Nanomaterials are materials with at least one dimension smaller than 100 nanometres (about 100,000 times thinner than a human hair). Because of their tiny size, they have unique properties that can be useful in many industries.1
However, without proper regulation, nanomaterials could pose risks to human health and the environment. A clear and consistent set of global rules is needed to manage these risks while supporting innovation and safe development.
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Governments around the world recognize the need for clear rules to manage the safe development and use of nanomaterials. This section reviews how different countries regulate them, including processes for testing, approval, and monitoring.
European Union: REACH and Specialized Frameworks
The European Commission (EC) classifies nanotechnology as a Key Enabling Technology (KET), which means it plays a vital role in innovation and industrial progress. As a result, multiple EU agencies and sector-specific regulations have been developed to oversee nanomaterials.
Updated Definition of Nanomaterials
On June 10, 2022, the European Union Observatory for Nanomaterials updated its definition of nanomaterials. According to this definition, nanomaterials include natural, incidental, or manufactured substances made up of particles or aggregates smaller than 100 nanometres. These tiny particles must account for more than 50 % of the material.
For certain safety assessments, this 50 % threshold may be adjusted to a range between 1 % and 50 %. The definition also specifically includes materials like carbon nanotubes (CNTs), fullerenes, and two-dimensional materials such as graphene, which can have one or more dimensions below 1 nanometre.2
Other EU agencies may use slightly different definitions depending on their regulatory needs, but this is the most recent EU-wide update.
Nanomaterial Regulation under REACH
Under the EU’s REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals), nanomaterials are referred to as “nanoforms.” Any company manufacturing or importing nanomaterials in the EU must register these substances and provide detailed information on their safety.
Since January 1, 2020, new legal requirements have made it mandatory for companies to comply with specific rules for nanoforms. Key changes introduced by the 2018 amendment include:
- Companies must define the nanoform clearly and include its toxicological profile in the registration documents (Regulation (EU) 2018/1881).
- A full risk assessment must be submitted by the manufacturer.
- Standard information must be included in a technical dossier and chemical safety report, along with guidance for downstream users.
- Companies can group nanoforms with similar properties to simplify documentation.3
By enforcing these requirements, the EU aims to improve safety in the production and use of nanomaterials and support responsible innovation.
Nanomaterials and the European Chemicals Agency (ECHA)
The European Chemicals Agency (ECHA) plays a central role in overseeing the regulation of nanomaterials under the EU’s REACH and CLP (Classification, Labelling and Packaging) frameworks. It provides updated guidance documents and supports both internal and external training programs related to nanomaterial development.
ECHA also contributes to international regulatory efforts, such as the Malta Initiative, which focuses on developing testing guidelines for nanomaterials. In addition, ECHA established the EU Observatory for Nanomaterials (EUON) in 2011, which became fully operational by 2016–2017 to improve transparency and support safe use of nanomaterials across the EU.
Nanomaterials Expert Group under ECHA
ECHA also set up the Nanomaterials Expert Group (NMEG) in 2012, in collaboration with REACH and CLP. This advisory group supports ECHA’s strategies for ensuring the safe development of nanomaterials and helps resolve technical issues related to their regulation.4 In 2024, NMEG published a manual identifying S-CIRCABC as the main platform for sharing nanomaterials-related documentation.5
European Food Safety Authority on Nanotechnology
The European Food Safety Authority (EFSA) has published guidance on assessing the risks of nanomaterials used in food products. Known as the Scientific Committee guidance on Nano-risk assessment (SC guidance), it outlines the technical requirements for evaluating particles such as nanoparticles.
The guidance includes detailed instructions on how to characterize the physical and chemical properties of nanomaterials, as well as how to assess exposure and identify potential health hazards. Applicants are responsible for selecting appropriate testing methods and clearly justifying their approach.
Risk assessments must combine data from hazard identification, exposure evaluations, and any other relevant sources. The goal is a complete picture of the nanomaterial’s safety for its intended use, including any uncertainties or conditions that affect the results. All documentation must comply with REACH and CLP regulations to ensure the protection of human and animal health.
United States: Regulation Through Existing Frameworks
In the United States, nanomaterials are regulated using existing laws rather than through nano-specific legislation.
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Environmental Protection Agency (EPA) and TSCA
The nanomaterials are regulated by the EPA under the Toxic Substance Control Act (TSCA) as chemical substances. The Environmental Protection Agency (EPA) oversees nanomaterials under the Toxic Substances Control Act (TSCA), treating them as chemical substances.
