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Indonesia Amends Cosmetic Ingredient Use Requirements: 1 Ingredient Added and 12 Ingredients Revised

The main amendments include: 1) Appendix I: List of Restricted Ingredients – 1 added and 7 revised 2) Appendix II: List of Permitted Colorants – 1 revised 3) Appendix III: List of Permitted Preservatives – 2 revised 4) Appendix IV: List of Permitted Sunscreens – 2 revised

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 (excluding 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 requirements specified in the Appendices;

  • Ingredients listed in Appendix II, III and IV that are not used as the colorant, preservative and sunscreen agent, and do not comply with the requirements in Appendix II, III and IV;

  • Colorants not listed in Appendix II (except for colorants specifically used for hair dyeing);

  • Preservatives and sunscreens not listed in Appendix III and IV;

  • Prohibited ingredients listed in Appendix V.

 

Notes:

  • Other cosmetic ingredients not listed in Appendix I can be used as long as it meets the safety, efficacy and quality requirements. Relevant scientific or empirical evidence proving compliance with safety, usefulness and quality requirements is required to provide and include in PIF;

  • When natural ingredients not listed in Appendix II, III and IV are used as colorants, preservatives or sunscreens in cosmetics, relevant scientific or empirical evidence is required to provide and include in PIF, and an approval from Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics is required.


On August 24, 2023, Indonesia proposed draft amendments to the Appendices in the Technical Requirements for Cosmetic Ingredients. 1 Three months later, on December 7, the finalized amendments were released and implemented. 2 It is important to note that cosmetics notification holders who obtained notification numbers before December 7 are required to ensure compliance with the new requirements by December 7, 2025.

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

220

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 7 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

42

A8

Dihydroxyacetone (INCI)

 

1,3-Dihydroxy-2-propanone

 

CAS No. 96-26-4

(a) Hair dye substance in

non-oxidative hair dye

products

 

(b) Self-tanning products

 

Use for dyeing eyelashes and eyebrows is not permitted.

(a) 6.25 %

(b) 10 %

/

For (b): This preparation does not contain sunscreen and does not protect the skin from sunburn.

124

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 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.

 

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. 219.

 

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) (1)

CAS No. 69-72-7

0.5% (as 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.

Not to be used for children under 3 years of age (2)

and its salts:


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

0.5% (as acid)

Not to be used in preparations for children under 3 years of age, except shampoo.

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. 219. The maximum content of this ingredient is 25% when used in products other than facial cosmetics in loose powder form and hair aerosol spray preparations.

/

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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