This week, the U.S. Food and Drug Administration (FDA) released its Cosmetic Ingredient Update, announcing: Structured Product Label (SPL)XForms is now available for cosmetic establishment registration and cosmetic listings under the Cosmetic Registration Modernization Act (MoCRA). XForms is an additional authoring tool option for Structured Product Labeling (SPL).
About SPL XForms
as before As reported by CosmeticsDesign last month, the SPL application isDocument markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility informationFor more information, please visit the FDA website. Accessible to SPL XForms herethere are separate options for registering cosmetic establishments and listing cosmetics.
SPL XForms is web-based, requires no download, and can be accessed from your Mac or PC. They are compatible with Mozilla Firefox (recommended) (6 and above), Microsoft Edge Chromium (110 and above), Google chrome (8 and above), and Apple Safari (4 and above), and up to according to the FDA website. 95% of errors.
Users can send email if they have questions or would like to receive updates on SPL XForms. FCY@sqn.uuf.tbiFor more information,
Other electronic submission options
Other submission options for Cosmetics List and Cosmetic Facility Registration include: cosmetics directa free SPL tool.Provide information to FDA/Office of Cosmetic Colors (OCAC) about cosmetic manufacturers/processors and commercially available cosmetic products” according to the website.
In addition to Cosmetics Direct, which went live last month, the F.D.A. Electronic Submission Gateway (ESG), we also accept submissions in SPL format. FDA’s ESG is “An agency-wide solution to accept the majority of electronic regulatory submissions“and that”Enables secure submission of premarket and postmarket regulatory information for review” according to the organization’s website.
“FDA ESG is a central submission point for electronically transmitting information to FDA.According to the landing page,”, and “In that context, FDA ESG is the pathway for submissions to reach the appropriate FDA center or office.”
For questions or issues with submitting cosmetic product listings or facility registration information via FDA ESG, users may contact us via email. RFTUrycQrfx@sqn.uuf.tbiAsk for help. FDA also maintains his ESG Center submission type pageFor more information,
Paper submission options
Under MoCRA, companies may also choose to submit product listings and facility registration information in paper forms. In its latest cosmetic ingredient update, the FDA announced:Availability of Form FDA 5066 and Form FDA 5067 as additional filing tools“option.
These forms are now available for download heremay also be submitted by mail to: Food and Drug Administration, Bureau of Cosmetic and Color, Registration and Listing of Cosmetic Facilities and Product Programs, 5001 Campus Drive, CPK1, Room 1B-046, College Park, MD 20740- 3835 or by email EYP-CncreFhozvffvbaf@sqn.uuf.tbi.
In its update, the FDA states that while electronic submission is not required, it is strongly recommended.To facilitate efficiency and timeliness of agency data submission and management”
