G/TBT/N/USA/1937  
3 November 2022  
(22-8246) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Food and Drug Administration (FDA), Health and Human Services (HHS) [1968]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Color 
Additive Certification; Quality (ICS code(s): 03.120); Processes in the food industry (ICS 
code(s): 67.020)  
5. Title, number of pages and language(s) of the notified document:  Color Additive 
Certification; Increase in Fees for Certification Services; (5 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA or we) 
is proposing to amend the color additive regulation to increase the fee for certification 
services. The change in fees will allow FDA to continue to maintain an adequate color 
certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C 
Act). The fees are intended to recover the full costs of operation of FDA's color certification 
program.  
7. Objective and rationale, in cluding the nature of urgent problems where 
applicable:  Quality requirements; Cost saving and productivity enhancement  
8. Relevant documents:   
87 Federal Register (FR) 66116, 2 November 2022; Title 21 Code of Federal Regulations 
(CFR) Part 80:  
https://www.govinfo.gov/content/pkg/FR -2022-11-02/html/2022 -23844.htm  
https://www.govin fo.gov/content/pkg/FR -2022-11-02/pdf/2022 -23844.pdf  
This proposed rule is identified by Docket Number FDA -2022-N-1635. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2022-N-
1635/document  and provides access to primary documents as well as comments received. 
Documents are also accessible from Regulations.gov  by searching the Docket Number . 
WTO Members and their stakeholders are asked to submit comments to the USA TBT 
Enquiry Point  by or before 4pm Eastern Time  on 3 January 2023. Comments received by G/TBT/N/USA/1937  
 
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  the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with 
the regulator and will also be submitted to the Docket  on Regulations.gov if received 
within the comment period.  
Color Additive Certification; Increase in Fees for Certification Services; Interim final rule; 
opportunity for public comment published 29 M arch 2005:  
https://www.govinfo.gov/content/pkg/FR -2005-03-29/html/05 -6155.htm  
https://www.g ovinfo.gov/content/pkg/FR -2005-03-29/pdf/05 -6155.pdf  
Primary and supporting documents available from Regulations.gov  at 
https://www.reg ulations.gov/docket/FDA -2005-N-0294/document . 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  3 January 2023  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2022/TBT/USA/22_740 8_00_e.pdf