EU UFI registration process for dental floss
Date：2026-04-13 09:54:45 Classification
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Guidelines for the EU UFI registration process for dental floss. Dental floss belongs to the category of oral care cosmetics and requires UFI (Unique Formula Identifier) registration for sale in the EU market. The following is the complete processing procedure:
1、 Confirm product classification and responsible person
Product Qualification: Clarify the regulatory classification of dental floss in the European Union. Regular dental floss is usually classified as a cosmetic (Regulation EC 1223/2009), and may be classified as a medical device if claimed to have therapeutic or medical effects.
Responsible Person Establishment: A responsible person must be designated within the European Union or EEA to be responsible for product compliance and notification obligations. The responsible party can be the manufacturer, importer, or designated third party.
2、 Prepare product technical documents
Formula information: Collect complete dental floss product formulas, including all ingredients and their concentrations, especially ingredients that may cause allergic reactions (such as fragrances, preservatives, etc.).
Product label information: Prepare a sample product label that includes necessary EU cosmetic label elements, such as ingredient list (country/origin), responsible person information, instructions for use, batch identification, etc.
Toxicological data: Organize the toxicological profile information of the product formula, which is the core data for subsequent submission to the Toxicology Center Notification (PCN).
3、 Generate UFI encoding
Encoding rule: UFI is a unique identifier composed of 20 hexadecimal digits, with a format of 4 sets of 4 characters, such as A1B2-C3D4-E5F6-G7H8.
Calculation method: UFI combines the key ingredient information (such as the highest concentration ingredient) in the product formula with the responsible person/product information through a specific algorithm to generate a calculation.
Tool acquisition: It can be automatically generated through official tools provided by the European Commission (such as the UFI generator developed by SCCS) or third-party compliance software.
4、 Submit Toxicology Center Notification (PCN)
Submission platform: Online submission can be made through the PCN submission portal operated by the European Chemicals Agency (ECHA).
Submission Content:
Basic product information (name, category, purpose)
UFI encoding
Detailed information of the responsible person
Product formula (arranging all ingredients in decreasing concentration)
Toxicology emergency contact information (24-hour emergency hotline)
Product label image
Submission deadline: The submission must be completed before the product is launched, and the information must be updated in real time.
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