On March 5, 2021, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on copper (nano) and colloidal copper (nano).  According to the final opinion, nine manufacturers notified the EC about 36 different products containing nanosized copper.  After initial evaluation and a request for additional information, two manufacturers withdrew their products from the notification, and these seven products were excluded from evaluation, resulting in the final evaluation of 29 nanosized copper products produced by seven manufacturers.  For three different copper nanomaterials, notification files were provided.  The final opinion states that for all three copper nanomaterials, “the notified files were insufficient regarding their characterisation and for conducting a safety evaluation.”  All copper nanomaterials claimed to have antimicrobial activity.  Most files contained declarations of safety without any supporting data or documentation, however, and based on the provided information, the final opinion states that it is not possible to perform a safety assessment on them.

The EC asked whether SCCS considers the nanomaterials copper and colloidal copper safe when used in leave-on and rinse-off dermal and oral cosmetic products at a maximum concentration of 1% (for both copper and colloidal copper) and with certain specifications, taking into account reasonably foreseeable exposure conditions.  SCCS states that it considered all the information provided by the notifiers and “is of the opinion that it is not possible to carry out safety assessment of the nanomaterials Copper and Colloidal Copper due to the limited or missing essential information.”  SCCS notes that much of the information provided on toxicity relates to copper as such, “and in the absence of full study reports, it is not possible to determine the relevance of the data for nano-forms of copper under the current evaluation.”  SCCS states that “[a]dequate information on various aspects both for the nanomaterial characterisation and the toxicological evaluation including experiment performance and experimental data obtained need to be provided.”

The EC also asked whether SCCS has any further scientific concerns with regard to the use of copper and colloidal copper in nano form in cosmetic products.  According to the final opinion, the information provided by the notifiers and obtained from scientific literature suggests possible systemic uptake of copper nanoparticles (and/or ionic copper), “which may lead to accumulation in certain organs — notably the liver and spleen.”  The final opinion notes that in addition, the available data indicate potential mutagenic/genotoxic and immunotoxic/nephrotoxic effects of copper nanomaterials.  The final opinion states that these indications “raise an alert that warrants further safety evaluation of copper nanomaterials used as cosmetic ingredients.”  SCCS details its concerns for consumer safety in this regard in Annex II of the final opinion.

On March 10, 2021, the Nanotechnology Industries Association (NIA) will hold a webinar on “Designing a global trade strategy for nanomaterials.”  NIA Director General Chiara Venturini will begin the webinar by providing an overview of recent and upcoming global trade developments.  Ted Kalmbach, Chief Strategy Officer at NIA member BNNANO, will discuss the experience of a U.S.-based nanomaterial company on growing international sales and partnerships, addressing when and how to consider setting up an international office, what issues and trends to keep in mind, and what would be the most promising.  Joe Pivarunas, Founder and Managing Editor of Nanalyze, will offer insight on what investors look for when assessing the potential of a nano company and whether the language shift from nano to advanced materials will play a part in investors’ decisions.  The webinar is free and open to non-members.

Bergeson & Campbell, P.C. is a proud NIA member.

Registration is open for the U.S. National Nanotechnology Initiative’s (NNI) March 23, 2021, webinar on “What We Know About NanoEHS:  Human Exposure.”  The webinar will feature experts from diverse disciplines to share their perspectives on key findings in quantifying and assessing the effects of human exposure to nanomaterials.  Keana Scott, Ph.D., Physical Scientist, Materials Measurement Science Division, National Institute of Standards and Technology (NIST), will moderate the panel, which will include:

  • Aaron Erdely, Ph.D., Research Biologist, National Institute for Occupational Safety and Health (NIOSH);
  • Barbara Herr Harthorn, Ph.D., Professor of Anthropology, University of California, Santa Barbara;
  • Thomas (Tom) Peters, Ph.D., Professor, Occupational and Environmental Health, University of Iowa; and
  • Paul Westerhoff, Ph.D., Fulton Chair of Environmental Engineering, Arizona State University.

