During the 38th ASEAN Cosmetic Scientific Body (ACSB) Meeting held on November 15 and 21, 2023, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient annexes.
The amendments include:
1. Addition of 15 entries and revision of 4 entries in Annex II – List of Substances Which Must Not Form Part of the Composition of Cosmetic (also known as the List of Prohibited Ingredients);
2. Revision of 5 entries in Annex III – List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down (also known as the List of Restricted Ingredients);
3. Revision of 1 entry in Annex IV – List of Colouring Agents Allowed for Use in Cosmetic Products (also known as List of Permitted Colorants);
4. Deletion of 1 entry from Annex VI – List of Preservatives Which Cosmetic Products May Contain (also known as List of Permitted Preservatives);
5. Addition of 2 entries to and revision of 1 entry in Annex VII – List of Permitted UV Filters Which Cosmetic Products May Contain (also known as List of Permitted UV Filters).
The below tables show the changes in red and indicate modifications compared to the previous lists.
1. Annex II – List of Prohibited Ingredients: 15 entries added and 4 entries revised
1) 15 ingredients were added to Annex II.
Substances | CAS No. | Ref. No. | Effective date |
N,N-diethyl-mtoluamide/ Diethyltoluamide (DEET) | 134-62-3, 26545-51-7 | A1144 | Malaysia: under request for internal consultation within the country; Vietnam: 15/11/2025; All ASEAN member states (AMS) except Malaysia and Vietnam: effective immediately |
Tetrafluoroethylene | 116-14-3 | 1681 | Philippines: effective immediately; All AMS except Philippines: 15/11/2024 |
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol;[DBMC] | 119-47-1 | 1682 | |
(5-chloro-2-methoxy-4-methyl-3- pyridyl)(4,5,6-trimethoxy-otolyl)methanone; pyriofenone | 688046-61-9 | 1683 | |
(RS)-1-{1-ethyl-4-[4-mesyl-3-(2- methoxyethoxy)-otoluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate | 1101132-67-5 | 1684 | |
Azamethiphos (ISO); S-[(6-chloro-2- oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate | 35575-96-3 | 1685 | |
3-methylpyrazole | 1453-58-3 | 1686 | |
N-methoxy-N-[1-methyl-2-(2,4,6- trichlorophenyl)-ethyl]-3- (difluoromethyl)-1-methylpyrazole-4- carboxamide; pydiflumetofen | 1228284-64-7 | 1687 | |
N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}- 3-(difluoromethyl)-1- methyl-1H-pyrazole-4-carboxamide; sedaxane | 874967-67-6 | 1688 | |
4-methylpentan-2-one; isobutyl methyl ketone (MIBK) | 108-10-1 | 1689 | |
Dimethomorph (ISO); (E,Z)-4-(3-(4- chlorophenyl)-3-(3,4- dimethoxyphenyl)acryloyl)morpholine | 110488-70-5 | 1690 | |
Imazamox (ISO); (RS)-2-(4-isopropyl-4- methyl-5-oxo-2-imidazolin-2-yl)-5- methoxymethylnicotinic acid | 114311-32-9 | 1691 | |
Thiamethoxam (ISO); 3-(2-chloro-thiazol- 5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine | 153719-23-4 | 1692 | |
Triticonazole (ISO); (RS)-(E)-5-(4- chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1- methyl)cyclopentanol | 138182-18-0 | 1693 | |
Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate | 13684-56-5 | 1694 |
2) Four entries in Annex II were revised.
Substances | CAS No. | Ref. No. |
Mercury and its compounds except those special cases included in Annex VI | 7439-97-6 54-64-8 62-38-4 94-43-9 102-98-7 1192-89-8 100-56-1 | 221 |
N,N'-Methylenedimorpholine; N,N'-methylenebismorpholine; [formaldehyde released from N,N'-Methylenebismorpholine]; [MBM] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0.1% w/w | 5625-90-1 | 1605 |
Reaction products of paraformaldehyde with 2-hydroxypropylamine (3:2); [formaldehyde released from 3,3'-methylenebis[5–methyloxazolidine]; [formaldehyde released from oxazolidin]; [MBO] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0.1% w/w | 1606 | |
Reaction products of paraformaldehyde with 2-hydroxypropylamine (1:1)); [formaldehyde released from a,a,atrimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol]; [HPT] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0.1% w/w | 1607 |
2. Annex III – List of Restricted Ingredients: 5 entries revised
Five entries in Annex III were revised.
Ref No. ACD # (EU #) | Substance/CAS No.(19) | 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 | |||
A | B | C | D | E | F |
12 | Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide, with the exception of the following substances in Annex II: Reference No. 1397, 1398, 1399
CAS No. 7722-84-1 | (a) Hair products (b) Skin products (c) Nail hardening products (d) Oral hygiene products, including mouth rinse, toothpaste. (e) Tooth whitening or bleaching products (i) For general consumer use (ii) For use by the consumer under the supervision of a qualified dental practitioner (iii) For application by a qualified dental practitioner only | (a) 12% of H2O2 (40 volumes), present or released (b) 4% of H2O2, present or released (c) 2% of H2O2, present or released (d) 0.1% of H2O2, present or released (e) (i) 0.1% H2O2 present or released (ii) >0.1% to < 6% H2O2 present or released (iii) >6% to 35% H2O2 present or released Thailand only: (f) Tooth whitening products with >6% H2O2 present or release is regulated as Medical Device. | (e) (ii) For supply only through a qualified dental practitioner. Not for direct sale to the general public. (iii) Only to be used by a qualified dental practitioner. Not for direct sale to the general public. | For (a) Wear suitable gloves
For (a) (b) (c) and (e): Contains hydrogen peroxide. Avoid contact with eyes. Rinse immediately if product comes into contact with them.
