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Indonesia Proposes to Amend Limitations for Contamination in Cosmetics

On November 9, 2023, Indonesia released the amended draft Regulation Concerning Limitations for Contamination in Cosmetics for public consultation. 1 The regulation aims to clarify the definition and scope of microbial, heavy metal, and chemical contamination of cosmetics. It also outlines administrative sanctions for enterprises that violate the regulation.

Main Content

1. General Requirements

2. Requirements and Testing

  • Requirements

  • Testing

3. Administrative Sanctions

4. Transitional Provisions

5. Closing

6. Appendix

  • Limitation Standards on Microbial Contamination

  • Limitation Standards on Heavy Metal Contamination

  • Limitation Standards on Chemical Contamination

Main Amendments

This draft proposes revisions to the limits of chemical contamination in cosmetics, while the contamination limits for microorganisms and heavy metals remain unchanged. The amended requirements are indicated in red in the table below.

1) Limitation Standards on Microbial Contamination


1. Cosmetics for children under 3 years old

2. Cosmetics used around the eyes

3. Cosmetics used in the area contacting with mucous membranes

Cosmetics except for those:

1. used for children under 3 years old

2. used around the eyes

3. used in the area contacting with mucous membranes

Total plate count

≤ 5x102 colony/g or colony/mL

≤ 103 colony/g or colony/mL

Mold and yeast

≤ 5x102 colony/g or colony/mL

≤ 103 colony/g or colony/mL

Pseudomonas   aeruginosa

Negative per 0.1 g or 0.1 mL sample (test sample)

Negative per 0.1 g or 0.1 mL sample (test sample)

Staphylococcus   aureus

Negative per 0.1g or 0.1 mL sample (test sample)

Negative per 0.1 g or 0.1 mL sample (test sample)

Candida albicans

Negative per 0.1 g or 0.1 mL sample (test sample)

Negative per 0.1 g or 0.1 mL sample (test sample)

2) Limitation Standards on Heavy Metal Contamination

Heavy Metal

Limitation

Mercury (Hg)

≤ 1 mg/kg or 1mg/L (1 ppm)

Lead (Pb)

≤ 20 mg/kg or 20 mg/L (20 ppm)

Arsenic (As)

≤ 5 mg/kg or 5 mg/L (5 ppm)

Cadmium (Cd)

≤ 5 mg/kg or 5 mg/L (5 ppm)

3) Limitation Standards on Chemical Contamination

Contamination

Limitation

1,4-Dioxane (1)

≤ 10 mg/kg or 10mg/L (10 ppm)

Acrylamide (2)

  • ≤ 0.1 mg/kg in leave on products

  • ≤ 0.5 mg/kg in other products

Diethylene glycol (3)

≤ 0.1%

Notes:

(1) For cosmetics contain ingredients made through the ethoxylation process such as sodium laureth sulphate or polyethylene glycol;

(2) For cosmetics contain polyacrylamides;

(3) As an unavoidable contamination in cosmetics.

Further Reading

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