. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1185 
20 December 2005 
 (05-6210) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
   
 
NOTIFICATION 
 
1. Member to Agreement notifying:  UNITED STATES
 
If applicable, name of local government involved:   
2. Agency responsible:  US Food and Drug Administration  
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):  All foods 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners 
5. Title, language and number of p ages of the notified document:  Food Additives 
Permitted for Direct Addition to Food for Human Consum ption; Synthetic Fatty Alcohols 
(Available in English, 3 pages)  
6. Description of content:  US Food and Drug Administration issued a final rule amending the 
food additive regulations under Ti tle 21, Code of Federal Regula tions part 172 for the safe use 
of n-octanol (n-octyl alcolhol) produ ced by a new manufacturing process, the 
hydrodimerization of 1,3-butadiene.  
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. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:  Final rule published 
in the Federal Register at 70 FR 72906 (Availa ble in English).  The notice can be found at 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/pdf/
05-23745.pdf  
10. Proposed date of adoption:  This rule is effective 8 Decembe r 2005.  In a notice published 
in the Federal Register of 26 May 1994 (59 FR 27281) FDA announced that the food additive 
petition had been filed.  
11. Proposed date of entry into force:  This rule is effe ctive 8 December 2005.  G/SPS/N/USA/1185 
Page 2  
 
 12. Final date for comments:  9 January 2006 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
Submit written or electronic comments identified by Docket No. 1994F-0153, 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. 
 Submit written submissions in the following ways: 
• FAX: 301-827-6870    
• Mail/Hand delivery/Courier [For paper, di sk, or CD-ROM submissions]: Division 
of Dockets Management (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 number for 
this rulemaking. All objec tions received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm
. 
13. Texts available from:  [   ] National noti fication authority, [ X ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:   
Ms. Lashonda McLeod, United States SPS Nati onal Notification Authority, USDA Foreign 
Agricultural Service, Food Safety & Technical Services Division, Stop 1027, Washington D.C. 20250.  Tel:  202-720-5683; Fax:  202-690-0677; E-mail:  fstsd@usda.gov
Complete 
text can be also be found on the Internet at  
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  and insert Docket No. 1994F-
0153.  For access to the docket to read bac kground documents or comments received, go to 
http://www.fda.gov/ohrms/dockets/default.htm  and insert the Docket No. 1994F-0153 into 
the "Search" box and follow the prompts.