Update on the Guidelines for Control of Cosmetic Products by NPRA in Malaysia

On July 4, 2023, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published Circular 2/2023, Guidelines for Control of Cosmetic Products, which outright prohibits 19 ingredients, limits three others, and allows the use of two more.

The Guidelines for Control of Cosmetic Products in Malaysia are periodically reviewed and updated to reflect changes made to the ASEAN Cosmetic Directive (ACD) by the National Pharmaceutical Review Agency (NPRA). Both the 36th ASEAN Cosmetics Committee (ACC) meeting, which was conducted electronically on November 30 and December 1, 2022, and the 37th ACC meeting, which took place on May 8 and 9, 2023, had previously agreed to update some of the substances listed in Annex II (List of prohibited substances), III (List of restricted substances), VI (List of preservatives), and VII (List of UV filters) on the ACD.

In Circular 2/2023 19 substances are added to Annex II (Appendix A), i.e. banned.  The full list that is quite similar to EU Amendment to Annex II (DLI 2019/831, EU 2019/1966, and EU 202J/850).can be found here (in Malay). Cosmetics containing components that have been notified are allowed to be sold until May 8, 2025.

Beginning on May 8, 2025, the revision also permits the usage of two additional substances listed in the table below. The two substances have been added to the List of permitted preservatives (Annex VI) and the List of UV filters (Annex VII) respectively.

The updated list of ingredients with restricted concentration allowed in cosmetics as per Annex VI and VII

Three more chemicals, together with their concentration requirements and restrictions, were added to the list of prohibited substances (Annex III) by the NPRA:

For Salicylic acid, as of November 21, 2024, conditions of use and warnings must be stated on product labels.  Methyl-N-m ethyIanthranilate used in leave-on products is restricted from 8 May 2025. The restriction does not apply to products that make claims about secondary UV protection, such as moisturizing and skin-lightening products. Use of ammonium silver zinc aluminium silicate, which is allowed in deodorant (both spray and non-spray types) and foundation is restricted to 1% from 8 May 2025.

The updated list of ingredients with restricted concentration allowed in cosmetics as per Annex III (Appendix B)

All Cosmetic Notification Holders are recommended to make thoughtful arrangements to prevent any potential problems. The holders of cosmetic notifications are reminded to follow all guidelines and legal requirements as outlined in Regulation 18A of the Drugs and Cosmetics Control Regulations of 1984 and the Guidelines for Control of Cosmetics Products in Malaysia.