MoCRA와 관련하여, 2023년 12월 19일, 미국 FDA에서는 "시설 등록 및 제품 리스팅 : 산업계를 위한 가이던스 최종판"을 발표하였습니다.

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products

Docket Number:

FDA-2023-D-1716

Issued by:

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NOTE: Appendix B of this guidance that describes frequently asked questions and answers is being distributed for comment purposes only.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

Announcements 

• 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)