The Ministry of Health Malaysia's National Pharmaceutical Regulatory Agency (NPRA) has issued Circular No. 2/2023, dated June 2023, regarding the status update of cosmetic product ingredients listed in the annexes of the Guidelines for Control of Cosmetic Products in Malaysia. The NPRA conducted periodic reviews and amendments to align the guidelines with changes made in the ASEAN Cosmetic Directive (ACD).
During the 36th and 37th virtual meetings of the ASEAN Cosmetic Committee (ACC) held in November-December 2022 and May 2023 respectively, agreement was reached to update certain substances in Annexes 11, III, VI, and VII of the ACD.
The amendments to the annexes include:
- Annex II (List of Prohibited Substances): Updated prohibition of substances in accordance with EU Amendments of Annex 11 (EU 20191831, EU 2019/1966, and EU 20211850). Cosmetics containing these substances are allowed in the market until May 8, 2025.
- Annex III (List of Restricted Substances): Updated and added conditions for the use of substances. Notified cosmetic products not complying with the new conditions are allowed in the market until November 21, 2024, for Salicylic acid, and until May 8, 2025, for Methyl-N-methylanthranilate and Ammonium silver zinc aluminum silicate.
- Annex VI (List of Preservatives): Updated and added conditions for the use of substances. Cosmetics not complying with the new conditions for Sodium hydroxymethylglycinate are allowed in the market until May 8, 2025.
- Annex VII (List of UV Filters): Updated and added conditions for the use of substances. Cosmetics not complying with the new conditions for Octocrylene are allowed in the market until May 8, 2025.
All Cosmetic Notification Holders are advised to plan carefully to avoid any issues arising from these changes and to adhere to all directives and legal regulations under the Control of Drugs and Cosmetics Regulations 1984 and Guidelines for Control of Cosmetic Products in Malaysia.
LINK TO CIRCULAR No. 2 2023