The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles.

The request notes that titanium dioxide is authorized both as a colorant under entry 143 of Annex IV and as an ultraviolet (UV) filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 (Cosmetics Regulation). The request states that in light of titanium dioxide’s classification as a Carcinogen Category 2 (i.e., suspected human carcinogen) by inhalation route only and its inclusion in Annex VI to Regulation (EC) No. 1272/2008 (Classification, Labeling, and Packaging (CLP) Regulation), SCCS has reassessed titanium dioxide. Subsequently, entry 321in Annex III was introduced and additional provisions in existing entries 143 of Annex IV and 27 and 27a of Annex VI were added that further restricted the use of titanium dioxide in cosmetic products.

As reported in our May 10, 2021, blog item, on May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive. According to EFSA, “[a] critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles.”

According to the request, in May 2022, the EC received a dossier submission by industry accompanied by a comprehensive, up-to-date review of the genetic toxicity database for titanium dioxide “providing scientific evidence to demonstrate the safety of non-nano (pigmentary) and nano form” of titanium dioxide in cosmetic products.

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Advanced Materials.” According to the dossier, advanced materials are “materials or material combinations with improved, novel or unique functionalities or properties” and represent a broad class of materials that include semiconductors, biomaterials, and nanomaterials. The dossier states that in many cases, novel materials offer solutions to environmental problems, e.g., by saving energy and materials because of lighter weight, and they can contribute to “a sustainable development of the environment, economy, and society.” The dossier notes that novel materials and/or new functionalities are also associated with uncertainties regarding human health and the environment. As a result, it is important to highlight safety-relevant aspects at an early stage and to identify potential risks in accordance with the precautionary principle. Because of the complexity of advanced materials, new approaches, such as the concepts of “safe by design” (SbD) and “safe and sustainable by design” (SSbD), are required to gain all the necessary knowledge regarding their safety. The dossier concludes that “[a]t present, it is still unclear whether all advanced materials are covered by existing chemical safety regulations. It is therefore necessary to review relevant regulations and corresponding risk assessment tools in this context to anticipate and fill any potential loopholes.”

The 4th Joint Symposium on Nanotechnology, organized by the German Federal Institute for Risk Assessment (BfR) and the Fraunhofer Network Nanotechnology (FNT), was held May 30-31, 2022. The conference included presentations on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the introduction of nanomaterials into the body, and future-oriented assessment approaches. The following presentations from the conference have been posted online.

Presentations from May 30, 2022

Presentations from May 31, 2022

On June 30, 2022, the Organization for Economic Cooperation and Development (OECD) published six new Test Guidelines (TG) and ten updated or corrected TGs. The new TGs include the first two harmonized methods for measuring certain nanomaterial-specific physical-chemical properties. According to OECD, these harmonized methods were developed to respond to regulatory needs in member and adhering countries, specifically for manufactured nanomaterials. The development of these TGs was supported financially by the European Commission (EC):

  • Test Guideline 124 on Volume Specific Surface Area of Manufactured Nanomaterials: This TG describes a procedure to determine the Volume Specific Surface Area (VSSA) of powdered solid manufactured nanomaterials. According to the TG, this physical-chemical property may influence the behavior and biological effects of manufactured nanomaterials and thus can be requested for the safety testing of manufactured nanomaterials. The TG states that data on VSSA or (mass) specific surface area (SSA) may provide information on the characteristic structure of the nanomaterial and can: help identify potential hazards or hazard modifications associated with similar structures; help to estimate nanomaterial fate in the environment; and help to identify modification of exposure site-specific hazards related to the physico-chemical properties. Moreover, in some cases, VSSA or SSA data can be used to relate dose to observed fate, behavior, and effects of a specific nanomaterial, as the surface area may be the toxicologically relevant dose metric.
  • Test Guideline 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials: The TG states that to address the specific needs of manufactured nanomaterials, the OECD TG No. 110, “Particle Size Distribution/Fibre Length and Diameter Distributions,” was identified as one of the TGs to require an update. The current TG 110, adopted in 1981, is valid only for particles and fibers with sizes above 250 nanometers (nm). The OECD Working Party on Manufactured Nanomaterials (WPMN) prioritized updating TG 110 to be applicable also to particles at the nanoscale or drafting a new nanomaterial-specific TG. The TG states that the WPMN eventually decided to develop a new TG that covers the size range from 1 nm to 1,000 nm, intended for particle sizes and particle size distribution measurements of nanomaterials. This TG overlaps with TG 110 in the size range from 250 nm to 1,000 nm. When measuring particulate or fibrous materials, the appropriate TG should be selected depending on the size range of particles tested. In line with TG 110, the new TG for nanomaterials includes separate parts for particles and fibers.

