Overview
ISO/TR 13121:2011 - Nanotechnologies - Nanomaterial risk evaluation is an ISO Technical Report that describes a practical, lifecycle‑focused process for identifying, evaluating, managing and communicating potential risks from manufactured nanomaterials. Intended as guidance (informative, not regulatory), the report helps organizations protect public health, workers, consumers and the environment by organizing and documenting information on nanomaterials, addressing uncertainty, and updating decisions as new data become available.
Key topics and technical requirements
This Technical Report structures a repeatable risk‑evaluation workflow and supporting activities:
- Five‑step process:
- Describe materials and applications
- Develop material profiles (physical/chemical properties, hazards, exposures)
- Evaluate risks (hazard × exposure)
- Assess risk management options
- Decide, document and act - then review and adapt
- Material characterization: focus on manufactured nanomaterials (typically ≤100 nm in one, two or three dimensions) and their intended uses and sourcing.
- Profiles and data: creation of physical/chemical, hazard and exposure profiles; prioritization of data gaps and use of reasonable assumptions or default values where information is incomplete.
- Data quality and testing guidance: evaluation of data quality, tiered testing approaches, and use of “bridging information” when appropriate.
- Risk management and governance: assessment of controls (substitution, engineering, PPE), cross‑functional decision teams, documentation, stakeholder communication, transparency and accountability.
- Lifecycle and documentation: consideration of manufacture, distribution, use/reuse, maintenance and end‑of‑life, plus annexes providing example data sets, testing approaches and an output worksheet.
Practical applications
ISO/TR 13121:2011 is valuable for organizations and activities involving nanomaterials:
- Product stewardship and EHS programs - implement a structured nanomaterial risk evaluation process.
- R&D and product development - identify potential hazards and data gaps early in design.
- Manufacturing and processing - evaluate exposure scenarios, workplace controls and supply‑chain documentation.
- Regulatory and public‑sector use - inform risk communication, monitoring and policy development (not a substitute for legal compliance).
- Consultants and laboratories - provide a common framework for testing, reporting and decision support.
Who should use this standard
- Manufacturers, processors, distributors and designers of products containing manufactured nanomaterials
- Environmental, health & safety (EHS) professionals and product stewards
- Regulators, NGOs, academics and risk consultants seeking a transparent, lifecycle approach to nanomaterial risk evaluation
Related standards and references
ISO/TR 13121:2011 was prepared by ISO/TC 229 (Nanotechnologies) and references global frameworks such as GHS, REACH and OECD guidance. Use it alongside applicable regulatory requirements and other ISO nanotechnology guidance for comprehensive risk management.
