The European Commission (EC) published a regulation on November 30, 2021, in the Official Journal of the European Union that denies the authorization of titanium dioxide (E171) as an additive in animal nutrition, in the additive category “sensory additives,” and in the functional group “colourants: substances that add or restore colour in feedingstuffs.” Under the regulation, existing stocks of the additive must be withdrawn from the market by March 20, 2022. Feed materials and compound feed produced with the additive or premixtures containing it before March 20, 2022, must be withdrawn from the market by June 20, 2022.

As reported in our October 13, 2021, blog item, the EC announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The European Union (EU) notified the World Trade Organization (WTO) of the draft regulation on October 13, 2021. The regulation would remove the authorization to use titanium dioxide (E171) in foods. The text also includes a commitment to review the necessity to maintain titanium dioxide (E171) or otherwise delete it from the EU list of food additives for exclusive use as a color in medicinal products within three years of the regulation entering into force. To allow for a smooth transition, the regulation would allow foods that contain titanium dioxide (E171) used in accordance with the rules applicable before the date of entry into force to be placed on the market until six months after that date. Those foods may then continue to be marketed until their date of minimum durability or “use by” date. More information on the draft proposal is available in the EC’s questions and answers on titanium dioxide.

In December 2021, the German Environment Agency (UBA) published a report entitled Development of a specific OECD Test Guideline on Particle Size and Particle Size Distribution of Nanomaterials. The UBA commissioned the Federal Institute for Occupational Safety and Health (BAuA) (project coordinator) and the Federal Institute for Materials Research and Testing (BAM) to develop an Organization for Economic Cooperation and Development (⁠OECD)⁠ Test Guideline for the determination of particle size and particle size distributions of nanomaterials. The report describes the considerations, essential steps, and organizational aspects of the development of the Test Guideline. It provides insights into the selection, preparation, and pre-validation of test materials used in an interlaboratory comparison and presents the results of the comparison tests and their impact on the final version of the OECD Test Guideline. Upon adoption at OECD level, the Test Guideline for the determination of particle size and particle size distributions of nanomaterials will be available on the website of the OECD Test Guideline Program. The draft Test Guideline is available online.

The American National Standards Institute (ANSI), which administers the U.S. Technical Advisory Group for the International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies, announced a survey seeking feedback on the use of terms related to advanced materials as part of its newly launched study group, Advanced and Emerging Materials. According to ANSI, the study group is charged with identifying and clarifying differences between the use of terms related to advanced materials across stakeholder groups. According to ANSI, the concept of advanced materials is of increasing importance to the nanotechnology community. In recent years, a number of nanotechnology-focused professional groups have expanded their scope to include advanced materials. ANSI states that regulatory research organizations have also included advanced and emerging materials or technologies within the scope of groups previously focused on nanotechnologies. The Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials recently decided to include advanced materials within their scope. The survey seeks comments from subject matter experts, stakeholders, and other interested parties and is aimed at identifying the scientific, technical, and social views of select terms and definitions related to advanced and emergent materials.

The Scientific Committee on Consumer Safety (SCCS) published its final opinion on HAA299 (nano) on November 25, 2021. The European Commission (EC) asked SCCS whether HAA299 (nano) is considered safe when used as an ultraviolet (UV) filter in cosmetic products up to a maximum concentration of ten percent. According to the final opinion, SCCS considers that HAA299 (nano) as covered within the provided characteristics “is safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%.” The final opinion states that based on the inflammatory effects on the lung after acute inhalation exposure, SCCS has concerns regarding the repeated use of products containing HAA299 (nano) in applications that could lead to inhalation exposure and does not recommend the use of HAA299 (nano) in applications that could lead to exposure of consumers’ lungs via inhalation. SCCS based its opinion on the currently available data that show “an overall very low or lack of dermal absorption of HAA299 (nano) in human skin.” If any new evidence shows that HAA299 (nano) used as a UV filter in cosmetic products can penetrate human skin (healthy, compromised, sunburned, or damaged) to reach viable cells in higher levels than demonstrated in this submission, SCCS may consider revising the assessment.

