Scope
The guideline covers health supplements in ASEAN regulatory work. It states limits for heavy metals and microbial contaminants across dosage forms.
Exact limit and units
| Metal | Matrix | Limit | Unit | Basis |
|---|---|---|---|---|
| Lead | Health supplements | NMT 10.0 | mg/kg or mg/L (10.0 ppm) | Finished health supplement product |
| Arsenic | Health supplements | NMT 5.0 | mg/kg or mg/L (5.0 ppm) | Finished health supplement product |
| Mercury | Health supplements | NMT 0.5 | mg/kg or mg/L (0.5 ppm) | Finished health supplement product |
| Cadmium | Health supplements | NMT 0.3 | mg/kg or mg/L (0.3 ppm) | Finished health supplement product |
The note states that, due to national regulatory requirements, the Philippines arsenic limit is 0.3 mg/kg or 0.3 mg/L.
How tested
The guideline does not prescribe one metal method in the extracted heavy-metal table. It frames the limits as contaminant specifications for product quality and safety.
Enforcement posture
The document is an ASEAN guideline with an express disclaimer, not a directly enforceable national regulation by itself. It is therefore loaded as guidance impurity limit in the structured register.
History of changes
Version 2.0 was adopted and endorsed through the ASEAN traditional medicines and health supplements committees, with document history indicating the 2015 endorsement and later public version.
How it compares
The generic ASEAN limits align with Singapore HSA health-supplement limits for Pb, arsenic, Hg, and Cd. The Philippines arsenic note is stricter than the generic ASEAN arsenic value.
Sources
Update history
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