In 2017, the EPA introduced a rule requiring one-time reporting and recordkeeping for certain nanomaterials already in use. Manufacturers, including importers and processors, must submit details such as chemical identity, production volume, manufacturing methods, uses, and any available health and safety data.7
For new nanomaterials, TSCA requires manufacturers to notify the EPA at least 135 days before beginning production. This pre-manufacturing review helps assess potential risks. To support these requirements, the EPA created the Chemical Information Submission System (CISS), which allows companies to submit data electronically under TSCA sections 4, 8(a), and 8(d).8
Nanomaterials Regulation under the U.S. Food and Drug Administration
The U.S. Food and Drug Administration regulates products containing nanomaterials under existing legal standards based on product type.
Because nanomaterials can behave differently than conventional materials, the FDA has issued guidance titled Drug Products, Including Biological Products, that Contain Nanomaterials: Guidance for Industry, which outlines how to evaluate their safety, quality, and performance.
The guidance emphasizes the importance of full characterization of nanomaterials, including structure, physico-chemical stability, and critical quality attributes (CQAs).
It notes that while some standardized methods for characterizing nanomaterials already exist, such as ISO 22412:2017 and ASTM E2859-11(2017), others are still being developed. Applicants must carefully assess whether the selected methods are appropriate for the specific nanomaterial in question.
In addition, all drug products that contain nanomaterials must be manufactured in compliance with current good manufacturing practices (CGMP), as required by section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
The FDA also requires that storage conditions, shelf life, and in-use conditions be backed by data confirming the chemical and physical stability of the product. Clinical development must follow all applicable safety and efficacy standards.9
U.S. Consumer Product Safety Commission (CPSC)
The U.S. Consumer Product Safety Commission (CPSC) has sought to address potential risks associated with nanomaterials by applying its existing regulatory frameworks. Currently, CPSC staff are working to update chronic hazard guidelines to better reflect the use of nanomaterials in consumer products. Central to this effort are hazard identification and a thorough review of toxicity data.
CPSC is also actively involved in several collaborative initiatives with federal and private organizations focused on nanomaterial production and use. These include participation in the Nanoscale Science, Engineering and Technology (NSET) subcommittee and the Nanotechnology Environmental Health Issues (NEHI) working group. Through these efforts, the agency supports data sharing and best practices for nanomaterial regulation.10
While no nanomaterial-specific federal or state laws exist in the U.S., regulatory bodies have adapted existing chemical safety frameworks to include nanoscale substances. Despite this, stronger, dedicated legislation is still needed to ensure adequate human health and environmental protection.
Canada: Coordinated Risk-Based Approach
Canadian Environmental Protection Act, 1999
Under the Canadian Environmental Protection Act of 1999 (CEPA 1999), major chemical substances (including nanomaterials) are regulated as part of Canada’s approach to environmental and human health protection.
Existing nanomaterials are those with nanoscale forms listed on the Domestic Substances List (DSL). However, the Chemicals Management Plan (CMP) does not specifically address the risk assessment of these nanoscale forms.11
In 2022, Canada introduced the Framework for the Risk Assessment of Manufactured Nanomaterials under CEPA 1999, offering a foundational guide for evaluating new and existing nanomaterials. Newly developed nanomaterials are subject to the New Substances Notification Regulations (Chemicals and Polymers).
This framework enabled staff from Environment and Climate Change Canada (ECCC) and Health Canada (HC) to gather information and compile a list of nanomaterials currently used in commerce. The data was then used to help prioritize substances for risk assessment.
The framework also introduced the use of Risk Quotients (RQ) and Margins of Exposure (MOE) to assess environmental and health impacts. An RQ equal to or greater than 1 indicates a potential hazard.
Health risks are evaluated by examining specific hazards, exposure levels, and relevant routes of contact for each nanomaterial. Risk to Canadians is assessed based on potential exposure through consumer products, food, water, and environmental contact, with particular attention paid to vulnerable populations.12
Role of Health Canada
Health Canada relies on existing laws and regulations to assess and manage potential health risks associated with nanomaterials. The department evaluates the safety of nano-enabled products and substances containing nanomaterials on a case-by-case basis.
In collaboration with Environment and Climate Change Canada, Health Canada participates in the Canada–United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative. This initiative supports information sharing and the development of joint strategies, including standardized terminology, naming conventions, and harmonized approaches to risk assessment and regulatory oversight.13
China: Evolving Standards and Institutional Development
China is rapidly advancing in nanotechnology, and regulatory systems are developing in parallel.
In 2011, the National Nanotechnology Standardization Technical Committee (NSTC) and Technical Committee 279 (TC279), operating under the Standardization Administration of China (SAC), began reviewing and drafting key standards related to nanomaterials. These covered terminology, testing methods, and safety considerations for nanoscale materials and biomedical applications.
NSTC-TC has also contributed to the development of testing protocols and technical standards for industrial and lab use, supporting applied research across sectors.
