Putrajaya, January 2026. National Pharmaceutical Regulatory Agency (NPRA) has issued Circular No. 1/2026 to align Malaysia’s Guidelines for Control of Cosmetic Products in Malaysia with decisions of the 42nd ASEAN Cosmetic Committee meeting held in Jakarta on 20–21 November 2025. The circular informs cosmetic notification holders of amendments to Annex II (Prohibited Substances), Annex III (Restricted Substances) and Annex VII (UV Filters) of the ASEAN Cosmetic Directive as adopted nationally.

What Changes in the Annexes

Annex II — Prohibited Substances

• 4-Methylbenzylidene Camphor (4-MBC). Newly listed under Annex II with a grace period. Notified cosmetic products that contain 4-MBC may remain on the market until 17 November 2028. After that date 4-MBC is prohibited.

• Miconazole and Miconazole Nitrate. Moved to Annex II with immediate effect. Notified products containing these substances are only permitted to remain on the market until the issuance date of this circular.

Annex III — Restricted Substances

• Genistein and Daidzein are retained as restricted with updated concentration limits and conditions of use. Notified products that do not meet the new limits may remain on the market only until 17 November 2027.

Annex VII — UV Filters

• The entry for 3-(4′-methylbenzylidene) camphor (4-MBC), currently allowed at a maximum of 4%, will be deleted from Annex VII on 17 November 2028, aligning with the prohibition of 4-MBC under Annex II after the grace period.

Implementation and Compliance

National Pharmaceutical Regulatory Agency (NPRA) advises cosmetic notification holders to plan transitions early. Companies should audit portfolios for the affected ingredients, update formulations and labeling to meet the revised limits for Genistein and Daidzein, and complete the immediate phase-out of Miconazole and Miconazole Nitrate. For 4-MBC, firms should schedule reformulation so that no products containing the substance remain on the market after 17 November 2028. Compliance will continue to be enforced under the Control of Drugs and Cosmetics Regulations 1984 and Malaysia’s cosmetic guidelines.