News & Updates

Ensuring the Safety, Quality, and Claimed Benefits of Cosmetic Products: Updates and Amendments to the ASEAN Cosmetic Drive

The Food and Drug Administration (“FDA”) issued on 12 November 2023 FDA Circular No. 2023-11 (“Circular”) highlighting updates and amendments to the ASEAN Cosmetic Drive (“ACD”) as adopted during the 37th ASEAN Cosmetic Committee (“ACC”) Meeting held on 24-25 May 2023. Under the ACD, the ASEAN Member States (“AMS”), through their National Regulatory Authorities (“NRAs”), shall undertake all necessary measures to ensure that only cosmetic products that conform to the provisions of the ACD, its Annexes and Appendices may be placed in the market.


The Circular applies to establishments that are engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and where applicable, the use, testing, promotion, advertising, or sponsorship of cosmetic products.


Among several updates, the Circular highlighted that the Terms of Reference (“TOR”) of the ASEAN Cosmetic Scientific Body (“ACSB”), particularly Article 3, was amended to include ASEAN Cosmetic Testing Laboratories Committee (“ACTLC”) representatives in the ACSB Meeting. Additionally, Article 2(c) of the TOR was revised to consider the scientific opinions from other regions and countries for amendments to the annexes. 


The Circular also outlined several updates and amendments on cosmetic ingredients and their restrictions as indicated in the ACD Ingredient Annexes. One of these amendments pertains to the substance Methyl-N-methylanthranilate (“M-N-MA”), Ref. No. 339. The ACSB discussed that there may be a different understanding and interpretation among ASEAN regulators and consumers on the condition of usage of M-N-MA in ASEAN for the use in day care products (with sun protection claims). Hence, it was agreed to insert a footnote entry for this substance to provide guidance in its condition of use: “This restriction does not apply to products with secondary UV protection claims, such as moisturizing and skin lightening products as described in the preamble of ASEAN Sunscreen Labeling Guidelines”. Thus, the AMS agreed to adopt the EU Annex III, entry 323, M-N-MA into the ACD Annex III with a grace period of 24 months. Effective 08 May 2025, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market.


The AMS likewise agreed to the removal of Sodium N-(hydroxymethyl) glycinate (“SMHG”) from the ASEAN Consolidated List of Banned Ingredients and the adoption of SHMG conditions of use under EU regulation Annex V, Ref #51 into ACD Annex VI with a 24-month grace period. Thus, SMHG now falls under ACD Annex VI – List of Preservatives Allowed for Use in Cosmetic Products with the limitation that it shall not be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of source, in the mixture as placed on the market is less than 0.1 % w/w. Effective 08 May 2025, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market.


For further information on other amendments and updates, the latest revision of the ACD Ingredient Annexes is accessible at the FDA website.


Finally, it was agreed to adopt the following Information Sharing Papers for dissemination, copies of which may be accessed through the FDA website:


1.   Information Sharing Paper for National Regulatory Authorities (NRAs) on the Refilling of Cosmetic Products

2.   Cosmetic Products Packaged in Vials/Ampoules/Syringes: An Information Sharing Paper

3.   Information Sharing Paper on Personalised Cosmetics.


It must be noted, however, that the foregoing Information Sharing Papers serve as reference for NRAs as they undertake measures to institute the necessary legal and technical infrastructure to achieve the objectives of the ACD. Thus, they are not to be interpreted as an obligatory regulatory requirement, unless otherwise adopted as a rule by the NRA of the AMS, nor are they to restrict the NRA from instituting additional regulatory mechanisms to ensure the proper implementation of the ACD in the local context.