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[Chemlinked] Indonesia to Amend Cosmetic Ingredient Use Requirements: 7 Newly Permitted Ingredients and 230 Newly Prohibited Ingredients
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등록일 2022-04-18
조회수 8087
On Mar. 29, 2022, Indonesia BPOM released the second draft amendments to Technical Requirements for Cosmetics Ingredients for public consultation. The main amendments include
1) revising the general requirements for prohibited cosmetic ingredients;
2) revising the use requirements for other ingredients (ingredients not listed in Appendix I) and natural ingredients;
3) adding 5 restricted ingredients and deleting 1 restricted ingredient;
4) adding 2 permitted sunscreens;
5) adding 230 prohibited ingredients.
Editor’s Note: This article was originally published on Dec. 14, 2021, and was updated on Apr. 15, 2022, as per the latest developments.
Background: Current Ingredient Use Requirements
Cosmetic ingredients in Indonesia shall comply with Technical Requirements for Cosmetic Ingredients and its appendices:
- Appendix I: restricted ingredients
- Appendix II: permitted colorants with limitations and conditions of use (not include hair dyes only for dyeing hair)
- Appendix III: permitted preservatives with limitations and conditions of use
- Appendix IV: permitted sunscreens with limitations and conditions of use
- Appendix V: prohibited ingredients
Prohibited cosmetic ingredients in Indonesia are:
- Ingredients listed in Appendix I that do not comply with the allowable limit and conditions of use;
- Ingredients listed in Appendix II, III and IV that do not comply with the specified requirements;
- Colorants, preservatives, and sunscreens not listed in Appendix II, III, and IV;
- Prohibited ingredients listed in Appendix V.
Notes:
- Other cosmetic ingredients not listed in Appendix I (hereafter referred to as “other ingredients”) can be used as long as it meets the safety, efficacy, and quality requirements. Relevant scientific or empirical evidence is required to provide and be included in Product Information File (PIF).
- When natural ingredients not listed in Appendix II, III, and IV are used as colorants, preservatives, or sunscreens in cosmetics (hereafter referred to as “natural ingredients”), relevant scientific or empirical evidence is required to provide and be included in PIF.
Main Amendments in the Draft
1. Revise the general requirements for prohibited cosmetic ingredients
The draft stipulates that the prohibited ingredients for cosmetics are (changes are marked in red):
- Ingredients listed in Appendix I that do not comply with the allowable limit and conditions of use;
- Ingredients listed in Appendix II, III and IV that do not comply with the specified requirements;
- Ingredients listed in Appendix II, III and IV not used as the colorant, preservative and sunscreen agent, and do not comply with the requirements listed in Appendix II, III and IV;
- Colorants not listed in Appendix II, except for hair dyes only for dyeing hair;
- Preservatives not listed in Appendix III;
- Sunscreens not listed in Appendix IV;
- Prohibited ingredients listed in Appendix V.
2. Revise 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, a policy recommendation on ingredient safety/efficacy/quality issued by Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics is newly required.
To apply for a policy recommendation, business actors need to submit the following documents:
- The application letter for the issuance of a policy recommendation on ingredient safety/efficacy/quality;
- Supporting data on ingredient safety/efficacy/quality.
Based on the request, Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics will evaluate the documents and submit a policy recommendation to BPOM (Indonesian FDA). Further provisions regarding the issuance of policy recommendations will be issued in the future.
3. Add 5 restricted ingredients to and delete 1 restricted ingredient from Appendix I
1) 5 restricted ingredients added
|
No. |
Ref No. in ACD |
Ingredient name / CAS No. |
Restrictions |
Conditions of use and warnings which must be printed on the labels |
||
|
Field of application and/or use |
Maximum authorized concentration in ready-for-use-preparation |
Other limitations and requirements |
||||
|
A |
B |
C |
D |
E |
F |
|
|
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% |
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.
|
/ |
|
207 |
325 |
Tagetes patula flower extract CAS No. 91722‐29‐1
Tagetes patula flower oil 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.
|
/ |
|
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% |
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.
|
/ |
|
209 |
/ |
2-Hydroxyethyl Methacrylate HEMA CAS No. 868-77-9 |
Preparations for nail care and makeup |
/ |
Applied by professionals |
- Only applied by professionals - May cause allergic reactions |
|
210 |
/ |
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 nail care and makeup |
/ |
Applied by professionals |
- Only applied by professionals - May cause allergic reactions |
2) 1 restricted ingredient deleted
|
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 |
4. Add 2 permitted sunscreens in Appendix IV
|
No. |
Ref No. in ACD |
Substance |
Maximum Authorised concentration |
Other limitations and requirements |
|
31 |
30 |
3,3-(1,4-Phenylene) bis (5,6-diphenyl-1,2,4-triazine) Phenylene Bis-Diphe-nyltriazine (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. |
5. Add 230 prohibited ingredients in Appendix V
The prohibited cosmetic ingredients in Appendix V are increased from 1,375 to 1,605. Find the 230 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 |
Further Reading
- Indonesia Unveils New Halal Label Logo
- Expert Insights: 35 FAQs on Cosmetic Regulations in Thailand, Indonesia, Malaysia and Vietnam
- Indonesia Implements New Technical Requirements for Cosmetics Claims
- [Webinar] How to Export Cosmetics to Indonesia
Reference Links
[1] Indonesia Released the Second Draft Amendments to Cosmetic Ingredient Use Requirements
출처 : Chemlinked
