G/SPS/N/USA/3435  
13 December 2023  
(23-8546) 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):  Food preparations, n.e.s. (HS code(s): 2106); Food technology 
(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:  Kerry Ingredients and Flavours Ltd.; Filing of Food 
Additive Petition; Notification of Petition . Language(s):  English . Number of pages:  2 
https://www.govinfo.gov/content/pkg/FR -2023-10-13/pdf/2023 -22613.pdf  
https://members.wto.org/crnattachments/2023/SPS/USA/23_14518_00_e.pdf  
6. Description of content:  The Food and Drug Administra tion (FDA or we) is announcing 
that we have filed a petition, submitted by Kerry Ingredients and Flavours Ltd., proposing 
that the food additive regulations be amended to provide for the safe use of vitamin D3 as 
a nutrient supplement in powdered drink mix es added to water or carbonated water, 
excluding drinks or drink mixes that are specially formulated or processed for infants.  
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/3435  
 
- 2 - 
 
  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 measur e  
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:   
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: Lane A. Highbarger, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240 –402–1204.   
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. 88, No. 197, Page 70918 or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2023-10-13/pdf/2023 -22613.pdf