Malaysia Cosmetics Regulation

Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations 1984. From year 2002 to the end of year 2007, the control of cosmetic products was conducted through pre-market registration; where the company which is responsible for placing the product in the local market submit product details and relevant certificates for review and registration before the product can be manufactured, imported or sold in the country.

As a member state of ASEAN Malaysia agreed to replace the system with a notification procedure starting from 1 January 2008 in conformance with the harmonization of cosmetic regulations in the ASEAN region. Instead of registration, companies are now required to only notify/declare their compliance status to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Regulatory Agency (NPRA). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines. A Notification Note should be printed out for every product and variant (if any) and will act as authorization to carry out the above-mentioned activities. The notification of a cosmetic product shall be valid for 2 years. The renewal should be done no later than 1 month prior to expiry together with the processing fee.

In the meantime, the applicant is fully responsible for the safety, quality and efficacy of the product. Cosmetic products must not contain any substance that may cause harm to the consumer when applied under normal or reasonably foreseeable conditions of use.

Active product monitoring via the Post Market Surveillance (PMS) program will be conducted by the authority to ensure that only safe products are being marketed. The activities consist the following:

  • Sample collection and testing
  • Monitoring of label compliance
  • Audit of premises for compliance to the Cosmetic GMP
  • Handling of product complaints
  • Monitoring of advertisements
  • Monitoring of adverse reactions
  • Audit on the PIF
  • Risk communication
  • Information sharing through ASEAN Post Marketing Alert System (PMAS)
  • [Market Analysis] Halal Cosmetics Market Rapid Growth Requires Further Regulatory Development

      ChemLinked Exclusive   9 Nov 2017   Jo Zhou

    Takehome: Halal cosmetics are a rapidly developing niche of the halal and mainstream market. The 100% natural ingredients commitment of halal products also attracts many non-Muslims. The increased popularity of these products...
  • ASEAN Explains Revision of Cosmetic Directive

      ChemLinked Exclusive   18 Aug 2017   Jo Zhou

    Take home: Apart from amendments of ingredients requirements on 26th ACSB (see news on CL), ASEAN Cosmetic Committee also discussed further revision of the ASEAN Cosmetic Directive during a recent...
  • ASEAN Revises and Supplements Cosmetic Ingredient Standards (2017-2018)

      ChemLinked Exclusive   6 Jul 2017   Jo Zhou

    Take home: ASEAN held the 26th ACSB Meeting during which it revised cosmetic ingredients requirements, shortly after ASEAN released the last revision list a month ago (see news: ASEAN Added New Standards for...
  • ASEAN Revises Sunscreen Labelling Guideline

      ChemLinked Exclusive   20 Jan 2015   Ben Teoh

    During the 21st meeting of the ASEAN Cosmetics Committee and ASEAN Cosmetics Scientific Body, the ASEAN Sunscreen Labelling Guideline was heatedly discussed by the representatives from all the member...
  • ASEAN Cosmetics Directory Further Aligns With EU Regulations

      ChemLinked Exclusive   20 Jan 2015   Ben Teoh

    The ASEAN Cosmetics Committee and ASEAN Cosmetics Scientific Body reviewed and implemented a series of EU regulations at their 21st meeting. Several EU regulations were entered into the ASEAN Cosmetics...