Malaysia Notifies and Adopts Updated ASEAN Cosmetic Directive Annexes

On 12 January 2023 the National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health of Malaysia, issued Circular No. 1/2023 on Information on the Updated Status of Ingredients in Annexes in the Guidelines for Control of Cosmetic Products in Malaysia (Circular 1/2023).

The circular announced Malaysia’s alignment of its cosmetic regulations with the latest changes made to the annexes of the Association of Southeast Asian Nations (ASEAN) Cosmetic Directive (ACD Annexes), which were adopted at the 36th ASEAN Cosmetic Committee (ACC) meeting (36th ACC meeting).

3E Review 

The 36th ACC meeting was held virtually on 30 November and 1 December 2022. Included in the decision is the regional agreement to amend the annexes of the ASEAN Cosmetic Directive (ACD Annexes), which are the lists of substances and ingredients that are prohibited, restricted, and permitted for use in cosmetic products. The changes affect Annex II, IV, VI, and VII of the ACD Annexes. In issuing Circular 1/2023, Malaysia aligned its cosmetics regulations with the following changes made at the 36th ACC meeting:

• Addition of 42 prohibited cosmetic ingredients to align ASEAN action with the amendment of the EU regulation on cosmetic products (Annex II, Regulation 1223/2009/EC)
• Revision to conditions of use of cosmetic colorant “white” (Ref. 77891) in cosmetic products containing titanium dioxide in powder form to comply with requirements of titanium dioxide specified in Annex III (Restricted Ingredients)
• Revision to conditions of use of salicylic acid and its related chemicals as restricted cosmetic ingredients
• Revision to conditions of use of titanium dioxide as UV filter substances

The changes will be effective from 21 November 2024.

All the changes were adopted and incorporated into the “Malaysia Guidelines for Control of Cosmetic Products” as an update on 23 December 2022. Similar to the ASEAN ACD Annexes, Malaysia’s five lists of cosmetic ingredients annexes are as follows:

• Annex II: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
• Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down
• Annex IV: List of Coloring Agents Allowed for Use in Cosmetic Products
• Annex VI: List of Preservatives Which Cosmetic Products May Contain
• Annex VII: List of UV Filters Which Cosmetic Products May Contain

3E Analysis

Companies engaged in trading cosmetic and personal care products are required to comply with these requirements per 18A of the Drugs and Cosmetics Control Regulations 1984 and the latest "Guidelines for Control of Cosmetic Products in Malaysia." They should review the details of the changes, including the implementation deadline that pertains to each change. Companies are advised to consult the ASEAN Directive and national regulations to ensure full compliance.