On August 7, 2023, the U.S. Food and Drug Administration (FDA) released the draftCosmetics & Personal CareGuidance for Industry: Cosmetic Facility Registration and Product Listing, further clarifying the requirements under the Modernization of Cosmetics Regulation Act of 2022. For Chinese cosmetic enterprises looking to export to the U.S., the following four key points cannot be overlooked:

New Electronic Submission Platform

? FDA plans to launch a new electronic submission platform in 202310 for facility registration and product listing.
? The FDA encourages companies to adopt electronic submission methods to improve the efficiency and timeliness of data submission and management.
? Additionally, the FDA is developing paper forms as an alternative submission tool to the electronic submission portal.

Facility Establishment Identifier (FEI)

? The FDA will use FEI as the mandatory number for facility registration.
? Facility owners or operators must obtain an FEI number before submitting registration.
? Responsible persons must obtain corresponding FEI numbers for each production or processing facility and provide them during product listing submission.
? If a facility qualifies for small business exemption and lacks an FEI number, the facility name/address may be provided as an alternative.

Two Exemptions for Facility Registration

? Small-scale businesses: Businesses with average annual cosmetic sales below $1 million in the U.S. market over the past three years may qualify as small-scale businesses.
? Specific product businesses: Businesses manufacturing products that also require compliance with drug orMedical Equipmentregulatory requirements may be exempt from registration.

Required content for product listing

? Product name, FDA cosmetic category, ingredient list, product listing number, registration number for each facility, responsible person information, and submission type.

With the significant growth in Chinas total cosmetic exports in 2022, the number of cosmetic companies exporting to the U.S. has also increased. Therefore, China Customs reminds businesses to strengthen communication with importers, monitor revisions to this draft guidance, and familiarize themselves with required procedures and content in advance. This ensures timely and accurate completion of registration and product listing submissions per U.S. requirements post-implementation, guaranteeing smooth export operations.

Draft original text:FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products | FDA

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