Cosmetic Compliance
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Functional Cosmetics Evaluation Regulation (Draft)
Local Title:
기능성화장품 심사에 관한 규정
Country/Region:
South Korea
Status:
Draft
Type:
Regulation
Release Date:
2021-06-03
Implementation Date:
/
Competent Authority:
Ministry of Food and Drug Safety
Document:
Summary

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. 

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History
Functional Cosmetics Evaluation Regulation (Jun. 30, 2021)
Date of Release: 2021-06-30
Date of Implementation : 2021-06-30
Status : In force
Functional Cosmetics Evaluation Regulation (Draft)
Date of Release: 2021-06-03
Date of Implementation : /
Status : Draft
Functional Cosmetics Evaluation Regulation (Dec. 30, 2020)
Date of Release: 2020-12-30
Date of Implementation : 2020-12-30
Status : Invalid
Regulation on the Examination of Functional Cosmetics (draft)
Date of Release: 2020-10-07
Date of Implementation : /
Status : Draft
Regulation on the Examination of Functional Cosmetics
Date of Release: 2019-06-17
Date of Implementation : 2019-06-17
Status : Invalid