A toxicology database for nanomaterials is in development to help inform safety standards for production, packaging, and transport. While SAC/TC279 manages these standards, most remain voluntary, and the distinction between voluntary and mandatory implementation is not always clear.14
In 2021, China introduced national standard GB/T30544.1, requiring applicants to design safety tests for biomedical devices containing nanomaterials. These tests must account for key risks such as the dosage and release rate of nanoparticles, as well as the route of exposure.15
Although still maturing, China’s regulatory landscape is gradually expanding to cover sectors like food, agriculture, and workplace safety.
Japan: Case-by-Case Assessment Using Existing Laws
Japan does not have a dedicated regulatory framework or authority specific to nanomaterials. Instead, safety concerns related to their use are addressed by expert teams on a case-by-case basis.
Currently, existing legislation such as Roudou Anzen Eisei Ho (the Industrial Safety and Health Act) and Haikibutsu Shori Ho (the Chemical Substances Control Act) is applied to regulate nanomaterials. While these laws are not nano-specific, they provide the basis for oversight.
The Ministry of Economy, Trade and Industry and the Ministry of Health, Labor, and Welfare have been actively involved in researching nanomaterial safety.16 In recent years, Japan has also begun collaborating with international organizations such as the European Medicines Agency (EMA) to develop more tailored guidelines and standards for nanomedicines. These efforts reflect Japan’s growing commitment to strengthening its regulatory approach and protecting public health.
Australia: Sector-Specific Oversight and Risk Tools
Australia takes a coordinated approach to managing the risks of nanomaterials, focusing on both environmental and human health. Several agencies oversee their use across different sectors.
Until 2020, industrial nanomaterials were regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). This role is now handled by the Australian Industrial Chemicals Introduction Scheme (AICIS), which evaluates the safety of nanomaterials used in products like paints, dyes, pesticides, and cosmetics.
Workplace exposure is managed by Safe Work Australia, which provides guidance to reduce health risks from materials like carbon nanotubes (CNTs). In the food sector, Food Standards Australia New Zealand (FSANZ) is responsible for regulating nanomaterials used in food and packaging. For medical devices, oversight falls under the Therapeutic Goods Administration (TGA), while the Australian Competition and Consumer Commission (ACCC) monitors general consumer products that contain nanomaterials.
To support safe use, regulatory bodies have developed risk assessment tools. For example, Workplace Health and Safety Queensland (WHSQ) created a control banding worksheet to help research institutions and industrial users assess nanomaterial exposure. The tool calculates severity scores and estimates exposure probabilities.18
Universities like UNSW and Griffith University are also contributing by creating practical tools and checklists for evaluating nanomaterial risks. These combined efforts help ensure thorough assessment of both existing nanomaterials and new nano-enabled products before they reach the market.
Global Alignment and the Path Forward
Although many countries have made progress in regulating nanomaterials, global alignment remains a major challenge. Differences in risk thresholds, regulatory definitions, and reporting requirements make it difficult to create a unified international framework.
The EU has led the way through its REACH legislation, which requires detailed safety assessments and technical documentation for nanoforms. However, many other regions still rely on older or more general chemical regulations that may not fully account for the unique properties of nanomaterials.
Manufacturers often struggle with inconsistent data requirements when registering products in different countries. Varying standards for testing methods and formatting create barriers to international compliance and increase costs for global companies. These issues highlight the need for a more standardized regulatory system worldwide.
Efforts are underway to address this. International organizations like the International Organization for Standardization (ISO) and the Organisation for Economic Co-operation and Development (OECD) are working with national governments to develop shared testing protocols and data submission templates.
Despite ongoing challenges, nanomaterials continue to drive innovation in science and technology. Researchers are exploring greener, more sustainable nanomaterials to support global climate and development goals. Meanwhile, new tools like artificial intelligence (AI) and machine learning (ML) are being used to improve toxicology predictions.
With continued international cooperation, the future of nanomaterial regulation will likely become more aligned, transparent, and responsive to emerging technologies.
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References and Further Reading
- Pacific Northwest National Laboratory (PNNL), Department of Energ, Gov. of USA. (2025). What are nanomaterials? [Online]. Available at: https://www.pnnl.gov/explainer-articles/nanomaterials [Accessed on: April 15, 2025].
- European Union Observatory for Nanomaterials, (EUON). (2025). Definition of nanomaterial. [Online]. Available at: https://euon.echa.europa.eu/definition-of-nanomaterial [Accessed on: April 15, 2025].
- Office Journal of the European Union. (2018). COMMISSION REGULATION (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances. L 308. [Online]. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R1881 [Accessed on: April 16, 2025].