On November 24, 2021, 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. 86 Fed. Reg. 66993. The proposed SNURs include one for a chemical substance identified generically as multi-walled carbon nanotubes (PMN P-20-72). According to EPA, the PMN states that the generic (non-confidential) use of the substance will be as an additive used to impart specific physiochemical properties to finished articles. According to EPA, it identified concerns for lung effects (lung overload and lung carcinogenicity) if respirable, poorly soluble particulates and fibers are inhaled, as well as concerns for eye irritation and systemic effects. EPA notes that based on the presence of a confidential residual, it also identified concerns for acute neurotoxicity, dermal and respiratory sensitization, mutagenicity, and carcinogenicity. EPA issued the Order on September 29, 2020, 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 substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

  • Use of personal protective equipment (PPE) where there is a potential for dermal exposure;
  • Use of a National Institute for Occupational Safety and Health (NIOSH)-certified particulate respirator with N-100, P-100, or R-100 cartridges with an assigned protection factor (APF) of at least 50 where there is a potential for inhalation exposure;
  • No domestic manufacture of the PMN substance (e., import only);
  • No exceedance of the confidential annual importation volume listed in the Order;
  • No importation of the PMN substance other than as confidentially described in the PMN and allowed in the Order;
  • No importation of the PMN substance such that the maximum weight percentage of the confidential impurity exceeds the confidential percentage identified in the Order;
  • No processing or use of the PMN substance other than for the confidential use allowed in the Order;
  • Disposal of the PMN substance and any waste streams from processing and use containing the PMN substance by incineration or landfill only;
  • No release of the PMN substance directly to air;
  • No processing or use of the PMN substance in application methods that generate a dust, mist, spray, vapor, or aerosol unless such application method occurs in an enclosed process;
  • Establishment of a hazard communication program, including human health precautionary statements on each label and in the safety data sheet (SDS); and
  • No release of the PMN substance to water.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures. The proposed SNUR requires persons who intend to manufacture (defined by statute to include import) or process the chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. Comments on the proposed SNUR are due December 27, 2021.

The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on November 22, 2021, rules amendments and regulatory changes beginning on November 23, 2021, and December 10, 2021, following amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019. After considering stakeholder feedback, the Minister for Regional Health signed the Industrial Chemicals (General) Legislation Amendment (2021 Measures No. 1) Rules 2021 on October 30, 2021. AICIS states that it has revised the “Guide to categorising your chemical importation and manufacture” and other pages on its website to reflect amendments that were made to the General and Transitional Rules. Changes that began on November 23, 2021, that concern nanoscale chemicals include:

  • Requirements for chemicals introduced at the nanoscale (items 1-19 in Schedule 1 of the amending rules): Internet content changes to clarify:
    • The criteria for introductions of chemicals at the nanoscale;
    • How the nanoscale criteria apply in practice; and
    • The associated recordkeeping obligations.

Changes that will begin on December 10, 2021, that concern nanoscale chemicals include:

  • Pre-introduction report requirement relating to nanoscale chemicals for research and development (R&D) (item 20 in Schedule 1 of the amending rules): An extra requirement will be added for pre-introduction reports that requires introducers to report whether the chemical is at the nanoscale. This applies to introductions of chemicals used only for R&D.

The Organization for Economic Cooperation and Development (OECD) recently published the following reports:

On December 2, 2021, OECD will host a webinar on how to assess exposure to nanomaterials. According to OECD, scientific knowledge to assess exposure to nanomaterials continues to improve, and new exposure tools and models for nanomaterials are being developed. To promote development in this area further, OECD compiled an inventory of available models and tools for assessing occupational, consumer, and environmental exposure to nanomaterials. OECD initially compiled 54 tools and models, and after in-depth analyses, ten occupational, seven consumer, and six environmental tools/models were recommended or evaluated as suitable for assessing exposure to nanomaterials. Detailed information on the analyses and evaluations are provided in the reports listed above. During the webinar, the researchers will present the key findings of the reports. Speakers and presentations will include:

  • Occupational project: Carla Ribalta Carrasco, Ph.D. (Danish National Research Center for Working Environment);
  • Consumer project: Mohammad Zein Aghaji, Ph.D. (Health Canada); and
  • Environmental project: Marc LaPointe, Mathieu Dextraze (Environment and Climate Change Canada).

