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On June 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 2/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. 1 The amendments align with the amendments made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 39th ASEAN Cosmetic Committee (ACC) meeting.
According to the Circular, the amendments are:
1) Annex III: List of Restricted Ingredients - 1 added and 3 revised
2) Annex II, III, VI and VII: List of Prohibited Ingredients, Restricted Ingredients, Permitted Preservatives and Permitted UV Filters - some administrative changes
Detailed amendments to each ingredient in Annex III are as follows (the text in red indicates changes to the previous lists).
Ref No ACD # (EU #) | Substance/CAS No. | Restrictions | Conditions of use and warning which must be printed on the labels | Effective Date | ||
Field of application and/or use | Maximum authorized concentration in the ready for use preparation | Other limitations and requirements | ||||
A | B | C | D | E | F | |
98 | Benzoic acid, 2-hydroxy- Salicylic acid CAS No. 69-72-7 | (a) Rinse-off hair products
(b) Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant
(c) Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant, nail polish | (a) 3.0% (b) 2.0% (c) 0.5% | (a) (b) (c) Not to be used in preparations for children under three years of age.
Not to be used 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 (8) | Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until November 21, 2025. |
101 | Pyrithione Zinc Zinc pyrithione CAS No. 13463-41-7 | Leave-on hair products Rinse-off hair products | 0.1%
1.0% | For purposes other than inhibiting the development of microorganisms in the product, this purpose has to be apparent from the presentation of the product As a preservative, see Annex VI, Part 1, No 8 | / | Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 14, 2026. |
340 (x) | Ammonium silver zinc aluminum silicate
CAS No. 130328-20-0 | (a) Powder Foundation
(b) Deodorant (Spray type, Non Spray type) | (a) 1% (b) 1% | / | / | Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 8, 2025. |
341 (326) | Acid Yellow 3 CAS No. 8004-92-0 | Non-oxidative hair dye products | 0.5% | / | / | Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until May 14, 2026. |
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