. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/1966/Add.1 
11 September 2012  
 (12-4831) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 4 September 2012, is being circulated at the 
request of the Delegation of the United States of America. 
 
_______________ 
  
Final Rule:  Food Additives Permitted for Direct  Addition to Food for Human Consumption;  
Vitamin D 2 Bakers Yeast;  Final Rule 
 The United States Food and Drug Administratio n published a Final Rule in the Federal 
Register on 29 August 2012 (77 FR 52228) amendi ng the food additive regulations in 21 CFR 
part 172 to provide for the safe use of vitamin D 2 bakers yeast as a source of vitamin D 2 and as a 
leavening agent in yeast-leavened baked products at  levels not to exceed 400 International Units of 
vitamin D 2 per 100 grams in the finished food.  This  action is in response to a petition filed by 
Lallemand, Inc.  The complete text of the Final Rule  in the Federal Register (available in English) can 
be obtained online at:  http://www.gpo.gov/fdsys/pkg/FR -2012-08-29/pdf/2012-21353.pdf  
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:    
Comment period:  (If the addendum extends the scope of th e previously notified measure in terms 
of products and/or potentially affected Members, a new deadline for receipt of comments should be 
provided, normally of at least 60 calendar days.  Under other circumstances, such as extension of 
originally announced final date for comments, th e comment period provided in the addendum may 
vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  28 September 2012.  This rule is effective 29 August 2012.  Submit 
either electronic or written objections and requests. G/SPS/N/USA/1966/Add.1 
Page 2  
 
  Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax num ber and e-mail address (if available) of other 
body: 
You may submit either electronic or written objecti ons and requests for a hearing, identified by 
Docket No. FDA 2009 F 0570, by any of the following methods: 
Submit electronic objections in the followi ng way:  Federal eRulemaking Portal:  
http://www.regulations.gov .  Follow the instructions for submitting comments. 
Submit written objections:  Fax:  301.827.6870.  Mail/Hand delivery/Courier (for paper or CD ROM 
submissions):  Division of Dockets Manageme nt (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  Instructions:  All submissions received must 
include the Agency name and Docket No. FDA ] 2009 ]F 0570.  All objections received will be posted 
without change to http://www.regulations.gov , including any personal information provided. 
For further information contact:  Judith Kidwe ll, Centre for Food Safety and Applied Nutrition 
(HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240.402.1071. 
Text available from:  [X] National Notification Au thority, [ ] National Enquiry Point.  Address, 
fax number and e-mail address (if available) of other body: 
United States SPS National Notification Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 14, Washington D.C. 20250;  Tel:  +(1 202) 720 
1301;  Fax:  +(1 202) 720 0433;  E-mail :  us.spsenquirypoint@fas.usda.gov  
 
__________