Overview
ISO 21315:2018 - Traditional Chinese medicine - Ganoderma lucidum fruiting body is an international standard that defines minimum requirements and test methods for the dried fruiting body (Lingzhi / Reishi) of Ganoderma lucidum. It applies to whole medicinal materials and decoction pieces sold and used as Chinese materia medica. The standard aims to harmonize quality control, reduce adulteration and support safety and efficacy of Ganoderma lucidum in global trade.
Key topics and requirements
- Identification and description
- Macroscopic morphological features: pileus 10–30 cm diameter, thickness 1–4 cm; stipe 4–15 cm long, 1–3.5 cm diameter; colour, texture, odour and taste descriptors included.
- Thin-layer chromatogram (TLC) identification: sample must show spots/bands matching a reference standard.
- Chemical and physical limits
- Moisture: mass fraction ≤ 17.0%
- Total ash: mass fraction ≤ 4.0%
- Water-soluble extractives: mass fraction ≥ 3.0%
- Marker compounds and assays
- Determination of polysaccharides and ganoderic acid A as marker compounds (informative annexes provide methods).
- Contaminant testing
- Heavy metals: arsenic, cadmium, lead, mercury to be determined (per ISO 18664).
- Pesticide residues: assessment for listed pesticides (e.g., DDT, quintozene; methods per CAC/MRL01 and CODEX STAN 229).
- Sampling and test methods
- Sampling guidance aligned with WHO 2011 “Quality control methods for herbal materials”.
- Test methods include macroscopic inspection, TLC, moisture (ISO 20409), total ash (ISO 1575), and specific annex procedures.
- Reporting, packaging and labelling
- Test reports must document sample ID, methods, results and anomalies.
- Packaging must protect product; storage, transport and labelling requirements reference ISO 21371.
Applications and users
ISO 21315:2018 is practical for:
- Quality control laboratories performing acceptance testing and batch release
- Manufacturers and processors of Ganoderma lucidum (cultivators, cutters, decoction-piece producers)
- Importers/exporters and distributors needing consistent product specifications for international trade
- Regulatory and pharmacopoeial authorities harmonizing limits and test protocols
- Researchers and formulators developing herbal medicines or supplements containing Lingzhi/Reishi
Related standards
- ISO 20409 (moisture testing for related TCM materials)
- ISO 1575 (total ash)
- ISO 18664 (heavy metals)
- ISO 21371 (labelling for TCM products)
- CAC/MRL01 and CODEX STAN 229 (pesticide residue methods)
- WHO 2011 guidance on sampling herbal materials
Using ISO 21315:2018 supports reliable, reproducible quality control for Ganoderma lucidum, helping reduce adulteration and ensure consumer safety in traditional Chinese medicine and nutraceutical markets.
