The European Union (EU) Observatory for Nanomaterials (EUON) announced on November 7, 2022, that it published a study on the EU market for nanomaterials, including substances, uses, volumes, and key producers, traders, and users. The study also covers the European Economic Area (EEA) countries and Switzerland. EUON states that according to the study, which was carried out in 2021 as a combination of literature research, surveys, and interviews, the European nanomaterial market is expected to grow in the next five years in both volume and value. According to EUON, although Brexit had an impact on this projection, interview participants did not perceive the COVID-19 pandemic to lead to a market slow-down. EUON notes that the study was conducted “before the crisis arising from the war in Ukraine, and hence its impact on the study outcomes is not known.” EUON states that while the largest segment is currently the metal oxides market, “growth is predicted to be driven mainly by nanoclays, nanocellulose and carbon-based nanomaterials.”

Technological advancement and public demand for functional, lightweight, and affordable state-of-the-art products are seen as the main drivers for growth. The industries most likely to drive market growth are aerospace, automotive, energy, food packaging, and construction. The use of nanomaterials in medicine and personal care are also expected to give the market a boost. EU and national public funding was identified as a significant enabler for the continued development and commercialization of new nanomaterials.

According to EUON, study participants perceived the current regulatory landscape, “which does not allow products containing nanomaterials to be easily commercialised,” as a significant barrier to growth. EUON states that potential upcoming changes in regulatory requirements and relatively high scale-up costs were also mentioned as “dampening the interest of companies in ramping up production. On the other hand, it was noted that a stricter regulatory regime can also help increase public trust in nanomaterial products.” According to respondents, the relatively negative public opinion toward nanomaterials is among other factors hindering growth.

EUON states that according to the study, there are approximately 2,200 existing products containing nanomaterials in the EU, EEA, and Swiss markets. According to EUON, more than 90 nanomaterial substances that are available in these markets have not been listed by any of the inventories on which EUON reports. EUON notes that some of the discrepancy can be due to regulation-specific conditions under which substances in nanoform need to be registered and/or notified.

On October 31, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for a number of chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 65548. The proposed SNURs include four chemical substances identified as:

  • Multi-walled carbon nanotubes (MWCNT); closed; 4.4-12.8 nanometer (nm) diameter; bundle length 10.6-211.1 micrometer (µm); Grade: Jenotube 6 (PMN P-20-62);
  • MWCNTs; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 µm; Grade: Jenotube 8 (PMN P-20-63);
  • MWCNTs; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 µm; Grade: Jenotube 10 (PMN P-20-64); and
  • MWCNTs; closed; 17.0-34.7 nm diameter; globular shape; Grade: Jenotube 20 (PMN P-20-65).

According to EPA, the PMNs state that the use of the substances will be as electrically conductive materials; heat dissipation materials; heat generation materials; additives for weight reduction; additives to improve physical or mechanical properties; additives in batteries, energy storage, and electrode applications; and additives in field emission applications. According to the notice, based on analogy to asbestos fibers and data for other MWCNTs, EPA identified concerns for lung effects (lung overload and lung carcinogenicity) if poorly soluble, respirable particulates and fibers are inhaled. Based on comparison to analogous chemical substances, EPA identified concerns for eye irritation and systemic effects. Based on the presence of cobalt oxide as a residual at 2.1%, EPA identified concerns for the P-20-64 chemical substance for acute neurotoxicity, dermal and respiratory sensitization, mutagenicity, and carcinogenicity. EPA states that it was unable to estimate the environmental hazard of these new chemical substances. EPA issued the Order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

  • No domestic manufacture (e., import only);
  • No processing or use of the PMN substances in an application method that generates a vapor, mist, dust, or aerosol unless such application method occurs in an enclosed process;
  • Use of personal protective equipment where there is a potential for dermal exposure;
  • Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 50 where there is a potential for inhalation exposure;
  • No manufacture of the PMN substances with a maximum weight percent of cobalt oxide impurity in exceedance of 2.1%;
  • Process and use of the PMN substances only as electrically conductive materials; heat dissipation materials; heat generation materials; additives for weight reduction; additives to improve physical or mechanical properties; additives in batteries, energy storage, and electrode applications; or as additives in field emission applications;
  • Establishment of a hazard communication program, including human health precautionary statements on each label and on the safety data sheet (SDS); and
  • No release of the PMN substances, or any waste stream containing the PMN substances, into water.