On November 15, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) announced the release of a report that it commissioned entitled “Study on the Product Lifecycles, Waste Recycling and the Circular Economy for Nanomaterials.” The study updates and expands on the 2016 Organization for Economic Cooperation and Development (OECD) document entitled “Nanomaterials in Waste Streams — Current Knowledge on Risks and Impacts.” The report covers waste streams containing nanomaterials; behavior and fate of nanomaterials in waste processes; exposure of waste management workers to nanomaterials; benefits and challenges of nanomaterials posed to the circular economy; impact of nanomaterials on recycling; main streams of nanomaterial recyclates; recycling abatement systems residues; potential for substitution of hazardous substances by nanomaterials in the recyclate streams; emission of nanomaterials; and emission control and best available techniques. The review covered 276 publications, including books, research reports, research and review papers, databases, and other Internet resources. The study specifically focuses on manufactured nanomaterials and incidental nanomaterials and on the EU situation and developments in nanomaterials, although researchers reviewed relevant studies from other countries where appropriate. The report includes the following nine conclusions and four recommendations:

  • Conclusion 1. Currently, it is not possible to give a sound evidence-based conclusion about the quantities of nanomaterials on the European market and in waste streams.
  • Conclusion 2. Public information about nanomaterials is important to waste managers, scientists, regulatory bodies, and consumers.
    • Recommendation 1. The development of public data sets containing information about nanomaterials and their presence in products should be promoted for practical and regulatory decision-making and the advancement of scientific research.
  • Conclusion 3. Research on behavior and fate of nanomaterials focuses on relevant nanomaterials in certain waste management facilities and is mostly conducted in a laboratory setting.
  • Conclusion 4. Generic mass flow models or fate models have been widely used to provide a general overview of the distribution of specific nanomaterials in the environment.
  • Conclusion 5. Substantial progress has been made in developing analytical tools for the characterization and measurement of nanomaterials.
    • Recommendation 2. Predictions from statistical model calculations should be compared to field-scale experiments to assess the quality of the predictions.
  • Conclusion 6. No studies about workers’ exposure to nanomaterials in waste management facilities were identified; existing studies focusing on manufacturing and research sites indicate exposure to nanomaterials through inhalation during manual activities, however.
    • Recommendation 3. Field research on the exposure to manufactured and incidental nanomaterials in waste management and recycling facilities should be performed.
  • Conclusion 7. The available research shows the high efficiency of incineration and wastewater treatment (for titanium dioxide, zinc oxide, cerium oxide, silver, gold, aluminum, cerium, cobalt, copper, iron, titanium, zinc, and manganese) in limiting emissions of nanomaterials to the environment.
  • Conclusion 8. Management of nanomaterials in waste is prescribed by general regulatory provisions, and nano-specific guidance is emerging.
  • Conclusion 9. Several potential contributions of nanomaterials to the circular economy were outlined in research publications; there is no evidence of circularity, economic feasibility, or environmental safety of the proposed applications, however.
    • Recommendation 4. The systematization of current research and evaluation of the economic, environmental, and social impact of the proposed applications of nanomaterials in the circular economy should be supported. Closer collaboration and exchange of ideas between researchers and industry is necessary to agree on the needs for nanotechnology solutions and launch appropriate research initiatives.

