. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1224/Add.1 
12 January 2009  
 (09-0061) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
  
The following communication, received on 7 January  2009, is being circulated at the request 
of the Delegation of the United States
. 
 
_______________  
  
Listing of Colour Additives Exempt from Certif ication; Food, Drug, and Cosmetic Labelling; 
Cochineal Extract and Carmine Declaration, Final Rule  
 
On 5 January 2009, FDA issued a final rule to re quire the declaration by name of the colour 
additives carmine and cochineal extract on all foods and cosmetics.  
 
The final rule published in the Federal Register at  74 FR 207 (available in English).   Text can 
be found at:  http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-31253.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. FDA-1998-P-0032 
(formerly Docket Number 1998P-0724) into the "Search" box and follow the prompts. 
 
This action is subsequent to a proposed rule published in the Federal Register on 30 January 
2006.  This notice can be found at:  Federal Re gister:  30 January 2006 (Volume 71, Number 19) 
Notices Page 4839-4851;  http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1104.htm . 
 This addendum concerns a: 
 
 [   ] Modification of final date for comments  [ X ] Notification of adoption, publication or entry into force of regulation 
 [   ] Modification of content and/or sc ope of previously notified draft regulation 
 [   ] Withdrawal of proposed regulation 
 [   ] Change in proposed date of adoptio n, publication or date of entry into force 
 [   ] Other:     
Comment period: (If the addendum extends the scope of th e previously notified measure in terms 
of products and/or potentially affected Members, a new deadline for receipt of comments should be 
provided, normally of at least 60 calendar days.  Under other circumstances, such as extension of 
originally announced final date for comments, th e comment period provided in the Addendum may 
vary.)  
 [   ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  4 February 2009 G/SPS/N/USA/1224/Add.1 
Page 2  
 
   This regulation is effective 5 January 2011.  All affected products initially introduced or 
initially delivered for introduction into intersta te commerce on or after this date shall fully 
comply, except as to any provisions that may be stayed by the filing of proper objections.  Voluntary compliance with this final regula tion, including making any required labelling 
changes, may begin immediately. 
 
Agency or authority designated to handle comments:  [   ] National Notification Authority, [   ] 
National Enquiry Point.  Address, fax number and E-mail address (if available) of other body
: 
 
Written or electronic obj ections and requests for a hearing, on 21 CFR 73.100 and 73.2087, identified by 
Docket No. FDA-1998-P-0032 (formerly Docket Nu mber 1998P-0724) and RIN number 0910—AF12, 
may be submitted by any of the following methods:  Submit electronic objections in the following way: • Federal eRulemaking Portal:  http://www.regulations.gov
.  Follow the instructions for 
submitting comments. 
 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 Administra tion, 5630 Fishers Lane, rm. 1061, Rockville, MD  
20852. 
 Instructions
:  All submissions received must include the agency name and Docket Number(s) and 
Regulatory Information Number (RIN) (if a RIN numb er has been assigned) fo r this rulemaking.  All 
objections received may be posted without change to http://www.regulations.gov , including any 
personal information provided. 
 
Text 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, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 27, Washington D.C. 20250;  Tel:  +(1 202) 720 
1301;  Fax:  +(1 202) 720 0433;  E-mail :  us.spsenquirypoint@fas.usda.gov  
 
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