. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1097 
3 August 2005 
 (05-3495) 
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:  U.S. 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):  all foods 
4. Regions or countries likely to be affected, to the extent relevant or practicable:   
Trading  Partners 
5. Title, language and number of pages of the notified document:   Listing of Color 
Additives Exempt from Certification; Tomato  Lycopene Extract and Tomato Lycopene 
Concentrate; 3 pages; available in English 
6. Description of content:  U.S. Food and Drug Administration issued a final rule amending 
the color additive regulations under Title 21, Code of Federal Regul ations part 73 for the safe 
use of tomato lycopene extract and tomato lyc opene concentrate as colo r additives in food.  
The petition included information on two forms of tomato lycopene extract that differ 
primarily in concentration.  The agency is listing the less concentrated one as tomato 
lycopene extract and the more concentrated form as tomato lycopene concentrate. 
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 43043 (available in English).  The notice can be found at http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/pdf/
05-14631.pdf  
10. Proposed date of adoption:   This rule is effective 26 August, 2005, except as to any 
provisions that may be stayed by the filing of proper objections. G/SPS/N/USA/1097 
Page 2  
 
  
11. Proposed date of entry into force:   This rule is effective 26 August, 2005, except as to any 
provisions that may be stayed by the filing of proper objections. 
12. Final date for comments:  25 August, 2005     
Agency or authority designated t o handle comment s:  [  ] Nation al notification authority, [ X ] 
National enquiry point, or addres s, fax number and E-mail addre ss (if available) of other 
body:    
Submit written or electronic objections and requests for a hearing identified by [INSERT 
Docket No. ], by any of the following methods: 
     Federal eRulemaking Portal: http://www.regulations.gov   
     Agency Web site:  http://www.fda/dockets/ecomments   
     E-mail: fdadockets@oc.fda.gov . Include Docket No. 2001C-0 486 in the subject line of 
the 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 Dr ug 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 r eceived will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm
. 
 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail add ress (if available) of other body: U.S. Enquiry 
Point, U.S. Department of Agriculture, St op 1027, Washington, DC  20250.  TEL (202) 
720-4051, FAX (202) 690-0677, fstsd@usda.gov .    Complete text can be also be found on 
the Internet at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-3026.htm  and insert 
Docket No. 2001C-0486.    For access to th e docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm  and insert the 
Docket No. 2001C-0486 into the "Search'' box and follow the prompts .