G/TBT/N/USA/1287/Add.3  
 
11 October 2021  
(21-7655) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  11 October 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for 
Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University 
Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural 
Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, 
Maricel Maffini, and Howard Mielke; Filing of Color Additive Petition  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[X] Notified measure published - date: 8 October 2021  
[X] Notified measure enters into force - date: 6 January 2022  
[X] Text of final measure available from1:  
https://www.govinfo.gov/content/pkg/FR -2021-10-08/html/2021 -21892.htm  
https://www.govinfo.gov/content/pkg/FR -2021-10-08/pdf/2021 -21892.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/final_measure/21_6496_00_
e.pdf 
Final rule; response to objections and denial of public hearing requests; removal of 
administrative stay  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol  if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  TITLE: Termination of Listing of Color Additives Exempt From Certification; Lead 
Acetate  
AGENCY: Food and Drug Administration, HHS  
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1287/Add.3  
 
- 2 - 
 
  ACTION: Final rule; response to objections and denial of public hearing requests; removal of 
administrative stay  
SUMMARY: Th e Food and Drug Administration (FDA or we) is responding to objections and a public 
hearing request that we received from Combe Inc., on the final rule entitled "Termination of Listing 
of Color Additives Exempt From Certification; Lead Acetate," which publ ished on 31 October 2018. 
The final rule amended the color additive regulations to no longer provide for the safe use of lead 
acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have 
concluded that the objection s do not raise issues of material fact that justify a hearing. Therefore, 
the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, 
and we are amending the color additive regulations to no longer provide for  the safe use of lead 
acetate in cosmetics intended for coloring hair on the scalp.  
This rule is effective 6 January 2022.  
This final rule and previous actions notified under the symbol  G/TBT/N/ USA/1287  are identified by 
Docket Number FDA -2017-C-1951. The Docket Folder is available on Regulations.gov 
at https://www.regulations.gov/docket/FDA -2017-C-1951/docume nt and provides access to 
primary and supporting documents as well as comments received. Documents are also accessible 
from Regulations.gov  by searching the Docket Number.  
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