On March 18, 2025, the FDA Philippines issued FDA Circular No. 2025-002, amending the ASEAN Cosmetic Directive (ACD). This circular will officially take effect 15 days after its publication.
The Main Content of Updates and Amendments to the ACD
1. N,N-diethyl-m-toluamide/Diethyltoluamide (DEET) has been added to Annex II (Annex II – List of substances which must not form part of the composition of cosmetic products, Ref. No. A1144) of the ACD , with no transition period granted.
2. Amendment to Annex III (List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down) of the ACD
(1) Restriction on the use of Zinc Pyrithione (ZPT).
- The maximum allowable concentration up to 1.0% in hair rinse-off products and 0.1% in leave-on hair products (ACD Annex III, Ref. No. 101)
- As a preservative in rinse-off products up to 1.0% in hair products, and rinse-off non-hair care products (excluding oral hygiene products) for up to 0.5% (ACD Annex VI, Ref. No. 8).
- A 24-month transition period is established. Starting from May 14, 2026, only products complying with the above restrictions will be allowed on the market.
(2) Acid Yellow 3 is included in Annex III, with its maximum permitted concentration restricted to 0.5% in non-oxidative hair dye products. A 24-month transition period is established, and starting from May 14, 2026, only products complying with this regulation will be allowed on the market.
(3) Salicylic Acid is included in Annex III, with its maximum permitted concentration restricted to 0.5% in nail care products. A 24-month transition period is established.
3. ASEAN Standards for the Use of CMR Category 1A and 1B Substances
The Technical Working Group (TWG), comprising the ASEAN Cosmetics Association (ACA), Singapore, Brunei, and the Philippines, has proposed ASEAN standards for the use of CMR (Carcinogenic, Mutagenic, and Reprotoxic) Category 1A and 1B substances to regulate their use in cosmetics within the ASEAN region. The TWG has discussed the criteria for CMR 1A and 1B following ACSB Chair’s comments during the 38th ACSB meeting and Indonesia’s comments to the TWG in Jan 2024.
Regulatory Requirements Interpretation of Zinc Pyrithione and Acid Yellow 3 in China
1. Zinc Pyrithione
The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Zinc Pyrithione (CAS No. 13463-41-7) used as anti-seborrheic, antidandruff, anti-sebum, hair conditioning, anticorrosive and preservative in cosmetics.
Zinc Pyrithione has been included in the Inventory of Existing Cosmetic Ingredients in China (2021 Edition), Inventory of Restricted Cosmetic Ingredients as well as List of Allowed Preservatives in the Safety and Technical Standards for Cosmetics. The specific scope of application, restriction conditions, and other details are shown in the table below.
2. Acid Yellow 3
The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Acid Yellow 3 (CAS No. 38615-46-2, 39354-67-1, 8004-92-0) used as hair dyeing in cosmetics.
Acid Yellow 3 has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) and the List of Allowed Colorants in the Safety and Technical Standards for Cosmetics.
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Further information
https://www.fda.gov.ph/wp-content/uploads/2025/03/FDA-Circular-No.2025-002-Annex.pdf