G/SPS/N/USA/2714
3 November 2014 
(14-6378)  Page: 1/2
Committee on Sanitary and Phytosanitary Measures  Original: English
 
  NOTIFICATION 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved:   
2. Agency responsible: US Food and Drug Administration 
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(s): 29, 30; ICS Code(s): 11. Dietary 
supplement and drug tablets and capsules. 
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: Colorcon, Inc.; Filing of Color Additive Petition 
Language(s): English  Number of pages: 1 
http://members.wto.org/crnattachments/2014/sps/USA/14_4891_00_e.pdf  
6. Description of content: The Food and Drug Administration (FDA) is announcing that 
we have filed a petition, submitted by Colorc on, Inc., proposing that the color additive 
regulations be amended to provide for the safe use of spirulina extract as a color 
additive in coating formulations applied to dietary supplement and drug tablets and capsules. 
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 st andard? 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 deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available:     G/SPS/N/USA/2714 
 
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  10. Proposed date of adoption (dd/mm/yy) : To be determined. 
Proposed date of publication (dd/mm/yy) : To be determined. 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined. 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Comments will be accepted at any time after 
publication of the notice of filing; however, if a final rule is promulgated, it will address 
only those comments that were received prior to publication of the final rule. 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body: Molly A. Harry, Center for Food Safety and Applied 
Nutrition (HFS-265), Food and Drug Admini stration, 5100 Paint Branch Pkwy., College 
Park, MD 20740-3835, Tel: +(1 240) 402 1075. 
13. Text(s) available from: [X] National Notifi cation Authority, [ ] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:  
United States SPS National Notification Auth ority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: 
us.spsenquirypoint@fas.usda.gov  
Text can also be found in the Federal Register Vol. 79, No. 204, Page 63062 or on the 
internet: http://www.gpo.gov/fdsys/pkg/FR- 2014-10-22/pdf/2 014-25089.pdf