On October 31, 2026, the Ministry of Health Malaysia (KKM), through the National Pharmaceutical Regulatory Agency (NPRA) under it, issued a media statement reporting that one facial toner had been detected to contain the scheduled poisons tretinoin and hydroquinone. The cosmetic notification for the product concerned has been cancelled and the product is no longer allowed to be sold in Malaysia.
About the Scheduled Poisons
Tretinoin and hydroquinone are not allowed to be used in cosmetics in Malaysia. Products containing such ingredients are classified as drugs and must be registered with Malaysia's Drug Control Authority (PBKD) before they can be placed on the market.
Drugs containing tretinoin and hydroquinone can only be used under the advice and monitoring of healthcare professionals; use without appropriate supervision may cause various adverse effects:
- Tretinoin: redness, discomfort, burning and peeling of the skin at the application site, and hypersensitivity to sunlight;
- Hydroquinone: may cause redness, discomfort, unintended skin color changes and skin sensitization at the application site; it may also inhibit the pigmentation process (depigmentation), reducing the skin's protection against harmful UV rays and increasing the risk of skin cancer.
Warning to Sellers and Distributors
Sellers and distributors of the cosmetic concerned must immediately stop selling and distributing it. Selling and distributing a cosmetic that has not been notified violates Regulation 18A(1)(a) of the Control of Drugs and Cosmetics Regulations 1984, constitutes an offence under Regulation 18A(15) of the same Regulations, and is punishable under Section 12 of the Sale of Drugs Act 1952.
CIRS Reminder
- Tretinoin and hydroquinone are pharmacologically active substances. Both are listed as prohibited ingredients in China’s Safety and Technical Standards for Cosmetics. They are also prohibited for use in cosmetics in Malaysia, and products containing these ingredients are regulated as drugs. Companies should review the formulations of their products exported to Malaysia and avoid the use of such ingredients.
- In Malaysia, cosmetics must be notified to the NPRA before being placed on the market, and selling products that have not been notified or whose notifications have been cancelled is illegal, exposing both individuals and companies to penalties ranging from fines to imprisonment. Companies concerned are advised to verify the notification status of their products in a timely manner and ensure that their products are placed on the market in compliance.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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