The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published on May 16, 2023, the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of the guidance is on cosmetic ingredients, but it notes that “some guidance is also indirectly given for the safety assessment of finished products.” The guidance includes a section on “special consideration for certain cosmetic ingredients” that addresses specific ingredients, including nanomaterials. It addresses:

  • Definition of nanomaterial: Under Article 2 (1) (k) of the Cosmetic Regulation, “nanomaterial” means “an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.” The guidance notes that it is likely that this definition will be aligned with the EC’s June 10, 2022, Recommendation on the definition of nanomaterial. According to the guidance, “[t]he Regulation therefore mainly covers those nanomaterials that are intentionally produced and are insoluble/poorly-soluble or biopersistent (e.g., metals, metal oxides, carbon materials, etc.), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions, etc.).”
  • Potential safety issues of nanomaterials: According to the guidance, as a general principle, certain specific attributes should add a further degree of safety concern. SCCS notes that it has published more specific Guidance on Risk Assessment of Nanomaterials (SCCS/1611/19, under revision), which is an update of a previous guidance published in 2012 (SCCS/1484/12), a Memorandum on the Relevance, Adequacy and Quality of the Data Expected in Safety Dossiers on Nanomaterials (SCCS/1524/13), and a checklist for the applicants submitting dossiers on nanomaterials as cosmetic ingredients (SCCS/1588/17). The guidance states: “In general, a number of reviews have concluded that the existing risk assessment paradigm, in use for conventional chemicals, should in principle be also applicable to engineered nanomaterials. However, it has also been pointed out that the current testing methods may need certain adaptations to take account of the special features of nanomaterials.”
  • Required information for nanomaterials: The guidance lists aspects that “deserve special attention.” According to the guidance, a full dataset “would be preferable.” The guidance states that at a minimum, in addition to safety data on the core nanomaterial, SCCS would require information/data on each material used for surface modification/coating of the nanomaterial to indicate that it is safe for use in the intended cosmetic product; data on physicochemical properties of the surface-modified/coated nanomaterial to show that they have not significantly changed compared to either the same material when uncoated, or with a different surface modification/coating that has already been assessed safe by SCCS; data on dermal penetration, stability of the surface modification/coating, and (photo)catalytic activity, where relevant; and data on interaction of nanomaterial with cells (cellular uptake).

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a May 17, 2023, news item stating that it believes that the European Commission’s (EC) revised Recommendation on the definition of nanomaterial, published in June 2022, “is too restrictive and could lead to a regression in the protection of public health and the environment.” ANSES “is therefore urging the French authorities to take a more inclusive definition into account and work towards its integration in the revision of sectoral regulations at [the] European level,” including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) regulations.

According to ANSES, the EC’s revised definition “tend[s] to restrict the number and type of objects that will ultimately be considered as such. Applied as it stands, this definition will, for example, lead to some nanoscale objects being overlooked, such as micellar nanovectors (vesicles, liposomes, lipid particles, etc.) designed to carry substances of interest in medicine, nutrition or agriculture, which are currently stimulating a great deal of interest and development.” Instead, ANSES recommends providing the “broadest possible definition” of the term “nanomaterial” based solely on dimensional criteria. ANSES also recommends establishing a uniform definition, regardless of the sector in which nanomaterials are used. ANSES calls for a broader definition of ”nanomaterial” than that recommended by the EC, to consider nanomaterials more comprehensively and not overlook any that could be a health concern. ANSES states that it developed a guide detailing the various parameters of such a definition, “pointing out those that may require choices to be made by the public authorities because they go beyond the strictly scientific field.” ANSES notes that in practice, it “invites the public authorities to take advantage of the revision of the European regulations on chemicals (REACH and CLP) and cosmetics to propose a broader definition. They will be able to do so once the review of other sectoral regulations has begun.”

The White House Office of Science and Technology Policy (OSTP) has extended the comment period for its April 5, 2023, request for information (RFI) seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 33174. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is interested in public input to inform an updated nanotechnology EHS research strategy, “specifically a strategy that focuses on the use of science-based risk analysis and risk management to protect public health and the environment while also fostering the technological advancements that benefit society.” OSTP seeks responses to the following questions:

