Malaysia Updates Cosmetic Product Regulations: New Bans and Restrictions Announced

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has issued Circular No. 3/2024, detailing significant updates to the "Guidelines for Control of Cosmetic Products in Malaysia". These revisions, effective from December 30, 2024, introduce new bans and restrictions on certain substances used in cosmetic products.

Newly Prohibited Substances

Effective November 19, 2026, the NPRA has added several substances to the list of prohibited ingredients in cosmetic products. These include:

• Benzophenone (CAS No. 119-61-9): Previously used as a UV blocker in various cosmetic formulations.

• N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid) (Pentetic acid) (CAS No. 67-43-6): Widely used for its chelating properties.

In total, 26 substances have been newly prohibited under these Directives.

Restricted Substances with Implementation Deadlines

The NPRA has also imposed specific restrictions on certain substances, with defined implementation deadlines:

• Butylated Hydroxytoluene (BHT) (CAS No. 128-37-0):

  • Mouthwash: Maximum concentration of 0.001%.

  • Toothpaste: Maximum concentration of 0.1%.

  • Leave-on and Rinse-off Products: Maximum concentration of 1%.

  • Restrictions will be enforced starting November 19, 2026.

• Homosalate (UV Filter) (CAS No. 118-56-9):

  • Facial Products (excluding propellant sprays): Maximum concentration of 7.34%.

  • Restriction will take effect on November 19, 2027.

Compliance and Enforcement

The NPRA emphasizes that all entities involved in the manufacture, sale, supply, import, or possession of cosmetic products must adhere to these updated guidelines. Non-compliance may result in regulatory action, including product recalls or penalties.

These regulatory changes are in line with decisions made at the 40th ASEAN Cosmetic Committee Meeting in November 2024, and reflect Malaysia's commitment to regional harmonization and consumer safety.

For detailed information and the complete list of affected substances, stakeholders are encouraged to consult the official NPRA directive here.