The European Union (EU) Observatory for Nanomaterials (EUON) has launched two calls for tenders to conduct studies on nanomaterials. The first call for tender is on valid in silico modeling tools and read-across approaches, including creating case studies on read-across for specific types of nanomaterials. According to the call for tender, the study proposes to examine the use of these tools for nanomaterials and to draw potential conclusions (for both regulators and industry/small- and medium enterprises (SME)) on the use of these approaches for specific categories of nanomaterials, including for metals, metal oxides, and organic nanomaterials. The study should use the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation as the regulatory framework for assessment of such approaches but should aim to generalize to other regulatory frameworks within the EU that may address nanomaterials. The study results will be peer reviewed as part of the set deliverables in the contract.

The second call for tender is for a study on nano-specific alternative methods in human risk/safety assessment under different EU regulations, considering the animal testing bans already in place for cosmetics and cosmetic ingredients. According to the call for tender, the study will be conducted as a systematic literature review on the currently available nano-specific replacement methods for the testing of the safety of nanomaterials. In addition, the literature review will be complemented with expert interviews and/or surveys. The study objective is to identify validated alternative methods, methods currently under validation, identification of the most promising methods to undergo validation, as well as to identify needs and/or make recommendations for further development in this area. The study results will be peer reviewed as part of the set deliverables in the contract.

Expressions of interest are due March 24, 2022.

On March 1, 2022, NanoHarmony held the first in a series of webinars covering the different phases that an Organization for Economic Cooperation and Development (OECD) test guideline (TG) progresses through during its journey from a science-based initial idea through to use by industry to fulfill regulatory obligations. A recording of the March 1, 2022, webinar on the use of TGs in industry is now available. A short survey is available to collect stakeholder viewpoints on the use of TGs and is a follow-up to the webinar. NanoHarmony invites all stakeholders to attend future webinars to give their opinions and to develop consensus on the barriers and ways of improving the TG process. The webinars will be highly interactive, and attendees will have the opportunity to share their experiences, thoughts, and suggestions.

On February 24, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Are nanoplastics hazardous? The way forward to overcome the uncertainties of risk assessment” by Dr. Anita Jemec Kokalj and Dr. Dana Kühnel about defining the criteria to evaluate which properties of nanoplastics should be reported in future studies to decrease uncertainties in their risk assessment. The authors state that nanoplastics “are complex environmental pollutants that come in multiple shapes, sizes, colours and polymer compositions.” According to the authors, there are currently two main uncertainties for the environmental risk assessment of nanoplastics: the challenging sampling situation in the environment and the subsequent risk quantification; and that the majority of current ecotoxicity studies investigate laboratory-produced primary nanoplastics with well-defined properties. The authors note that these latter studies do, however, enable the development of guidelines for further research on secondary nanoplastics. Existing research with primary nanoplastics can be used as a model to define the criteria to evaluate which physico-chemical properties of nanoplastics should be reported in future studies. The authors suggest that “once further refined, the existing study quality assessment originally developed for nano(eco)toxicity studies can now be applied to nanoplastics studies, with a further outlook for microplastics.” This will allow better comparisons across different studies and more relevant parameters to be reported. The authors conclude that “[o]verall, this will help decrease uncertainties in risk assessment, as the relevant parameters for nanoplastics exposure, fate and hazard assessment will be better defined in the future.”

As reported in our July 9, 2021, blog item, NanoHarmony aims to support the development of Organization for Economic Cooperation and Development (OECD) test guidelines (TG) and guidance documents (GD) for eight endpoints where nanomaterial-adapted test methods have been identified as a regulatory priority. To identify difficulties arising during the development process for TGs and GDs, NanoHarmony asked stakeholders to share their experiences in a short survey. According to NanoHarmony’s February 16, 2022, news item, NanoHarmony received 73 responses from different stakeholder groups, including regulators, developers, and users. NanoHarmony states that in general, OECD TGs/GDs are perceived as a very useful tool. Respondents identified specific needs for updates to or developing new TGs/GDs for nanomaterials. In the next step, NanoHarmony will conduct personal interviews to obtain more in-depth views from a selection of the respondents. NanoHarmony states that it will use the results of the survey and the interviews to map the challenges encountered in the TG/GD development process.

During the first half of 2022, NanoHarmony is hosting a webinar series covering the different phases that an OECD TG progresses through during its journey from a science-based initial idea through to use by industry to fulfill regulatory obligations. NanoHarmony invites all stakeholders to attend to give their opinions and to develop consensus on the barriers and ways of improving the TG process. The webinars will be highly interactive, and attendees will have the opportunity to share their experiences, thoughts, and suggestions. The first webinar will be held March 1, 2022, on Phase 4: Using Test Guidelines. Registration is now open.

The National Nanotechnology Initiative (NNI) will hold a webinar on “What We Know about NanoEHS: Building International Bridges” on March 1, 2022. NNI states that it has supported the emergence of an international community of collaborative researchers on the environmental, health, and safety aspects of nanomaterials (nanoEHS). According to NNI, “[b]y advancing tools, methods, and standards for robust health and safety evaluation, these cooperative efforts have furthered the safe and responsible development of nanotechnology around the world.” Treye Thomas, Program Manager, Chemicals Nanotechnology and Emerging Materials, Consumer Product Safety Commission (CPSC), will moderate a panel that includes:

  • Anil Patri, Director, Nanotechnology Core Facility, Office of Scientific Coordination, U.S. Food and Drug Administration (FDA);
  • Nora Savage, Program Director, Chemical, Biological, Environmental, and Transport Systems (CBET), National Science Foundation (NSF); and
  • Mark Wiesner, James B. Duke Distinguished Professor of Civil and Environmental Engineering, Duke University.

