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

ISO 8961:2026 is an International Standard published by ISO for Traditional Chinese medicine - Areca catechu seed. It specifies minimum requirements and test methods for Areca catechu seed sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. The standard does not apply to processed decoction pieces of Areca catechu seed.

What does ISO 8961:2026 specify?

ISO 8961:2026 specifies how Areca catechu seed is described, sampled, tested, packaged, stored, transported, marked and labelled. In practice, it gives buyers, laboratories, manufacturers and regulators a common basis for checking identity, basic quality and selected contaminants.

The document is organized into:

• Scope
• Normative references
• Terms and definitions
• Descriptions
• Requirements and recommendations
• Sampling
• Test methods
• Test report
• Package, storage and transportation
• Marking and labelling

It also includes four informative annexes that support the tests and provide comparison information.

Annex	What it covers
Annex A	Determination of moisture
Annex B	Thin-layer chromatogram (TLC) identification
Annex C	Determination of marker compounds
Annex D	Comparative reference information from national and regional standards

What are the key requirements of ISO 8961:2026?

ISO 8961:2026 focuses on identity, purity, moisture control, chemical markers and contamination checks. The most practical effect is that a batch must look, smell and behave like genuine Areca catechu seed before it is accepted for trade or testing.

Identity and basic appearance

Clause 5 requires Areca catechu seed materials to be clean and dry, with no living insects, mouldy seeds or visible external contaminants. Clause 5 also describes the expected size, shape, colour, texture, cross-section, odour and taste, and Clause 5.3 describes the microscopic features used for identification. This matters because visual and microscopic checks are the first screen for substitution, deterioration and contamination.

Chemical identification

Clause 5.7 requires TLC identification, and Clause 7.4 points to Annex B for the procedure. The TLC result is judged by matching the positions and colours of spots or bands from the test solution and the reference drug solution. In practice, this gives a simple identity check that supports routine quality control.

Moisture and ash

Clause 5.4 sets a moisture limit of no more than 10,0%, while Clauses 5.5 and 5.6 require determination of total ash and acid-insoluble ash. Clause 7.2 points to Annex A for moisture, and Clause 7.3 uses the ash method in ISO 23723. These tests matter because excess water encourages spoilage, and ash values help show whether the material contains unusual mineral contamination or adulteration.

Extractives and marker compounds

Clause 5.8 requires determination of water-soluble, ethanol-soluble and hexane-soluble extractives. Clause 5.9 requires marker compounds such as arecoline and arecaidine, and it sets a minimum for arecoline. Annex C gives the analytical approach for the marker compounds. In practice, these tests help show whether the material has the expected chemical profile and whether processing or storage has changed its composition.

Contaminants and residues

Clauses 5.10 to 5.14 require determination of aflatoxins, ochratoxin A, pesticide residues, heavy metals and sulfur dioxide. Clause 7 assigns the test methods by reference to other ISO documents. This is important for safety and trade, because these contaminants affect acceptability, regulatory clearance and end-user confidence.

Sampling, reporting and handling

Clause 6 says sampling shall follow ISO 23723. Clause 7.1 requires random collection of at least 500 g from each sample batch for macroscopic identification. Clause 8 sets the test report contents, including sample identification, sampling method, test method, results and any unusual features. Clauses 9 and 10 control packaging, storage, transportation, marking and labelling so that the product remains protected and traceable after testing or during trade.

What terms does ISO 8961:2026 define?

• Seed - The standard uses this as the mature ovule with an embryo and stored food surrounded by a protective coat.
• Areca catechu seed - The standard defines this as the dried ripe seed of Areca catechu L. (Fam. Palmae).
• Sample batch - This is a set of samples collected from the same particular place at the same time, which helps keep batch identity clear.
• Sample - The standard uses this for representative material taken from a product or a part of a product.
• TLC - Thin-layer chromatogram (TLC) identification is the identity check based on comparing spots or bands from test and reference solutions.
• Marker compound(s) - These are the named chemical markers used to characterize the material, including arecoline and arecaidine.

Who uses ISO 8961:2026?

ISO 8961:2026 is used by laboratories, quality managers, buyers, traders, inspectors and manufacturers dealing with natural medicines based on Areca catechu seed. It is also relevant to importers and exporters working in international trade, because the standard is written for traded medicinal materials and decoction pieces.

The document is also useful for regulators and organizations involved in cultivation, regulation and quality control. The introduction states that harmonized requirements are intended to support farmers, consumers, enterprises and governments, so the standard is practical for both supply-chain checks and official oversight.

What changed in ISO 8961:2026 from the previous edition?

ISO 8961:2026 is the first edition of this International Standard. It presents the initial ISO requirements and test methods for Areca catechu seed.

Which standards are used with ISO 8961:2026?

ISO 8961:2026 relies on several other ISO documents for test methods, sampling, storage and labelling.

• ISO 23723 - Provides general requirements for herbal raw material and materia medica, and it is used for sampling and for the ash test method.
• ISO 21371 - Provides labelling requirements for products intended for oral or topical use, which supports Clause 10.
• ISO 22217 - Provides storage requirements for raw materials and decoction pieces, which Clause 9 applies to storage.
• ISO 22258 - Provides the gas chromatography method for pesticide residues.
• ISO 22283 - Provides the LC-FLD method for aflatoxins.
• ISO 22590 - Provides the titration method for sulfur dioxide.
• ISO 18664 - Provides the method for heavy metals.
• ISO/TS 13126 - Provides the liquid chromatography method for ochratoxin A.

What does the ISO 8961:2026 document contain?

ISO 8961:2026 contains a descriptive section with plant and seed figures, followed by requirements for appearance, microscopy, moisture, ash, extractives, marker compounds and contaminant limits. It also contains test methods for macroscopic identification, moisture, ash, TLC identification, marker compounds and the contaminant analyses.

Annex A gives a worked moisture method with apparatus, procedure and calculation formula. Annex B gives TLC reagents, apparatus, sample preparation and a schematic chromatogram. Annex C gives the HPLC-UV procedure for marker compounds and a chromatographic system description with reference chromatograms. Annex D compares national and regional quality requirement items for Areca catechu seed and is explicitly for comparison only.

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
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or ISO’s member body in the country of the requester.
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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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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
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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
...