G/SPS/N/USA/2966  
 
22 November 2017  
(17-6385) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member: UNITED STATES OF AME RICA 
If applicable, name of local government involved:  
2. Agency responsible: 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): 282110, 2106; ICS Code(s): 67  
4. Regions or countries likely to be affect ed, 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; Notice of 
Petition . Language(s): English.  Number of pages: 1 
https://www.gpo.gov/fdsys/pkg/FR -2017-11-09/pdf/2017 -24421.pdf  
https:/ /members.wto.org/crnattachments/2017/SPS/USA/17_5200_00_e.pdf  
6. Description of content: The Food and Drug Administration (FDA) is announcing the filing 
of a petition, submitted by Colorcon, Inc., proposing that the color  additive regulations be 
amended by expanding the permitted uses of synthetic iron oxide as a color additive to 
include use in dietary supplement 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 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) :  
[ ] 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/2966  
 
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  10. Proposed date of adoption (dd/mm/yy) : Not applicable  
Proposed date of publication (dd/mm/yy) : Not applicable  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Not applicable  
[ ] Trade facilitating measure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle 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, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740; Tel: +(1 240) 402 1075  
13. Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Text can be found in the Federal Register, Vol. 82, No. 216, page 52037 or on the internet 
at: https://www.gpo.gov/fdsys/pkg/FR -2017-11-09/pdf/2017 -24421.pdf