G/SPS/N/USA/3273  
 
14 September 2021  
(21-6815) 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): 1104, 1516, 1704, 2001, 2009, 2105, 2202, 0401, 
0402, 0403, 0404, 0405, 0406; 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:  Fermentalg; Filing of Color Additive Petition . 
Language(s):  English . Number of pages:  2 
https://www.govinfo.gov/content/pkg/FR -2021-09-09/pdf/2021 -19405.pdf  
https://members.wto.org/crnattachments/2021/SPS/USA/21_5785_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 Fermentalg, proposing that the color additive 
regulations be amended to provide for the safe use of blue Galdieria extract, derived from 
unicellular red algae ( Galdieria sulphuraria ), as a color additive in various fo od categories 
at levels consistent with good manufacturing practice.  
The color additive petition was filed on 27 July 2021.  
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 st andard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/USA/3273  
 
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  9. Other relevant documents and language(s) in which these are available:    
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  
[X] 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 
availa ble) of other body:   
ADDRESSES: 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.  
FOR FURTHER INFORMATION CONTACT: Step hanie A. Hice, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, +(301) 348 1740.  
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. 86, No. 172, Page  50495  or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2021-09-09/pdf/2021 -19405.pdf