Nanomaterials are supplies with at the very least one dimension smaller than 100 nanometres (about 100,000 occasions thinner than a human hair). Due to their tiny dimension, they’ve distinctive properties that may be helpful in lots of industries.1
Nevertheless, with out correct regulation, nanomaterials might pose dangers to human well being and the setting. A transparent and constant set of worldwide guidelines is required to handle these dangers whereas supporting innovation and protected improvement.
Governments world wide acknowledge the necessity for clear guidelines to handle the protected improvement and use of nanomaterials. This part opinions how totally different nations regulate them, together with processes for testing, approval, and monitoring.
European Union: REACH and Specialised Frameworks
The European Fee (EC) classifies nanotechnology as a Key Enabling Know-how (KET), which implies it performs a significant position in innovation and industrial progress. In consequence, a number of EU companies and sector-specific laws have been developed to supervise nanomaterials.
Up to date Definition of Nanomaterials
On June 10, 2022, the European Union Observatory for Nanomaterials up to date its definition of nanomaterials. In line with this definition, nanomaterials embrace pure, incidental, or manufactured substances made up of particles or aggregates smaller than 100 nanometres. These tiny particles should account for greater than 50 % of the fabric.
For sure security assessments, this 50 % threshold could also be adjusted to a spread between 1 % and 50 %. The definition additionally particularly contains supplies like carbon nanotubes (CNTs), fullerenes, and two-dimensional supplies akin to graphene, which may have a number of dimensions beneath 1 nanometre.2
Different EU companies might use barely totally different definitions relying on their regulatory wants, however that is the newest EU-wide replace.
Nanomaterial Regulation beneath REACH
Beneath the EU’s REACH regulation (Registration, Analysis, Authorisation and Restriction of Chemical substances), nanomaterials are known as “nanoforms.” Any firm manufacturing or importing nanomaterials within the EU should register these substances and supply detailed info on their security.
Since January 1, 2020, new authorized necessities have made it necessary for corporations to adjust to particular guidelines for nanoforms. Key adjustments launched by the 2018 modification embrace:
- Firms should outline the nanoform clearly and embrace its toxicological profile within the registration paperwork (Regulation (EU) 2018/1881).
- A full threat evaluation have to be submitted by the producer.
- Customary info have to be included in a technical file and chemical security report, together with steering for downstream customers.
- Firms can group nanoforms with comparable properties to simplify documentation.3
By implementing these necessities, the EU goals to enhance security within the manufacturing and use of nanomaterials and help accountable innovation.
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Nanomaterials and the European Chemical substances Company (ECHA)
The European Chemical substances Company (ECHA) performs a central position in overseeing the regulation of nanomaterials beneath the EU’s REACH and CLP (Classification, Labelling and Packaging) frameworks. It supplies up to date steering paperwork and helps each inner and exterior coaching applications associated to nanomaterial improvement.
ECHA additionally contributes to worldwide regulatory efforts, such because the Malta Initiative, which focuses on growing testing pointers for nanomaterials. As well as, ECHA established the EU Observatory for Nanomaterials (EUON) in 2011, which turned totally operational by 2016–2017 to enhance transparency and help protected use of nanomaterials throughout the EU.
Nanomaterials Knowledgeable Group beneath ECHA
ECHA additionally arrange the Nanomaterials Knowledgeable Group (NMEG) in 2012, in collaboration with REACH and CLP. This advisory group helps ECHA’s methods for making certain the protected improvement of nanomaterials and helps resolve technical points associated to their regulation.4 In 2024, NMEG printed a guide figuring out S-CIRCABC as the principle platform for sharing nanomaterials-related documentation.5
European Meals Security Authority on Nanotechnology
The European Meals Security Authority (EFSA) has printed steering on assessing the dangers of nanomaterials utilized in meals merchandise. Referred to as the Scientific Committee steering on Nano-risk evaluation (SC steering), it outlines the technical necessities for evaluating particles akin to nanoparticles.
The steering contains detailed directions on methods to characterize the bodily and chemical properties of nanomaterials, in addition to methods to assess publicity and determine potential well being hazards. Candidates are answerable for choosing acceptable testing strategies and clearly justifying their strategy.
Danger assessments should mix knowledge from hazard identification, publicity evaluations, and some other related sources. The aim is a whole image of the nanomaterial’s security for its supposed use, together with any uncertainties or circumstances that have an effect on the outcomes. All documentation should adjust to REACH and CLP laws to make sure the safety of human and animal well being.