  1. What are the research accomplishments in the following six core research areas identified in the 2011 NNI EHS Strategy? The six core research areas are: (1) Nanomaterial Measurement Infrastructure; (2) Human Exposure Assessment; (3) Human Health; (4) Environment; (5) Risk Assessment and Risk Management Methods; and (6) Informatics and Modeling.
  2. What research gaps remain in addressing the six NNI EHS core research areas listed in question 1?
  3. The ethical, legal, and societal implications (ELSI) of nanotechnology are considered across the core research areas of the 2011 strategy. What additional ways could ELSI be more fully integrated throughout a refreshed NNI EHS research strategy?
  4. What broad themes should the revised strategy adopt to integrate and connect the six research areas?
  5. How should the updated NNI EHS research strategy reflect the evolution of nanotechnology beyond engineered nanomaterials to complex systems, structures, and devices?
  6. The 2011 strategy focused on engineered nanomaterials and did not include incidental nanoscale materials such as nanoplastics and certain nanoscale particulate emissions such as those from 3D printing. If the updated strategy is revised to include some non-engineered or incidental nanomaterials, describe how to scope the strategy in a way that complements rather than being redundant with existing health and environmental research (e.g., by excluding the large body of existing research on air pollution, which can include nanoscale particles).

Comments are due on or before 5:00 p.m. (EDT) on June 16, 2023.

As reported in our May 10, 2023, blog item, the National Nanotechnology Initiative (NNI) is holding two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. According to NNI, the breakdown of bulk plastics to micro- and nanoscale particles in the environment “has further challenged efforts to understand the potential human and environmental impacts of plastics over their full life cycles,” leading to “a tremendous increase in national and international collaborations to identify and implement effective solutions.” The first session, on May 22, 2023, focused on activities of agencies that primarily fund or conduct research. A second session, scheduled for June 6, 2023, will focus on activities of agencies with regulatory responsibilities or that engage in interagency or international collaborations on the subject of micro- and nanoplastics. The agenda for the June 6, 2023, session includes:

  • 1:00 p.m. (EDT) — Reconvening/introductory remarks (Anil Patri, Director, Nanotechnology Core Facility, U.S. Food and Drug Administration (FDA), moderator);
  • 1:05 p.m. (EDT) — U.S. Department of State: International Collaborations and Negotiations (Rob Wing);
  • 1:15 p.m. (EDT) — U.S. Environmental Protection Agency (EPA): Overview (Kay Ho);
  • 1:25 p.m. (EDT) — FDA: Scientific Review (Stacey Wiggins);
  • 1:35 p.m. (EDT) — Agency for Toxic Substances and Disease Registry (ATSDR) and National Center for Environmental Health (NCEH): Overview (Custodio Muianga, Gaston Casillas, and Max Zarate-Bermudez);
  • 1:50 p.m. (EDT) — Consumer Product Safety Commission (CPSC): Interagency Collaborations (Joanna Matheson); and
  • 2:00 — Facilitated questions and answers and discussion.

Registration for the June 6, 2023, session is open.

The National Nanotechnology Initiative (NNI) will hold two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. NNI states that the plastic waste issue includes more than just solid waste accumulation. According to NNI, the breakdown of bulk plastics to micro- and nanoscale particles in the environment “has further challenged efforts to understand the potential human and environmental impacts of plastics over their full life cycles,” leading to “a tremendous increase in national and international collaborations to identify and implement effective solutions.” The panel of speakers includes participants in the informal U.S. government nanoplastics interagency interest group that coordinates activities on this subject across the federal agencies, who will provide highlights of agency programs and activities. The first session, on May 22, 2023, will focus on activities of agencies that primarily fund or conduct research. A second session, scheduled for June 6, 2023, will focus on activities of agencies with regulatory responsibilities or that engage in interagency or international collaborations on the subject of micro- and nanoplastics.

The agenda for the May 22, 2023, session includes:

  • 10:30 — Introduction/background (Anil Patri, Director, Nanotechnology Core Facility, U.S. Food and Drug Administration (FDA), moderator);
  • 10:35 — National Institute of Standards and Technology (NIST): Overview (Kate Beers, Manager, Circular Economy Program, NIST);
  • 10:45 — National Science Foundation (NSF): Overview (Anne-Marie Schmoltner, Program Director, Environmental Chemistry, NSF);
  • 10:55 — U.S. Department of Agriculture (USDA): Overview (Hongda Chen, National Program Leader for Bioprocess Engineering and Nanotechnology, USDA/National Institute of Food and Agriculture (NIFA));
  • 11:05 — U.S. Department of Energy (DOE): Overview, including WaterPact (Ben Maurer, Sustainable Oceans Lead, National Renewable Energy Laboratory (NREL));
  • 11:15 — National Oceanic and Atmospheric Administration (NOAA) Marine Debris Program (Amy Uhrin, Chief Scientist, Marine Debris Division, NOAA);
  • 11:25 — U.S. Geological Survey (USGS): Overview (Shawn Fisher, Hydrologist, USGS New York Water Science Center);
  • 11:35 — National Institute of Environmental Health Sciences (NIEHS): Overview (Nigel Walker, Acting Chief, Systems Toxicology Branch, National Institutes of Health (NIH)/NIEHS); and
  • 11:45 — Facilitated questions and answers and discussion.

