February 14, 2026
Cosmetic product safety is a top public health priority in Southeast Asia’s largest consumer market. To protect consumers from exposure to toxic impurities, microbiological hazards, and harmful chemical residues, Indonesia’s National Agency of Drug and Food Control (BPOM / NADFC) has strengthened its regulatory oversight through BPOM Regulation No. 16 of 2024 on Cosmetic Contamination Limits.
This regulation modernizes Indonesia’s cosmetics safety framework by defining permissible contamination thresholds, laboratory testing expectations, and enforcement measures for manufacturers and importers.
This technical guide from Maven Regulatory Solutions provides a comprehensive overview of the contaminant classifications, testing limits, transition timelines, compliance requirements, and 2026 regulatory trends.
Regulatory Authority Overview
The Indonesian BPOM (NADFC) regulates:
- Cosmetic safety and quality
- Ingredient compliance
- Product notification
- Post-market surveillance
- Contamination control standards
BPOM Regulation No. 16/2024 officially replaces Regulation No. 12/2019, introducing updated contaminant thresholds aligned with global cosmetic safety risk frameworks.
Classification of Cosmetic Contaminants Under BPOM
BPOM classifies cosmetic contaminants into three regulatory risk categories:
| Contaminant Type | Regulatory Description | Risk Concern |
| Microbial Contaminants | Bacteria, yeast, molds | Infection, irritation, product spoilage |
| Heavy Metals | Toxic metallic elements & metalloids | Bioaccumulation, systemic toxicity |
| Chemical Contaminants | Harmful residual chemicals | Carcinogenicity, neurotoxicity, organ damage |
Cosmetics are not required to be completely contaminated-free; instead, strict maximum permissible limits (MPLs) apply.
Heavy Metal Contamination Limits
Trace heavy metals may enter cosmetics through raw material impurities or processing.
| Heavy Metal | Maximum Limit |
| Lead (Pb) | ≤ 20 ppm |
| Mercury (Hg) | ≤ 1 ppm (unintentional only) |
| Arsenic (As) | ≤ 5 ppm |
| Cadmium (Cd) | ≤ 5 ppm |
These limits align with global cosmetic toxicology risk thresholds.
Microbiological Contamination Requirements
Products are divided into Category A (high-risk) and non-A products.
Category A includes:
- Products for children under 3
- Eye-area cosmetics
- Mucosal contact products
| Test Parameter | Category A | Other Cosmetics |
| Total Plate Count | ≤ 500 CFU/g or ml | ≤ 1,000 CFU/g or ml |
| Yeast & Mold | ≤ 500 CFU/g or ml | ≤ 1,000 CFU/g or ml |
| Pathogens (P. aeruginosa, S. aureus, C. albicans) | Negative in 0.1 g/ml | Negative in 0.1 g/ml |
Chemical Contaminant Limits
| Substance | Permissible Level |
| 1,4-Dioxane | ≤ 10 mg/kg or L |
| Acrylamide | ≤ 0.1 mg/kg (non-rinse), ≤ 0.5 mg/kg (others) |
| Diethylene Glycol (DEG) | ≤ 0.1% |
These substances are typically process impurities and must be controlled through raw material qualification and GMP.
Laboratory Testing Requirements
Testing must be conducted in:
- BPOM-accredited laboratories
- GMP-certified internal labs
All analytical methods must be validated, verified, and scientifically robust (e.g., ICP-MS for metals, microbial challenge tests, GC-MS for chemical residues).
Regulation Implementation Timeline
| Milestone | Date |
| Regulation Issued | 3 September 2024 |
| Regulation Effective | 12 months after issuance (2025) |
| Full Compliance Expectation | 2026 onward |
Enforcement & Administrative Sanctions
Non-compliance may result in:
- Written warnings
- Product withdrawal
- Destruction orders
- Temporary distribution ban (up to 1 year)
- Notification number revocation
- Suspension of manufacturing/import activity
2026 Regulatory Trends in Indonesian Cosmetic Compliance
- Increased scrutiny of microbial challenge testing
- Emphasis on toxicological risk assessment
- Digitalization of BPOM cosmetic notification systems
- Focus on supply chain impurity control
- Stronger post-market surveillance
FAQs BPOM Cosmetic Contamination Regulation
Q1: Which regulation governs cosmetic contamination?
BPOM Regulation No. 16/2024.
Q2: Are heavy metals completely banned?
No, but strict trace limits apply.
Q3: Are microbial limits different for eye products?
Yes, stricter Category A thresholds apply.
Q4: Is in-house lab testing allowed?
Yes, if GMP-certified.
Q5: What happens if limits are exceeded?
Products may be recalled and licenses suspended.
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