The proposed SNURs would designate as a “significant new use” the absence of these protective measures.

EPA states that it determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a significant new use notice (SNUN) for a significant new use that will be designated by this SNUR. EPA determined that the results of specific target organ toxicity, carcinogenicity, eye irritation, and aquatic toxicity testing may be potentially useful to characterize the human health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. Comments are due November 30, 2022.

NanoHarmony and NANOMET have published a status report summarizing the current status of projects aiming to develop or adapt Organization for Economic Cooperation and Development (OECD) Test Guidelines (TG) and Guidance Documents (GD) for nanomaterials, as well as the outlook for each project as of July 2022. The status report is intended to be a living document that will be updated regularly. A large part of the status report comprises activities in European Union (EU) projects like NanoHarmony, Gov4Nano, RiskGONE, and NANORIGO, and national projects that contribute within the Malta Initiative to the development of TGs and GDs for nanomaterials. Apart from the projects supported by the OECD Working Group of National Co-ordinators of the TGs program (WNT) or OECD Working Party on Manufactured Nanomaterials (WPMN), an additional number of standardization activities are presented that develop test methodologies for which the initiators foresee an OECD project status in the near future.

The U.S. Environmental Protection Agency (EPA) will hold a webinar on November 1, 2022, on a new research funding opportunity, “Developing and Demonstrating Nanosensor Technology to Detect, Monitor, and Degrade Pollutants.” EPA states that environmental pollutants such as pesticides, insecticides, dyes, phenols, endocrine disrupters, polycyclic aromatic hydrocarbons, per- and polyfluoroalkyl substances (PFAS), heavy metals, and nitrogen compounds can have adverse effects on human health even at low concentrations. Efforts are consistently being made to develop reliable and simple sensors to detect pollutants even at low levels. According to EPA, environmental remediation technologies cover a vast range of applications that require tailored engineering solutions for successful implementation. Technologies applied for the treatment of water, soil, or air involve contaminant degradation or sequestration and often use related processes, such as adsorption or reduction/oxidation (redox) reactions. During the webinar, EPA will provide an overview of the research grant funding opportunity, and attendees will have a chance to ask questions. EPA will post a copy of the webinar slides on the funding opportunity’s web page. Registration is open.

The Organization for Economic Cooperation and Development will hold a webinar on November 3, 2022, on the safer and sustainable innovation approach (SSIA) for more sustainable nanomaterials and nano-enabled products. According to OECD, SSIA is an approach aiming to boost safer and sustainable innovations by integrating safety and sustainability at an early stage of the design phase of innovative materials, products, applications, and processes. SSIA combines the Safe-and-Sustainable-by-Design (SSbD), Regulatory Preparedness (RP), and Trusted Environment (TE) concepts to identify and minimize sustainability impacts, as well as potential health and environmental risks in the innovation process. OECD states that SSIA relies on early dialogue between industry and regulators and is facilitated by a “Trusted Environment.” SSIA aims to anticipate the regulatory challenges posed by innovative nanomaterials, nano-enabled products, or other advanced materials by minimizing the gap between technological innovations and the development of suitable risk assessment tools and frameworks. OECD notes that it is organizing the webinar to increase awareness of this approach and gather input from potential users, such as innovators and regulators, to ensure its applicability.

A summary of OECD’s report entitled Sustainability and Safe and Sustainable by Design: Working Descriptions for the Safer Innovation Approach is available in our September 12, 2022, blog item. More information on OECD’s report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products is available in our December 29, 2020, blog item.

