Nanotechnology could transform fields from medicine and agriculture to energy and consumer electronics, as these materials engineered at the 1–100 nm scale can behave in ways their bulk forms never do. This mix of extraordinary promise and genuine uncertainty makes policy, safety, and regulation not a bureaucratic afterthought, but the foundation for trust and sustainable innovation.1
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Why does Nanotechnology Need More Regulation?
In principle, nanomaterials are just small chemicals, so existing safety laws do a lot of the heavy lifting. In practice, many nanomaterials have additional, size-dependent properties that convolute the risk assessment process.1
Some nanoparticles can move through the body in ways larger particles cannot, crossing lung, gut, placental or even blood–brain barriers; others persist or transform in soils, sediments, and wastewater in ways that standard models fail to predict.1
For this reason, regulators increasingly discuss a dual perspective: every engineered nanomaterial has both a chemical identity and particle-level features (size, shape, surface area, coating, and solubility) that may be toxicologically relevant.
In a 2023 paper, Vega-Baudrit et al list an unusually broad set of policy reasons to regulate:
- protecting human health and ecosystems
- ensuring worker safety; building consumer trust
- promoting fair trade
- protecting privacy and intellectual property
- encouraging corporate social responsibility
- and supporting public education and dialogue.
Their message: nanotechnology governance is not only about “is this safe?” but also “is this fair, transparent, and sustainable?” 2
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Adapting Regulatory Architectures
Most countries have chosen to adapt existing laws rather than create new legislation specifically for nanotechnology. The European Union is a leading example.
Under its Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, EU companies must now provide detailed information about nanoforms of substances, including particle size distribution, shape, surface treatment, and specific surface area. These details are crucial because they can affect exposure and risk.4
The EU has also issued a recommendation defining a nanomaterial as one where at least half of the particles are in the one to one hundred nanometre range, including those within aggregates. Other regions have taken different approaches.5,6
The United States, for instance, does not have a single legal definition of nanomaterial. Instead, materials with nanoscale dimensions or novel properties may be subject to extra scrutiny under existing laws.6
Some countries, such as Malaysia, only regulate substances as nanomaterials if they exhibit new properties compared to their bulk form. China and others refer to the technical definition from the International Organization for Standardization (ISO), which focuses on size but does not specify a minimum fraction of nanoscale particles.2, 6
These variations may seem minor, but they have real consequences. Decisions about which products are regulated and how depend on how strictly regulators define nanomaterials and whether they require evidence of new properties.
Building Measurement and Test Infrastructures
Effective regulation relies on accurate methods for measuring and testing nanomaterials. The Organisation for Economic Co-operation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN), created in 2006, plays a key role in aligning testing strategies across countries.4
The Working Party tests representative nanomaterials to see if existing OECD test guidelines are suitable and adapts them where necessary. This has led to new guidance on issues such as dispersion stability, inhalation toxicity, aquatic and sediment toxicity, and bioaccumulation.4
New methods have also been developed to measure properties like particle size distribution, volume-specific surface area, and hydrophobicity for nanomaterials. Standardization bodies, such as the ISO and the European Committee for Standardization (CEN), have introduced workplace tests for dust generation and exposure to nanopowders.4
Promoting data that are findable, accessible, interoperable, and reusable is also becoming a priority. Clear guidance on sample preparation and dosing is essential, since stable dispersions of nanomaterials are technically challenging to achieve. Shared measurement infrastructures and data standards help regulators and scientists compare results and make informed decisions.4
Beyond Hard Law: The Softer Side of Nano-Governance
Binding legislation is just one part of nano-governance. V. Baudrit et al. also distinguish between hard regulation, which consists of formal laws with sanctions, and soft regulation, such as voluntary codes of conduct, ethical guidelines, certification schemes, and corporate responsibility initiatives.3
Hard regulation covers chemical registration, worker protection, product safety, labelling, and sector-specific rules for food, cosmetics, pesticides, medical devices, and pharmaceuticals. These frameworks can require pre market safety assessments, exposure controls, and post market monitoring for products containing nanomaterials.3
Soft regulation operates differently. European funding programmes, for example, have incorporated responsible research and innovation principles, encouraging scientists and companies to consider societal impacts, ethics, and sustainability from the start.