The National Nanotechnology Initiative (NNI) held a webinar on November 16, 2021, entitled “What We Know about NanoEHS: Risk Assessment and Risk Management.” The webinar’s speakers explored the impact of advances in risk assessment and risk management on the safe and responsible development of nanotechnology. The panel included:

  • Rick Canady, Director and Founder, NeutralScience L3C;
  • Igor Linkov, Research Physical Scientist, Environmental Laboratory, U.S. Army Engineer Research and Development Center (ERDC);
  • Mary Schubauer-Berigan, Deputy Director, Evidence Synthesis and Classification Branch, International Agency for Research on Cancer (IARC), World Health Organization (WHO); and
  • Paul Schulte, Director, Division of Science Integration, National Institute for Occupational Safety and Health (NIOSH).

Schulte introduced the panel and provided the basis for discussing developments in the environmental, health, and safety aspects of nanomaterials (nanoEHS) historically, what researchers have learned, and where research is headed. Schulte noted that the innovation of nanoparticles has led researchers to conduct risk assessments and evaluate risk management in groups or categories, rather than by individual particles. Schulte highlighted the work that has been done in occupational safety and exposure studies, but stated that most of this research has been limited to extrapolating animal studies to humans to develop occupational exposure limits. Schulte stated that epidemiological studies in humans could help ensure that data on classification groups properly address particle overload and the effects of exposure to various combinations of nanoparticles in risk management policy.

Schubauer-Berigan focused her presentation on the work that has been done in the past ten years on multi-walled and single-walled carbon nanotubes and carbon nanofibers. Schubauer-Berigan discussed studies that show biomarkers that may be able to help in exposure assessment and hazard identification. She discussed the variance in respiratory and dermal exposure in occupational workers, but noted that no one aspect of exposure was most relevant at this time. Future studies in occupational exposure settings will work to address these questions. Schubauer-Berigan did note that multi-walled carbon nanotubes have been listed for re-evaluation by IARC and that this was of particular concern for bulk materials. Future research will need to address risk assessments and evaluations involving bulk materials blended with multi-walled and single-walled carbon nanotubes and carbon nanofibers.

Canady shifted the discussion to the real-life applicability and everyday use of the research that has been produced. Canady spoke to how nanoEHS managers and regulatory bodies can move forward with this information to promote and protect worker safety. He noted that much of the data on exposure assessments is challenging to apply as the studies vary in particles, doses, concentrations, and potency values. He expressed concern that nanoparticle toxicity research can be too varied to assess threshold-based hazards. Canady’s proposed solution is to develop regulatory decision matrices and fund further research so as not to stifle agencies or industry innovation.

The final panelist of the day, Linkov, expanded on Canady’s proposition, likening research developments in nanotechnology to developments in the knowledge of COVID-19. Linkov asserted that past knowledge and lessons in conventional chemical risk assessment and management can be used to build off emerging research in the nanoEHS field. He expressed concern that exposure and toxicity assessments may not adequately represent particle migration. Linkov advocated for a regulatory approach that is similar to the regulatory approach of conventional chemicals. Linkov noted that no matter how good risk assessments become, there will always be a gap between the risk assessment and the regulatory field because innovation will accelerate faster than the ability to acquire data. His solution to this gap is to use the known data and historical risk management techniques and apply them to new materials.

The International Organization for Standardization (ISO) recently published ISO/TS 23650:2021, “Nanotechnologies — Evaluation of the antimicrobial performance of textiles containing manufactured nanomaterials.” ISO states that the standard specifies the antimicrobial performance assessment method for textiles containing manufactured (metals/metal oxides) nanomaterials. The textiles in the standard include fabric, yarn, and fiber in which manufactured nanomaterials are used during the production or finishing process. The standard also specifies protocols to determine the quantity of nanomaterials released from the textiles following washing and/or exposure to artificial human body sweat. ISO notes that the standard covers only the antibacterial, antifungal, and anti-odor performance assessment method of textiles containing manufactured nanomaterials. The standard does not cover textiles that have therapeutic applications or the environmental, health, and safety (EHS) issues related to textiles containing manufactured nanomaterials. ISO states that the standard does not cover the release of nanomaterials as a result of aging, dry attrition, and abrasion, “although it is considered as an effective factor in releasing nanomaterials.”