Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EC Amends Cosmetics Regulation to Allow Use of Titanium Dioxide (Nano) as UV Filter

Posted in International, Legal/Regulatory Issues

The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation.  Under the amendment, the entry for titanium dioxide is revised to state that the combined use of titanium dioxide and titanium dioxide (nano) must not exceed 25 percent maximum concentration in ready-for-use preparation.  The amendment also adds an entry for titanium dioxide (nano), stating that it must not exceed 25 percent maximum concentration in ready-for-use preparation.  Titanium dioxide (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.  Only nanomaterials having the following characteristics are allowed:

  • Purity ≥ 99 percent;
  • Rutile form, or rutile with up to 5 percent anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes;
  • Median particle size based on number size distribution ≥ 30 nanometers (nm);
  • Aspect ratio from 1 to 4.5, and volume specific surface area ≤ 460 square meters per cubic meter (m2/cm3);
  • Coated with silica, hydrated silica, alumina, aluminum hydroxide, aluminum stearate, stearic acid, trimethoxycaprylylsilane, glycerin, dimethicone, hydrogen dimethicone, or simethicone;
  • Photocatalytic activity ≤ 10 percent compared to corresponding non-coated or non-doped reference, and
  • Nanoparticles are photostable in the final formulation.

OECD Publishes Dossier Summaries for CNTs, Fullerenes, and Silicon Dioxide

Posted in OECD, Research

The Organization for Economic Cooperation and Development (OECD) recently published several dossier summaries for nanomaterials tested as part of its Testing Program of Manufactured Nanomaterials.  Under the Program, sponsors tested 11 nanomaterials for:  nanomaterial information/identification; physical-chemical properties and material characterization; environmental fate; toxicological and eco-toxicological effects; environmental toxicology; mammalian toxicology; and material safety.  The new summaries available include:

NanoSafety Cluster Publishes 2016 Edition of Compendium of Projects

Posted in International, Research

On July 11, 2016, the NanoSafety Cluster (NSC) published the 2016 edition of the Compendium of Projects in the European NanoSafety Cluster.  According to NSC, the focus of investment and research “has moved increasingly towards predictive and high throughput approaches to nanosafety, including safety-by-design, bioinformatics, as well as the utilisation of nano-characterisation and safety datasets to support regulation and nanoproduct commercialisation.”  The 2016 Compendium contains entries from nine running Seventh Research Framework Program (FP7) projects, and 11 Horizon 2020 projects (seven running and four in negotiations), offering “exciting insights” into the state-of-the-art collaborative research occurring across Europe.  The Compendium also includes updates from the NSC Working Groups (WG) and provides introductions to two new WGs — Safety by Design (WG9) and the Industrial Innovation Liaison (WGi2L/WG10).  According to the Compendium, it intends to bring the research community closer together and show the potential for synergy.  To establish links and communication between researchers well before the publication of their results, the Compendium focuses on the projects’ strategic aims, covers specific work objectives and the methods used in research, and documents human capacities and partnerships.

EC Denies 2014 Petition Seeking EU-Wide Ban on Nanoparticles

Posted in International, Legal/Regulatory Issues

On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles.  The petition summary states:  “Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer.  Because the precautionary principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible.”  In its response, the EC states that nanoparticles “are ubiquitous in the environment,” and while some manufactured nanomaterials may potentially be carcinogenic, others are not.  The EC states that the general regulatory framework on chemicals, along with the sectoral legislation, “are appropriate to assess and manage the risks from nanomaterials, provided that a case-by-case assessment is performed.”  The EC notes that the need to modify the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to include more specific requirements for nanomaterials was identified.  According to the EC, a final impact assessment of the proposed changes is being prepared, and the modification of technical REACH Annexes to include specific considerations for nanomaterials is planned for early 2017.  The EC states that it created a web portal intended to improve communication regarding nanomaterials, and that this web portal will soon be superseded by the EU Nano Observatory, which will be managed by the European Chemicals Agency (ECHA).  The EC concludes that it has “no plans for a generic ban of nanomaterials,” and as it states in the petition response, “[n]anotechnology has a considerable potential to develop tools that protect human health and the environment and address other societal challenges, and the Commission supports its responsible development and use.”