United States: Regulation By Present Frameworks
In the US, nanomaterials are regulated utilizing present legal guidelines somewhat than by nano-specific laws.
![Two women in a lab work on food research, using a microscope, petri dish, and test tubes filled with chemical solutions.]()
Picture Credit score: PanuShot/Shutterstock.com
Environmental Safety Company (EPA) and TSCA
The nanomaterials are regulated by the EPA beneath the Poisonous Substance Management Act (TSCA) as chemical substances. The Environmental Safety Company (EPA) oversees nanomaterials beneath the Poisonous Substances Management Act (TSCA), treating them as chemical substances.
In 2017, the EPA launched a rule requiring one-time reporting and recordkeeping for sure nanomaterials already in use. Producers, together with importers and processors, should submit particulars akin to chemical id, manufacturing quantity, manufacturing strategies, makes use of, and any out there well being and security knowledge.7
For brand spanking new nanomaterials, TSCA requires producers to inform the EPA at the very least 135 days earlier than starting manufacturing. This pre-manufacturing overview helps assess potential dangers. To help these necessities, the EPA created the Chemical Info Submission System (CISS), which permits corporations to submit knowledge electronically beneath TSCA sections 4, 8(a), and eight(d).8
Nanomaterials Regulation beneath the U.S. Meals and Drug Administration
The U.S. Meals and Drug Administration regulates merchandise containing nanomaterials beneath present authorized requirements primarily based on product sort.
As a result of nanomaterials can behave in another way than typical supplies, the FDA has issued steering titled Drug Merchandise, Together with Organic Merchandise, that Include Nanomaterials: Steerage for Business, which outlines methods to consider their security, high quality, and efficiency.
The steering emphasizes the significance of full characterization of nanomaterials, together with construction, physico-chemical stability, and demanding high quality attributes (CQAs).
It notes that whereas some standardized strategies for characterizing nanomaterials exist already, akin to ISO 22412:2017 and ASTM E2859-11(2017), others are nonetheless being developed. Candidates should rigorously assess whether or not the chosen strategies are acceptable for the particular nanomaterial in query.
As well as, all drug merchandise that include nanomaterials have to be manufactured in compliance with present good manufacturing practices (CGMP), as required by part 501(a)(2)(B) of the Federal Meals, Drug, and Beauty (FD&C) Act.
The FDA additionally requires that storage circumstances, shelf life, and in-use circumstances be backed by knowledge confirming the chemical and bodily stability of the product. Medical improvement should comply with all relevant security and efficacy requirements.9
U.S. Client Product Security Fee (CPSC)
The U.S. Client Product Security Fee (CPSC) has sought to handle potential dangers related to nanomaterials by making use of its present regulatory frameworks. Presently, CPSC employees are working to replace power hazard pointers to higher mirror the usage of nanomaterials in shopper merchandise. Central to this effort are hazard identification and an intensive overview of toxicity knowledge.
CPSC can be actively concerned in a number of collaborative initiatives with federal and personal organizations centered on nanomaterial manufacturing and use. These embrace participation within the Nanoscale Science, Engineering and Know-how (NSET) subcommittee and the Nanotechnology Environmental Well being Points (NEHI) working group. By these efforts, the company helps knowledge sharing and greatest practices for nanomaterial regulation.10
Whereas no nanomaterial-specific federal or state legal guidelines exist within the U.S., regulatory our bodies have tailored present chemical security frameworks to incorporate nanoscale substances. Regardless of this, stronger, devoted laws remains to be wanted to make sure ample human well being and environmental safety.
Canada: Coordinated Danger-Based mostly Strategy
Canadian Environmental Safety Act, 1999
Beneath the Canadian Environmental Safety Act of 1999 (CEPA 1999), main chemical substances (together with nanomaterials) are regulated as a part of Canada’s strategy to environmental and human well being safety.
Present nanomaterials are these with nanoscale varieties listed on the Home Substances Listing (DSL). Nevertheless, the Chemical substances Administration Plan (CMP) doesn’t particularly tackle the danger evaluation of those nanoscale varieties.11
In 2022, Canada launched the Framework for the Danger Evaluation of Manufactured Nanomaterials beneath CEPA 1999, providing a foundational information for evaluating new and present nanomaterials. Newly developed nanomaterials are topic to the New Substances Notification Rules (Chemical substances and Polymers).