On October 7, 2022, the White House Office of Science and Technology Policy (OSTP) and the National Nanotechnology Coordination Office (NNCO) made key announcements intended to advance the Biden Administration’s efforts “to leverage the promise of science and technology to benefit all Americans.” They also complement the Administration’s ongoing Creating Helpful Incentives to Produce Semiconductors (CHIPS) and Science Act implementation efforts “that will ensure the United States remains a world leader in the industries of tomorrow.” The announcements include:

  • Nano4EARTH: NNCO announced the inaugural National Nanotechnology Challenge, Nano4EARTH. Nano4EARTH will leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies and industries that address climate change. Nano4EARTH recognizes the role nanotechnology plays in: evaluating, monitoring, and detecting climate change status and trends; averting future greenhouse gas emissions; removing existing greenhouse gases; training and educating a highly skilled workforce to harness nanotechnology solutions; and developing higher resilience to, and mitigation of, climate change-induced pressures for improved societal/economic resilience. Members of the National Nanotechnology Initiative (NNI) community — the scientists, engineers, entrepreneurs, and government leaders developing solutions at the nanoscale — are invited to participate in Nano4EARTH. The Nano4EARTH kickoff workshop (to be held in early 2023) will serve as an information-gathering exercise to identify key feasible outputs of the challenge and effective ways to measure success.
  • NNCO Leadership: OSTP and NNCO announced Dr. Branden Brough as the new Director of NNCO and Dr. Quinn Spadola as its Deputy Director. Dr. Brough joins NNCO from the Molecular Foundry, a U.S. Department of Energy-funded nanoscale science research center that provides users from around the world with access to cutting-edge expertise and instrumentation. He will also serve as OSTP’s Assistant Director for Nanotechnology. Dr. Spadola was the Associate Director of Education for the National Nanotechnology Coordinated Infrastructure (NNCI), a network of open nanotechnology laboratory user facilities supported by the National Science Foundation, and the Director of Education and Outreach for the Southeastern Nanotechnology Infrastructure Corridor NNCI site at the Georgia Institute of Technology.

According to a September 29, 2022, press release, the Japan Business Council in Europe (JBCE) has proposed a harmonization of the classification of multi-walled carbon nanotubes (MWCNT) “based on the latest knowledge on the effects of carbon nanotubes (CNTs) in organisms.” JBCE notes that this classification is consistent with the classification of the International Agency for Research on Cancer (IARC). JBCE states that “the morphologies, physicochemical properties, and effects on the human organism depend on the different methods for carbon nanotube production” and that “from a chemical management perspective, different types of CNTs should be evaluated depending on their characteristics instead of simply grouping them all together under the category ‘CNTs.’” JBCE proposes that:

  • MWCNTs similar to MWCNT-7 should be classified as suspected human carcinogens (Carc. 2) in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification. According to JBCE, “[t]herefore, straight CNTs, that are neither particularly long nor particularly short, should be considered possibly carcinogenic, as they might have asbestos-like effects in humans even though this has not been scientifically proven yet”; and
  • MWCNTs other than MWCNT-7 should be classified as non-carcinogenic in the GHS classification.


The National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “NIOSH News for National Nanotechnology Day!” on October 6, 2022. In honor of National Nanotechnology Day, October 9, the item summarizes NIOSH’s work in the area of engineered nanomaterials, including the NIOSH Nanomaterial Exposure Assessment Technique (NEAT 2.0), which can be used to identify the potential for exposure to engineered nanomaterials in the workplace. According to NIOSH, the sampling strategy consists of the following important steps:

  • Collect Basic Workplace Information: Workflow, number of workers, tasks performed, materials used, and other indicators of potential exposure;
  • Design and Implement the Sampling Plan: Full-shift and task-based integrated filter-based sampling, direct reading instruments, and engineering controls evaluation;
  • Risk Assessment: Evaluate background and engineering controls data; use the hierarchy of controls to develop mitigation strategies for exposure potential; and communicate potential risks; and
  • Risk Management: Confirm ongoing control of risk by performing additional measurements, if necessary.

NIOSH states that by performing these steps, a comprehensive exposure assessment can be performed to assist with the identification of potential nanomaterial exposures in an occupational setting. By determining exposure potential, the facility can then work to control exposure using mitigation strategies and the hierarchy of controls.

