. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1749 
9 January 2008  
 (08-0082) 
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 numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Astaxanthin dimethyldisuccinate as colour additive in the feed of salmonid fish 
to enhance the colour of their flesh, 2309 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  US 
trading partners 
5. Title, language and number of pages of the notified document:   
DSM Nutritional Products, Inc.; Filing of Colour Additive Petition (available in English, 
2 pages)   
DSM Nutritional Products, Inc.; Filing of Colour Additive Petition; correction (available in 
English, 1 page) 
6. Description of content:  The Food and Drug Administration (FDA) is announcing that DSM 
Nutritional Products, Inc. has filed a petition propos ing that the colour additive regulations be 
amended to provide for the safe use of Astaxa nthin dimethyldisuccinate as a colour additive 
in the feed of salmonid fish to enhance the colour of their flesh in 21 CFR 73 Listing of 
Colour Additives Exempt  from Certification.  
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:   Filing notice published 
in the Federal Register at 72 FR  68166 (available in English)  
http://www.fda.gov/OHRMS/ DOCKETS/98fr/E7-23473.pdf  and the corrected notice at 72 
FR 73028  http://www.fda.gov/OHRMS/ DOCKETS/98fr/E7-24911.pdf    
10. Proposed date of adoption:  To be determined. G/SPS/N/USA/1749 
Page 2  
 
  11. Proposed date of entry into force:  To be determined. 
12. Final date for comments:  Comments will be accepted at anytime after publication of the 
notice of filing; however, if a final rule is pr omulgated, it will address only those comments 
that were received prior to publication of the final rule. 
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 Number 2007C-0474 , by any of 
the following methods: • Federal eRulemaking Portal: http://www.re gulations.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/C ourier [For paper, disk, or CD-R OM 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 objections received  will be posted without change to 
http://www.fda.gov/ohrms /dockets/default.htm
 
13. Texts available from:  [ X ] National notificati on authority, [   ] Na tional enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS National Notification Aut hority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720-1301;  Fa x:  +(1 202) 690-0677;  E-mail:  
us.spsenquirypoint@fas.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. 2007C-
0474.    For access to the docket to read b ackground documents or comments received, go to 
http://www.fda.gov/ohrms /dockets/default.htm  and insert the Docket No. 2007C-0474 into 
the "Search'" box and follow the prompts.