Additional Submission Tools for Cosmetic Product Facility Registration and Product Listing

Recommendation
12/13 November 2025
How to implement EU-GMP Chapter 8
The FDA announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This follows the recently announced launch of Cosmetics Direct, FDA's electronic submission portal.
Xforms is one option of creating an SPL file with cosmetic product facility registration and cosmetic product listing information. However, the agency is also accepting facility registrations and product listings via Cosmetics Direct and SPL-formatted submissions through the Electronic Submissions Gateway (ESG).
Furthermore, the FDA also announced the availability of Form FDA 5066 and Form FDA 5067 as an additional submission tool for providing cosmetic product facility registration and cosmetic product listing information to the agency. These paper forms are available at Registration & Listing of Cosmetic Product Facilities and Products.
While electronic submission is not required, the agency strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.
Related GMP News
08.10.2025Risk-based Determination of the Scope and Frequency of Audit Trail Reviews
01.10.2025Decentralised Manufacturing: New UK Framework in Operation
24.09.2025Responsibilities for the Audit Trail (Review)
17.09.2025When Training Falls Short: FDA Findings on GMP Training Deficiencies in 2025
17.09.2025Dealing with Systems without Audit Trail Functionality