FDA announces SPL XForms now available for cosmetic product listing and facility registration submissions



This week, the U.S. Food and Drug Administration (FDA) released a Cosmetics Constituent Update announcing that Structured Product Labeling (SPL)​ XForms are now available for cosmetic product facility registration and cosmetic product listings under the Modernization of Cosmetics Registration Act (MoCRA​). XForms are an additional authoring tool option for Structured Product Labeling (SPL).

About SPL XForms

As previously reported​ by CosmeticsDesign last month, SPL submissions are “a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information​,” as detailed on the FDA website. SPL XForms can be accessed here​, and there are separate options for Cosmetic Facility Registration and Cosmetic Product Listings.

SPL XForms are web-based, require no downloads, and can be accessed on Mac or PCs. They are compatible with Mozilla Firefox (recommended) (6 and higher), Microsoft Edge Chromium (110 and higher), Google chrome (8 and higher) and Apple Safari (4 and higher) and contain a built-in validator to detect up to 95% of errors, according to the FDA’s website.

For questions or to receive updates on SPL XForms, users can email FCY@sqn.uuf.tbi​ for more information.

Other electronic submission options

Other submission options for cosmetic product listings and cosmetic product facility registrations include Cosmetics Direct​, a free SPL tool that will “provide information to FDA/Office of Cosmetics and Colors (OCAC) about cosmetic product manufacturers/processors and cosmetic products on the market​,” according to the website.



Source link

About The Author