. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/873/Add.1 
22 November 2004 
 (04-5067) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
 
 
 The following communication, dated 17 November 2004, is being circulated at the request of 
the Delegation of the United States.  
_______________ 
  
Final Rule;  Food Additives Permitted in Food on an  Interim Basis or in Contact With Food Pending 
Additional Study;  Mannitol  
  The Food and Drug Administration publis hed a Final Rule in the Federal
 Register  on 
15 November 2004 (69 FR 65540) amending the food additive regulations to permit the manufacture 
of mannitol by fermentation of sugars such as fruct ose, glucose, or maltose by the action of the 
microorganism Lactobacillus intermedius (fermentum) .  This action is in response to a petition filed 
by zuChem, Inc.  This document can be obtained online at:   http://www.fda.gov/OHRMS/DOCKETS/98fr/04-25243.htm
 
 or 
http://frwebgate2.access.gpo.gov/cgi-
bin/waisgate.cgi?WAISdocID= 53806318174+1+0+0&WAIS action=retrieve  
  This rule is effective 15 November 2004.  Any person who will be adversely affected by this 
regulation may file written or electronic objections and requests for a hearing with the Division of 
Dockets Management by 15 December 2004.  Su bmit written objections and requests for a hearing 
identified by Docket No. 2004F-0066, by any of the following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov
.  Follow the instructions for submitting 
comments. • Agency Web site:  http://www.fda.gov/dockets/ecomments
.  Follow the instructions for submitting 
comments on the agency Web site.  
• E-mail:  fdadockets@oc.fda.gov .  Include Docket No. 2004F-0066 in  the subject line of your e-mail 
message.   • Fax:  301-827-6870 • Mail/Hand delivery/Courier [For paper, disk, or  CD-ROM submissions]:  Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fish ers Lane, rm. 1061, Rockville, 
MD  20852.  
  All submissions received must include the agency name and docket number for this rulemaking.  All objections received wi ll be posted without change to  
http://www.fda.gov/ohrms/dockets/default.htm
, including any personal information provided.  
 
 In a notice published in the Federal Register of 19 February 2004 (69 FR 7759), the Food 
and Drug Administration announced th at a food additive petition (FAP 4A4754) had been filed.  The G/SPS/N/USA/873/Add.1 
Page 2  
 
 petition proposed to amend the food additive regulat ions in Sec.  180.25 Mannitol (21 CFR 180.25) to 
permit the manufacture of mannitol by fermentation of  sugars such as fructose, glucose, and maltose 
by the action of the microorganism L. intermedius (fermentum). 
 
 For further information contact:  Celeste J ohnston, Center for Food Safety and Applied 
Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD  
20740-3835, 301-436-1282. 
 
 Ms. Julie Morin, United States SPS Enquiry Point Officer, USDA Foreign Agricultural Service, Food Safety & Technical Services Division, Stop 1027, Washington D.C. 20250.  Tel:  202-720-4051;  Fax:  202-690-0677;  Email:  fstsd@usda.gov
 
 
 
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