The March 2021 issue of Environmental Factor, a monthly newsletter published by the National Institute of Environmental Health Sciences (NIEHS), includes an item entitled “New graphene nanochannel filters hold promise for contaminant clean-up.”  According to the item, an NIEHS-funded study found a new strategy to design nanomaterials to filter contaminants better from water.  To improve the usefulness of graphene oxide nanosheets for filtering contaminants from liquid, the researchers modified how the sheets are assembled, “reduc[ing] the distance water must pass through while optimizing the amount of contact it has with the membrane.”  The item states:  “In proof-of-concept tests, the team demonstrated that water vapor could easily pass through the vertically aligned zirconium-graphene membranes, while the organic molecules hexane and 2-propanol could not.”  The researchers “also showed that their strategy successfully retained molecular selectivity while remaining stable at high temperatures and resistant to swelling, all important factors for scaling up the approach.”

The Verband der Mineralfarbenindustrie e. V. (VdMi), which represents German manufacturers of inorganic, organic, and metallic pigments, fillers, carbon black, ceramic and glass colors, food colorants, artists’ and school paints, masterbatches, and products for applied photocatalysis, has published a “Comparative Compilation of relevant nano definitions in different regulations and their corresponding consequences.”  The compilation notes that pigments and fillers often fall under the legislative definitions of nanomaterials “because they show their best properties with correspondingly small particle sizes — without being intentionally a nanomaterial.”  VdMi states that the variety of product-specific regulations “often results in different consequences for the same product, depending on the application.”  For example, according to VdMi, “no uniform definition for a nanomaterial has been found within [European Union (EU)] legislation to date.”  For consumers, these discrepancies “are incomprehensible and weaken the trust in a comprehensive risk assessment and appropriate risk management.”  For industry, “it is often difficult to understand the various requirements, especially in the field of downstream users close to end customers.”

VdMi intends the compilation “to provide an initial overview of the nano-definitions implemented in the various EU regulations and their differences, as well as — according to our interpretation — the resulting consequences for the products concerned.”  The compilation does not include national regulations, such as nano registration registers.  VdMi notes that the compilation “does not claim to be complete and will be updated and expanded as necessary.  The legal basis for all matters is always the corresponding legal text.”  The compilation is available in German and English.

On February 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “eREACHNano helps you to register nanoforms under REACH” by Dorte Rasmussen, Ph.D., who has been working on the exposure and risk assessment of chemicals at DHI A/S for almost 25 years.  Rasmussen describes eREACHNano, a tool developed to explain Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements for nanoforms.  According to Rasmussen, eREACHNano guides companies through the registration process for nanoforms and the registration requirements using e-learning modules developed through the eREACHNano project by DHI A/S in cooperation with the N-Nano project group, a working group of the Nordic Council of Ministers.  Rasmussen states that eREACHNano provides an introduction to nanoforms, describing the main elements of REACH, its actors, and their roles and responsibilities.  The tool places extra emphasis on describing the documentation on safe use and explaining where the distinction between bulk chemicals and nanoforms should be made.  Rasmussen notes that eREACHNano focuses on — but is not limited to — helping small- and medium-sized companies that may not have sufficient in-house expertise on regulations that cover nanomaterials.

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 20th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in September 2020.  Below are highlights from the Tour de Table:

  • Canada: Canada is developing a nanomaterial regulatory risk assessment framework to outline approaches and key considerations (g., unique properties of nanomaterials).  The framework will inform the assessment of manufactured nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA), including existing nanomaterials in commerce in Canada, and new nanomaterials notified prior to being manufactured or imported into Canada.  It will provide guidance to regulators on the assessment of nanomaterials for their risk to the environment and human health.  According to the Tour de Table, Canada will share a draft risk assessment framework with partners of the OECD WPMN for peer-review.
  • United States: The U.S. Environmental Protection Agency (EPA) completed review of low volume exemptions for two graphene oxide substances, a metal oxide substance, and a carbon nanotube.  EPA allowed the exemptions under conditions that limit human and environmental exposures to prevent unreasonable risks.  Additionally, EPA reviewed and completed six pre-manufacture notices (PMN) for nanoscale materials, including one carbon nanotube and six quantum dots.  These new chemical substances were regulated with consent orders owing to limited available data on nanomaterials; these consent orders limit uses and human and environmental exposure to prevent unreasonable risks.

