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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 August 24, 2023, Indonesia introduced draft amendments to the Appendices in the Technical Requirements for Cosmetic Ingredients. 1 The main amendments are summarized as follows. Added requirements are highlighted in red and deleted requirements are marked with a strikethrough.
1) Adding 1 restricted ingredient to Appendix I List of Restricted Ingredients
No. | Ref. No. 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 | ||||
a | b | c | d | e | f | |
219 | 339 | Methyl-N-methylanthranilate* CAS No. 85-91-6 | (a) Leave-on products
(b) Rinse-off products | (a) 0.1%
(b) 0.2% | (a) Not to be used in sunscreen preparations and products marketed for exposure to UV rays, both natural and artificial.*
(a) and (b) - Not to be used with compounds that can form nitroso; - Maximum nitrosamine content: 50 μg/kg (in raw materials); - Stored in a nitrite-free container. | / |
*This restriction does not apply to products with secondary UV protection claims as described in the preamble of ASEAN Sunscreen Labeling Guidelines. This kind of products include moisturizing and skin lightening products, to name a few. | ||||||
2) Amending the use requirements of 6 restricted ingredients in Appendix I List of Restricted Ingredients
No. | Ref. No. 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 | ||||
a | b | c | d | e | f | |
124 | 98 | Salicylic acid (INCI) CAS No. 69-72-7
Benzoic acid, 2-hydroxy- | (a) Rinse-off hair products
(b) Other products except skin, body, hand care; eye shadows; mascara; eyeliners; lipstick; roll-on deodorant
(c) Skin, body, hand care*; eye shadows; mascara; eyeliners; lipstick; roll-on deodorant**
*Preparations included in skin, body and hand care are body cream, body serum, body oil, body butter, body balm, etc. Apart from these preparations, follow point (b). **Preparations included in roll-on deodorants 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, except shampoo;
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.
These levels are inclusive of any use of salicylic acid.
As a preservative, see Appendix III List of Permitted Preservatives, No.49.
***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 and in prolonged skin contact. |
206 | 324 | Tagetes minuta flower extract CAS No. 91770-75-1
Tagetes minuta flower oil CAS No. 91770-75-1/8016-84-0 | (a) Leave-on products
(b) Rinse-off products | (a) 0.01%
(b) 0.1% | (a) Not to be used in sunscreen preparations and products marketed for exposure to UV rays, both natural and artificial.
Notes: This restriction does not apply to products with secondary UV protection claims as described in the preamble of ASEAN Sunscreen Labeling Guidelines. This kind of products include moisturizing and skin lightening products, to name a few.
(a) and (b) - Alpha terthienyl (terthiophen) content in extract/oil: ≤ 0.35%. - When used in combination with Tagetes patula (No. 207) or Tagetes erecta (No. 208), the total content of Tagetes in ready-to-use cosmetics must not exceed the maximum concentration limit stated in column d. | / |
207 | 325 | Tagetes patula flower extract CAS No. 91722-29-1
Tagetes patula flower oil CAS No. 91722-291/8016-84-0 | (a) Leave-on products
(b) Rinse-off products | (a) 0.01%
(b) 0.1% | (a) Not to be used in sunscreen preparations and products marketed for exposure to UV rays, both natural and artificial.
Notes: This restriction does not apply to products with secondary UV protection claims as described in the preamble of ASEAN Sunscreen Labeling Guidelines. This kind of products include moisturizing and skin lightening products, to name a few.
(a) and (b) - Alpha terthienyl (terthiophen) content in extract/oil: ≤ 0.35%. - When used in combination with Tagetes minuta (No. 206) or Tagetes erecta (No. 208), the total content of Tagetes in ready-to-use cosmetics must not exceed the maximum concentration limit stated in column d. | / |
208 | 327 | Tagetes erecta flower extract CAS No. 90131-43-4
Tagetes erecta flower oil CAS No. 90131-43-4 | (a) Leave-on products
(b) Rinse-off products | (a) 0.01%
(b) 0.1% | (a) Not to be used in sunscreen preparations and products marketed for exposure to UV rays, both natural and artificial.
Notes: This restriction does not apply to products with secondary UV protection claims as described in the preamble of ASEAN Sunscreen Labeling Guidelines. This kind of products include moisturizing and skin lightening products, to name a few.
