Malaysia NPRA Updates Cosmetic Ingredient Requirements Under the ASEAN Cosmetic Directive

On July 7, 2026, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) issued Circular No. 2/2026, updating the status of several cosmetic ingredients listed in the annexes to the “Guidelines for Control of Cosmetic Products in Malaysia.” The changes follow decisions made at the 43rd ASEAN Cosmetic Committee meeting, held virtually on May 12–13, 2026.

The circular affects four annexes:

• Annex II: Prohibited substances
• Annex III: Restricted substances
• Annex IV: Permitted coloring agents
• Annex VI: Permitted preservatives

Some changes take effect immediately, while others include transition periods for existing notified products. Cosmetic Notification Holders should therefore review affected formulations and notified products and determine whether any changes are required.

What the Circular Changes

The update combines administrative changes with new prohibitions and revised conditions of use. While some ingredients have simply been updated or removed from the annexes, others now face tighter requirements, creating different compliance priorities for affected products.

The key changes are set out below.

Annex II: Prohibited Cosmetic Substances

NPRA has made the following changes to Annex II:

• Verbena essential oils: The entry for Lippia citriodora Kunth. and derivatives other than absolute when used as fragrance ingredients have been administratively updated. The substance is listed under Reference No. 450.
• Pentetic Acid: Removed from Annex II and therefore no longer prohibited.
• Four antifungal substances: Bifonazole, Clotrimazole, Thiabendazole and Tioconazole have been added to Annex II as prohibited substances.

Action: Products containing any of the four newly prohibited substances may no longer remain on the Malaysian market from the date of the circular. Cosmetic Notification Holders should identify affected products and take action immediately.

Annex III: Restricted Cosmetic Substances

NPRA has revised the conditions applicable to several restricted ingredients:

• Verbena absolute: The entry for Lippia citriodora Kunth. has been updated. Its use is permitted at a maximum concentration of 0.2%.
• Margosa extract: Extract obtained from the kernels of Azadirachta indica is restricted to a maximum concentration of 0.1% in all cosmetic products.
• Kojic Acid: The maximum permitted concentration has been revised according to product type:
  • 1% in face, neck and hand leave-on products and all rinse-off products
  • 0.2% in body leave-on products

Existing notified products that do not comply with the revised requirements may remain on the market during the applicable transition period. For margosa extract, the transition period ends on April 29, 2029, while for kojic acid, it ends on April 29, 2028.

Cosmetic Notification Holders should therefore review affected formulations against the revised concentration limits and plan any necessary changes before the transition period ends.

Annex IV: Permitted Coloring Agents

NPRA has revised the permitted conditions for CI 45430, with different concentration limits depending on the intended application:

• Lip products: Maximum concentration of 10%
• Toothpaste and products intended to come into contact with the mucous membranes of the oral cavity: Maximum concentration of 0.0025%

Existing notified products that do not comply with the revised limits may remain on the market until April 29, 2028.

Annex VI: Permitted Preservatives

NPRA has removed the following preservatives from Annex VI:

• Chlorophene
• 2-Chloroacetamide

Their removal is consistent with their inclusion in Annex II as prohibited substances, ensuring that the permitted-preservatives and prohibited-substances lists remain aligned.

Final Thoughts

The core challenge of Circular No. 2/2026 lies in its staggered timelines. To avoid market disruptions, cosmetic notification holders must quickly audit their products, identify which ingredients face immediate mandates versus grace periods, and map out strategic reformulations.

Navigating these Malaysian requirements from abroad can be daunting. Operating locally in Malaysia, Cisema bridges the gap for global cosmetic brands, delivering hands-on, end-to-end support for ingredient audits, NPRA notifications, and ongoing compliance.

To assess how the latest ingredient changes may affect your products and determine the appropriate next steps, contact Cisema today.

Further Information

• Explore Cisema’s cosmetic registration services in Malaysia
• Learn how cosmetic product notification works in Malaysia.

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About the Author: Shouzheng Tan

Shouzheng Tan is Vice President of Southeast Asia at Cisema, based in Penang, Malaysia. He brings more than a decade of experience in the medical device industry, specializing in regulatory registration and market access across Southeast Asia. In his role, he works closely with overseas manufacturers to develop and implement effective regulatory strategies for medical devices throughout the region, including key markets such as Malaysia. His expertise is complemented by working knowledge of quality management systems, allowing him to support clients across both regulatory and compliance requirements.

References

• NPRA Circular No. 2/2026: Status Update on Ingredients in the Annexes to the Guidelines for Control…
• NPRA Guidelines for Control of Cosmetic Products in Malaysia: Annexes I–VII

Appendix – Summary of the Main Changes