On April 12, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano). The EC asked whether SCCS considers the nanomaterial hydroxyapatite safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions. SCCS states that having considered the data provided, and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion.” This is because the available data and information are not sufficient to exclude concerns over the genotoxic potential of hydroxyapatite (nano). The EC also asked whether SCCS has any further scientific concerns with regard to the use of hydroxyapatite in nano form in cosmetic products. The opinion states that although the particle shape of the nanomaterial considered in this opinion is reported as rod-shaped, “SCCS is aware that, depending on the manufacturing process, needle-shaped HAP nanoparticles may also be produced.” According to the opinion, the available information indicates that hydroxyapatite (nano) in needle-shaped form “is of concern in relation to potential toxicity” and “should not be used in cosmetic products.” SCCS concluded that there is a basis for concern that the use of hydroxyapatite (nano) in cosmetic products “can pose a risk to the consumer.”
Registration is open for the U.S. National Nanotechnology Initiative’s (NNI) April 27, 2021, webinar on “What We Know about NanoEHS: Environment.” The webinar will feature experts from diverse disciplines to share their perspectives on key findings on the effects of engineered nanomaterials in the environment. Elijah Petersen, Ph.D., Research Scientist, National Institute of Standards and Technology (NIST), will moderate the panel, which will include:
- Jorge Gardea-Torresdey, Ph.D., Dudley Professor of Environmental Science & Engineering and of Chemistry, The University of Texas at El Paso;
- Patricia Holden, Ph.D., Professor of Environmental Microbiology, University of California, Santa Barbara; and
- Greg Lowry, Ph.D.., Walter J. Blenko, Sr. Professor of Civil and Environmental Engineering, Carnegie Mellon University.
The International Organization for Standardization (ISO) published a news item on April 1, 2021, entitled “The Science of Tiny Little Things.” According to the item, ISO has recently made some revisions and updates to its comprehensive 13-part series of International Standards for nanotechnology. Updated standards include ISO/TS 80004-3, Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects, which defines terms and concepts for carbon nano-objects, ISO/TS 80004-6, Nanotechnologies – Vocabulary – Part 6: Nano-object characterization, and ISO/TS 80004-8, Nanotechnologies – Vocabulary – Part 8: Nanomanufacturing processes. The item states that work is underway “to develop a standard that will consolidate some of the most fundamental terminology in the series.” The item lists the following standards that are in the current series:
- ISO/TS 80004-1, Nanotechnologies – Vocabulary – Part 1: Core terms;
- ISO/TS 80004-2, Nanotechnologies – Vocabulary – Part 2: Nano-objects;
- ISO/TS 80004-4, Nanotechnologies – Vocabulary – Part 4: Nanostructured materials;
- ISO/TS 80004-5, Nanotechnologies – Vocabulary – Part 5: Nano/bio interface;
- ISO/TS 80004-7, Nanotechnologies – Vocabulary – Part 7: Diagnostics and therapeutics for healthcare;
- ISO/TS 80004-9, Nanotechnologies – Vocabulary – Part 9: Nano-enabled electrotechnical products and systems;
- ISO/TS 80004-11, Nanotechnologies – Vocabulary – Part 11: Nanolayer, nanocoating, nanofilm, and related terms;
- ISO/TS 80004-12, Nanotechnologies – Vocabulary – Part 12: Quantum phenomena in nanotechnology; and
- ISO/TS 80004-13, Nanotechnologies – Vocabulary – Part 13: Graphene and related two-dimensional (2D) materials.
The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition. The Toy Safety Directive 2009/48/EC prohibits the use of substances in toys if those substances are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). The use of such substances may be permitted under certain conditions, however. To permit the use of a CMR substance of category 2, the substance has to be evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure. An additional condition is that the substance is not prohibited for use in consumer articles under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Titanium dioxide in powder form containing one percent or more of particles with aerodynamic diameter ≤ ten micrometers (μm) has been classified as carcinogenic category 2 by inhalation.
SCHEER has called for scientific information on:
- The chemical and physical specifications of titanium dioxide used in toys;
- The size distribution of pigment grade titanium dioxide used in toys;
- The migration or release of titanium dioxide from toys; and
- Exposure measurements on titanium dioxide used in toys.
Submissions are due April 28, 2021. The call for information will remain open after this date, however, and additional studies (e.g., ongoing studies and research that are not completed by the deadline) may be passed to the working group at a later stage, if needed.
The EC asked SCHEER:
- To review the available data on the use of titanium dioxide leading to inhalation exposure in particular in toys and toy materials; and
- To evaluate whether the uses of titanium dioxide in toys and toy materials can be considered safe in light of the exposure identified, and in light of the classification of titanium dioxide as carcinogenic category 2. Safe toys and toy materials should be indicated.
According to the timeline in the EC’s request, the preliminary opinion is expected in mid-2021, and the final opinion in fall 2021.