The European Commission (EC) notified the World Trade Organization (WTO) on February 11, 2022, of a draft amendment to the Cosmetics Regulation regarding the use of certain nanomaterials in cosmetics products. The EC states that the amendment is required to enact the prohibition to use in cosmetic products certain nanomaterials for which the Scientific Committee on Consumer Safety (SCCS) identified a basis of concern. The draft amendment would revise Annex II to the Cosmetics Regulation (list of substances prohibited in cosmetic products) to implement uniformly within the internal market the prohibition to use the nanomaterials for which a basis of concern has been identified. The nanomaterials are styrene/acrylates copolymer, sodium styrene/acrylates copolymer, copper, colloidal copper, hydroxyapatite, gold, colloidal gold, gold thioethylamino hyaluronic acid, acetyl heptapeptide-9 colloidal gold, platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum. The EC did not provide a proposed date of adoption or date of entry into force.

On January 18, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “What does ‘Graphene’ really look like and why is it not ‘carbon nanotubes’” by Dr. Alberto Bianco, Dr. Maurizio Prato, and Dr. Kostas Kostarelos, of the Graphene Flagship, an EU research initiative, about graphene and why it is not the same as carbon nanotubes. The article states that in particular, the authors wish to emphasize “that ‘graphene’ as a single type of material does not really exist, nor is it used as such in industrial applications.” According to the authors, a major difference between the materials exists at the supply end of the chain. The authors state that “[d]ue to the facile production and industrial upscaling of processes for some types of graphene materials, there are now hundreds of producers around the world, with thousands of different graphene material products marketed as ‘graphene.’” These products are incorporated into hundreds of different products, including fabrics, paints, anti-corrosion coatings, and structural alloys, “creating an environment that is particularly challenging for the application of quality control measures and regulatory responsibility and accountability.” The authors contrast this with carbon nanotubes, for which there are only a few manufacturers “that can be more easily regulated.” The authors suggest that the “‘democratisation’ of graphene material production therefore should be addressed by future regulatory bodies overseeing the quality of the exact graphene materials used in different products.”

The Organization for Economic Cooperation and Development (OECD) published a February 2022 report entitled Important Issues on Risk Assessment of Manufactured Nanomaterials. The report provides the current practices, challenges, and strategies for assessing the risk of manufactured nanomaterials in circumstances where data are limited, and the report states that there is a necessity for more research on specific risk assessment issues. As such, the report presents an overview of the chemical risk assessment paradigm and describes how various member countries have adapted existing regulatory frameworks to the assessment of nanomaterials. It also presents the state of science on nanomaterials risk assessment as of May 2021 and highlights priorities for research toward specific risk assessment issues. OECD notes that the report is a living document. As such, the report “remains subject to refinement as research affords further understanding of how to assess and manage nanomaterials.” The report “is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models.”

The European Chemicals Agency (ECHA) has published a January 2022 update to the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification (version 2.0). The main changes to the document include additional guidance on the joint submission of data, clarifications regarding the need for one data set per nanoform or set of nanoforms, and information on the registration of sets of nanoforms versus single nanoforms. Changes to the Appendix are limited to Sections 2 and 5 of the currently published document. ECHA intends the document to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” for the purpose of registration. The document outlines what is expected in terms of characterization of the nanoforms and sets of nanoforms in the registration dossier. Finally, the document provides important information related to the joint submission of data on nanoforms, as well as on confidentiality aspects.

On January 21, 2022, the European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published a second statement on emerging health and environmental issues. SCHEER members have identified nine emerging issues in the non-food area as having a potential impact on human health and/or the environment in the future and have given them overall prioritization scores (*, 1, 2, or 3, where * is uncertain and three is high). The emerging issues identified include nanotechnology organics (prioritization score two) and the emerging risk of the conversion of micro to nano plastics in the environment (prioritization score three):

  • Nanotechnology organics: Organic substances are increasingly used in complex particulate formulations, including medical and agricultural applications that specifically make use of nanotechnology. This includes the combination of organic and inorganic substances, especially in medical developments, spurring growth in the development of new materials. SCHEER states that there is therefore a risk of incorrectly applied risk assessment and invalid assumptions, such as “it is organic/biological so it must be safe,” or “it is a nanomaterial so we know it cannot be absorbed.” According to the statement, organic nanoparticles can be considered borderline materials as they are organic in nature and have sizes in the nano-range (below one micrometer (μm)), and sometimes even below 100 nanometers (nm), the size indicated for nanomaterials/nanoparticles. Organic nanostructures behave like nanoparticles when intact, but change to organic biological behavior after dissociation at a potential target site. It is necessary that a clear distinction is made in the risk assessment between so-called hard solid (in)soluble nanomaterials (g., metal and metal oxides) and so-called “soft” nanomaterials composed of organic molecules, as they can have a totally different interaction/effect in biological systems.
  • Nanoplastics: According to SCHEER, the production, use, and disposal of plastic materials is “now ubiquitous.” Plastic polymers have not been considered substances of health concern because they are generally inert in nature and are unlikely to be absorbed in the body due to large molecular sizes. They are nevertheless highly persistent in the environment, where they may end up via a variety of disposal/emission routes. Gradual degradation of plastic materials over time is known to result in microplastics. SCHEER notes that these are, “in theory, likely to further degrade to nano-plastics.” SCHEER notes that this subject has been the focus of recent research and development and has been proposed as a topic of emerging environmental risk that needs further exploration.

The Commission Services will be invited to include these emerging issues in their policies and research agenda.