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Background: Current Ingredient Use RequirementsCosmetic ingredients in Indonesia shall comply with Technical Requirements for Cosmetic Ingredients and its appendices:
Prohibited cosmetic ingredients in Indonesia are:
Notes:
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On March 1, 2024, the Indonesian Agency for Food and Drug Control (BPOM) released the amended draft of the Technical Requirements for Cosmetic Ingredients for public consultation until March 19, 2024. 1 The proposed amendments include:
1) Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin;
2) Appendix I: List of Restricted Ingredients – 1 revised;
3) Appendix III: List of Permitted Preservatives – 1 deleted;
4) Appendix IV: List of Permitted Sunscreens – 1 revised;
5) Appendix V: List of Prohibited Ingredients – 75 added.
1. Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin
The requirements proposed to be deleted are as follows:
1) The mandatory attachment of hydroquinone content test results to the PIF. The test results can be in:
a. Certificate of cosmetic analysis
b. Cosmetic stability test
2) The labeling of cosmetics' storage conditions on the packaging.
2. Slightly adjusting the expression in the use requirements for Salicylic acid in Appendix I List of Restricted Ingredients
Ref. No. in ACD | Ingredient name/CAS No. | Restrictions | Conditions of use and warnings which must be printed on the label | ||
Field of application and/or use | Maximum authorized concentration | Limitations and other requirements | |||
98 | Salicylic acid (INCI)
CAS No. 69-72-7
Benzoic acid, 2-hydroxy- | (a) Rinse-off hair products
(b) Other products except body and hand skin care; preparations used in the eye area; preparation of lip care and makeup; roll-on deodorant
(c) Body and hand skin care*; preparations used in the eye area; preparation of lip care and makeup; roll-on deodorant **
*Preparations included in body and hand skin care are body lotion, body gel, body cream, body serum, body oil, body butter, body balm, etc. Apart from these preparations, follow point (b).
**Preparations included in roll-on deodorant are deodorants, antiperspirants and antiperspirant deodorants. | (a) 3.0%
(b) 2.0%
(c) 0.5% | (a), (b), and (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 dental and oral care preparations.
For uses other than as a preservative, the use must be explained on the product labeling.
As a preservative, see Appendix III List of Permitted Preservatives, No.46.
***Should not be used in spray preparations. Permitted for use in body powder and face powder as long as it is proven safe by a safety assessment issued by a safety assessor. | (a), (b), and (c)
Not used for children under 3 years of age
Notes: This warning applies to all preparations that may be used in children under 3 years of age. |
3. Deleting 1 preservative from Appendix III List of Permitted Preservatives
Ref No. in ACD | Substance | Maximum authorized concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
40 | 2-Benzyl-4-chlorophenol
Chlorophene (INCI)
CAS No. 120-32-1 | 0.2% | / | / |
4. Amending the use requirements for Benzophenone-3 in Appendix IV List of Permitted Sunscreens
Ref No. in ACD | Substance | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
4 | 2-Hydroxy-4-methoxy-benzophenone/Oxybenzone (INN)
Benzophenone-3 (INCI)
CAS No. 131-57-7 | a) Face products, hand products, and lip products, excluding propellant and pump spray products: 6%
b) Body products, including propellant and pump spray products: 2.2%
c) Other products: 0.5% | For a) and b): Not more than 0.5% to protect product formulation
For a): If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 5.5%
For b): If used at 0.5% to protect product formulation, the levels used as UV filter must not exceed 1.7% | For a) and b): Contains Benzophenone-3 (4) |
(4): Not required if the Oxybenzone level is ≤ 0.5% and when it is used only for product protection purposes. | ||||
5. Adding 75 prohibited ingredients to Appendix V List of Prohibited Ingredients
The prohibited cosmetic ingredients in Appendix V are increased from 1,606 to 1,681. Find the 75 newly prohibited ingredients here (highlighted items).
Newly Prohibited Cosmetic Ingredients (Excerpt)
No. | Ref No. in ACD | Substance | CAS No. |
1608 | 1387 | 2-Chloracetamide | 79-07-2 |
1609 | 1388 | Octamethylcyclotetrasiloxane; D4 | 555-67-2 |
1610 | 1391 | Acetaldehyde; ethanal | 75-07-0 |
1611 | 1393 | N-Methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone | 872-50-4 |
1612 | 1397 | Sodium perborate [1]; Sodium peroxometaborate; sodium peroxoborate [2] | 15120-21-5 [1] 7632-04-4 [2] 10332-33-9 [2] 10486-00-7[2] |
1613 | 1398 | Perboric acid (H3BO2(O2)), monosodium salt trihydrate [1]; Perboric acid, sodium salt, tetrahydrate [2]; Perboric acid (HBO(O2)), sodium salt, tetrahydrate sodium peroxoborate hexahydrate [3] | 13517-20-9 [1] 37244-98-7 [2] 10486-00-7 [3] |
ChemLinked’s Notes
The proposed additions to Indonesian Appendix V List of Prohibited Ingredients align with the amendments made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 36th, 37th, and 38th ASEAN Cosmetic Scientific Body (ACSB) meetings;
The proposed revisions to Appendix III List of Permitted Preservatives and Appendix IV List of Permitted Sunscreens correspond to the amendments adopted during the 37th and 38th ACSB meetings;
For salicylic acid in Appendix I List of Restricted Ingredients, the only adjustment is the serial number in the usage requirements, which is a result of the removal of two preservatives from Appendix III. The usage limit and conditions for salicylic acid remain unchanged.
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