Between November 2018 and August 2020, EPA received notification of ten nanoscale substances that met reporting criteria pursuant to its authority under Section 8(a) of the Toxic Substances Control Act (TSCA), bringing the total number of notifications to 77.  Reporting criteria exempt nanoscale chemical substances already reported as new chemicals under TSCA and those nanoscale chemical substances that do not have unique or novel properties.  Most reporting was for metals or metal oxides.

Since January 2005, EPA has received and reviewed more than 230 new chemical notices for nanoscale materials under TSCA, including fullerenes, quantum dots, and carbon nanotubes.  EPA has issued consent orders and significant new use rules (SNUR) regulating new chemical submissions of these nanoscale materials permitting manufacture under limited conditions.

  • European Union (EU): Amendments to Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanomaterials took effect on January 1, 2020.  By January 1, 2020, the European Chemicals Agency (ECHA) had received 86 unique submissions for 34 substances covering nanomaterials.  ECHA had received a further 37 unique submissions by May 31, 2020 (e., by the deadline for submissions to the Tour de Table), resulting in a total of 54 substances covering nanoforms for which registration dossiers have been submitted following the updated REACH requirements.  Up-to-date information on the nanomaterials registered under REACH, as well as information on nanomaterials notified to different EU nanomaterial inventories, can be found on the EU Observatory for Nanomaterials (EUON) website.

The Occupational Safety and Health Administration (OSHA) is scheduled to publish a notice of proposed rulemaking (NPRM) on February 16, 2021, that would modify the Hazard Communication Standard (HCS) to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7 “to address issues that arose during the implementation of the 2012 update to the HCS, and provide better alignment with other U.S. agencies and international trading partners, without lowering overall protections of the standard.”  The NPRM notes that “the change in section 9 (physical characteristics to include particle characteristics) will identify exposure issues that are not addressed by the current format.”  According to the NPRM, “[t]his should, among other things, improve the hazard information required for nanomaterials.”

The NPRM states that in addition to directly enhancing worker protections through improved hazard communication, updating the HCS will also improve the availability of information to support larger efforts to address workplace hazards such as the use of aggregate exposures and cumulative risk models for use in setting occupational exposure limits and assessing impacts on worker health.  The NPRM uses the increased use of nanosilver in consumer products as a “real-world example of the potential effects of aggregate exposure.”  The NPRM cites a 2018 National Institute for Occupational Safety and Health (NIOSH) review of nanosilver and states that the review “indicates that the current OSHA [permissible exposure limit (PEL)] for silver is adequate to protect workers from silver’s adverse health effects.”  The NPRM claims that the increased presence of nanosilver in consumer products, as well as the increased environmental exposures from the manufacture, use, and disposal of these consumer products, “indicates that the OSHA PEL may be inadequate to protect workers if nanosilver continues to be added to new consumer products.”  According to the NPRM, “[t]his example highlights the importance of an effective overarching hazard communication strategy in understanding and managing exposures and risk.”

Comments on the NPRM, including requests for hearing, will be due 60 days after publication in the Federal Register.  OSHA states that it will schedule an informal public hearing on the NPRM if a request is made during the comment period.  If a hearing is requested, OSHA will announce the details in the Federal Register.

In December 2020, the European Commission (EC) Directorate-General (DG) for Research and Innovation opened a call for tenders for “Providing market data about nanotechnology to enhance transparency.”  The description states that the study on nanotechnology/nanomaterials is aimed to provide a new set of data from the period of 2017 to 2020 into the NanoData database, available on the European Union (EU) Observatory for Nanomaterials (EUON) website.  This study will follow up on the previous NanoData study that took place in 2013-2017.  Tenders are due February 22, 2021.

On February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on “Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment” to discuss the scope, content, and use of Test Guideline No. 318:  Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document.  According to OECD, “[t]he increased production and wide usage of manufactured nanomaterials suggest a higher probability of finding them in the environment.  Therefore, testing the dissolution rate and dispersion stability for toxicity assessment are of paramount importance for adequate hazard assessment.”  Test Guideline No. 318 describes a test procedure to obtain information on dispersion stability of nanomaterials in simulated environmental media.  The accompanying guidance document provides additional recommendations on dispersion stability measurements.  OECD states that it is developing a Test Guideline to determine the solubility and dissolution rate of nanomaterials in the aqueous environmental media and that the webinar will include discussion of this Test Guideline.