IRSST Studies Efficacy of N95 Respirators in Conditions Representative of Human Breathing

Posted in Occupational Health and Safety Issues, Research

On June 28, 2016, Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) issued a press release announcing the availability of a study on “Efficiency Evaluation of N95 FFRs under Cyclic and Constant Flows.”  Researchers tested the efficacy of N95 filtering facepiece respirators (FFR) in conditions of constant and cyclical air flow, simulating human breathing, from 42 to 360 liters per minute.  According to the press release, N95 respirators “are the personal safety equipment most commonly used in Quebec by industrial and health-care workers to protect themselves against exposure to ultrafine particles” (UFP) (diameter of particles less than 100 nanometers).  Researchers examined the impact of breathing frequency and inhalation flow rate on the efficacy of N95 respirators; compared the efficacy of N95 respirators in conditions of cyclical air flow with the results for constant air flow; and assessed the impact of the clogging time of the filter on the performance of N95 respirators as a function of relative humidity and air flow (cyclical and constant).  The press release states that UFPs “are potentially toxic and liable to cause serious health problems.  They may be of natural origin (sea spray, smoke from forest fires or volcanic activity) or human origin (welding, diesel or exhaust fumes) and, due to their nanometric size, these particles may, once inhaled, be deposited deep in the lungs’ alveoli.”  According to the press release, the study results indicated that the influence of a high inhalation flow rate significantly affected the penetration of UFPs, while the impact of breathing frequency was moderate.  Researchers established that with a constant air flow, the best assessment of UFP penetration levels is obtained using a moderate inhalation flow rate typical of the human respiratory cycle.  The results also showed that filter clogging time and relative humidity have a major impact on particle penetration through N95 respirators.

CRS Prepares “Policy Primer” on Nanotechnology

Posted in Federal, Legal/Regulatory Issues, Research, United States

The Congressional Research Service (CRS) prepared a June 28, 2016, report, Nanotechnology: A Policy Primer. The report provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness in the field, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. According to the report, while more than 60 nations established similar programs after the launch of the National Nanotechnology Initiative (NNI), “it appears that several have moved away from centralized, coordinated nanotechnology-focused programs (e.g., the United Kingdom, Japan, Russia), some in favor of market- or application-oriented topic areas (e.g., health care technologies).” Using the criteria of R&D expenditures and non-financial outputs such as scientific papers or patents, the U.S. “appears to be the overall global leader in nanotechnology, though some believe the U.S. lead may not be as large as it was for previous emerging technologies.” The report states that in recent years, China and the European Union (EU) Member States have surpassed the U.S. in the publication of nanotechnology papers. The report notes that there is general agreement that more research on EHS implications is needed to protect the public and the environment, assess and manage risks, and create a regulatory environment that “fosters prudent investment in nanotechnology-related innovation.” Nanomanufacturing may require the development of new technologies, tools, instruments, measurement science, and standards, while public understanding and attitudes may also affect the environment for R&D, regulation, and market acceptance of products incorporating nanotechnology.

EFSA Priority Topics for Guidance Development Include Nanotechnologies

Posted in International, Legal/Regulatory Issues

On June 20, 2016, the European Food Safety Authority (EFSA) published a scientific opinion entitled “Priority topics for the development of risk assessment guidance by EFSA’s Scientific Committee in 2016-2018.”  EFSA asked its Scientific Committee to review its cross-cutting guidance for scientific assessments to identify gaps requiring either new or revised guidance.  The Scientific Committee identified topics to be included in its 2016-2018 work program without ranking their priority.  According to the scientific opinion, work is already underway in three areas, including nanotechnologies, that are intended to lead to new or revised cross-cutting guidance.  The Scientific Committee will continue to keep priorities for cross-cutting guidance across EFSA’s fields of responsibility under review.  Regarding nanotechnologies, the scientific opinion states:

Future developments are expected in the field of nano-encapsulates and nano-composites in applications such as novel foods, food/feed additives, biocides, food contact materials, but especially as pesticides.  In line with the revision of EFSA’s cross-cutting guidance documents (EFSA Scientific Committee, 2015), the Scientific Committee Nanomaterial Guidance (EFSA Scientific Committee, 2011) requires updating to stay aligned with fast developments in both scientific innovations and legal requirements in this area.  The need for this update has been agreed as a priority for the new Scientific Committee in 2015.  The guidance update should take into account the general extensions needed to cover also nanopesticides and nanoformulations, food contact materials, food and feed additives and novel foods; as well an update of the physico-chemical property measurements and the other data needed for food/feed assessment.  In addition, a second guidance document should be produced on the environmental risk assessment for nanoparticles used in the food chain.

