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) |
|
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. | |
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