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Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 27 Additions and 5 Revisions

During the 40th ASEAN Cosmetic Committee Meeting, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient Annexes II, III, and VII.

The ASEAN Cosmetic Committee (ACC) and the ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to review and amend the ASEAN Cosmetic Directive (ACD). During these meetings, authorities generally review the updates from the European Union (EU) and decide whether to implement any bans or revisions to the ASEAN region.

During the 40th ACC meeting held from November 18 to 22, 2024. amendments were made regarding the ingredient annexes II, III, and VII. The key amendments are as follows:

1) Annex II - List of substances which must not form part of the composition of cosmetic products: 26 added and 2 revised

2) Annex III - List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down: 1 added and 1 revised

3) Annex VII - List of permitted UV filters which cosmetic products may contain: 2 revised

Detailed amendments to each annex are listed in the tables below (the text in red indicates changes to the previous lists).

a. Annex II List of Prohibited Ingredients: 26 added and 2 revised

Status

Substances

CAS No.

Ref No.

Revision

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 sulphide under the condition laid down in Annex III part 1 reference # 23, and the barium sulphate, lakes, salts, and pigments prepared from colouring agents listed in Annex IV

7440-39-3

46

Addition

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

Except Thailand

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

methyl 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

6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

-

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

Pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo) pentaacetate

7216-95-7

1716

N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid); Pentetic Acid (INCI)

Except Thailand

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

b. Annex III - List of Restricted Ingredients: 1 added and 1 revised

Status

Ref No. ACD #

(EU #)

Substance/CAS No.(19)

Restrictions

Field of Application and/or Use

Maximum Authorized Concentration in the Ready for Use Preparation

Other Limitations and Requirements

A

B

C

D

E

Revision

101

Pyrithione Zinc

Zinc pyrithione

CAS No. 13463-41-7

Leave-on hair products

Rinse-off hair products

0.1%

1.0% (2% for the Philippines)

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

Addition

342

2,6-Di-Tert-Butyl-4-Methylphenol

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%

/

(19) The CAS numbers under this column are not exhaustive to cover all the intended substances. They are provided as references where available.

c. Annex VII - List of Permitted UV Filters: 2 revised

Reference No.

Substance

Maximum Authorized Concentration

Other Limitations and Requirements

Conditions of Use and Warnings Which Must be Printed on the Label

3

Homosalate (INN)

CAS No. 118-56-9

10%7.34%

Face products with the exception of propellent spray products

/

4

2-Hydroxy-4-methoxy-benzophenone/Oxybenzone

Benzophenone-3(6)

CAS No. 131-57-7

a) 6%

b) 2.2%

c) 0.5%

For a) and b) Not more than 0.5% to protect product formulation

 

a) Face products, hand products, and lip products, excluding propellant and pump spray products

If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 5.5%.

 

b) Body products, including propellant and pump spray products

If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 1.7%.

 

c) Other products

For a) and b): Contains Benzophenone-3(1)

Notes:

(1) Not required if concentration is 0.5 % or less and when it is used only for product protection purposes.

(6) Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.

Further Reading:

Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 15 Revised and 1 Added

Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 17 Added, 11 Revised, and 1 Deleted

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