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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

    Our Services

    • ASEAN Cosmetics Notification
    • ASEAN Cosmetics Formula/Label Review
    • ASEAN Cosmetics Regulatory Compliance Consultation

    If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

    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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