Overview
ISO 24066:2026 specifies the quality and safety requirements, as well as the test methods, for Euodia fruit (also known as Evodia or Tetradium fruit). Widely recognized in Traditional Chinese Medicine (TCM) as wúzhūyú (吴茱萸), Euodia fruit is used globally as both a functional herb and natural medicine. This international standard supports the harmonization of global trade for Euodia fruit in both whole medicinal materials (Chinese materia medica) and decoction pieces. It ensures consistent quality, safety, and accurate identification, in response to varying national and regional standards that can previously complicate commercial exchanges.
Key Topics
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Product Identification:
Defines Euodia fruit specifically as the dried, nearly ripe fruit of certain Euodia species and their botanical variations.
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Quality and Safety Requirements:
- General: Must be clean, free from foreign matter, insects, visible mould, and contaminants.
- Physical Characteristics: Includes specific macroscopic and microscopic features for authentic identification, such as spheroidal shape, distinctive aroma, and presence of oil dots.
- Chemical and Safety Parameters: Covers moisture content, total ash, ethanol-soluble extractives, presence of marker compounds, heavy metals, pesticide residues, and sulfur dioxide.
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Test Methods:
Includes macroscopic and microscopic identification, thin-layer chromatography (TLC), and established procedures for determining moisture, ash, extractives, heavy metals, and pesticide residues. Reference is made to several harmonized ISO test methods and national pharmacopoeial standards.
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Packaging, Storage, and Labelling:
Establishes protective packaging and storage requirements to maintain product integrity. Details compulsory information for labelling in line with ISO standards, including scientific name, quality specifications, origin, and shelf life.
Applications
ISO 24066:2026 is essential for stakeholders in the herbal medicine supply chain, including producers, processors, exporters, importers, regulators, and quality assurance professionals. The standard provides:
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Consistent Quality for International Trade:
Enables suppliers and buyers to align expectations and ensures regulatory compliance across countries.
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Reliable Quality Control:
Laboratories and manufacturers can use standardized test methods for batch testing, ensuring authenticity and quality.
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Enhanced Consumer Safety:
By stipulating limits on heavy metals, pesticide residues, and other potential contaminants, the standard helps safeguard end users and builds trust in traditional medicines.
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Harmonization with National Standards:
The standard references and bridges diverse national and regional requirements documented in Chinese, Japanese, Korean, Hong Kong, and European pharmacopoeias, facilitating smoother cross-border trade.
Related Standards
- ISO 18664: Traditional Chinese Medicine - Determination of heavy metals in herbal medicines
- ISO/TS 21310: Microscopic examination of medicinal herbs
- ISO 21371: Labelling requirements for products intended for oral or topical use
- ISO 22217: Storage requirements for raw materials and decoction pieces
- ISO 22258: Determination of pesticide residues in natural products by gas chromatography
- ISO 22590: Determination of sulfur dioxide in natural products by titration
- ISO 23723: General requirements for herbal raw material and materia medica
These related specifications ensure broader compliance and enable integration with wider quality management and product safety systems in the herbal medicine industry.
By applying ISO 24066:2026, stakeholders in the international herbal sector gain a unified approach to the assessment, quality assurance, and regulatory alignment of Euodia fruit, benefiting both trade efficiency and consumer safety.