Industry associations may adopt internal standards for nanosafety testing, worker training, and public communication that exceed legal requirements.3
Civil society organisations and professional bodies contribute by publishing best practice guidelines and fostering public dialogue about nanotechnology. These efforts aim to broaden oversight, reduce polarization, and build public confidence in regulatory processes.3
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Remaining Challenges and Emerging Practices
Despite progress, important gaps remain. Measuring nanomaterials in complex environmental and biological samples is still difficult. Reference materials are limited, and alternative test methods that reduce or replace animal testing are not yet fully validated. There is also uncertainty about which dose metrics are most relevant for different nanomaterials and exposure routes.7
The market is moving toward more complex materials, such as multi-component particles, composites, and devices that integrate nanoscale materials with electronics or biological systems. These products challenge existing regulatory categories and introduce new questions about data protection and surveillance.7
Differences between national definitions and information requirements can encourage companies to introduce products first in jurisdictions with weaker or less specific nano policies.
Developing countries face challenges in building measurement capacity, training inspectors, and coordinating agencies, even as they aim to use nanotechnology for economic growth and environmental goals.7
Nevertheless, emerging regulatory practices are promising. Authorities and funders increasingly promote safety and sustainability by design, integrating hazard, exposure, and life cycle considerations into the earliest stages of material development.7
Regulators are experimenting with tiered and integrated assessment frameworks that use data from similar materials, combine experimental and computational methods, and reduce unnecessary testing.7
Guidance for industry emphasizes the importance of worker protection, clearer labeling, accessible communication, and public engagement to foster trust, while international cooperation through bodies like the OECD and ISO helps align test methods and data requirements, reducing duplication and fragmentation.7
The Road Ahead
Regulating nanotechnology is about enabling innovation under conditions that society considers acceptable, not stopping it.
Experience to date shows that existing chemical and product laws can manage many nanomaterials, provided they are updated to include information on particle-level properties and supported by strong measurement and exposure science. Formal rules must be complemented by professional standards, corporate accountability, and inclusive dialogue with affected groups.2
As nanotechnology advances into smart materials, quantum devices, and advanced energy systems, regulatory approaches will need to remain flexible and responsive to new evidence. Refining definitions, improving methods for exposure assessment and alternative testing, and involving diverse stakeholders in research and policy will be central.
With these elements in place, governance can help guide nanotechnology toward benefits that are widely shared, while keeping risks under careful control.2
References and Further Readings
- Stretz, H.; Kiss, A.; Mealio, K.; Ayeni, O., Regulatory and Environmental Issues of Nanotechnology Safety. In Nanotechnology Safety, Elsevier: 2025; pp 59-76.
- Rasmussen, K.; Sayre, P.; Kobe, A.; Gonzalez, M.; Rauscher, H., 25 Years of Research and Regulation: Is Nanotechnology Safe to Commercialize? Frontiers in Toxicology 2025, 7, 1629813.
- Vega-Baudrit, J.-R.; Camacho, M.; Araya, A., Regulating Nanotechnology: Ensuring Responsible and Safe Innovation in the Advancement of Science and Technology. Ciencia, Tecnología y Salud 2023, 10, 177-191.
- Bleeker, E. A.; Swart, E.; Braakhuis, H.; Cruz, M. L. F.; Friedrichs, S.; Gosens, I.; Herzberg, F.; Jensen, K. A.; von der Kammer, F.; Kettelarij, J. A., Towards Harmonisation of Testing of Nanomaterials for EU Regulatory Requirements on Chemical Safety–a Proposal for Further Actions. Regulatory Toxicology and Pharmacology 2023, 139, 105360.
- The European Commission Updates the Definition of Nanomaterial. https://www.merieuxnutrisciences.com/the-european-commission-updates-the-definition-of-nanomaterial/.
- Yang, M. Navigating Nanomaterial Definitions: Regulatory Divergence and What It Means for Compliance https://ithosglobal.com/navigating-nanomaterial-definitions/.
- Hunt, N. et al., Regulatory Preparedness for Multicomponent Nanomaterials: Current State, Gaps and Challenges of Reach. NanoImpact 2025, 37, 100538.
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