Overview
ISO 21371:2018 - Traditional Chinese medicine (TCM) - Labelling requirements of products intended for oral or topical use - defines general labelling requirements for finished manufactured TCM products and packaged herbs. The standard specifies essential and informative label elements to help consumers and practitioners choose and use TCM products safely. It applies to products intended for oral or topical use and covers labelling visibility, legibility and format.
Key topics and requirements
ISO 21371:2018 outlines mandatory and optional labelling content and format. Key topics include:
- Essential labelling elements (both packaged herbs and finished products):
- Product name (brand)
- Category of the product as defined in the marketed country/region (e.g., pharmaceutical, supplement, food)
- Net weight/quantity (mass or volume units: kg, g, L, mL as appropriate)
- Contact information (name, full address - not PO box - and telephone of distributor/importer; previous distributor info if changed in last 12 months)
- Name of raw materials with Latin (scientific) name plus part used (e.g., liquorice (Glycyrrhiza uralensis) root)
- Warning statements where applicable (e.g., for children, pregnant women)
- Expiry date based on stability data or scientific rationale, legible without opening packaging
- Storage method (special conditions before opening)
- Batch/lot number (with allowed prefixes)
- Additional elements for finished manufactured products:
- Excipients listed separately from active ingredients
- Administration method
- For extracts: formula name, amounts, constituent raw materials and extraction method (including solvent)
- For single-herb extracts: extract name, amount, raw material weight, extraction method
- For non-extract products: herbal name and amount
- Informative elements (optional but recommended):
- TCM product/raw material codes, daily dosage or range, manufacturer name/address, permitted indications/functionality (subject to market rules), certification claims (e.g., GMP, HACCP), notices, country of origin.
- Format requirements: labelling must be in the official language of the sale country, legible font size and colour, and located on the outside packaging so it’s readable without opening.
Applications and who uses it
ISO 21371:2018 is used by:
- TCM manufacturers and contract packagers to design compliant labels
- Quality managers and regulatory affairs teams to ensure market entry compliance
- Distributors and importers for traceability and adverse-event reporting
- Packaging designers and print vendors for format and legibility specifications
- Regulators and testing bodies for conformity checks
Benefits include improved consumer safety, traceability (batch/lot), clearer ingredient disclosure (Latin names), and smoother international trade compliance.
Related standards and references
Annex A of ISO 21371:2018 lists related labelling requirements and guidance, including:
- WHO Guidelines for the Appropriate Use of Herbal Medicines
- EU/EC regulations (e.g., EC Reg. No.1223/2009, No.655/2013, EU Directive 2001/83/EC)
- National regulatory frameworks (examples in Annex A: Germany, UK)
These references help align TCM labelling with regional regulatory requirements and claims rules.