WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2067 
13 August 2010  
 (10-4326) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES
 
If applicable, name of local government involved:    
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  The following food additives are covered in this filing notice:  Hydrogen 
peroxide (HS Code: 2847), amino acids (H S Code: 2922.49.40), folic acid (HS Code: 
2936.29.10), vitamin D3 (HS Code: 2936.29.50), vitamin D2 (HS Code: 2936.29.50), 
gellan gum, 1,3-butylene glycol (HS Code: 2905 .39.10), epoxidized soybean oil (HS Code: 
1518.00), glycerides and polyglycerides of hydrogenated vegetable oils, acacia gum (HS Code: 1301.20.00), acesulfame potassium, asp artame (HS Code: 29.24.29.10), dioctyl 
sodium sulfosuccinate, glycine (HS Code : 2922.49.40), sucralose, sucrose acetate 
isobutyrate, polydextrose, sodium stearoyl lactylate, propylene glycol alginate, oleic acid 
derived from tall oil fatty acids (HS Code: 2916.15.10), olestra, sucrose oligoesters, a-
acetolactate decarboxylase enzyme preparation , Candida guilliermondii , Candida 
lipolytica , ethyl acetate (HS Code: 2915.31.00), so lvent extraction process for citric acid 
(HS Code: 2918.14.00), boiler water additiv es: sodium carboxymethyl cellulose and 
sorbitol anhydride esters, ozone, hydrogen peroxide solution (HS Code: 2847), mannitol 
(HS Code: 2905.43.00), brominated vegeta ble oil (HS Code: 1518.00), saccharin (HS 
Code: 2925.11.00) 
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:  United States Pharmacopeial Convention;  Filing of Food 
Additive Petition  Language:  English  Number of pages:  3   
6. Description of content:  The Food and Drug Administration (FDA) is announcing that the 
United States Pharmacopeial Convention h as filed a petition proposing that the food 
additive regulations that incorporate by re ference food-grade specifications from prior 
editions of the Food Chemicals Codex (FCC) be  amended to incorporate by reference food-
grade specifications from the FCC, 7th Edition. 
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.    G/SPS/N/USA/2067 
Page 2  
 
  8. Is there a relevant international stan dard?  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:  Filing notice 
published in the Federal Register at  75 FR 48353 (available in English) 
http://edocket.access.gpo.g ov/2010/pdf/2010-19722.pdf    
10. Proposed date of adoption (dd/mm/yy) :  To be determined. 
Proposed date of publication (dd/mm/yy) :  10 August 2010 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  To be determined. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Comments will be accepted at anytime after publication of the notice 
of filing.  However, if a final rule is promulgated, it will address only those comments 
received prior to publica tion of the final rule. 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if available) of other body:   
Submit written comments on the document to th e Division of Dockets Management (HFA-
305), Food and Drug Administ ration, 5630 Fishers Lane, rm . 1061, Rockville, MD 20852, 
United States.   
It is also possible to submit electronic comments to:  http://www.regulations.gov
.  Submit 
comments by indicating Docket Number FDA-2010-F-0320 and United States Pharmacopeial Convention;  F iling of Food Additive Petition.  G/SPS/N/USA/2067 
 Page 3 
 
 
  13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
United States SPS National Notification Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Di vision (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  
us.spsenquirypoint@fas.usda.gov 
 
Complete text can also be found on the Internet at 
http://edocket.access.gpo.g ov/2010/pdf/2010-19722.pdf  
 
For access to the docket to read background documents or comments received, go to 
http://www.regulations.gov  and insert the Docket No. FDA-2010-F-0320 into the "Search" 
box and follow the prompts.