- European Chemicals Agency (ECHA), (2025). Nanomaterials Regulations. [Online]. Available at: https://echa.europa.eu/regulations/nanomaterials [Accessed on: April 17, 2025].
- Nanomaterials Expert Group (NMEG), ECH. (2024). ECHA NMEG Manual. Version 4. Available at: https://echa.europa.eu/search?p_p_id=com_liferay_portal_search_web_portlet_SearchPortlet&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_com_liferay_portal_search_web_portlet_SearchPortlet_mvcPath=%2Fsearch.jsp [Accessed on: April 17, 2025].
- EFSA Scientific Committee, More S. et. al. (2021). Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: Human and animal health. EFSA Journal. 19(8). e06768. Available at: https://www.doi.org/10.2903/j.efsa.2021.6768
- United States Environmental Protection Agency (EPA). (2024). Fact Sheet: Nanoscale Materials. Reviewing New Chemicals under the Toxic Substances Control Act (TSCA). [Online]. Available at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/fact-sheet-nanoscale-materials#:~:text=As%20part%20of%20the%20Agency’s,substances%20in%20commerce%20pursuant%20to [Accessed on: April 17, 2025].
- United States Environmental Protection Agency (EPA). (2017). Chemical Substances When Manufactured or Processed as Nanoscale Materials: TSCA Reporting and Recordkeeping Requirements. Environmental Protection; Chemicals; Hazardous Materials; Recordkeeping and Reporting Requirements; Reporting and Recordkeeping Requirements. 40 CFR Part 704. 3641 – 3655. EPA-HQ-OPPT-2010-0572-0137. [Online]. Available at: https://www.regulations.gov/document/EPA-HQ-OPPT-2010-0572-0137 [Accessed on: April 17, 2025].
- U.S. Department of Health and Human Services Food and Drug Administration. (2022). Drug Products, Including Biological Products, that Contain Nanomaterials Guidance for Industry. 19640025 FNL. 1-29. [Online]. Available at: https://www.fda.gov/media/157812/download?attachment [Accessed on: April 17, 2025].
- U.S. Consumer Product Safety Commission (CPSC) (2024). CPSC Nanomaterial Statement. [Online]. Available at: https://www.cpsc.gov/s3fs-public/CPSCNanostatement.pdf [Accessed on: April 18, 2025].
- Government of Canada. (2025). Nanomaterials, Chemical Safety: Chemical Substances. [Online]. Available at: https://www.canada.ca/en/health-canada/services/chemical-substances/nanomaterials.html [Accessed on: April 20, 2025].
- Environment and Climate Change Canada, Health Canada. (2022). Framework for the risk assessment of manufactured nanomaterials under the Canadian Environmental Protection Act, 1999 (draft). A-Z index: substances addressed in the third phase of the Chemicals Management Plan. [Online]. Available at: https://www.canada.ca/content/dam/eccc/documents/pdf/pded/nanomaterials/Framework-risk-assessment-nanomaterials.pdf [Accessed on: April 20, 2025]
- Government of Canada. (2024). Regulating Nanomaterials at Health Canada. [Online]. Available at: https://www.canada.ca/en/health-canada/services/science-research/emerging-technology/nanotechnology/regulating-nanomaterials.html [Accessed on: April 21, 2025].
- Jarvis D. et. al. (2011). Regulation and Governance of Nanotechnology in China: Regulatory Challenges and Effectiveness. European Journal of Law and Technology, Vol. 2, No.3. Available at: https://www.ejlt.org/index.php/ejlt/article/download/94/155?inline=1
- Yang, D. et. al. (2021). NMPA Initiates Regulation of Nanomaterials in Medical Devices. [Online]. Available at: https://cisema.com/en/nmpa-initiates-regulation-of-nanomaterials-in-medical-devices/ [Accessed on: April 22, 2025].
- Nasu, H. et. al. (2013). Nanotechnology in Japan: A route to energy security after Fukushima?. Bulletin of the Atomic Scientists, 69(5), 68-74. Available at: https://doi.org/10.1177/0096340213501367
- Prof. Jagadish et. al. (2019). Nanotechnology Regulation in Australia. Australian Academy of Science. [Online]. Available at: https://www.science.org.au/curious/technology-future/nanotechnology-regulation-australia#:~:text=Worksafe%20Australia%20is%20responsible%20for,fall%20under%20other%20regulatory%20jurisdictions. [Accessed on: April 22, 2025].
- Workplace Health and Safety Queensland. (2025). Nanomaterial control banding risk assessment. [Online]. Available at: https://www.worksafe.qld.gov.au/safety-and-prevention/hazards/hazardous-exposures/nanotechnology/nanomaterial-control-banding-risk-assessment [Accessed on: April 22, 2025].