(a) and (b) - Alpha terthienyl (terthiophen) content in extract/oil: ≤ 0.35%. - When used in combination with Tagetes minuta (No. 206) or Tagetes patula (No. 207), the total content of Tagetes in ready-to-use cosmetics must not exceed the maximum concentration limit stated in column d. | / |
209 | 328 | 2-Hydroxyethyl Methacrylate HEMA CAS No. 868-77-9 | Preparations for the care and make-up of nails | / | Applied by professionals
Notes: Professionals are people who have been professionally trained in their fields. | - Only applied by professionals. - May cause an allergic reaction. |
210 | 329 | 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 CAS No. 41137-60-4/72869-86-4 | Preparations for the care and make-up of nails | / | Applied by professionals
Notes: Professionals are people who have been professionally trained in their fields. | - Only applied by professionals. - May cause an allergic reaction. |
3) Amending the use requirements of 1 colorant in Appendix II List of Permitted Colorants
No. | Colour Index (CI) No. | Ingredient name | Color | Field of application and/or use | Maximum authorized concentration and other requirements | |||
1 | 2 | 3 | 4 | |||||
147 | 77891 | Pigment White 6 | White | X | Titanium dioxide in powder form, which contains 1% or more particles with an aerodynamic diameter of ≤ 10 μm, shall be used in accordance with the requirements set out in Appendix I List of Restricted Ingredients, No. 218.
Notes: For the use of titanium dioxide as a sunscreen agent, see Appendix IV List of Permitted Sunscreens. | |||
Notes: Field 1: Permitted colorants in all cosmetics. Field 2: Permitted colorants in cosmetics except for cosmetics used around the eyes. Field 3: Permitted colorants in cosmetics except for cosmetics that come into contact with mucous membranes. Field 4: Colorants which are only permitted in rinse-off products. | ||||||||
4) Amending the use requirements of 2 preservatives in Appendix III List of Permitted Preservatives
No. | Ref. No. ACD # | Ingredient name/CAS No. | Maximum authorized concentration | Limitations and other requirements | Marking/Warning |
a | b | c | d | e | |
49 | 3 | Salicylic acid (INCI) and garamnya (1) CAS No. 69-72-7
Calcium salicylate (INCI) CAS No. 824-35-1
Magnesium salicylate (INCI) CAS No. 18917-89-0
MEA-salicylate (INCI) CAS No. 59866-70-5
Sodium salicylate (INCI) CAS No. 54-21-7
Potassium salicylate (INCI) CAS No. 578-36-9
TEA-salicylate (INCI) CAS No. 2174-16-5 | Salicylic acid: 0.5% (as acid)
Salicylic acid salts: 0.5% (as acid) | Salicylic acid: - Not to be used in preparations for children under 3 years of age.
- Not to be used in dental and oral care preparations.
- Not to be used in applications that may lead to exposure of the end user's lungs by inhalation.
Salicylic acid salts: Not to be used in preparations for children under 3 years of age, except shampoo. | Salicylic acid: Not to be used for children under 3 years of age (2)
Salicylic acid salts: Not to be used for children under 3 years of age (3) |
51 | 51 | Sodium hydroxymethylamino acetate
Sodium hydroxymethylglycinate (INCI) CAS No. 70161-44-3 | 0.5% | Not to be used unless the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, can be less than 0.1% w/w in the mixture as placed on the market. | / |
Notes: 1. For use other than preservatives, see Appendix I List of Restricted Ingredients, No.124. 2. This marking/warning applies to all preparations that may be used in children under 3 years of age. 3. This marking/warning applies to all preparations that may be used in children under 3 years of age in prolonged skin contact. | |||||
5) Amending the use requirements of 2 sunscreens in Appendix IV List of Permitted Sunscreens
No. | Ref. No. ACD # | Ingredient name/CAS No. | Maximum authorized concentration | Limitations and other requirements | Marking/Warning |
a | b | c | d | e | |
4 | 10 | 2-Cyano-3,3-diphenyl acrylic acid, 2-etylhexyl ester(1)
Octocrylene (INCI) CAS No. 6197-30-4 | a. Spray propellant preparation: 9%
b. Other preparations: 10% | / | / |
24 | 27 | Titanium dioxide(2)
Titanium dioxide (INCI) CAS No. 13463-67-7/1317-70-0/1317-80-2 | 25%(3) | Titanium dioxide in powder form, which contains 1% or more particles with an aerodynamic diameter of ≤ 10 μm, shall be used in accordance with the requirements as stated in Appendix I List of Restricted Ingredients, No. 218. The maximum content of this ingredient is 25% when used in products other than facial cosmetics in powder form and hair preparations in aerosol form. | / |
Notes: 1. Benzophenone used as a contaminant and/or degradation of Octocrylene must be suppressed below the limit of contamination; 2. In the case of using a combination of titanium dioxide and titanium dioxide (nano), the concentration must not exceed 25%; 3. For the use of titanium dioxide as a colorant, see Appendix II List of Permitted Colorants, CI 77891. | |||||
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