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          Guidance for Industry:  Registration and Listing of Cosmetic Product Facilities and ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry:  Registration and Listing of Cosmetic Product Facilities and Products
					
		
		December 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2023-D-1716
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of the Commissioner, Office of the Chief Scientist


This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. This guidance document explains, among other things:

The statutory requirement to submit cosmetic product facility registrations and product listings;
	Definitions;
	Who is responsible for making the submissions;
	What information to include in the submissions;
	How to make the submissions; and
	When to make the submissions.FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should*in FDA guidances means that something is suggested or recommended, but not required.

**NOTE: Appendix B of this guidance that describes frequently asked questions and answers is being distributed for comment purposes only.**

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the Appendix B before we begin work on the final version of Appendix B, submit either electronic or written comments on this document by January 18, 2024. You may submit comments electronically on Regulations.gov to docket folder FDA-2023-D-1716. See the *Federal Register*notice for additional information on commenting.


Download the Guidance

Related Resources

Cosmetic Product Categories and Codes
	Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
	Registration & Listing of Cosmetic Product Facilities and Products
	More Cosmetic Guidance & RegulationsAnnouncements

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products (December 2023)
	FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (November 2023)
	FDA Issues Update on Cosmetic Product Facility Registration and Cosmetic Product Listing (November 2023)
	FDA Publishes Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings (October 2023)
	FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products (August 2023)
	FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program(March  2023)Submit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2023-D-1716.

                                                                                  Content current as of:
      12/18/2023
         
                  
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