The ASEAN Cosmetic Directive (ACD) is a regional agreement designed to harmonize technical requirements for cosmetic products across ASEAN member states, eliminating technical barriers to trade and facilitating free market circulation.
The ASEAN Cosmetic Committee (ACC) and the ASEAN Cosmetic Scientific Body (ACSB) convene biannually to review and update regulatory standards. On June 30, 2026, official revisions were promulgated for Annex II (Prohibited Substances), Annex III (Restricted Substances), Annex IV (Allowed Colorants), and Annex VI (Allowed Preservatives).
I. Annex II — Prohibited Substances List
Key updates to the prohibited list involve newly added antifungal agents, tightened thresholds for hazardous impurities, and item adjustments:
- Entry 450 Adjustment: Removed CAS No. 8024-12-2 corresponding to Verbena essential oils and their derivatives (excluding verbena absolute).
- Entry 1541 Revision (Tightened Benzene Limits): Imposed stricter purity mandates on petroleum, coal, tar, natural gas, and their derivatives. Ingredients containing Benzene $\ge 0.1\%\text{ w/w}$ or Benzo[a]pyrene $\ge 0.005\%\text{ w/w}$ are now strictly prohibited.
- Entry 1717 Deletion: Removed the specific entry for Pentetic Acid (Diethylene Triamine Pentaacetic Acid) and its salts (except in Thailand).
- Addition of 4 Prohibited Substances (Entries 1725–1728):
- Bifonazole (CAS No. 60628-96-8)
- Clotrimazole (CAS No. 23593-75-1)
- Thiabendazole (CAS No. 148-79-8)
- Tioconazole (CAS No. 65899-73-2)
(Note: The four substances added above are antifungal ingredients commonly used in pharmaceuticals and are now explicitly banned from cosmetic formulations across ASEAN.)
II. Annex III — Restricted Substances List
Revisions to the restricted list directly alter maximum concentration limits for formulations, with significant restrictions placed on Kojic Acid:
- Entry 206 Revision: Added synonyms related to Verbena absolute (e.g., Lemon Verbena Absolute, Aloysia Citrodora Absolute) and removed the corresponding CAS number. The maximum permitted concentration remains at $0.2\%$.
- Entry 343 Revision: Removed the specific exemption clause for Genistein (“except Indonesia”). A unified maximum concentration of $0.007\%$ is now enforced across all ASEAN member states.
- Addition of 2 Restricted Substances (Entries 345 & 346):
- Margosa, ext. (Neem Seed Extract, CAS No. 84696-25-3): Maximum permitted concentration is set at $0.1\%$ in all cosmetics. (Other Neem extracts not specifically mentioned remain permitted unless restricted in other annexes.)
- Kojic Acid:
- Leave-on face (and neck) care, hand care products, and all rinse-off products: Maximum allowed concentration is $1.0\%$.
- Leave-on body care products: Maximum allowed concentration is $0.2\%$.
III. Annex IV — Allowed Colorants List
Refined application scopes and concentration limits for the traditional colorant CI 45430 (Red):
- Lip Products: Maximum permitted concentration is capped at $10\%$.
- Toothpaste and Oral Mucosa Products: Maximum permitted concentration is tightened to $0.0025\%$.
IV. Annex VI — Allowed Preservatives List
The permitted preservative list undergoes reduction as two substances are officially removed and can no longer be used as cosmetic preservatives in ASEAN:
- Entry 40: 2-Benzyl-4-chlorophenol (Chlorophene)
- Entry 41: 2-Chloroacetamide
V. Operational Compliance Actions
Restructure Preservative and Colorant Systems: Formulations utilizing Chlorophene or 2-Chloroacetamide as preservatives must transition to alternative systems and undergo fresh stability and Preservative Efficacy Testing (PET). Products for lip and oral care utilizing CI 45430 must recalibrate formulation percentages to comply with new limits.
Audit Prohibited Ingredients: Conduct immediate inventory and formulation checks to identify newly banned antifungal agents (Bifonazole, Clotrimazole, Thiabendazole, and Tioconazole). Due to lower impurity thresholds for Benzene and Benzo[a]pyrene, strengthen purity monitoring and demand Certificates of Analysis (COA) for mineral and petroleum-derived raw materials.
Reformulate Restricted Products: Re-evaluate dosage levels in formulations containing Kojic Acid, Neem Seed Extract, or Verbena Absolute based on product category (e.g., face vs. body; leave-on vs. rinse-off).
