ISO 21315:2026

Traditional Chinese medicine — Ganoderma lucidum fruiting body

This document specifies requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to the 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: 10-Feb-2026
• 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: 6060 - International Standard published
• Start Date: 11-Feb-2026
• Due Date: 08-Jun-2027
• Completion Date: 11-Feb-2026

Relations

• Revises: ISO 21315:2018 - Traditional Chinese medicine — Ganoderma lucidum fruiting body
• Effective Date: 15-Jun-2024

Overview

ISO 21315:2026 specifies the international requirements and test methods for the Ganoderma lucidum fruiting body, a medicinal fungus widely recognized as Lingzhi or Reishi in traditional Chinese medicine. This standard ensures the consistent quality, authenticity, and safety of Ganoderma lucidum fruiting bodies, whether they are used as whole medicinal materials or as decoction pieces. Ganoderma lucidum is revered for its health benefits and is utilized globally in a range of herbal and pharmaceutical products. ISO 21315:2026 provides a harmonized framework to support regulatory compliance, facilitate international trade, and protect consumer health.

Key Topics

• Product Description: The standard covers the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.) Karst., specifying morphological features such as shape, size, color, and odor.
• Quality and Safety Requirements:
  • Must be clean and free of contaminants, insects, and mold.
  • Authentication: Identification via thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC).
  • Physicochemical Properties: Assessment of moisture content, total ash, and water-soluble extractives.
  • Marker Compounds: Determination of key bioactive components such as polysaccharides and ganoderic acid A to verify product quality.
  • Contaminant Limits: Testing for heavy metals (e.g., arsenic, cadmium, lead, mercury) and pesticide residues.
• Sampling and Testing Methods: Detailed procedures for sampling, macroscopic identification, and laboratory analyses, referencing established ISO methods.
• Packaging, Storage, and Labelling:
  • Packaging must prevent contamination and preserve product integrity.
  • Storage conditions are specified to maintain quality during transportation and warehousing.
  • Labelling must include product name, scientific name, origin, batch number, expiry date, and key quality attributes.

Applications

ISO 21315:2026 serves several critical applications in the supply chain of Ganoderma lucidum fruiting body:

• Quality Control: Producers, processors, and laboratories use this standard to ensure the authenticity and consistent quality of Lingzhi products.
• Regulatory Compliance: Helps manufacturers and distributors meet national and international requirements for herbal medicinal products.
• Supply Chain Management: Provides a common language for trade partners and ensures mutual recognition of test results across borders.
• Consumer Protection: Reduces risks of adulteration and contamination while ensuring effective health benefits for end-users.
• Research and Development: Offers a methodological foundation for further studies and product innovation involving Ganoderma lucidum.

Related Standards

For comprehensive quality assurance, the following related ISO standards are referenced in ISO 21315:2026:

• ISO 18664: Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine.
• ISO 19609-2: Quality and safety of raw materials and finished products - Identity testing.
• ISO 21371: Labelling requirements for traditional Chinese medicine products.
• ISO 22217: Storage requirements for raw materials and decoction pieces.
• ISO 22258: Determination of pesticide residues in natural products by gas chromatography.
• ISO 23723: General requirements for herbal raw material and materia medica.

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By implementing ISO 21315:2026, stakeholders in the traditional Chinese medicine industry can enhance product quality, increase trust in Ganoderma lucidum products, and ensure safe global trade practices. This standard is essential for anyone engaged in the cultivation, processing, analysis, or commercialization of Lingzhi/Reishi.