NIOSH Publishes PPOP on Nanotechnology Research Center

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, Research, United States

On June 15, 2016, the National Institute for Occupational Safety and Health (NIOSH) posted a number of Program Performance One-Pagers (PPOP), including a May 2016 PPOP on the NIOSH Nanotechnology Research Center (NTRC).  The PPOP states that the NTRC focuses on increasing understanding of hazards and related health risks to workers who make and use nanomaterials and preventing occupational exposures to nanomaterials.  The PPOP includes the following future NIOSH actions:

  • Analyze biomarkers from research studies of nanomaterial workers;
  • Publish the first in a series of nanomaterial handling guidance, “Workplace Design Solutions: Protecting Workers during the Handling/Weighing of Nanomaterials”;
  • Use data on high volume nanomaterials to characterize the size and location of the nanomaterial workforce; and
  • Complete the draft “Current Intelligence Bulletin: Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials.”

NIOSH Explores Workplace Exposure to Multi-Walled Carbon Nanotubes

Posted in Federal, Occupational Health and Safety Issues, Research, United States

The May 2016 issue of NIOSH Research Rounds includes an item entitled “Research Explores Workplace Exposure to Carbon Nanotubes.”  The National Institute for Occupational Safety and Health (NIOSH) summarizes the following two published papers by NIOSH investigators with partners at Kazan State Medical University, in Kazan, Russia, that explore whether workplace exposure to multi-walled carbon nanotubes could pose a risk for lung disease.  For both studies, participants from the same facility in Kazan volunteered to participate.

  • Integrated Analysis of Dysregulated ncRNA and mRNA Expression Profiles in Humans Exposed to Carbon Nanotubes: NIOSH states that workers exposed to multi-walled carbon nanotubes were significantly more likely than unexposed workers to have abnormal changes related to various cell functions including cell growth and cell death.  This study, published in the peer-reviewed journal PLOS ONE, is the first to look at these cellular changes in blood samples from workers exposed to multi-walled carbon nanotubes.  According to NIOSH, since this study had only a small number of participants, large-scale studies are needed to determine whether the observed ribonucleic acid (RNA) changes are useful markers of exposure in workers.  Additional work also is needed to determine if the effects observed are specific to the multi-walled carbon nanotubes and if this information can assist in developing good risk management practices.  The investigators recommended that these findings be considered when comparing the results from similar studies in the U.S., such as an ongoing study at NIOSH; and
  • Fibrosis Biomarkers in Workers Exposed to MWCNTs: Workers exposed to multi-walled carbon nanotubes were significantly more likely than non-exposed workers to have cellular changes that correlated with lung inflammation and scarring.  NIOSH states that these findings, published in the peer-reviewed journal Toxicology and Applied Pharmacology, underscore the importance of implementing strict control measures as a reasonable precaution to prevent exposure to workers handling multi-walled carbon nanotubes.  The findings indicate that future studies should consider using the observed biomarkers to assess the health effects of workplace exposure to multi-walled carbon nanotubes.  In addition, according to investigators, a repository of biological samples would be a valuable tool for future studies.

nanoIndEx Publishes Guidance Document on Assessment of Personal Exposure to Airborne Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues

In June 2016, the “Assessment of Individual Exposure to manufactured nanomaterials by means of personal monitors and samples” (nanoIndEx) project published a guidance document entitled Assessment of Personal Exposure to Airborne Nanomaterials.  The three-year project was funded under the Safe Implementation of Innovative Nanoscience and Nanotechnology (SIINN) European Research Area Network (ERA-NET).  Its aim was to determine the field readiness and usability of the instrumentation available for personal exposure assessment; use this information to generate reliable data on personal exposure in real workplaces; and distribute the findings to stakeholders.  The guidance document summarizes the key findings of the project, and is intended to present the state of the art in personal exposure assessment for nanomaterials.  The conclusions section states:  “Unfortunately, many nanotoxicological studies have used excessive, unrealistically high doses of [manufactured nanomaterials] and it is therefore debatable what their findings mean for the lower real-world exposures of humans.  Moreover, it is not clear how to establish realistic exposure dose testing in toxicological studies, as available data on occupational exposure levels are still sparse.”  According to the guidance document, future studies should focus on the potentially adverse effects of low-level and realistic exposure to manufactured nanomaterials, especially through the use of exposure doses similar to those identified in environmental sampling.