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Malaysia Cosmetic Product Registration

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Malaysia Cosmetic Product Registration

COSMETIC REGISTRATION IN MALAYSIA

Regulatory Authority

National Pharmaceutical Regulatory Agency (NPRA) Malaysia

Link for Regulatory Authority

https://npra.gov.my/index.php/en/

Local Regulation

Control of Drugs and Cosmetic Regulations (CDCR) 1984

Who can Register? 

Cosmetic Notification Holder (CNH): Cosmetics-related locally incorporated company or legal entity with a permanent address and registration with the Malaysian Companies Commission. The CNH may or may not be the proprietor of the product.

Data to be Communicated

  • Specifications of the products, such as the name, type, intended application, and presentation
  • Name, address, and legitimate contact number (and e-mail address) of the manufacturer(s) and assembler(s), if applicable.
  • Details of the person representing CNH, including a working phone number
  • Complete product ingredient list (the content, i.e. proportion (percent) of the restricted components must be mentioned) 
  • Name and address of the importer(s), if any
  • A letter of authorization, a declaration, or a letter of contract manufacturing is required.
  • The product’s label(s)

Product Information Requirements:

  • The product’s qualitative and quantitative composition, and in the case of perfume compositions, the composition’s name and code number, as well as the identity of the supplier
  • Raw material and final product specifications
  • The production technique is per the Guideline for Cosmetic Good Manufacturing Practices.
  • Evaluation of the finished product, its ingredients, their chemical structure, and the degree of exposure for human health.
  • Existing evidence of harmful effects on human health as a result of using the cosmetic product

Process to Register Cosmetic Product

  • Prior to manufacturing, selling, supplying, importing, or possessing any cosmetic product, the Cosmetic Notification Holder (CNH) must notify the DPS.
  • All notice submissions must be made online through the NPRA Quest system on the NPRA website at http://npra.moh.gov.my.
  • A CNH must first register for a Quest membership before submitting a notification request. On the NPRA website, there is a step-by-step tutorial on registering for Quest membership.

Timeframe and Fees

The notification of a cosmetic product shall be valid for two years.

Additional Information

The processing fee for notification of a cosmetic product is RM 50.00 for each product. The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released Announcement No. 2/2023 on July 4, 2023, to amend the Guidelines for Control of Cosmetic Products in Malaysia: The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has announced the revision of the Guidelines for Control of Cosmetic Products in Malaysia through Announcement No. 2/2023, issued on July 4, 2023. 

This revision includes the addition of 19 prohibited substances in alignment with the requirements of the ASEAN Cosmetics Directive (ACD), such as 2-Chloroacetamide, Acetaldehyde, Quinoline, Styrene, and Vinyl acetate, many of which are classified as CMR substances. The transitional period for existing products will extend until May 8, 2025.

Additionally, three substances have been added to the list of restricted substances, including Benzoic acid, 2-hydroxy- (CAS No.: 69-72-7), Methyl N-methyl anthranilate (CAS No.: 85-91-6), and Ammonium Silver Zinc Aluminium Silicate (CAS No.: 130328-20-0). Cosmetics containing restricted substances will require approval for sale after the Regulations come into effect. 

Furthermore, two substances have been approved for use: Sodium hydroxy methylamino acetate and 2-cyano-3, 3-diphenylacrylic acid, 2-ethylhexyl ester (CAS No.: 6197-30-4). The ASEAN Cosmetics Directive (ACD) serves as a framework for regulating the manufacturing, import, and sales of cosmetics across the ten ASEAN member countries. 

It aims to harmonize cosmetic regulations to facilitate trade within the region. All ASEAN member countries are required to incorporate the revised content of the ACD into their national legislation. Malaysia has updated its cosmetic substances list to align with the revisions made during the 36th and 37th ASEAN Cosmetics Committee (ACC) meetings held in November and May respectively.

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