On January 19, 2026, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia officially issued Circular No. 1/2026, announcing updates to the ingredient lists in Annex II, III, and VII of the Guidelines for Control of Cosmetic Products in Malaysia. These amendments stem from the latest resolutions of the 42nd ASEAN Cosmetic Committee (ACC) Meeting, aiming to align national standards with the updated ASEAN Cosmetic Directive (ACD).
The update covers three major categories: prohibited substances, restricted substances, and UV filters, setting new compliance benchmarks for cosmetic enterprises.
I. Annex II — Two New Prohibited Substances
According to the circular, the following ingredients are now listed as Prohibited Substances:
- 4-Methylbenzylidene Camphor (4-MBC)
- CAS: 36861-47-9 / 38102-62-4
- Market Grace Period: Permitted for sale until November 17, 2028.
- Miconazole & Miconazole Nitrate
- CAS: 22916-47-8 / 22832-87-7
- Enforcement: Prohibited from sale immediately as of the date of the circular.
Notified products containing these substances must be removed from the market or reformulated within the specified deadlines.
II. Annex III — Updated Restricted Substances
Two soy isoflavone ingredients have been added to the restricted list with defined maximum allowable concentrations:
| Ingredient | Max Allowable Concentration | Effective Date (For Market Presence) |
| Genistein | 0.007% | Until November 17, 2027 |
| Daidzein | 0.02% | Until November 17, 2027 |
Products exceeding these new limits are only permitted to remain on the market until November 17, 2027.
III. Annex VII — Adjustments to UV Filters
4-Methylbenzylidene Camphor (4-MBC) has been removed from the list of permitted UV Filters. Previously, 4-MBC was allowed as a UV filter at a maximum concentration of 4%.
Key Timelines:
- 4-MBC will be officially deleted from the UV Filter list starting November 17, 2028.
- Existing products containing this ingredient can continue to be sold until this date.
IV. NPRA Reminders to Industry
The NPRA emphasizes that:
- All cosmetic notification holders should plan formula adjustments and product updates early to avoid non-compliance due to prohibited or restricted ingredients.
- Enterprises must continuously comply with Section 18A of the Control of Drugs and Cosmetics Regulations 1984 and all requirements of the Guidelines for Control of Cosmetic Products in Malaysia.
V. What Does This Mean for Your Business?
This update significantly impacts the following categories:
✔ Antifungal/Medicated Cosmetics: Any products containing Miconazole or its nitrate must be withdrawn from the market immediately.
✔ Sunscreen Products: With a clear timeline for the 4-MBC ban, companies must urgently identify and test alternative UV filters.
✔ Functional Skincare: Products containing soy isoflavones need an immediate reassessment of formulation concentrations to meet the new 0.007% and 0.02% limits.