(e) (ii) and (iii) To be printed on the label Not to be used on a person under 18 years of age. Percentage of Hydrogen Peroxide to be declared.
(ii) Not for direct sale to the public. For supply only through qualified dental practitioner. Read & follow the instructions and use the product accordingly. Do not use the product within two weeks prior to, or immediately after dental restoration. Not for use by pregnant women or habitual tobacco and/or alcohol users. Stop using immediately if you experience any tooth sensitivity, gum irritation, toothache, defective restorations, gingivitis, nausea etc. Store out of reach of children.
(iii) Not for direct sale to the public. Only to be used by a qualified dental practitioner.
Do not use the product within two weeks prior to, or immediately after dental restoration. Not for use by pregnant women or habitual tobacco and/or alcohol users. Stop using immediately in cases of tooth sensitivity, gum irritation, toothache, defective restorations, gingivitis, nausea etc. |
324 (308) | Tagetes minuta flower extract (22) CAS No. 91770-75-1
Tagetes minuta flower oil (22) CAS No. 91770-75-1/8016-84-0 | a) Leave-on products b) Rinse-off products | a) 0.01% b) 0.1% | For (a) and (b). Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0.35%.
For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. (22)
For (a) and (b): In case of combined use with Tagetes patula (entry 325) or Tagetes erecta (entry 327), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (d) | / |
325 (309) | Tagetes patula flower extract (22) CAS No. 91722-29-1
Tagetes patula flower oil (22) CAS No. 91722-29-1/8016-84-0 | a) Leave-on products b) Rinse-off products | a) 0.01% b) 0.1% | For (a) and (b). Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0.35%.
For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. (22)
For (a) and (b): In case of combined use with Tagetes minuta (entry 324) or Tagetes erecta (entry 327), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (d) | / |
327 (1383 Annex II) | Tagetes erecta flower extract (22) CAS No. 90131-43-4
Tagetes erecta flower oil (22) CAS No. 90131-43-4 | a) Leave-on products b) Rinse-off products | a) 0.01% b) 0.1% | For (a) and (b). Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0.35 %.
For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. (22)
For (a) and (b): In case of combined use with Tagetes minuta (entry 324) or Tagetes patula (entry 325), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (d) | / |
339 (323) | Methyl-N-methylanthranilate (22) CAS No. 85-91-6 | (a) Leave-on products (b) Rinse-off products | (a) 0.1% (b) 0.2% | For (a): Not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light. (22)
For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers | |
Note No. 19: The CAS Numbers under this column are not exhaustive to cover all the intended substances. They are provided as reference where available.
Note No. 22: This restriction does not apply to products with secondary UV protection claims, such as moisturizing and skin lightening products as described in the preamble of ASEAN Sunscreen Labeling Guidelines.
3. Annex IV – List of Permitted Colorants: 1 entry revised
One entry in Annex IV was revised.
Colour Index Number or Denomination | Colour | Field of application | Other limitations and requirements | |||
1 | 2 | 3 | 4 | |||
45430 (2) | Red | X | Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo3H-xanthen-9-yl)benzoic acid | |||
Note No. 2: The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 9.
4. Annex VI – List of Permitted Preservatives: 1 entry deleted and preamble revised
1) One entry was deleted from Annex VI – List of Permitted Preservatives. As a grace period was granted, the deletion will be effective from May 8, 2025.
Ref. No. | Substance | Maximum authorized concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
a | b | c | d | e |
31 | Methenamine 3-chloroallylochloride (INN) | 0.2% |
2) The fifth point in the preamble of Annex VI was revised.
5. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde (Entries 20,21,27,30,31,33,46,49,51,55) must be labelled with the warning “contains formaldehyde” where the concentration of formaldehyde in the finished product exceeds 0.05%. |
5. Annex VII – List of Permitted UV Filters: 2 entries added and 1 entry revised
1) Two ingredients are added as permitted UV filters with immediate effect.
Ref No. | Substance | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
32 | 1,1'-(1,4-piperazinediyl)bis[1-[2-[4- (diethylamino)-2-hydroxybenzoyl]phenyl]-methanone
Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine
CAS No. 919803-06-8 | 10% (7) | ||
33 | 1,1'-(1,4-piperazinediyl)bis[1-[2-[4- (diethylamino)-2-hydroxybenzoyl]phenyl]- methanone
Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano)
CAS No. 919803-06-8 | 10% (7) | Only nanomaterials having the following characteristics are allowed: - Purity ≥ 97% - Median particle size D50 (50% of the number below this diameter): ≥50 nm of number size distribution.
Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. |
Note No. 7: In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10%.
2) One entry in Annex VII – List of Permitted UV Filters was revised. From November 15, 2026, the revision will be effective.
Ref No. | Substance | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
4 | Oxybenzone (INN) 2-Hydroxy-4-methoxy-benzophenone/Oxybenzone (6)
Benzophenone-3
CAS No. 131-57-7 | 6% 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%.
Other products | Contains oxybenzone(1) For a) and b): Contains Benzophenone-3 (1) |
Note No. 1: Not required if concentration is 0.5 % or less and when it is used only for product protection purposes.
Note No. 6: Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.
From the specified effective dates, only products that meet the new regulations will be allowed to be made available on the market, while non-compliant products will be subject to withdrawal. Therefore, it is essential for cosmetic companies to thoroughly review their products and verify their compliance with the updated requirements to prevent any potential issues.
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