On June 28, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Models to Characterize Exposures to Manufactured Nanomaterials in OECD” by Vladimir Murashov, Ph.D., Senior Scientist in the Office of the Director, National Institute for Occupational Safety and Health (NIOSH), and John Howard, M.D., Director of NIOSH and Administrator of the World Trade Center Health Program in the U.S. Department of Health and Human Services. The authors describe recently completed international projects conducted under the umbrella of the Organization for Economic Cooperation and Development (OECD). Created in 2007 and led by NIOSH, the OECD Steering Group on Exposure Measurement and Mitigation of Nanomaterials (SG8) addresses the exposure component of the risk assessment and risk management program for manufactured nanomaterials. As reported in our November 23, 2022, blog item, on December 2, 2021, the SG8 organized a webinar to present four recent publications on models to characterize exposures to manufactured nanomaterials in workers, consumers, and the environment.

According to the authors, while the results of these SG8 projects “can help guide private and public sector risk assessment and risk management professionals to choose adequate models to identify exposure to manufactured nanomaterials,” the following challenges remain:

  • There is a paucity of high-quality experimental exposure data and a very limited number of exposure scenarios hindering model performance testing;
  • Most existing models tend to overestimate exposure due to the application of the precautionary approach in the absence of sufficient data; and
  • Existing models do not account for agglomeration and aggregation of nanomaterials.

SG8 plans to continue its activities, building on the outputs of exposure model projects and providing further authoritative guidance on the use of exposure models for specific exposure situations. The authors state that for its part, “NIOSH supports international activities aimed at improving safety and health of workers handling manufactured nanomaterials and nano-enabled products.”

The European Union (EU) Observatory for Nanomaterials (EUON) announced on June 17, 2022, that it is looking for topics that could be addressed in its upcoming studies. EUON conducts up to three studies annually to address knowledge gaps on nanomaterials. EUON is looking for study topics that address:

  • Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
  • Specific issues surrounding the uses of nanomaterials; or
  • Information about markets for nanomaterials (e.g., the market for specific materials such as graphene or specific market sectors).

EUON states that the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. Studies are run for three to nine months and according to EUON should be based on desk research and surveys (should not require laboratory research). Proposals are due July 18, 2022. The EUON team will assess all proposals. The selected proposals will be carried out through EUON’s existing procurement channels. EUON will make the outcome and study reports publicly available on its website.

On June 17, 2022, Canada published its draft Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA) for a 60-day public comment period. The plain language summary states that the framework describes how scientists at Environment and Climate Change Canada (ECCC) and Health Canada (HC) conduct risk assessments on nanomaterials. The draft risk assessment framework outlines approaches and considerations for informing the risk assessment of nanomaterials under CEPA, including both existing nanomaterials on the Domestic Substances List (DSL) and new nanomaterials notified under the New Substances Notification Regulations (Chemicals and Polymers). A substance is assessed as a nanomaterial if it meets the criteria described in HC’s working definition for nanomaterial and particle size distribution threshold (number or mass-based), as stated in both the draft framework and the New Guidance Document for the notification and testing of new substances: chemicals and polymers. Comments are due August 16, 2022.

The framework discusses in detail the nanomaterial-specific considerations for risk assessment, including:

  • The key physical and chemical properties specific for nanomaterial identification and used for grouping or classifying nanomaterials for information gathering;
  • The data considerations used in a nanomaterial risk assessment, such as test data or modeling; and
  • The behavior of nanomaterials throughout the life cycle of the nanomaterial (from production to disposal) and characterizing those potential effects on human health and the environment.