Standards Content (Sample)

International
Standard
ISO 21315
Second edition
Traditional Chinese medicine —
2026-02
Ganoderma lucidum fruiting body
Médecine traditionnelle chinoise — Organe fructifère de
Ganoderma lucidum
Reference number
© ISO 2026
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 on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.3 Identification .3
5.3.1 Thin-layer chromatography (TLC) identification .3
5.3.2 High performance liquid chromatography (HPLC) identification .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Water-soluble extractives .3
5.7 Marker compounds .3
5.8 Heavy metals .3
5.9 Pesticide residues .3
6 Sampling . 3
7 Test methods . 3
7.1 Macroscopic identification .3
7.2 Identification .4
7.2.1 Thin-layer chromatography (TLC) identification .4
7.2.2 High performance liquid chromatography (HPLC) identification .4
7.3 Determination of moisture .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) Thin-layer chromatography (TLC) identification . 6
Annex B (informative) Determination of polysaccharides . 8
Annex C (informative) Determination of ganoderic acid A . 10
Annex D (informative) National and regional quality requirements for Ganoderma lucidum
fruiting body . . 14
Bibliography .15

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
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The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21315:2018), which has been technically
revised.
The main changes are as follows:
— added a note to entry in 3.1 to elucidate the correct name for the widely cultivated medicinal fungus
Ganoderma lucidum in China;
— revised the recommendation for the moisture from “should not be more than 17,0 %” to “should be
determined” in 5.4;
— revised the recommendation for the water-soluble extractives from “should not be less than 3,0 %” to
“should be determined” in 5.6;
— added the principle of the test method, a table of relative retention time and correction factor of ganoderic
acids in Annex C;
— updated the edition dates and requirements of the Chinese Pharmacopoeia, the United States
Pharmacopoeia and the Korean Herbal Pharmacopoeia, and added the requirements from the European
Pharmacopoeia in Annex D.
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
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 2 000 years, such as China, Japan and the Republic of Korea. This fungus can tonify Qi, and is 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. The market of Ganoderma
lucidum has developed rapidly, with increases 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. Though Ganoderma lucidum has been recorded in several pharmacopoeias,
[1] [2] [3]
such as Chinese Pharmacopoeia , the Korean Herbal Pharmacopoeia , the European Pharmacopoeia ,
[4]
and the United States 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 can differ, national standards bodies can modify the values given in 5.5 in their
national standards. Examples of national and regional values are given in Annex D.

v
International Standard ISO 21315:2026(en)
Traditional Chinese medicine — Ganoderma lucidum fruiting
body
1 Scope
This document specifies requirements and test methods for Ganoderma lucidum fruiting body that is derived
from Ganoderma lucidum (Leyss. ex Fr.) Karst.
It is applicable to the 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 18664, Traditional Chinese medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 19609-2, Traditional Chinese medicine — Quality and safety of raw materials and finished products made
with raw materials — Part 2: Identity testing of constituents of herbal origin
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
Ganoderma lucidum fruiting body
dried sporocarp of Ganoderma lucidum (Leyss. ex Fr.) Karst.
Note 1 to entry: Based on recent taxonomic research, the correct name for the widely cultivated medicinal fungus
[5]
Ganoderma lucidum in China is Ganoderma lingzhi Sheng H.Wu, Y.Cao & Y.C.Dai (= Ganoderma sichuanense J.D.Zhao &
[6]
X.Q. Zhang ).
3.2
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality

3.3
reference substance
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 Ganoderma lucidum
Key
1 pileus
2 stipe
3 tubular pores
4 spore
Figure 1 — Structure of Ganoderma lucidum
5 Quality and safety requirements and recommendations
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.
b) The presence of living insects, moulds and external contaminants which are visible to the naked eye
shall not be permitted.
5.2 Morphological features
a) The fruiting body is umbrella-shaped in outline. The pileus is reniform, semi-rounded or suborbicular,
with a diameter ranging from 10 cm to 30 cm and a thickness from 1 cm to 4 cm.
b) The colour of the pileus varies, ranging from yellowish-brown to reddish-brown, with a lustrous
appearance. It features circular stripes and radiating wrinkles.
c) The stipe is cylindrical, typically ranging in length from 4 cm to 15 cm and in diameter from 1 cm to
3,5 cm. It exhibits a reddish-brown hue with a luminous
...