This regulation mainly regulates the requirements for evaluation dossiers of functional cosmetics including the scope, requirement, exemption conditions of required dossiers and the standard of evaluation including product name, ingredient and its amount, dosage, efficacy, usage, warning and testing methods.
Contents:
Chapter 1 Purpose
Chapter 2 Definition
Chapter 3 Examination Subjects
Chapter 4 Data Scope
Chapter 5 Data Requirement
Chapter 6 Exception of Data Submission
Chapter 7 Data Preparation
Chapter 8 Further Data Complement
Chapter 9 Product Name
Chapter 10 Raw Material and Contents
Chapter 11 Texture
Chapter 12 Deleted
Chapter 13 Effectiveness and Efficiency
Chapter 14 Usage and Dosage
Chapter 15 Precautions for Use
Chapter 16 Deleted
Chapter 17 Standard and Test Method
Chapter 18 Consultation
Chapter 19 Re-evaluation of the Provisions
Amendments:
On June 3, 2021, MFDS issued the draft of Functional Cosmetics Evaluation Regulation to solicit public opinion. The authority proposed to add the ISO testing method as the permitted SPF testing method. The draft also specifies the application dossier scope and situations of dossier submission exemption.
Original regulatory document
