As Indonesia’s market for Natural Medicines (OBA) and Health Supplements (SK) continues to surge, the BPOM Directorate of Supervision of Traditional Medicines and Health Supplements has intensified its focus on a “silent” danger: Heavy Metal Contamination.
Unlike bacteria, heavy metals cannot be killed with heat; they are invisible, tasteless, and accumulate in the human body over time, leading to chronic health failure.
Why Heavy Metals are the “Invisible Gatekeeper” for BPOM
For global brands, heavy metal testing is often the most challenging part of the BPOM registration process. Because herbal ingredients naturally absorb minerals from the soil and water, contamination can occur long before the raw materials ever reach your factory.
According to BPOM Regulations, products must meet strict maximum limits.
The “Big Four” Metals & Their Legal Limits
| Metal Type | Natural Medicine (OBA) Limit | Health Supplement (SK) Limit |
| Lead (Pb) | < 10.0 mg/kg | < 5.0 mg/kg |
| Cadmium (Cd) | < 0.3 mg/kg | < 1.0 mg/kg |
| Arsenic (As) | < 5.0 mg/kg | < 5.0 mg/kg |
| Mercury (Hg) | < 0.5 mg/kg | < 0.5 mg/kg |
Note: Limits are measured in mg/kg or ppm (parts per million).
The Health Consequences of Non-Compliance
The International Agency for Research on Cancer (IARC) classifies these metals as Category 1 carcinogens. If a product exceeds these limits, BPOM considers it a major safety violation, leading to:
- Cadmium (Cd): Severe kidney damage and increased risk of reproductive cancers.
- Lead (Pb): Cardiovascular disease and impaired cognitive development in children.
- Arsenic (As): DNA damage and central nervous system disorders.
- Mercury (Hg): Chronic kidney disease and neurological issues (tremors/seizures).
How Contamination Happens (And How to Prevent It)
Contamination is rarely intentional. It usually stems from three preventable sources:
- Soil & Water Quality: Natural plants (herbs) absorb metals from contaminated ground or irrigation.
- Incompatible Equipment: Using low-grade metal machinery for grinding or mixing can leach lead or cadmium into the product.
- Cross-Contamination: Using raw materials from unverified suppliers who do not conduct heavy metal pre-screening.
Secure Your BPOM Registration with Product Registration Indonesia
In Indonesia, failing a heavy metal test during a BPOM audit not only delays your launch but can also result in a permanent blacklisting of your manufacturer. We take a proactive approach to your market entry:
- Raw Material Pre-Audit: We help you review laboratory certificates of analysis (CoA) against Indonesian standards before you apply for registration.
- Technical Lab Support: We coordinate with BPOM-accredited laboratories to ensure your testing methods (AAS or ICP-MS) meet local regulatory expectations.
- End-to-End Registration: From initial document preparation to securing your POM TR/TI/SD registration codes.
Don’t let heavy metals sink your Indonesian expansion. Contact us today for a comprehensive BPOM registration and compliance review to ensure your product is as safe as it is effective.
