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According to Philippine's Circular on December 15, 2021, ASEAN made changes to cosmetic ingredients in the Annexes of ASEAN Cosmetic Directive (ACD) during the 33rd ASEAN Cosmetic Scientific Body (ACSB) meeting. 1 The revision has been in effect except for the ingredients subject to grace periods. Details of the amendments are as follows:
1. Add 3 prohibited ingredients in Annex II: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
| Substances | CAS No. | Ref. No. | Effective Date |
| 1,2,4-Trihydroxybenzene when used as a substance in hair and eyelash dye products | 533-73-3 | 1642 | 2022.05.28 |
| 4-Amino-3-hydroxytoluene when used as a substance in hair and eyelash dye products | 2835-98-5 | 1643 | |
| 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid when used as a substance in hair and eyelash dye products | 117907-43-4 | 1644 |
2. Add 2 restricted ingredients in Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down
| Ref. No. | Substance/CAS No. | Restrictions | Conditions of use and warning | Effective Date | |
| Field of application and/or use | Other limitations and requirements | ||||
| 328 (313) | 2-Hydroxyethyl Methacrylate HEMA 868-77-9 | Nail Products | Professional use only | For professional use only Can cause an allergic reaction | 2022.11.28 |
| 329 (314) | 11,14-Dioxa-2,9-diazaheptadec-16-enoic Acid, 4,4,6,16- tetramethyl-10,15-dioxo, 2-[(2-methyl-1-oxo-2 propenyl) oxy] ethyl ester DI-HEMA TRIMETHYLHEXYL DICARBAMATE 41137-60-4/72869-86-4 | Nail Products | Professional use only | For professional use only Can cause an allergic reaction | |
3. Amend requirements for the carbon black entries in Annex IV: List of Colouring Agents Allowed for Use in Cosmetic Products
| Colour Index Number or Denomination | Colour | Field of application | Other limitation and requirements | ||||
| 1 | 2 | 3 | 4 | Before Amending | After Amending | ||
| 77266 | Black | X | Purity>97% with the following impurity profile: Ash content≤0.15%, total Sulphur≤0.65%, total PAH≤500 ppb, and benzo(a)pyrene≤5 ppb, dibenz(a,h)anthracene≤5 ppb, total As≤3 ppm, total Pb≤10 ppm, total Hg≤10 ppm | Purity>97% with the following impurity profile: Ash content≤0.15%, total Sulphur≤0.65%, total PAH≤500 ppb, and benzo(a)pyrene≤5 ppb, dibenz(a,h)anthracene≤5 ppb, total As≤3 ppm, total Pb≤10 ppm, total Hg≤1 ppm | |||
| 77266 (nano) | Black | X | 10% max. concentration in the finished product Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed: ● Purity>97% with the following impurity profile: Ash content≤0.15%, total Sulphur≤0.65%, total PAH≤500 ppb, and benzo(a)pyrene≤5 ppb, dibenz(a,h)anthracene≤5 ppb, total As≤3 ppm, total Pb≤10 ppm, total Hg≤10 ppm ● Primary particle size≥20 nm | 10% max. concentration in the finished product Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed: ● Purity>97% with the following impurity profile: Ash content≤0.15%, total Sulphur≤0.65%, total PAH≤500 ppb, and benzo(a)pyrene≤5 ppb, dibenz(a,h)anthracene≤5 ppb, total As≤3 ppm, total Pb≤10 ppm, total Hg≤1 ppm ● Primary particle size≥20 nm | |||
4. Amend the preamble as well as requirements for ingredients in Annex VI: List of Preservatives Which Cosmetic Products May Contain
Revise the 5th statement of the Preamble to "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%".
Remove the limitation "Except for Indonesia" from the substance Biphenyl-2-ol.
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