Registration for the May 22, 2023, is open.

On May 2, 2023, the European Commission’s (EC) Joint Research Center (JRC) announced that it published a guidance document entitled Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial. As reported in our June 10, 2022, blog item, in June 2022, the EC published a new Recommendation aimed at harmonizing the interpretation of the term “nanomaterial” in regulatory contexts. The updated definition of nanomaterials replaced the previous one released in October 2011 and presently used in several legislations, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. According to JRC, the new definition makes it easier to identify nanomaterials. These materials consist of solid natural, incidental, or man-made particles and most of the particles are in the 1-100 nanometer (nm) range. It serves different policy, legislative, and research purposes when addressing nanomaterials or issues concerning products of nanotechnologies. JRC states that the new definition will facilitate the formulation of a single nanomaterial definition in European Union (EU) legislation in the future, including on chemicals, novel food, cosmetics, biocides, or medical devices; “preparat[i]ons for updates have already begun in several sectors.” The new JRC guidance is intended to help stakeholders to understand the new definition and will support regulatory implementation of the new definition. The guidance gives an overview of the key terminology and concepts, provides a decision tree to identify nanomaterials, and addresses identification of nanomaterials through measurements.

Along with the new guidance document, JRC announced that it has launched a free course on nanomaterials in EU legislation available on the EU Academy. More specifically, according to JRC, participants will learn about:

  • What a nanomaterial is and what makes it special in a legal context;
  • The EC’s definition of nanomaterial and the challenges to implement it;
  • The EU legislative framework for chemicals and how it is implemented; and
  • Why different pieces of EU legislation address chemicals and nanomaterials differently.

The U.S. Food and Drug Administration (FDA) announced on May 3, 2023, that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R. Section 73.575, which permits the use of titanium dioxide in foods. FDA states that the petitioners assert that the intended use of titanium dioxide no longer meets the safety standard under 21 C.F.R. Section 70.3(i), “and cite, as evidence, an opinion by the European Food Safety Authority (EFSA) entitled ‘Safety assessment of titanium dioxide (E171) as a food additive’ that was published in May 2021 . . ., and other publications.” FDA invites comments, additional scientific data, and other information related to the issues raised by the petition. FDA states that if it determines that the available data justify repealing Section 73.575 to no longer provide for the safe use of titanium dioxide in foods, it will publish its decision in the Federal Register in accordance with 21 C.F.R. Section 71.20. Comments are due July 3, 2023.

As reported in our January 14, 2022, blog item, the European Commission (EC) announced on January 14, 2022, that it adopted a ban on the use of titanium dioxide (E171) as a food additive. The ban applied after a six-month transition period, and beginning summer 2022, titanium dioxide (E171) may no longer be added to food products. According to the EC, titanium dioxide “is used to impart white colour to many foods, from baked goods and sandwich spreads to soups, sauces, salad dressing and food supplements.” The EC states that European Union (EU) member states unanimously endorsed the EC’s proposal, put forward in October 2021. The EC based its proposal on EFSA’s scientific opinion that concluded that E171 could no longer be considered safe when used as a food additive. More information is available in the EC’s questions and answers (Q&A).

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has begun a public consultation on its preliminary opinion on fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes (nano). The EC asked SCCS if it considers fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported via the Cosmetic Product Notification Portal (CPNP), taking into account reasonably foreseeable exposure conditions. SCCS states that having assessed the information provided by the notifiers, and the information available from published literature, it “has not been able to conclude on the safety of fullerenes and (hydrated) hydroxylated forms of fullerenes due to a number of uncertainties and data gaps in regard to physicochemical, toxicokinetic and toxicological aspects.” SCCS indicated these uncertainties and data gaps in relevant sections of its preliminary opinion and states that they “must be addressed by the Notifiers to enable a conclusion on the safety of the materials for use in cosmetic products.” SCCS notes that, in particular, it has not been able to conclude on the genotoxicity potential of fullerenes (C60 and C70). According to SCCS, “[t]he available evidence indicates that hydrated forms of hydroxylated fullerenes are genotoxic and hence SCCS considers them as not safe for use in cosmetic products.” In view of equivalence, “the same concerns over genotoxicity potential also apply to hydroxylated fullerenes.”