This framework enabled employees from Atmosphere and Local weather Change Canada (ECCC) and Well being Canada (HC) to collect info and compile an inventory of nanomaterials presently utilized in commerce. The information was then used to assist prioritize substances for threat evaluation.
The framework additionally launched the usage of Danger Quotients (RQ) and Margins of Publicity (MOE) to evaluate environmental and well being impacts. An RQ equal to or better than 1 signifies a possible hazard.
Well being dangers are evaluated by inspecting particular hazards, publicity ranges, and related routes of contact for every nanomaterial. Danger to Canadians is assessed primarily based on potential publicity by shopper merchandise, meals, water, and environmental contact, with specific consideration paid to weak populations.12
Position of Well being Canada
Well being Canada depends on present legal guidelines and laws to evaluate and handle potential well being dangers related to nanomaterials. The division evaluates the protection of nano-enabled merchandise and substances containing nanomaterials on a case-by-case foundation.
In collaboration with Atmosphere and Local weather Change Canada, Well being Canada participates within the Canada–United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative. This initiative helps info sharing and the event of joint methods, together with standardized terminology, naming conventions, and harmonized approaches to threat evaluation and regulatory oversight.13
China: Evolving Requirements and Institutional Improvement
China is quickly advancing in nanotechnology, and regulatory programs are growing in parallel.
In 2011, the Nationwide Nanotechnology Standardization Technical Committee (NSTC) and Technical Committee 279 (TC279), working beneath the Standardization Administration of China (SAC), started reviewing and drafting key requirements associated to nanomaterials. These lined terminology, testing strategies, and security issues for nanoscale supplies and biomedical functions.
NSTC-TC has additionally contributed to the event of testing protocols and technical requirements for industrial and lab use, supporting utilized analysis throughout sectors.
A toxicology database for nanomaterials is in improvement to assist inform security requirements for manufacturing, packaging, and transport. Whereas SAC/TC279 manages these requirements, most stay voluntary, and the excellence between voluntary and necessary implementation just isn’t at all times clear.14
In 2021, China launched nationwide normal GB/T30544.1, requiring candidates to design security assessments for biomedical units containing nanomaterials. These assessments should account for key dangers such because the dosage and launch price of nanoparticles, in addition to the route of publicity.15
Though nonetheless maturing, China’s regulatory panorama is steadily increasing to cowl sectors like meals, agriculture, and office security.
Japan: Case-by-Case Evaluation Utilizing Present Legal guidelines
Japan doesn’t have a devoted regulatory framework or authority particular to nanomaterials. As an alternative, security issues associated to their use are addressed by professional groups on a case-by-case foundation.
Presently, present laws akin to Roudou Anzen Eisei Ho (the Industrial Security and Well being Act) and Haikibutsu Shori Ho (the Chemical Substances Management Act) is utilized to control nanomaterials. Whereas these legal guidelines aren’t nano-specific, they supply the premise for oversight.
The Ministry of Financial system, Commerce and Business and the Ministry of Well being, Labor, and Welfare have been actively concerned in researching nanomaterial security.16 In recent times, Japan has additionally begun collaborating with worldwide organizations such because the European Medicines Company (EMA) to develop extra tailor-made pointers and requirements for nanomedicines. These efforts mirror Japan’s rising dedication to strengthening its regulatory strategy and defending public well being.
Australia: Sector-Particular Oversight and Danger Instruments
Australia takes a coordinated strategy to managing the dangers of nanomaterials, specializing in each environmental and human well being. A number of companies oversee their use throughout totally different sectors.
Till 2020, industrial nanomaterials had been regulated by the Nationwide Industrial Chemical substances Notification and Evaluation Scheme (NICNAS). This position is now dealt with by the Australian Industrial Chemical substances Introduction Scheme (AICIS), which evaluates the protection of nanomaterials utilized in merchandise like paints, dyes, pesticides, and cosmetics.
Office publicity is managed by Secure Work Australia, which supplies steering to cut back well being dangers from supplies like carbon nanotubes (CNTs). Within the meals sector, Meals Requirements Australia New Zealand (FSANZ) is answerable for regulating nanomaterials utilized in meals and packaging. For medical units, oversight falls beneath the Therapeutic Items Administration (TGA), whereas the Australian Competitors and Client Fee (ACCC) screens common shopper merchandise that include nanomaterials.
