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Editor’s Note: This article was originally published on Dec. 14, 2021, and was firstly updated on Apr. 15, 2022, and secondly updated on Aug. 10, 2022, as per the latest developments.
Background: Previous 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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In December 2021 and March 2022, Indonesia released the first and second draft amendments to Technical Requirements for Cosmetics Ingredients. On July 28, 2022, Indonesia released and implemented the finalized amendment to Technical Requirements for Cosmetics Ingredients. 1
Business actors who already have a cosmetics notification number prior to July 28, 2022, must comply with the revised requirements before July 28, 2024.
Main Amendments
1. Revising the scope of prohibited cosmetic ingredients and adding 231 prohibited cosmetic ingredients
The finalized amendment stipulates that the prohibited ingredients for cosmetics are:
1. Ingredients listed in Appendix I that do not comply with the allowable limit and conditions of use;
2. Ingredients listed in Appendix II, III and IV that
do not comply with the specified requirements;
not used as the colorant, preservative and sunscreen agent, and do not comply with the requirements listed in Appendix II, III and IV;
3. Colorants not listed in Appendix II, except for hair dyes only for dyeing hair;
4. Preservatives not listed in Appendix III;
5. Sunscreens not listed in Appendix IV;
6. Prohibited ingredients listed in Appendix V.
The prohibited cosmetic ingredients in Appendix V are increased from 1,375 to 1,606. Find the 231 newly prohibited ingredients here.
Newly Prohibited Cosmetic Ingredients (Excerpt)
No. | Ref No. in ACD | Substance | CAS No. |
1376 | 1381 | 3-and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC) | 51414-25-6; 31906-04-4 |
1377 | 1382 | 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) | 526-37-4 |
1378 | 1383 | 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol) | 57074-21-2 |
1379 | 1384 | 2-chlorobenzene-1,4-diamine (2-Chloro-p-Phenylenediamine), sulfate salts and their dihydrochloride salts, when used in hair dye preparation | 615-66-7; 61702-44-1 (sulfate); 615-46-3 (dihydro chloride) |
1380 | 1385 | Cis-1-(3-chloroallyl)-3,5,7- triaza-1-azoniaadamantane chloride (cis-CTAC) | 51229-78-8 |
1381 | 1390 | 2,2’-((3,3’,5,5’-Tetramethyl-(1,1’-biphenyl)-4,4’-diyl)-bis(oxymethylene))-bis-oxirane | 85954-11-6 |
1382 | 1392 | 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid | 93107-30-3 |
2. Revising the use requirements of other ingredients and natural ingredients
If business actors intend to use other ingredients or natural ingredients in cosmetics, in addition to scientific or empirical evidence, an approval from Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics is newly required.
To obtain the approval, business actors shall apply electronically to Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics to review the ingredient safety, efficacy and quality. The documents required are as follows:
administrative documents in the form of application letter for review of ingredient safety, efficacy, and quality;
technical documents in the form of supporting data on ingredient safety, efficacy, and quality.
Based on the application, Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics will evaluate the documents.
3. Adding 14 restricted ingredients to, deleting 1 restricted ingredient from, and amending the use requirements of 2 restricted ingredients in Appendix I
1) Adding 14 restricted ingredients
No. | Ref No. in ACD | Substance / CAS No. |
206 | 324 | Tagetes minuta flower extract CAS No. 91770‐75‐1 Tagetes minuta flower oil CAS No. 91770‐75‐1/8016‐84‐0 |
207 | 325 | Tagetes patula flower extract CAS No. 91722‐29‐1 Tagetes patula flower oil CAS No. 91722‐29‐1/8016‐84‐0 |
208 | 327 | Tagetes erecta flower extract CAS No. 90131‐43‐4 Tagetes erecta flower oil CAS No. 90131‐43‐4 |
209 | 328 | 2-Hydroxyethyl Methacrylate HEMA CAS No. 868-77-9 |
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 |
211 | 330 | 4-(3-aminopyrazolo[1,5-A]pyridin-2-yl)-1,1-dimethylpiperazin-1-iumchloride hydrochloride Dimethylpiperazinium Aminopyrazolopyridine HCl CAS No. 1256553-33-9 |
212 | 331 | 1-(3-((4-Aminophenyl) amino)propyl)-3-methyl-1H-imidazol-3-ium chloride hydrochloride Methylimidazoliumpropyl pphenylenediamine HCl CAS No. 220158-86-1 |
213 | 332 | Di-[2-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium]-ethyl]disulphide dimethanesulfonate HC Orange No. 6 CAS No. 1449653-83-1 |
214 | 333 | Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulfonate Acid Orange 7 CAS No. 633-96-5 |
215 | 334 | Phenol, 4,4'-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo- Tetrabromophenol Blue CAS No. 4430-25-5 |
216 | 335 | Indigofera tinctoria, dried and pulverised leaves of Indigofera tinctoria L Indigofera tinctoria leaf Indigofera tinctoria leaf powder Indigofera tinctoria leaf extractIndigofera tinctoria extract CAS No. 84775-63-3 |
217 | 336 | Diphenyl(2,4,6- trimethylbenzoyl) phosphine oxide Trimethylbenzoyl diphenylphosphine oxide CAS No. 75980-60-8 |
