI.  Sulphites (sulphur dioxide and it s salts) in concentration equal to or greater than 
10 (ten) parts per million (ppm), expressed in sulphur dioxide.  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or cou ntries:   
5. Title of the notified document: 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   Language(s): Portuguese   Number 
of pages: 6 
http://portal.anvisa.gov.br/wps/wcm/connect/48e9d400445246c4a670ae7f5a7b924e/Co
nsulta+P%C3%BAblica+n+29+GGALI.pdf?MOD=AJPERES  
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 material s which are packaged in the absence of consumers, incl uding those 
intended to be used exclusively for industrial processing and at food establishments.  G/SPS/N/BRA/939  
 
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  This resolution is complementary to the Resolution number 259, of 20 September 2002, 
which approves the technical regulation for 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 g luten, namely wheat, rye, 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 ( Macadamia  spp.);  
XIII.  Nut (Juglans  spp.);  
XIV.  Pecan ( Carya illinoensis ); 
XV. Pistachio ( Pistacia vera  L.); and  
XVI.  Sulphites (sulphur dioxide and its salts) in concentration equal to or greater than 
10 (ten) parts per million (ppm), expressed in sulphur dioxide.  
Alterations in the list provided here within can be made upon updates on Codex 
Alimentarius guidelines or scientific evidences showing the cause -effect of the food 
consumption and adverse events, its epidemiologi cal magnitude and its severity.  
The food, ingredients, additive s, 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 intentionally added of ingredients, food 
additives, technological coadjuvants  or raw materials  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 incidenta l 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: Allerg ic: May Contain (source names).  
Declarations required at articles 6, 7 and 8 of this  Resolution must be gro uped 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 8 February 2002 which approves 
the technical regulation on labelling of packed food and beverage that contain gluten.  
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 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 Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number)    G/SPS/N/BRA/939  
 
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  [ ] International Plant Protection Convention (e.g.  ISPM number)    
[X] None  
Does this proposed regulation conform to the relevant international stan dard?   
[ ] 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: 
The Brazilian Official Journal (Diário Oficial da União), 9 J une 2014, 108th edition, 
Section 1, p. 76. Draft Resolution (Consulta Pública) number 29, 5 June 2014, issued by 
the Brazilian Health Surveillance Agency (ANVISA). When adopted, it will be published at 
the Brazilian Official Journal  (available in Portugues e). 
10. Proposed date of adoption (dd/mm/yy) : To be determined after the end of the 
consultation period.  
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 mo nths from date of publication , 
and/or  (dd/mm/yy) : To be determined after the end of the consultation period.  
[ ] Trade facilitating measure   
12. Final date for comments: [ ]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 August 2014  
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:  
Ana Paula S. J. da Silveira e Silva  
Tel: +(55 61) 3462 5 402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Texts available from: [ ]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Ana Paula S. J. da Silveira e Silva  
Tel: +(55 61) 3462  5402/5404/5406  
E-mail: rel@anvisa.gov.br