Overview
ISO 21590:2026 defines international requirements for the quality and safety of Crocus sativus stigma, commonly known as saffron stigma, when used as a traditional Chinese medicine ingredient. This ISO standard establishes a unified framework for Crocus sativus stigma (Xihonghua) intended for use in global trade, including applications in Chinese materia medica and decoction pieces. By setting minimum quality benchmarks and safety protocols, it promotes consistent, safe, and effective utilization of this herbal raw material across different countries and regulatory environments.
The standard is developed by the International Organization for Standardization (ISO) Technical Committee ISO/TC 249, dedicated to traditional medicine, ensuring that all requirements reflect best practices in the field of herbal medicines.
Key Topics
ISO 21590:2026 outlines essential quality and safety criteria for Crocus sativus stigma as a medicinal product, supporting international consistency and consumer protection. Key topics covered include:
- General Characteristics: Stigma must be clean, free from foreign matter, and not contaminated with living insects.
- Morphological Features: Standards specify visual, tactile, and olfactory criteria, such as characteristic odor and slightly bitter taste.
- Microscopic Identification: Includes recognition of unique cellular structures and saffron powder color under the microscope.
- Thin-Layer Chromatogram (TLC) Identification: Ensures the specific chemical profile of the stigma.
- Moisture and Total Ash Content: Establishes limits to maintain quality and minimize degradation (moisture ≤12%, total ash ≤7.5%).
- Heavy Metals and Pesticide Residues: Requires determination of hazardous substances like arsenic, mercury, lead, cadmium, and specific pesticides.
- Artificial Colorants: Mandates the absence of non-natural coloring agents.
- Marker Compounds: Specifies determination of key constituents such as crocin-I and crocin-II.
- Sampling, Testing, and Reporting: Details protocols for consistent sampling and robust test reporting.
- Packaging, Storage, and Labelling: Sets rules to ensure product integrity during transportation and storage, as well as comprehensive product labelling.
Applications
ISO 21590:2026 is highly relevant for stakeholders in the herbal medicine and traditional Chinese medicine (TCM) sectors, especially where Crocus sativus stigma is handled as a raw material. Practical applications include:
- Manufacturing and Trade: Provides clear specifications for producers and suppliers, facilitating international commerce and regulatory compliance.
- Pharmaceutical Quality Control: Enables consistent testing and quality assessment in analytical laboratories.
- Regulatory Authorities: Supports harmonized evaluation and inspection of imported and exported saffron stigma used in TCM preparations.
- Clinical and Retail Sectors: Assists practitioners and retailers in sourcing standardized, safe, and effective herbal products.
- Research Institutions: Offers a reference point for scientific studies on Crocus sativus stigma quality and pharmacology.
ISO 21590:2026 supports safer use, enhanced global trade, and increased trust in natural medical products by enforcing strict quality and safety requirements.
Related Standards
Several ISO standards complement ISO 21590:2026, streamlining the quality assurance process for traditional Chinese medicine herbal raw materials:
- ISO 3632-2: Spices - Saffron (Crocus sativus L.) - Part 2: Test methods
- ISO 18664: Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine
- ISO/TS 21310: Microscopic examination of medicinal herbs
- ISO 21371: Labelling requirements for TCM products 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 23723:2021: General requirements for herbal raw material and materia medica
These standards together create a comprehensive quality and safety framework, enhancing international reliability and fostering trust in the supply and use of traditional Chinese medicinal materials.