Cosmetic Compliance
Intelligence & Solutions
Guidelines for Control of Cosmetic Products in Malaysia (2017)
Local Title:
Guidelines for Control of Cosmetic Products in Malaysia (2017)
Country/Region:
Malaysia
Competent Authority:
National Pharmaceutical Regulatory Agency
Type:
Regulation
Status:
Invalid
Release Date:
2017-02-01
Implementation Date:
2017-02-01
Document
Language Source Title Access
EN
Official Guidelines for Control of Cosmetic Products in Malaysia (2017)
EN
Official Annex I Part 1 Illustrative List of Cosmetic Products by Categories
EN
Official Annex I Part 2 Non Permissible Product Name For Cosmetic Product
EN
Official Annex I Part 3 Charges For Quest Membership
EN
Official Annex I Part 4 Manual For Quest3 Online Submission For Cosmetic Notification
EN
Official Annex I Part 5 List Of Types of Changes For Notified Product
EN
Official Annex I Part 6 Guideline For Safety Assessment Of Cosmetic Products
EN
Official Annex I Part 7 Cosmetic Labeling Requirements
EN
Official Annex I Part 8 Cosmetic Claims Guideline
EN
Official Annex I Part 9 Guideline For Cosmetic Advertisement
EN
Official Annex I Part 10 Guideline For Good Manufacturing Practice
EN
Official Annex I Part 11 List Of Equivalent Cosmetic GMP Guidelines
EN
Official Annex I Part 12 Guideline For Product Information File PIF
EN
Official Annex I Part 13 Guide Manual For Adverse Event Reporting
EN
Official Annex I Part 14 Heavy Metal And Microbiological Test Limit For Cosmetic Product
EN
Official Annex I Part 15 GUIDELINE FOR SUNSCREEN PRODUCT July 2017
EN
Official Annex II – List of Substances Which Must not Form Part of the Composition of Cosmetic
EN
Official Annex III - List of Substances Which Cosmetic Products Must not Contain Except Subject to Restrictions and Conditions Laid Down
EN
Official Annex IV: List of Colouring Agent Allowed for Use in Cosmetic Products 2017
EN
Official Annex V: List of Excluded from the Scope of the Directive
EN
Official Annex VI List of Preservatives Which Cosmetic Products May Contain 22 June 2022
EN
Official Annex VII List of UV Filters Which Cosmetic Products May Contain 15 November 2021
Summary
This GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA shall serve as reference for notification process including quality control, inspection and post-market surveillance activities of cosmetics. This document will replace the GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA Initial Publication 1st January 2008.

The content of this guideline is adapted from the ASEAN Cosmetic Directive (ACD). This guideline shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing cosmetics for human use in Malaysia, which include but not limited to the following:
  • Sale of Drugs Act 1952

  • Control of Drugs and Cosmetics Regulations 1984

  • Dangerous Drugs Act 1952 Poisons Act 1952

  • Medicines (Advertisement & Sale) Act 1956

  • Patents Act 1983

  • Wildlife Conservation Act 2010 (Laws of Malaysia Act 716)

  • International Trade in Endangered Species Act 2008 (Act 686)

  • Medical Device Act 2012 Trade Descriptions Act 2011


The written laws shall take precedence over this guideline in any event of discrepancy.

The scope of this guideline includes information relating to:
  • Submission of cosmetic notification through the NPRA Quest online system.

  • Regulatory requirements for cosmetic products

  • Post market surveillance activities

Cosmetic Notification Holder (CNH) shall understand the content of this guideline and the governing legislations before submission of a cosmetic notification is made.
 
The NPRA may request for information or specify conditions not described in this guideline that are deemed necessary to ensure the quality, safety and claimed benefit of the cosmetics.
 
Regular review of regulatory policies will continue, taking into account the global regulatory environment to allow for timely and pertinent changes. CNH may refer to Directives and Circulars published on the NPRA website for the latest updates on regulatory policies.
 
Changes to the guideline may be made when necessary by the NPRA and CNH is advised to refer to NPRA website for the latest updates of the cosmetic guideline and other related guidelines.
History
2024-01-19
2023-07-04
2023-01-12
2022-07-19
In force
Release Date: 2022-07-19
Implementation Date : 2022-08-01
2022-07-18
In force
Release Date: 2022-07-18
Implementation Date : 2022-07-18
2022-07-06
2021-12-13
2021-09-29
2021-05-07
2017-02-01
Guidelines for Control of Cosmetic Products in Malaysia (2017)
Invalid
Release Date: 2017-02-01
Implementation Date : 2017-02-01
Noteworthy Information