NIOSH also reports on the results of an online survey of 45 companies in the United States and Canada that fabricate, manufacture, handle, dispose of, or otherwise use nanomaterials. The survey included questions about the nanomaterials in use and the overall occupational health and safety culture at the companies, as well as whether the companies interacted with NIOSH or used NIOSH resources to inform their health and safety practices and policies. According to NIOSH, more than a third of the 45 respondents reported using at least one NIOSH resource for information about safe handling of nanomaterials, although larger companies were more likely to report using NIOSH resources. NIOSH states that “[w]hile the survey was limited by the small sample size, it provided valuable insight, including that future NIOSH outreach should specifically target small businesses that use or handle nanomaterials.”

NANORIGO, RiskGONE, and Gov4Nano, in collaboration with the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN), will hold a conference in January 2023 on “Future-proof Approaches for Risk Governance.” According to NANORIGO’s September 14, 2022, press announcement, the conference is intended to help shape international approaches to addressing future challenges in risk governance of nano- and advanced materials. This includes safe and sustainable by design (SSbD) and harmonization and standardization. The conference will comprise two parts:

  • In person (by invitation only) at the OECD Conference Centre in Paris on January 24-25, 2023; and
  • An online session open to all on January 31, 2023.

Registration is open to indicate interest to participate in the conference. Spaces for the in-person event are limited.

The main aim of the conference is to ensure that results from NANORIGO, RiskGONE, and Gov4Nano’s projects are used to support the implementation of the European Union’s (EU) Chemical Strategy for Sustainability (CSS) and address future challenges in risk governance of new and advanced materials. NANORIGO states that an invitation is extended to all stakeholders that can contribute to this discussion and are involved in ongoing initiatives related to the CSS and/or (risk) governance of advanced materials. This includes representatives from non-governmental organizations (NGO), industry, research organizations, the European Commission (EC), EU member states, and experts from the OECD WPMN, and in particular those involved in:

  • Research projects in the context of the implementation of the CSS, g., projects on SSbD;
  • Developing harmonization and standardization approaches for advanced (nano) materials;
  • Nanosafety research; and
  • Regulatory risk assessment or method development of new (nano) materials.

The Organization for Economic Cooperation and Development (OECD) has published for comment a draft study report entitled “Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nanomaterials.” Switzerland conducted experimental work with selected nanomaterials using OECD Test Guideline (TG) 442D (KeratinoSensTM) and made a basic in vitro to in vivo correlation to outline the potential relevance of the results for prediction of skin sensitisation of nanomaterials. According to the draft report, a limited number of relevant nanomaterials for testing within this project, as well as limited availability of in vivo skin sensitisation data for nanomaterials, led Switzerland, in discussion with experts and the OECD secretariat, “to the final conclusion that a study report was the most appropriate way of documenting the outcome of this project and to make it available by publication in the Series on Testing and Assessment for any interested parties carrying out further work related to nanomaterials in the area of skin sensitisation.” The test materials included:

  • Two qualities of titanium dioxide nanoparticles and a nickel (II) oxide particle preparation. All three materials showed negative results in the KeratinoSensTM At least partial cytotoxicity at the top concentration indicated that there was cellular exposure.
  • Silver and gold were obtained in dispersion form and tested directly without further processing. Both silver and gold gave a clear, dose-dependent luciferase induction in KeratinoSensTM Cytotoxicity was measured in parallel, and the positive result occurred at non-cytotoxic levels, indicating a final positive rating according to the standard prediction model.
  • Three tattoo inks were tested as tattoo inks have been discussed in regard to the potential induction of skin sensitisation. Both qualities of black tattoo inks were negative in the KeratinoSensTM assay, while a preparation with pigment red tattoo ink gave a clearly positive result at non-cytotoxic concentrations.
  • Polyethylenglycoldiacrylate nanotubes (PEGDA 575) made from organic polymers tested negative in KeratinoSensTM.

Comments are due November 7, 2022. Instructions for commenting are available on the OECD website.