ISO 8961:2026

• Abstract:

  This document specifies the minimum requirements and test methods for Areca catechu seed. This document applies to Areca catechu seed that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. This document does not apply to processed decoction pieces of Areca catechu seed.

• Status: Published
• Publication Date: 27-Jul-2026
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 28-Jul-2026
• Due Date: 06-May-2027
• Completion Date: 28-Jul-2026

Overview

ISO 8961:2026, Traditional Chinese medicine - Areca catechu seed, specifies the minimum quality requirements and test methods for Areca catechu seed, one of the key raw herbal materials in international trade, especially in Traditional Chinese Medicine (TCM). Also known as Bing Lang, Areca catechu seed holds a vital place in over 100 traditional prescriptions. This standard ensures the safe, consistent, and effective use of Areca catechu seed as a natural medicine for global trade, covering both whole medicinal materials and decoction pieces derived from the plant (excluding processed decoction pieces).

Key Topics

• Scope of Application:
  Applies to Areca catechu seeds used in natural medicines-mainly those traded internationally and utilized in TCM formulations.

• Quality Requirements:

  • Clean, dry seeds free of living insects, mold, and contaminants.
  • Strict morphological and microscopic identification to ensure authentic, high-quality material.
  • Moisture content not exceeding 10%.
  • Limits on total ash, acid-insoluble ash, heavy metals (arsenic, lead, mercury, cadmium), and extraneous residues.

• Identity Verification:

  • Use of thin-layer chromatography (TLC) for botanical and chemical identification.
  • Determination of marker compounds (such as arecoline and arecaidine), ensuring a minimum arecoline content of 0.20%.

• Contaminant Control:

  • Testing for aflatoxins, ochratoxin A, pesticide residues, sulfur dioxide, and heavy metals using internationally accepted methods.

• Packaging, Storage, and Transportation:

  • Odor- and flavor-proof packaging.
  • Storage in dry, cool, and dark environments-temperature not exceeding 25°C.
  • Protection against light, moisture, and contamination during transport.

• Marking and Labelling:

  • Labels must include product name, net mass, contact information, raw material details, production and expiry dates, storage recommendations, and lot number, in accordance with ISO 21371.

Applications

ISO 8961:2026 has practical value for stakeholders across the international herbal medicine supply chain:

• Manufacturers and Processors:
  Ensures uniform quality control in sourcing and preparing Areca catechu seed as a raw material or decoction piece for TCM.

• Regulators and Inspectors:
  Provides a harmonized, internationally recognized reference for inspection, certification, and quality assurance.

• Importers and Exporters:
  Promotes smoother global trade by clarifying and standardizing the requirements for quality, test methods, packaging, and labelling.

• Healthcare Practitioners and Pharmacists:
  Increases confidence in the safety and efficacy of Areca catechu seed used in prescribed traditional remedies.

• Farmers and Supply Chain Operators:
  Helps align cultivation, harvest, and handling practices to meet international standards, enhancing access to wider markets.

Related Standards

ISO 8961:2026 references and aligns with several key standards for test methods and additional requirements, including:

• ISO 18664: Determination of heavy metals in herbal medicines
• ISO 21371: Labelling requirements for oral or topical TCM products
• ISO 22217: Storage requirements for raw materials and decoction pieces
• ISO 22258: Determination of pesticide residues in natural products
• ISO 22283: Determination of aflatoxins in herbal products
• ISO 22590: Determination of sulfur dioxide
• ISO 23723: General requirements for herbal raw materials
• ISO/TS 13126: Determination of ochratoxin A in natural products

By adopting ISO 8961:2026, organizations facilitate consistent international trade, enhance consumer protection, and contribute to the global harmonization of standards in traditional Chinese medicine.

