ISO 25099:2026

Overview

ISO 25099:2026, published by the International Organization for Standardization (ISO), sets out the international requirements and test methods for Curcuma rhizome, specifically from Curcuma phaeocaulis, Curcuma kwangsiensis, and Curcuma wenyujin. Known collectively as “E’zhu” or zedoary, these rhizomes are widely used in Traditional Chinese Medicine (TCM) and traded globally as herbal raw materials and decoction pieces. This standard is designed to harmonize international quality specifications, ensuring consistency, safety, and efficacy in the global herbal market.

Key ISO 25099:2026 features:

• Applies to unprocessed Curcuma rhizomes and their decoction pieces
• Defines quality, safety, and identification criteria
• Excludes processed Curcuma products and proprietary preparations

Key Topics

ISO 25099:2026 addresses critical quality assurance and control topics, including:

• Morphological and macroscopic features: Detailed descriptions enable visual identification of Curcuma phaeocaulis, Curcuma kwangsiensis, and Curcuma wenyujin rhizomes.
• Microscopic identification: Ensures authenticity by examining structural and cellular characteristics, supporting differentiation between Curcuma species.
• Chemical identification: Methods like Thin-Layer Chromatography (TLC) and High-Performance Liquid Chromatography (HPLC) verify the presence of characteristic marker compounds (e.g., germacrone).
• Physicochemical parameters:
  • Moisture, total ash, and acid-insoluble ash content
  • Levels of ethanol-soluble extractives and essential oils
• Contaminant limits: Specifications for heavy metals (arsenic, cadmium, lead, mercury) and pesticide residues ensure safety.
• Packaging and labelling: Defines mandatory labelling (scientific name, origin, batch, mass) and packaging requirements to preserve product integrity.

Test methods are referenced to relevant ISO standards, supporting reliable and reproducible assessment for quality control laboratories and supply chains.

Applications

ISO 25099:2026 finds significant practical value across the international herbal medicine industry:

• Quality assurance in sourcing and procurement: Herbal suppliers and buyers use the standard to specify and verify the quality of raw Curcuma rhizome materials.
• Regulatory compliance: National authorities, customs, and inspection agencies rely on ISO 25099 to assess imported and exported Traditional Chinese herbal materials, harmonizing international and domestic quality requirements.
• Product safety and efficacy: TCM practitioners, manufacturers, and retailers benefit from assurance that batches of Curcuma rhizome meet defined safety thresholds for contaminants and maintain key pharmacological properties.
• Labelling and traceability: Clear labelling enhances traceability and consumer confidence, facilitating market access and reducing the risk of adulteration or misidentification.
• International trade facilitation: Harmonized criteria reduce disputes and streamline cross-border trade in botanical raw materials.

By supporting standardized assessment and transparent labelling, ISO 25099:2026 underpins trust and consistency in the Traditional Chinese Medicine market.

Related Standards

To ensure complete and compliant application of ISO 25099:2026, the following related ISO standards are referenced:

• ISO 18664: Determination of heavy metals in herbal medicines
• ISO/TS 21310: Microscopic examination of medicinal herbs
• ISO 21371: Labelling requirements for herbal products
• ISO 22217: Storage requirements for raw materials and decoction pieces
• ISO 22258: Determination of pesticide residues
• ISO 22590: Determination of sulfur dioxide in natural products
• ISO 23723: General requirements for herbal raw material and materia medica

Utilizing these related standards together ensures comprehensive quality, safety, and regulatory compliance for Curcuma rhizome used in Traditional Chinese Medicine and international trade.