Update on Cosmetic Ingredient Regulations under the ASEAN Cosmetic Directive (2026)

On 25 February 2026, the Drug Administration of Vietnam (DAV) – Ministry of Health issued Official Letter No. 647/QLD-MP regarding updates to cosmetic ingredient regulations following the outcomes of the 42nd ASEAN Cosmetic Committee (ACC 42) and 42nd ASEAN Cosmetic Scientific Body (ACSB 42) meetings.

🚫 Prohibited Substances (Annex II) – Newly Added

The following ingredients are added to the List of Prohibited Substances:

  • 4-Methylbenzylidene Camphor (CAS: 36861-47-9 / 38102-62-4)
    ➜ Effective in Vietnam from 17 November 2028

  • Miconazole / Miconazole Nitrate
    ➜ Effective from 21 November 2025

In addition, the CAS number for Octamethylcyclotetrasiloxane (D4) has been updated.

⚠️ Restricted Substances (Annex III) – Newly Added

Two additional ingredients have been included with concentration limits:

  • Genistein (Genisteol)
    ➜ Maximum concentration: 0.007%

  • Daidzein (Daidzeol)
    ➜ Maximum concentration: 0.02%

📅 Effective date: 17 November 2027

☀️ Annex VII – UV Filters

  • 4-Methylbenzylidene Camphor has been removed from the UV filter list

  • The substance has been reclassified as a prohibited ingredient (Annex II).

📅 Implementation Timeline

After the effective dates:

✔ Only cosmetic products compliant with the updated regulations may be marketed.
Non-compliant products must be withdrawn from the market.

📌 Actions Required for Cosmetic Businesses

Manufacturers, importers, and distributors should:

🔍 Review product formulations
📋 Verify ingredients against the Annexes of the ASEAN Cosmetic Directive
📦 Adjust manufacturing, import, and distribution plans accordingly
⚠️ Mitigate risks of product recall or regulatory non-compliance

🔎 For more details: https://medgate.vn/wp-content/uploads/2026/03/647_QLD_MP_signed.pdf

https://medgate.vn/wp-content/uploads/2026/03/Annex-IV-Part-1-Release_15-Dec-20231.pdf

https://medgate.vn/wp-content/uploads/2026/03/Annex-VI_Release_07-Jun-20241.pdf

https://medgate.vn/wp-content/uploads/2026/03/Annex-VII_Release_12th-December-2025-clean.pdf