Malaysia Revised Guidelines for Control of Cosmetic Products

On December 30, 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) revised the Guidelines for Control of Cosmetic Products in Malaysia. The revisions were issued as Circular 3/2024 and took effect immediately upon publication.

The revisions followed the 40th ASEAN Cosmetic Committee (ACC) meeting held in Bangkok, Thailand on November 21-22, 2024. During the meeting amendments were made to Annex I (List of Prohibited Substances), Annex III (List of Restricted Substances), and Annex VII (List of Permitted UV Filters) of the ASEAN Cosmetic Directive (ACD).

The ACD is an agreement among ASEAN countries to harmonize the requirements of cosmetic products to reduce technical barriers to trade in the region.

Regulatory Amendments

The key amendments include:

Adding 28 substances to Annex I (List of Prohibited Substances in Cosmetics). Details are provided in the table below. The transition period extends until November 19, 2026.

Substances	CAS No.	Ref No.
Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione	58-55-9	A1137
Barium salts and Barium Peroxide, with the exception of barium sulfide under the condition laid down in Annex III part 1 reference #23, and the barium sulfate, lakes, salts, and pigments prepared from coloring agents listed in Annex IV	7440-39-3	46
Ammonium bromide	12124-97-9	1695
Dibutyltin bis(2-ethylhexanoate)	2781-10-4	1696
Dibutyltin di(acetate)	1067-33-0	1697
Tellurium dioxide	7446-07-3	1698
Barium diboron tetraoxide	13701-59-2	1699
2,2-dimethylpropan-1-ol,tribromo derivative; 3-bromo-2,2- bis(bromomethyl)propan-1-ol	36483-57-5/1522-92-5	1700
2,4,6-tri-tert-butylphenol	732-26-3	1701
4,4'-sulphonyldiphenol;bisphenol S	80-09-1	1702
Benzophenone	119-61-9	1703
Quinoclamine(ISO); 2-amino-3-chloro-1,4-naphthoquinone	2797-51-5	1704
Perfluoroheptanoic acid; tridecafluoroheptanoic acid	375-85-9	1705
Methy l N-(isopropoxycarbonyl)-L-valyl-(3RS)- 3-(4-chlorophenyl)-β-alaninate; valifenalate	283159-90-0	1706
6-[C12-18-alkyl-(branched,unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts	-	1707
6-[(C10-C13)-alkyl-(branched,unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid	2156592-54-8	1708
Bentazone(ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide	-	1709
1,3,5-triazine-2,4,6-triamine;melamine	108-78-1	1710
Fluopicolide(ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide	607-285-6	1711
N-(2-nitrophenyl)phosphoric triamide	874819-71-3	1712
N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide;isoflucypram	1255734-28-1	1713
Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide[≥78%syn isomers≤15%anti isomers relative content]; isopyrazam	881685-58-1	1714
Cumene	98-82-8	1715
Pentapotassium2,2',2",2",2"-(ethane-1,2-diylnitrilo) pentaacetate	7216-95-7	1716
N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI)	67-43-6	1717
Acetamiprid(ISO); (1E)-N-[(6-chloropyridin-3-yl)methyl]-N'-cyano-N-methylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1- methylacetamidine	135410-20-7/160430-64-8	1718
Pendimethalin(ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene	40487-42-1	1719
Bentazone(ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide	25057-89-0	1720

(*Note: The content displayed in the CAS No. column may refer to EC numbers)

Amendments to Annex III (List of Restricted Substances in Cosmetics) include additional restrictions on Butylated Hydroxytoluene, with specific requirements outlined below.

Ref No ACD # (EU#)	Substance/CAS No	Restrictions			Conditions of use and warning which must be printed on the labels
Ref No ACD # (EU#)	Substance/CAS No	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
342	2,6-Di-Tert-Butyl-4-Methylphenoi Butylated Hydroxytoluene （CAS No. 128-37-0）	a)Mouthwash b)Toothpaste c)Other leave-on and rinse-off products	a)0.001% b)0.1% c)1%

Amendments to Annex VII (List of Permitted UV Filters in Cosmetics) include updated usage requirements for Homosalate, with a maximum allowed concentration of 7.34%, aligning with the requirements of the EU Cosmetics Regulation.

Ref No.	Substance	Maximum authorized concentration	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
3	Homosalate CAS No.118-56-9	7.34%	Face products with the exception of propellent spray products

Interpretation of Butylated Hydroxytoluene and Homosalate

Butylated Hydroxytoluene

Under China Cosmetic Regulations

The Chinese Cosmetic Ingredient Regulatory Database (ChinaCosIng), independently developed by CIRS Group, indicates that Butylated Hydroxytoluene (CAS No. 128-37-0), used as an antioxidant, flavoring, fragrance, perfuming, or masking in cosmetics.

Malaysia,Cosmetic,Control,Guideline,ASEAN,Prohibit,Restrict

Butylated Hydroxytoluene has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) with the maximum historical usage in leave-on cosmetic products of 2.6% and the Inventory of Existing Toothpaste Ingredients in China (China Oral Care Industry Association), with the maximum historical usage of 0.03%.

Under International Cosmetic Regulations

According to the Global Cosmetic Ingredient Regulatory Database (Global CosIng), independently developed by CIRS Group, the EU has set usage requirements on Butylated Hydroxytoluene.

Note: The Global CosIng is currently only available in Chinese

List Item	100318# 2,6-Di-Tert-Butyl-4-Methylphenol
Product Type Body Parts	(a) Mouthwash (b) Toothpaste (c) Other leave-on and rinse-off products
Maximum Concentration	(a) 0.001% (b) 0.1% (c) 0.8%
Other	From July 1, 2023, cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From January 1, 2024, cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.

Homosalate

Under Chinese Cosmetic Regulations

ChinaCosIng, indicates that Homosalate (CAS No. 118-56-9) can be used as flavoring, fragrance, perfuming, masking, UV absorber, or UV filter in cosmetics.

Homosalate has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) and the List of Allowed Sunscreen Agents with the maximum allowable concentration when used in cosmetics of 10%.

Under International Cosmetic Regulations

According to Global CosIng the following table outlines the usage requirements for Homosalate as specified in the EU Cosmetics Ingredients Database (EU-CosIng).

List Item	28808# Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester / Homosalate
Product Type Body Parts	Face products with the exception of propellent spray products
Maximum Concentration	7.34%
Other	From January 1, 2025, cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From July 1, 2025, cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.

Further Information

Official Notice

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