Overview
ISO/TR 11773:2013 - "Global distribution of reference materials" is an ISO Technical Report published by ISO/REMCO that provides an inventory of problems and practical recommendations for the international transport, import and export of non-nuclear, non-radioactive reference materials (RMs). The report focuses on the packaging, labelling and documentation needed to comply with legal and customs requirements worldwide. It is informative in nature and does not replace detailed regulatory rules (for example, labelling specifics under the GHS).
Key Topics
- Scope and definitions: Distinguishes certified reference materials (CRMs) from other RMs and clarifies what constitutes a CRM for customs purposes (tariff heading 3822.00).
- Customs and tariff issues: Guidance on the use and interpretation of customs tariff 3822.00, EU provisions (e.g., Commission Regulation references) and databases such as TARIC to check import/export restrictions.
- Labelling recommendations:
- Follow UNECE GHS principles where applicable and EU Regulation 1272/2008 for CLP in the EU.
- Keep external labels generic (e.g., “Milk powder” + CRM code) to avoid misinterpretation of analytes or hazard.
- Ensure label contents match pro‑forma invoices and SDS.
- Transport constraints:
- Air transport governed by IATA/ICAO dangerous-goods rules; road by ADR.
- Many couriers restrict dangerous goods (including dry ice); limited/excepted quantity provisions can apply (example harmonization allowing small inner/outer quantity limits).
- Practical tips: avoid Friday arrivals for refrigerated RMs; mark packages with storage temperature.
- Export/import challenges:
- Intellectual property or re‑export laws (e.g., US Commerce Control) may restrict movement.
- Regulatory requirements (e.g., FDA registration, animal by-products legislation, trade embargos) can block or delay shipments.
- Documentation and administration:
- Importance of SDS, certificates of origin/health, and using online resources (MARKET ACCESS DATABASE, TARIC) to anticipate importer requirements.
Applications
ISO/TR 11773:2013 is practical for:
- Reference material producers (RMPs) preparing international shipments
- Laboratories and proficiency test providers receiving RMs
- Regulators, customs officers and accreditation bodies seeking context for RM circulation issues
- Logistics and courier services handling laboratory materials
Use the report to reduce shipment delays, align labelling/packaging with global expectations, and prepare correct documentation for import/export clearance.
Related standards (if applicable)
- Globally Harmonized System (GHS) / UNECE guidance
- IATA/ICAO dangerous goods regulations
- ADR (road transport of dangerous goods)
- EU CLP Regulation (Regulation 1272/2008)
- Customs tariff heading 3822.00 (CRMs)
Keywords: ISO/TR 11773:2013, global distribution of reference materials, reference material transport, CRMs, customs tariff 3822, labelling, packaging, documentation, IATA, GHS, TARIC.