. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/84 
8 October 2004 
 (04-4223) 
Committee on Technical Barriers to Trade Original:  English 
   
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration  (87)  
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):    
Cosmetics (HS Chapter 3304) (ICS 71.100)   
5. Title, number of pages and language(s) of the notified document:   Listing of Color 
Additives Subject to Certification;  D&C Black No. 2; (4 pages, in English) 
6. Description of content:   FDA announces a Final Rule adding Section 74.2052 to  part 74 of 
Title 21 of the Code of Federal Regulations to  provide for the safe use of D&C Black No. 2, 
a high purity furnace black, subject to FDA batch certification, as a color additive in the 
following cosmetics:  Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and 
rouge, makeup and foundation, and nail enamel.  The regulation describes the identity, specifications, uses and restrictions, labelling, and certification requirements for the safe use of the color additive in cosm etics in the United States.    
7. Objective and rationale, including the na ture of urgent problems where applicable:  
FDA concludes that there is a reasonable cer tainty that no harm will result from the 
petitioned use of D&C Black No. 2 as a color additi ve in the following cosmetics:  Eyeliner, 
brush-on-brow, eye shadow, mascara, lipstick,  blushers and rouge, makeup and foundation, 
and nail enamel.  The agency also concludes th at the color additive will achieve its intended 
technical effect, and thus, is suitable for this  use.  Because the color additive may contain 
low levels of potentially carcinogenic polynuclear aromatic hydrocarbon (PAH) contaminants, the FDA set PAH specifications for D&C Black No. 2 and is requiring that 
the color additive be from a batc h that has been certified by FDA.  In addition, to limit the 
amounts of heavy metals present in the color additive, specifications have been set for 
arsenic, lead, and mercury.    
8. Relevant documents:   69 Federal Register (FR) 44927 28 July 2004;  Title 21 Code of 
Federal Regulations (CFR) Part 74.  Will a ppear in the Federal Register when adopted. G/TBT/N/USA/84 
Page 2  
 
9. Proposed date of adoption:   
Proposed date of entry into force:   }30 August 2004 
10. Final date for comments:   Comments on the rule can be submitted anytime; however, the 
final date for filing objections to the ru le was 27 August 2004.  No objections were 
received. 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:        
Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/04-
17153.htm  
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/pdf/
04-17153.pdf  
 