218 | 337 | 2-Furaldehyde Furfural CAS No. 98-01-1 |
219 | 338 | Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter < 10 μm Titanium Dioxide CAS No. 13463-67-7 / 1317-70-0 / 1317-80-2 |
2) Deleting 1 restricted ingredient
No. | Ref No. in ACD | Substance/CAS No. | Restrictions | Conditions of use and warning which must be printed on the labels | ||
Field of application and/or use | Maximum authorised concentration in the ready-for-use preparation | Other limitations and requirements | ||||
52 | 13 | Formaldehyde (INCI) CAS No. 50-00-0 | Nail hardening products | 5% as formaldehyde | Function as a preservative, specified in Appendix III of this Agency Regulation, at number 31. | - Protects nail cuticles with moisturizer or oil - Contains formaldehyde |
3) Amending the use requirements of 2 restricted ingredients
No. | Ref No. in ACD | Substance/CAS No. | Restrictions | Conditions of use and warning which must be printed on the labels | ||
Field of application and/or use | Maximum authorised concentration in the ready for use preparation | Other limitations and requirements | ||||
166 | 326 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3- dimethylbutan-2-one
Climbazole
CAS No. 38083-17-9
| (a) Rinse-off anti-dandruff shampoo (b) Rinse-off Conditioner
| (a) 2.0% (b) 0.5% | Function as a preservative, see Appendix III, at number 21. | / |
42 | A8 | Dihydroxyacetone (INCI) CAS No. 96-26-4 | (a) Hair dye substance in non-oxidative hair dye products (b) Self-tanning products | (a) 6.25% (b) 10% | / | (b) This product does not contain a sunscreen and does not protect the skin from sunburn. |
4. Amending use requirements of the pigment black entries in Appendix II
No. | Colour Index number | Ingredient name | Colour | Field of application | Other limitation and requirements | |||
1 | 2 | 3 | 4 | |||||
129 | 77266 | Pigment Black 6 & 7 | Black | X | Purity > 97% with the following impurity profile: - Ash content ≤ 0.15%; - Total Sulfur ≤ 0.65%; - Total Poly Aromatic Hydrocarbon (PAH) ≤ 500 ppb, benzo(a)pyrene ≤ 5 ppb, and dibenz(a,h) anthracene ≤ 5 ppb; - As ≤ 3 ppm; - Pb ≤ 10 ppm; - Hg ≤ 1 ppm | |||
130 | 77266 | Pigment Black 6 & 7 (nano) | Black | X | 10% maximum 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:
- Ash content ≤ 0.15%; - Total Sulfur ≤ 0.65%; -Total Poly Aromatic Hydrocarbon (PAH) ≤ 500 ppb, benzo(a)pyrene ≤ 5 ppb, and dibenz(a,h)anthracene ≤ 5 ppb; - As ≤ 3 ppm; - Pb ≤ 10 ppm; - Hg ≤ 1 ppm
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5. Amending the preamble of, adding 1 preservative to, deleting 1 preservative from, and amending the use requirements of 3 preservatives in Appendix III
1) Revising the 4th statement of the Preamble to "All finished products containing formaldehyde or substances in this appendix and which release formaldehyde (Entries 9, 11, 12, 13, 14, 29, 34, 37, 42, 51) must be labelled with the warning 'contains formaldehyde' where the concentration of formaldehyde in the finished product exceeds 0.05%".
2) Adding 1 permitted preservative
No. | Ref No. in ACD | Substance/CAS No. | Maximum authorized concentration |
57 | 60 | 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone (INCI) | 0.7% |
3) Deleting 1 permitted preservative
No. | Ref No. in ACD | Substance / CAS No. | Restrictions | Note |
31 | 5 | Formaldehyde and paraformaldehyde (7) Formaldehyde (INCI) CAS No. 50-00-0 Paraformaldehyde (INCI) CAS No. 30525-89-4 | - Oral hygiene products: 0.1% (as free formaldehyde) - Other products: 0.2% (as free formaldehyde)
Do not use in aerosol products (spray) | Delete the ingredient and the corresponding footnote, as the substances are prohibited in cosmetic products under Appendix V. |
4) Amending the use requirements of 3 permitted preservatives
No. | Ref No. in ACD | Substance/CAS No. | Maximum authorized concentration | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
10 | 7 | Biphenyl-2-ol o-Phenylphenol (INCI) CAS No. 90-43-7 | - Rinse-off products: 0.2% (as phenol) - Leave-on products: 0.15% (as phenol) | / | Avoid contact with eyes |
21 | 32 | 1‐(4‐Chlorophenoxy)‐1-(imidazol‐1‐yl)‐3,3‐dimethylbutan‐2‐one | - Hair lotions: 0.2% - Rinse‐off conditioner: 0.5% | / | / |
46 | 28 | Poly(1-hexamethylenebiguanide hydrochloride)
Polyaminopropyl biguanide (INCI) CAS No. 32289-58-0/27083-27-8/ 28757-47-3/133029-32-0 | 0.1% | Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. | / |
6. Adding 2 permitted sunscreens in Appendix IV
No. | Ref No. in ACD | Substance/CAS No. | Maximum Authorised concentration | Other limitations and requirements |
31 | 30 | 3,3-(1,4-Phenylene) bis (5,6-diphenyl-1,2,4-triazine) Phenylene Bis-Diphenyltriazine (INCI)
CAS No. 5514-22-2 | 5% | Not to be used in application that may lead to exposure of the end user's lungs by inhalation. |
32 | 31 | 2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate
CAS No. 1419401-88-9 | 3% | - Not to be used in application that may lead to exposure of the end-user's lungs by inhalation. - Maximum nitrosamine content: 50μg/kg (in raw material terms); - Kept in nitrite-free containers. |
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