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Understanding CAN/CSA-ISO/TR 13121-13 (2017): A Comprehensive Guide to Nanomaterial Risk Evaluation
Guidance for assessing and managing nanomaterial risks in accordance with Canadian adoption of ISO/TR 13121:2011
Scope and Application of CAN/CSA-ISO/TR 13121-13 (2017)
CAN/CSA-ISO/TR 13121-13 (2017) is the Canadian adoption of ISO/TR 13121:2011, a Technical Report titled Nanotechnologies — Nanomaterial Risk Evaluation. It provides a systematic framework for evaluating the potential risks associated with manufactured nanomaterials throughout their life cycle, from raw material acquisition through to disposal. The document is intended for use by scientists, engineers, risk managers, regulators, and anyone involved in the development, production, or handling of nanomaterials.
While ISO/TR 13121 is not a normative standard, its adoption by the Standards Council of Canada through the CSA Group (now CSA Group) gives it national recognition and positions it as a key reference for risk evaluation in Canada. The report outlines a process for collecting, evaluating, and documenting information needed to support decisions about nanomaterial risk, and it is applicable to any nanoscale object (e.g., nanoparticles, nanofibers, nanotubes, nanostructured materials).
Tip: CAN/CSA-ISO/TR 13121-13 (2017) is a guidance document rather than a prescriptive standard. It offers flexibility in methodology while promoting transparency and traceability in risk evaluations.
Key Areas Covered
- Hazard identification — characterizing the intrinsic properties of nanomaterials that may cause harm
- Exposure assessment — evaluating the likelihood and magnitude of human or environmental exposure
- Risk characterization — integrating hazard and exposure information to describe overall risk
- Risk management and communication — developing measures to control risks and conveying findings to stakeholders
Technical Requirements and Framework
The report does not mandate specific testing methods but instead describes a best‑practice process that consists of several iterative steps. The core of the framework is the Nanomaterial Risk Evaluation Decision Framework, which is built around seven key elements:
| Element | Description |
|---|---|
| 1. Material Characterization | Describe the nanomaterial’s physical and chemical properties, including size distribution, shape, surface chemistry, and composition. |
| 2. Hazard Assessment | Collect and evaluate data on potential adverse effects using in silico, in vitro, or in vivo methods. |
| 3. Exposure Assessment | Evaluate the routes, magnitude, frequency, and duration of exposure for humans and the environment. |
| 4. Risk Characterization | Combine hazard and exposure information to estimate risk, including uncertainty and variability. |
| 5. Risk Management | Identify and implement measures to eliminate, reduce, or control risks (e.g., engineering controls, PPE). |
| 6. Documentation & Communication | Transparently record assumptions, data, and decisions; report findings to decision‑makers and the public. |
| 7. Iteration & Review | Update the risk evaluation when new information becomes available or when the material/process changes. |
Important: The framework encourages the use of the As Low As Reasonably Achievable (ALARA) approach when quantitative risk data are insufficient, which is frequently the case for novel nanomaterials.
Data Quality and Documentation
A critical technical requirement emphasized in the TR is the need for thorough documentation. Users must record the source of data, the assumptions made, and the level of certainty associated with each parameter. This ensures that the risk evaluation is transparent and defensible, especially when used to support regulatory submissions or internal decision‑making.
Implementation Highlights
Organizations implementing CAN/CSA-ISO/TR 13121-13 (2017) should integrate the risk evaluation process into their existing health, safety, and environmental management systems. The following steps are key to successful adoption:
Building a Cross‑Functional Team
Risk evaluation in nanotechnology requires expertise in materials science, toxicology, industrial hygiene, and regulatory affairs. The TR recommends assembling a team that can address all relevant aspects and ensure that assumptions are validated across disciplines.
Tailoring the Process to the Material
Because nanomaterials vary widely in their properties and applications, the evaluation should be scaled appropriately. For example, a well‑studied industrial nanomaterial may rely more on existing literature, while an entirely new material may require extensive testing.
Best Practice: Use the report’s worst‑case bounding estimates early in the evaluation to quickly identify high‑risk scenarios. Then refine with more specific data as needed.
Life Cycle Perspective
The TR explicitly requires consideration of all life cycle stages: synthesis, formulation, incorporation into products, use, and end‑of‑life. This prevents risk from being overlooked in downstream processes such as recycling or workplace cleaning.
Compliance and Regulatory Alignment
CAN/CSA-ISO/TR 13121-13 (2017) is not a mandatory standard under Canadian law, but it is frequently referenced by regulators and industry as a benchmark for due diligence. Compliance with the TR can help meet the requirements of broader regulations, such as the Canadian Environmental Protection Act (CEPA) and the Hazardous Products Act, by demonstrating a systematic approach to risk evaluation.
Supporting Regulatory Submissions
When reporting to regulatory agencies (e.g., Health Canada, Environment and Climate Change Canada), a risk evaluation conducted in accordance with this TR can provide the structured evidence needed for product approvals or notification filings. The transparency demanded by the document aligns well with the principles of Good Laboratory Practice (GLP) and ISO 14000 standards.
Note on Limitations: The TR acknowledges that for many nanomaterials, adequate hazard or exposure data may be lacking. In such cases, the risk evaluation should clearly state data gaps and describe the strategy for addressing them, rather than being considered incomplete.
Relation to Other Standards
CAN/CSA-ISO/TR 13121-13 (2017) is part of a broader set of nanotechnology‑related standards. It complements ISO/TS 80004 (Nanotechnologies — Vocabulary) and ISO/TS 12901 (Occupational risk management for nanomaterials). Organizations may use these together to develop a comprehensive risk management program.
Frequently Asked Questions
Q: Is CAN/CSA-ISO/TR 13121-13 (2017) mandatory for companies handling nanomaterials in Canada?
A: No, it is a voluntary guidance document. However, following its framework can demonstrate due diligence and help meet obligations under existing Canadian health, safety, and environmental regulations.
A: No, it is a voluntary guidance document. However, following its framework can demonstrate due diligence and help meet obligations under existing Canadian health, safety, and environmental regulations.
Q: How does this document differ from ISO/TR 13121:2011?
A: The technical content is identical. The main difference is the Canadian preface and administrative details that reflect its adoption by the CSA Group. Both are based on the same 2011 edition.
A: The technical content is identical. The main difference is the Canadian preface and administrative details that reflect its adoption by the CSA Group. Both are based on the same 2011 edition.
Q: Can this TR be used for regulatory approval of new nanomaterial products?
A: Yes, it provides a structured process that can support regulatory submissions. However, specific regulatory requirements may also demand additional data or methodologies not covered in the TR.
A: Yes, it provides a structured process that can support regulatory submissions. However, specific regulatory requirements may also demand additional data or methodologies not covered in the TR.
Q: What is the role of life cycle assessment in this risk evaluation?
A: The TR includes life cycle thinking as a core element. Evaluators must consider all stages of the nanomaterial’s life to identify potential hazards and exposure points that might otherwise be missed.
A: The TR includes life cycle thinking as a core element. Evaluators must consider all stages of the nanomaterial’s life to identify potential hazards and exposure points that might otherwise be missed.
Tip for New Users: Start by applying the framework to a well‑known nanomaterial (e.g., nano‑TiO₂) to build familiarity before tackling complex or novel materials.