International
Standard
ISO 8961
First edition
Traditional Chinese medicine —
2026-07
Areca catechu seed
Médecine traditionnelle chinoise — Graine d'Areca catechu
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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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 Requirements and recommendations . 3
5.1 General characteristics .3
5.2 Morphological features .3
5.3 Microscopic identification .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Acid-insoluble ash .4
5.7 Thin-layer chromatogram (TLC) identification .4
5.8 Extractives .5
5.9 Marker compound(s) .5
5.10 Aflatoxins .5
5.11 Ochratoxin A .5
5.12 Pesticide residues .5
5.13 Heavy metals .5
5.14 Sulfur dioxide . .5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Determination of moisture content .5
7.3 Determination of total ash and acid-insoluble ash content .5
7.4 Thin-layer chromatogram (TLC) identification .5
7.5 Determination of marker compound(s).5
7.6 Determination of aflatoxins . .6
7.7 Determination of ochratoxin A .6
7.8 Determination of heavy metals .6
7.9 Determination of pesticide residues .6
7.10 Determination of sulfur dioxide residues .6
8 Test report . 6
9 Package, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Determination of moisture . 8
Annex B (informative) Thin-layer chromatogram (TLC) identification . 9
Annex C (informative) Determination of marker compounds .11
Annex D (informative) Comparative reference information from national and regional
standards . 14
Bibliography .16

iii
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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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).
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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.
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
Areca catechu seed is a well-known traditional Chinese medicine, and its pinyin name is Bing Lang. Currently,
it is commonly used as one of the main traditional Chinese materia medica in over 100 prescriptions based
on its wide spectrum of biological and pharmacological activities, for treating various gastrointestinal,
parasitic and oedematous diseases. The global import and export trade volume is huge with sustainable
growth in recent years. The countries of trade mainly include India, China, Thailand, Malaysia, Myanmar,
Cambodia, Indonesia, Viet Nam, Nepal and Bangladesh. However, the following concerns exist regarding the
quality control of Areca catechu seed:
a) The processing method, storage practices and operation technology of Areca catechu seed have not been
standardized, which can affect the quality and safety of medicinal materials.
b) The requirements for Areca catechu seed are different in different countries, including China, Japan, the
Republic of Korea and Thailand. The applicability of standards is limited and affects international trade.
c) Areca catechu seed is ranked no. 39 in the priority list of single herbal medicines for developing
standards in ISO/TR 23975, which is in the high priority of developing international standards.
Therefore, there is a clear and urgent need to develop an International Standard for the quality control of
Areca catechu seed and its products.
This document aims to harmonize the existing standards to ensure the safety and effectiveness of Areca
catechu seeds, which can benefit farmers, consumers, enterprises and governments involved in the
cultivation, regulation and trade of Areca catechu seed.
As national implementation can differ, and examples of national and regional values are given in Annex D.

v
International Standard ISO 8961:2026(en)
Traditional Chinese medicine — Areca catechu seed
1 Scope
This document specifies the minimum requirements and test methods for Areca catechu seed.
This document applies to Areca catechu seed that is sold and used as natural medicines in international
trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this
plant.
This document does not apply to processed decoction pieces of Areca catechu seed.
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 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 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
ISO/TS 13126, Traditional Chinese medicine — Determination of ochratoxin A in natural products by liquid
chromatography coupled with fluorescence detector
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
seed
mature ovule consisting of an embryo and its store of food surrounded by a protective seed coat
3.2
Areca catechu seed
dried ripe seed (3.1) of Areca catechu L. (Fam. Palmae)

3.3
sample batch
samples (3.4) collected from the same particular place at the same time
[SOURCE: ISO 21317:2019, 3.5]
3.4
sample
representative material taken from a product, or a part of product
[SOURCE: ISO 11596:2021, 3.1.4, modified — The words "quantity of" have been removed from the definition;
note 1 to entry has been removed.]
4 Descriptions
The structure of Areca catechu and the dried ripe seed are shown in Figure 1.
a) Plant of Areca catechu L. b) Areca catechu seed piece
Key
1 plant morphology
2 inflorescences
3 infructescence
4 fruit
5 fruit longitudinal section
Figure 1 — Structure of plant and seed of Areca catechu L.

5 Requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling.
a) Areca catechu seed materials shall be clean and dry.
b) The presence of living insects, mouldy seeds and external contaminants which are visible to the naked
eye shall not be permitted.
5.2 Morphological features
a) The seeds are rounded-conical or flattened nearly spherical, 15 mm to 35 mm in length and 15 mm
to 30 mm in diameter. Externally pale yellowish-brown or pale reddish-brown, with slightly dented
reticulate furrow, and a rounded concave micropyle in the centre of the base, on t
...