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

On 25 February 2026, the Drug Administration of Vietnam (DAV) โ€“ 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.

๐Ÿšซ Prohibited Substances (Annex II) โ€“ Newly Added

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

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

  • Miconazole / Miconazole Nitrate
    โžœ Effective from 21 November 2025

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

โš ๏ธ Restricted Substances (Annex III) โ€“ Newly Added

Two additional ingredients have been included with concentration limits:

  • Genistein (Genisteol)
    โžœ Maximum concentration: 0.007%

  • Daidzein (Daidzeol)
    โžœ Maximum concentration: 0.02%

๐Ÿ“… Effective date: 17 November 2027

โ˜€๏ธ Annex VII โ€“ UV Filters

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

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

๐Ÿ“… Implementation Timeline

After the effective dates:

โœ” Only cosmetic products compliant with the updated regulations may be marketed.
โŒ Non-compliant products must be withdrawn from the market.

๐Ÿ“Œ Actions Required for Cosmetic Businesses

Manufacturers, importers, and distributors should:

๐Ÿ” Review product formulations
๐Ÿ“‹ Verify ingredients against the Annexes of the ASEAN Cosmetic Directive
๐Ÿ“ฆ Adjust manufacturing, import, and distribution plans accordingly
โš ๏ธ Mitigate risks of product recall or regulatory non-compliance

๐Ÿ”Ž For more details:ย 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