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be withdrawn from the market.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.