The framework also details the ecological and human health risk characterization of nanomaterials:

  • Ecological risk characterization approach for nanomaterials: The ecological risk characterization of nanomaterials considers relevant ecological processes that may affect the potential exposure and hazardous effects of nanomaterials. This includes investigating how nanomaterials are transported in the environment and their environmental fate. In addition, ECCC scientists investigate how biotic and abiotic components can influence the bioavailability, persistence, or toxicity of a nanomaterial; and
  • Human health risk characterization approach for nanomaterials: Human health risks of nanomaterials are characterized based on nanomaterial-specific hazards and exposures for relevant routes of exposure. Characterization of the risks to Canadians are based on, but not limited to, use of products available to consumers and exposure via food, drinking water, and environmental media. Special consideration is given to the potential risks to vulnerable populations (for example, children, pregnant women).

The draft framework states that the conclusions reached through the assessment process for nanomaterials under CEPA may differ between the traditional chemical form of a substance and the nanomaterial form of the same substance and may differ among different nanoscale forms of the same substance. ECCC and HC scientists use a weight-of-evidence approach to combine the multiple lines of evidence and their uncertainties to conclude if a nanomaterial reaches the environment in a quantity or concentration or under conditions that meet any of the criteria for toxicity as set out under CEPA.

The National Nanotechnology Initiative (NNI) will hold a public webinar on June 28, 2022, on “Nanotechnology Commercialization: Perspectives from a Regional Innovation Ecosystem.” Participants will hear from members “of a vibrant nanotechnology innovation ecosystem anchored by the Mid-Atlantic Nanotechnology Hub at the Singh Center for Nanotechnology (part of the National Nanotechnology Coordinated Infrastructure).” The speakers will share their perspectives on topics such as nanotechnology research and development (R&D), the technology development pathway, partnerships, funding, and the importance of resources, such as the federally funded user facilities around the country. NNI notes that the webinar supports Goal 2 of the NNI 2021 Strategic Plan to promote nanotechnology commercialization and aims to engage with and enhance connections among regional innovation ecosystems to support nanotechnology commercialization. The panel, moderated by Lisa E. Friedersdorf, Ph.D., Director, National Nanotechnology Coordination Office (NNCO), includes:

  • Anthony P. Green, Ph.D., Chief Scientific Officer, Ben Franklin Technology Partners of Southeastern Pennsylvania;
  • Gerald Lopez, Ph.D., Director, Business Development, Singh Center for Nanotechnology, University of Pennsylvania; and
  • Brendan DeLacy, Ph.D., President and Founder, Ballydel Technologies.

Registration is now open.

The European Union (EU) Observatory for Nanomaterials (EUON) announced on June 10, 2022, that NanoData has been updated with “a new look and feel to improve the user experience.” NanoData is the knowledge base on nanosciences and -technology hosted by EUON. It contains data on different products, research projects, publications, patents, and organizations. According to EUON, users can now visualize statistics through built-in charts and graphs. The data can be easily filtered by different sectors and geographic locations. EUON states that users will be able to benefit from a bulk download feature “at a later date.” To bring users the latest nano-news in one place, EUON has also merged the news sections from the EUON website and NanoData into a new tab on the EUON website. Users can access daily a selection of news about nanomaterials from around the web. Later in 2022, EUON will refresh NanoData “with more and up-to-date information.”

On June 10, 2022, the European Commission (EC) announced that it is clarifying the definition of nanomaterials in a new Recommendation that supports a coherent European Union (EU) regulatory framework for nanomaterials, helping to align legislation across all sectors. The EC states that the new definition should be used in EU and national legislation, policy, and research programs. The Recommendation states:

‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil at least one of the following conditions:

  1. one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
  2. the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
  3. the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.

In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered.

However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.

 
The new definition replaces the definition published in 2011. According to the EC, it developed the revisions following a comprehensive review, and the revisions “should allow easier and more efficient implementation, but will not significantly affect the scope of identified nanomaterials.”