The Society of Toxicology (SOT) in conjunction with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide a colloquia series on Emerging Toxicological Science: Challenges in Food and Ingredient Safety. The colloquia will present scientific information that is high-quality, cutting-edge, future-oriented toxicological science and is intended to provide a well-grounded foundation to inform the work of FDA employees. On April 8, 2021, there will be a live webcast on the toxicology of nanoparticles. Richard Canady, Ph.D., and Kapal Dewan, MS, CLSp(CG), are Colloquium Co-Chairs. The agenda includes:
- Welcome, George Daston, SOT President, Procter & Gamble Company;
- Overview and Speaker Introductions, Richard Canady, Ph.D., NeutralScience LC3;
- Lessons Learned from Nanomaterial Characterization: Critical Quality Attributes that Influence Biological Properties, Anil Patri, Ph.D., National Center for Toxicological Research (NCTR);
- Standard Dose Measurement for Nanomaterials: What to Include in Exposure and Toxicity so That We Can Bound Dose Estimates for Safety?, Christie Sayes, Ph.D., Baylor University;
- Dosing-Related Challenges in Toxicity Studies and Risk Assessment of Titanium Dioxide in Food, Walter Brand, Ph.D., National Institute for Public Health and the Environment (RIVM) in The Netherlands;
- Practical Application to Regulatory Toxicology: Issues Faced in Consideration of Developing Health Guideline Values, Lynne Haber, Ph.D., University of Cincinnati Risk Science Center; and
- Roundtable discussion moderated by Richard Canady, Ph.D., and including all speakers, as well as Timothy Duncan, Ph.D., FDA, and Agnes Oomen, Ph.D., RIVM.
The webcast is open to the public at no charge. Registration will require creating an online account. SOT notes that these sessions are not a public forum to discuss toxicology regulatory issues.
NanoHarmony held a webinar on March 17, 2021, on “Identification and solving barriers for translating science to regulation and standards.” According to NanoHarmony, the webinar focused on helping to identify the obstacles faced by stakeholders in developing new test methods and having them introduced as new test guidelines and guidance documents. A recording of the webinar is now available online, as well as the following slides:
- Claus Svendsen, CEH, welcome and introduction;
- Eric Bleeker, National Institute for Public Health and the Environment (RIVM), “The OECD process: From knowledge generation to embedding in a test guideline or guidance document”;
- Lya Hernández, RIVM, “How knowledge flows can address the knowledge needs of regulators”;
- Susan W.P. Wijnhoven, RIVM, “What do risk assessors want and need?”;
- Adriënne J.A.M. Sips, RIVM, “Developing regulatory readiness levels to address barriers and aid the flow of knowledge: Stakeholder feedback and discussion”; and
- Claus Svendsen, CEH, close and next steps.
Registration is now available for NanoHarmony’s July 7, 2021, webinar on “Learning lessons from the past — and knowing what your customer needs.”
On March 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “ECETOC task force ensures society benefits from safe nanomaterials via efficient safety assessments that require minimal animal testing” by authors from BASF and the Center for Chemical Safety Assessment (ECETOC). The column reviews ways to assess the safety of nanomaterials while minimizing animal testing. According to the authors, the NanoApp developed by the ECETOC Task Force on Nanomaterials helps users group similar nanoforms, which can be useful when registering nanoforms via sets of similar nanoforms, or when doing read-across between nanoforms for particular information requirements.
The European Union (EU) Observatory for Nanomaterials (EUON) announced on March 19, 2021, that it is looking for topic suggestions that could be addressed in its upcoming studies. According to EUON, up to three studies are conducted annually to address knowledge gaps on nanomaterials that are of interest to the general public and the research community. EUON states that it seeks studies that address:
- Questions relating to the health and safety 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 (g., the market for specific materials, such as graphene, or specific market sectors).
The scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials, and it should be possible to execute the study within three to nine months. The studies should be based on desk research and surveys and should not require laboratory research. Proposals are due April 19, 2021. The EUON secretariat will assess all study proposals. Selected studies will be carried out through the EUON’s existing procurement channels. The outcome and study reports will be made publicly available on the EUON website.
Gov4Nano is a Horizon 2020 project that aims to design an effective risk governance process for nanotechnologies, including improving the availability of nano-relevant data. To meet its aims, Gov4Nano is conducting a “Data Sharing and FAIR Data Use Survey” to obtain views and opinions from data users and producers on data availability and sharing and how these can be improved. Gov4Nano seeks to determine how barriers to data availability can be lowered and incentives for data sharing can be raised. According to Gov4Nano, the questionnaire will take five to ten minutes. Gov4Nano states that the information provided will contribute to improvements in the availability and sharing of nanomaterial environmental, health, and safety (nanoEHS) data to the user community. Gov4Nano “want[s] to hear from all data users and producers, whatever your role.”
The questionnaire can be answered anonymously. Gov4Nano states that it will hold all individual responses “confidentially and securely, for use only by the Gov4Nano project.” Interested respondents can opt to provide a contact e-mail to obtain further information on Gov4Nano’s ongoing work on data management and its implementation.
On March 4, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced that it is recommending an eight-hour occupational exposure limit (OEL) of 0.80 micrograms per cubic meter (µg/m3) for titanium dioxide nanoparticles. According to ANSES, compliance with this value “should help prevent lung inflammation, an effect that occurs at the lowest exposure concentrations.” Due to the lack of available data on the immediate or short-term effects of titanium dioxide nanoparticles, in accordance with its methodological guide, ANSES states that it also recommends not exceeding the concentration of 4.0 µg/m3 over a 15-minute period. Compliance with this value should help limit the size and number of exposure peaks over the working day, according to ANSES.
ANSES notes that an expert appraisal on the assessment of methods for measuring titanium dioxide nanoparticles in air is currently under way. ANSES states that this will determine which method(s) to use to measure titanium dioxide nanoparticle concentrations in air in view of the OELs it recommended. In addition, ANSES states, the studies it requested when assessing titanium dioxide under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation “should enable these values to be further refined.”
The press release is also available in French.