G/SPS/N/BRA/1350  
 
11 January 2018  
(18-0346) 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): ICS Code(s): 13, 65  
4. Regions or countries likely to be affected, to the extent rele vant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft resolution (Consulta Publica) number 457, 
28 December  2017. Language(s): Portuguese.  Number of pages: 41 
http://portal.anvisa.gov.br/documents/10181/3898888/CONSULTA+PUBLICA+N+457+GG
ALI.pdf/33b58cec -33cd-4295-867c-4ff44e01ca88  
6. Description of content: This Normative Instruction establishes the lists of nutrients, 
bioactive substances, enzymes and probiotics, limits of use, claims and supplementary 
labeling of food supplements.  
Annex I defines the list of probiotics and source ingredients of nutrients, bioactive 
substances and enzymes authorized for use in food supplements.  
Annex II sets out the list of minimum levels of nutrients, bioactive substances, enzymes 
and probiotics to be provided by dietary suppl ements in the daily recommendation for 
consumption and by the population group indicated by the manufacturer.  
Annex III sets out the list of maximum levels of nutrients, bioactive substances, enzymes 
and probiotics which can not be exceeded by food supplem ents in the daily 
recommendation for consumption and by the population group indicated by the 
manufacturer.  
Annex IV sets out the list of claims authorized for use on the labeling of food supplements 
and their composition and labeling requirements.  
Annex V  sets out the list of supplementary labeling requirements for food supplements.  
Annex VI defines the list of essential amino acid quantities of the reference protein.  
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) :  G/SPS/N/BRA/1350  
 
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  [ ] 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 deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are av ailable:   
10. Proposed date of adoption (dd/mm/yy) : On the date of its publication.  
Proposed date of publication (dd/mm/yy) : On 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) : 9 April 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:  
Patrícia Oliveira Pereira Tagliari  
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:   
Patrícia Oliveira Pereira Tagliari  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br