G/SPS/N/USA/3300  
 
6 January 2022  
(22-0165) 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): 2102; 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:  Lallemand Inc.; Filing of Food Additive Petition . 
Language(s):  English . Number of pages:  1 
https://www.govinfo.gov/content/pkg/FR -2021-12-29/pdf/2021 -28162.pdf  
https://members.wto.org/crnattachments/2022/SPS/USA/22_0160_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 Lallemand Inc., proposing that the food 
additive regulations be amended to provide for the safe use of vitamin D2 heat -killed 
("inactive ") baker's yeast as a source of vitamin D2 in specific food categories.  
7. Objec tive 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 sta ndard:  
[ ] 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 stand ard:  
9. Other relevant documents and language(s) in which these are available:    G/SPS/N/USA/3300  
 
- 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 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 designate d to handle comments: [  ] National Notification 
Authority, [  ] National Enquiry Point. Address, fax number and e -mail address 
(if available) 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 F URTHER INFORMATION CONTACT: Katie Overbey, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240 -402-7536.  
13. Text(s) available from: [  ] National Notification Authority, [  ] National Enq uiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Text can be found in the Federal Register, Vol. 86, No. 247, Page  74018  or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2021-12-29/pdf/2021 -28162.pdf