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Malaysia Updates Cosmetic Regulatory Guidelines with New Entries for Prohibited and Restricted Substances

from CIRS by

On July 10, 2025, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia issued Announcement No. Bil (18) dlm. NPRA/PPPK/01/04 to revise the Cosmetic Regulatory Guidelines in Malaysia. The updated guidelines take effect from the date of publication.

Key Amendments Include:

  • Addition to Annex II (List of Prohibited Substances): 2-Ethylhexanoic Acid and its salt, Trimethylolpropane Triacrylate
  • Addition to Annex III (List of Restricted Substances): Salicylic Acid (as specified in the table below).

Substance/

CAS No

Restrictions

Conditions of use and warning which must be printed on the labels

Field of application and/or use

Maximum authorized concentration in the ready for use preparation

Other limitations and requirements

Salicylic acid
CAS No 69-72-7

Rinse-off hair products

(a) 3%

(a)(b)(c)

Not to be used in preparations for children under three years of age. Not to be use in applications that may lead to exposure of the end user’s lungs by inhalation. Not to be used in oral products.

For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product.

These levels are inclusive of any use of salicylic acid.

As a preservative, see Annex VI, Part 1, No.3

(a)(b)(c)

Not to be used for children under three years of age

Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant, nail polish

(b) 2%

Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant, nail polish

(c) 0.5%

Regulatory Requirements Interpretation of Salicylic Acid

The Global Cosmetic Ingredient Regulatory Database-Global CosIng, independently developed by CIRS Group indicates that Salicylic Acid is included in the following key lists globally.

Malaysia,Cosmetic,Guideline,Prohibition,Restriction,Ingredient

In China, Salicylic Acid has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) (I), List of ingredients restricted in cosmetic products (more details could be found in the following first figure) and List of preservatives allowed in cosmetic products (more details could be found in the following second figure).

2

3

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Further Information

https://npra.gov.my/index.php/en/directives-cosmetic-products/1527742-pekeliling-bil-1-2025-makluman-berkenaan-status-kemaskini-bahan-bahan-dalam-annex-pada-guidelines-for-control-of-cosmetic-products-in-malaysia.html

  

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