ISO 21315:2018

Traditional Chinese medicine - Ganoderma lucidum fruiting body

This document specifies minimum requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.

Médecine traditionnelle chinoise — Organe fructifère de Ganoderma lucidum

General Information

• Status: Published
• Publication Date: 19-Dec-2018
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 9092 - International Standard to be revised
• Start Date: 08-Jun-2024
• Completion Date: 13-Dec-2025

Relations

• Revised: ISO/FDIS 21315 - Traditional Chinese medicine - Ganoderma lucidum fruiting body
• Effective Date: 15-Jun-2024

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.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21315
First edition
2018-12
Traditional Chinese medicine —
Ganoderma lucidum fruiting body
Médecine traditionnelle chinoise — Organe fructifère de
Ganoderma lucidum
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 2
5.1 General characteristics . 2
5.2 Ganoderma lucidum fruiting body . 3
5.2.1 Morphological features of fruiting body . 3
5.2.2 Thin-layer chromatogram (TLC) identification . . 3
5.2.3 Moisture . 3
5.2.4 Total ash . 3
5.2.5 Water-soluble extractives . 3
5.2.6 Marker compounds . . 3
5.2.7 Heavy metals . 3
5.2.8 Pesticide residues . 3
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 TLC identification . 4
7.3 Determination of moisture content . 4
7.4 Determination of total ash . 4
7.5 Determination of water-soluble extractives . 4
7.6 Determination of marker compounds . 4
7.7 Determination of heavy metals . 4
7.8 Determination of pesticide residues . 4
8 Test report . 4
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) TLC identification. 6
Annex B (informative) Determination of water-soluble extractives . 8
Annex C (informative) Determination of polysaccharides . 9
Annex D (informative) Determination of ganoderic acid A .11
Annex E (informative) Reference values of national and regional limits of moisture, total
ash, water-soluble extractives, polysaccharides, ganoderic acid A and heavy metals
in Ganoderma lucidum fruiting body .14
Bibliography .15
Foreword
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.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved

Introduction
Ganoderma lucidum fruiting body is the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.)
Karst., which is also known as Lingzhi or Reishi. It has been used as a medicinal mushroom in many
Asian countries for more than 2000 years, such as China, Japan and Korea, making it one of the oldest
mushrooms known to have been used medicinally. This fungus can tonify Qi, and is traditionally used
to treat fatigue, cough and insomnia in traditional Chinese medicine. Modern pharmacological studies
also demonstrate its great potential in tumour treatment and immuno-enhancement. Therefore,
the market of Ganoderma lucidum has developed very rapidly, as indicated by the increase in yield,
production output and trade volume.
However, there remain many challenges, such as adulteration of similar species, and lack of suitable
testing methods for quality assessment. In addition, though Ganoderma lucidum has been recorded in
several pharmacopoeias, such as Chinese Pharmacopoeia, United States Pharmacopeia Herbal Medicines
Compendium and the Korean Herbal Pharmacopoeia, the specifications and quality requirements in
these standards vary. Therefore, there is a clear and urgent need to develop an international standard
for harmonizing the existing standards, as well as ensuring the safety and effectiveness of Ganoderma
lucidum fruiting body.
As national implementation may differ, National Standards Bodies are invited to modify the values
given in 5.2.3, 5.2.4 and 5.2.5 in their national standards. Examples of national and regional values are
given in Annex E.
INTERNATIONAL STANDARD ISO 21315:2018(E)
Traditional Chinese medicine — Ganoderma lucidum
fruiting body
1 Scope
This document specifies minimum requirements and test methods for Ganoderma lucidum fruiting
body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst.
It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica
(whole medicinal materials) and decoction pieces derived from this fungus.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1575, Tea — Determination of total ash
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
CAC/MRL01, Maximum Residue Limits for Pesticides in Food
CODEX STAN 229, Analysis of pesticide residues: Recommended methods
World Health Organization. 2011, Quality control methods for herbal materials, General advice on
sampling
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
fruiting body
dried sporocarp of Ganoderma lucidum (Leyss. ex Fr.) Karst.
3.2
reference standard
authentic substance used as a measurement base for TLC identification or marker compound
quantification
4 Descriptions
Ganoderma lucidum fruiting body is the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.) Karst.
in the family of Ganodermataceae shown in Figure 1.
a)  Fruiting body of Ganoderma lucidum b)  Vertical section of pileus
Key
1 pileus
2 stipe
3 pileus diameter
4 stipe length
5 spore
6 crust
7 context
8 tube
Figure 1 — Structure of Ganoderma lucidum
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling.
a) Ganoderma lucidum fruiting body shall be clean and free from foreign matter.
2 © ISO 2018 – All rights reserved

b) The presence of living insects, moulds and external contaminants which are visible to the naked
eye shall not be permitted.
5.2 Ganoderma lucidum fruiting body
5.2.1 Morphological features of fruiting body
a) Outline of fruiting body umbrella-shaped, pileus reniform, semi-rounded or surrounded, 10 cm to
30 cm in diameter, 1 cm to 4 cm thick.
b) Colour of pileus varies, yellowish-brown to reddish-brown, lustrous, with circular stripe and
radiate wrinkle.
c) Stipe cylinder, usually 4 cm to 15 cm long, 1 cm to 3,5 cm in diameter, reddish-brown, luminous;
attachment of the stipe to the pileus varies from lateral to nearly central.
d) Spore small and fine, yellowish-brown.
e) Odour slightly aromatic, taste slightly bitter.
f) Crust hard, colour similar to pileus or darker, the context varies in colour from yellowish-brown to
dark brown, the length of tube layer varies from short (less than one-third of the pileus thickness)
to long (more than one-third of the pileus thickness).
5.2.2 Thin-layer chromatogram (TLC) identification
The identification of Ganoderma lucidum fruiting body with thin-layer chromatogram (
...