   
  
G/SPS/N/USA/3214  
 
25 November 2020  
(20-8496) 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:  Food and Drug Administration (FDA)  
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): 2936; ICS Code(s): 67  
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 
https://www.govinfo.gov/content/pkg/FR -2020-11-20/pdf/2020 -25600.pdf  
https://members.wto.org/crnattachments/2020/SPS/USA/20_7218_00_e.pdf  
6. Description of content:  The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive 
regulations be amended to expand the safe use of calcium carbonate to include use in 
dietary supplement tablets and capsules.  
7. Objective and rationale: [X]  food saf ety, [  ] 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 Co mmission (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 standa rd:  
9. Other relevant documents and language(s) in which these are available:   G/SPS/N/USA/3214  
 
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  10. Proposed date of adoption (dd/mm/yy) :  
Proposed date of publication (dd/mm/yy) :  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) :  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) :  
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:   
For access to the docket to read background documents or comments received, go to 
https:// www.regulations.gov and insert the docket number found in brackets in the 
heading of this document into the ''Search'' box and follow the prompts, and/or go to the 
Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.  
FOR FURTHER INFORMATION CONTACT: Christopher Kampmeyer, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240 -402-1255.  
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. 85, No. 225, page  74304  or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2020-11-20/pdf/2020 -25600.pdf  
United States SPS National Notification Authority, USDA Foreign Ag ricultural 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   
 