Based on the currently available scientific literature and SCCS’ expert judgement, the EC requested that SCCS assess any further scientific concerns with regard to the use of fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes in cosmetic products and whether a potential risk to human health can be identified according to Article 16(6) of Regulation (EC) No. 1223/2009 (Cosmetics Regulation). SCCS states that in Annex 1 of its preliminary opinion, it notes the basis for concerns over risks that the use of fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes in cosmetic products may pose to the consumer. The preliminary opinion includes the following list of concerns:

  • The potential presence of impurities, heavy metals, accompanying contaminants, and/or organic solvents in the notified nanomaterials;
  • Lack of data on stability of hydroxylated fullerenes and their hydrated forms;
  • The potential ability of fullerenes and derivatives to induce production of free oxyradicals when used in cosmetic products;
  • Phototoxicity of hydroxylated fullerenes, with similar concerns for the hydrated forms of hydroxylated fullerenes;
  • Sensitizing potential of hydroxylated fullerenes;
  • Dermal absorption and systemic availability of the nanoparticles after use in cosmetic products;
  • Distribution of systemically available fullerenes to various organs in the body and potential accumulation of the nanoparticles in certain organs, such as lungs and liver; and
  • The available information does not allow SCCS to exclude genotoxic/carcinogenic potential of any of the materials assessed in the preliminary opinion.

Comments are due June 12, 2023.

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022.  The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials. Risk assessment decisions, including the type of nanomaterials assessed, testing recommended, and outcomes of the assessment include:

  • The U.S. Environmental Protection Agency (EPA) completed review of five low volume exemptions that included modified graphene materials and multi-walled carbon nanotube chemical substances. EPA granted one exemption, while the other four exemptions were denied or withdrawn before being denied. The Tour de Table states that EPA allowed the one exemption under conditions that limited human and environmental exposures to prevent unreasonable risks. Additionally, EPA reviewed and completed six premanufacture notices (PMN) for multi-walled carbon nanotube chemical substances. According to the Tour de Table, EPA regulated all six of the new chemical substances with a consent order “due to limited available data on nanomaterials.” The consent orders limited uses and human and environmental exposure to prevent unreasonable risks.

The Tour de Table includes the following information regarding risk management approaches in the United States:

  • Between June 2021 and June 2022, EPA received notification of seven nanoscale substances based on amorphous silica that met reporting criteria pursuant to its authority under the Toxic Substances Control Act (TSCA) Section 8(a), bringing the total number of notifications to 85. Reporting criteria exempted nanoscale chemical substances already reported as new chemicals under TSCA and those nanoscale chemical substances that did not have unique or novel properties. According to the Tour de Table, most reporting was for metals or metal oxides.
  • Since January 2005, EPA has received and reviewed more than 255 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. A manufacturer or processor wishing to engage in a designated significant new use identified in a SNUR must submit a significant new use notice (SNUN) to EPA at least 90 days before engaging in the new use. A sanitized version (i.e., without confidential business information (CBI)) of such a consent order is available. The Tour de Table notes that because of CBI claims by submitters, EPA may not be allowed to reveal to the public the chemical substance as a nanoscale material in every new chemical SNUR it issues for nanoscale materials. EPA will continue to issue SNURs and consent orders for new chemical nanoscale materials in the coming year.
  • Because of limited data to assess nanomaterials, the consent orders and SNURS contain requirements to limit exposure to workers through the use of personal protective equipment (PPE), limit environmental exposure by not allowing releases to surface waters or direct releases to air, and limit the specific applications/uses to those described in the new chemical notification.

Regarding updates, including proposals, or modifications to previous regulatory decisions, the Tour de Table states that “[t]he approaches used given the level of available information are consistent with previous regulatory decisions. EPA’s assessments now assume that the environmental hazard of a nanomaterial is unknown unless acceptable hazard data is submitted with nanomaterial submission.”

The Tour de Table lists the following new regulatory challenge(s) with respect to any action for nanomaterials:

  • Standards/methods for differentiating between different forms of the same chemical substance that is a nanomaterial;
  • Standardized testing for the physical properties that could be used to characterize/identify nanomaterials; and
  • Differentiation between genuinely new nanoscale materials introduced in commerce and existing products that have been in commerce for decades or centuries.

As reported in our March 16, 2023, blog item, on March 14, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) issued a call for study proposals. EUON is looking for studies on:

  • 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).

According to EUON, the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. EUON will assess all proposals, and if selected, they will be carried out through EUON’s existing procurement channels. EUON will post the outcome and study reports on its website. EUON states that it usually conducts two studies each year to address knowledge gaps on nanomaterials. EUON notes that studies are based on desk research and surveys and should not require laboratory research. On April 26, 2023, EUON announced that it has extended the deadline for proposals to May 12, 2023.