To help protected use, regulatory our bodies have developed threat evaluation instruments. For instance, Office Well being and Security Queensland (WHSQ) created a management banding worksheet to assist analysis establishments and industrial customers assess nanomaterial publicity. The device calculates severity scores and estimates publicity possibilities.18
Universities like UNSW and Griffith College are additionally contributing by creating sensible instruments and checklists for evaluating nanomaterial dangers. These mixed efforts assist guarantee thorough evaluation of each present nanomaterials and new nano-enabled merchandise earlier than they attain the market.
World Alignment and the Path Ahead
Though many nations have made progress in regulating nanomaterials, international alignment stays a serious problem. Variations in threat thresholds, regulatory definitions, and reporting necessities make it tough to create a unified worldwide framework.
The EU has led the way in which by its REACH laws, which requires detailed security assessments and technical documentation for nanoforms. Nevertheless, many different areas nonetheless depend on older or extra common chemical laws that will not totally account for the distinctive properties of nanomaterials.
Producers usually wrestle with inconsistent knowledge necessities when registering merchandise in numerous nations. Various requirements for testing strategies and formatting create limitations to worldwide compliance and enhance prices for international corporations. These points spotlight the necessity for a extra standardized regulatory system worldwide.
Efforts are underway to handle this. Worldwide organizations just like the Worldwide Group for Standardization (ISO) and the Organisation for Financial Co-operation and Improvement (OECD) are working with nationwide governments to develop shared testing protocols and knowledge submission templates.
Regardless of ongoing challenges, nanomaterials proceed to drive innovation in science and expertise. Researchers are exploring greener, extra sustainable nanomaterials to help international local weather and improvement targets. In the meantime, new instruments like synthetic intelligence (AI) and machine studying (ML) are getting used to enhance toxicology predictions.
With continued worldwide cooperation, the way forward for nanomaterial regulation will probably grow to be extra aligned, clear, and aware of rising applied sciences.
References and Additional Studying
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- European Union Observatory for Nanomaterials, (EUON). (2025). Definition of nanomaterial. [Online]. Out there at: https://euon.echa.europa.eu/definition-of-nanomaterial [Accessed on: April 15, 2025].
- Workplace Journal of the European Union. (2018). COMMISSION REGULATION (EU) 2018/1881 of three December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Analysis, Authorization and Restriction of Chemical substances (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to handle nanoforms of drugs. L 308. [Online]. Out there at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R1881 [Accessed on: April 16, 2025].
- European Chemical substances Company (ECHA), (2025). Nanomaterials Rules. [Online]. Out there at: https://echa.europa.eu/laws/nanomaterials [Accessed on: April 17, 2025].
- Nanomaterials Knowledgeable Group (NMEG), ECH. (2024). ECHA NMEG Guide. Model 4. Out there 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, Extra S. et. al. (2021). Steerage on threat evaluation of nanomaterials to be utilized within the meals and feed chain: Human and animal well being. EFSA Journal. 19(8). e06768. Out there at: https://www.doi.org/10.2903/j.efsa.2021.6768
- United States Environmental Safety Company (EPA). (2024). Truth Sheet: Nanoscale Supplies. Reviewing New Chemical substances beneath the Poisonous Substances Management Act (TSCA). [Online]. Out there at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/fact-sheet-nanoscale-materials#:~:textual content=Aspercent20partpercent20ofpercent20thepercent20Agency’s,substancespercent20inpercent20commercepercent20pursuantpercent20to [Accessed on: April 17, 2025].
- United States Environmental Safety Company (EPA). (2017). Chemical Substances When Manufactured or Processed as Nanoscale Supplies: TSCA Reporting and Recordkeeping Necessities. Environmental Safety; Chemical substances; Hazardous Supplies; Recordkeeping and Reporting Necessities; Reporting and Recordkeeping Necessities. 40 CFR Half 704. 3641 – 3655. EPA-HQ-OPPT-2010-0572-0137. [Online]. Out there at: https://www.laws.gov/doc/EPA-HQ-OPPT-2010-0572-0137 [Accessed on: April 17, 2025].
- U.S. Division of Well being and Human Companies Meals and Drug Administration. (2022). Drug Merchandise, Together with Organic Merchandise, that Include Nanomaterials Steerage for Business. 19640025 FNL. 1-29. [Online]. Out there at: https://www.fda.gov/media/157812/obtain?attachment [Accessed on: April 17, 2025].
- U.S. Client Product Security Fee (CPSC) (2024). CPSC Nanomaterial Assertion. [Online]. Out there at: https://www.cpsc.gov/s3fs-public/CPSCNanostatement.pdf [Accessed on: April 18, 2025].
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