. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1224 
3 February 2006 
 (06-0451) 
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 Ad ministration (FDA)  
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):  32050015, 32030010, 32050005 (carmine and cochineal extract)  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  U.S. 
trading partners  
5. Title, language and number of pages of the notified document:  Final rule.  Listing of 
Color Additives Exempt from Certificati on; Food, Drug, and Cosmetic Labelling; 
Cochineal Extract and Carmine Declarati on (Available in English;  13 pages).  
6. Description of content:  FDA has issued a proposed rule to require the declaration by name 
of the color additives carmine and cochin eal extract on all foods and cosmetics.  
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:  Proposed rule 
published in the Federal Register:  30 January 2006, (Volume71, Number 19 FR 4839). Available in English.  Page 4839-4851 , http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-
1104.htm . 
10. Proposed date of adoption:  Upon publication of final rule  
11. Proposed date of entry into force:  2 years after publication of final rule  G/SPS/N/USA/1224 
Page 2  
 
  12. Final date for comments:   1 May 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 Number 1998P-0724, 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, disk, 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.  
13. Texts available from:  [ X ] National notifi cation authority, [   ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:   
Ms Lashonda McLeod, United States SPS Nationa l Notification Authority, USDA Foreign 
Agricultural Service, Food Safety & Technical Services Division, Stop 1027, Washington, DC 20250.  Tel:  202-720-5683;  Fa x:  202-690-0677;  Email:  fstsd@fas.usda.gov  
Complete text can also be found on the Internet. 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1104.htm .  For access to the docket to 
read background documents or comments received, go to 
http://www.fda.gov/ohrms/dockets/default.htm  and insert the Docket No. 1998P-0724 into 
the "Search" box and follow the prompts.