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 Committee Publishes Final Opinion on Titanium Dioxide (Nano Form) as UV-Filter in Sprays

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published on January 24, 2018, its final opinion on titanium dioxide (nano form) as an ultraviolet (UV)-filter in sprays.  The EC asked SCCS to address the following questions:

  1. In light of the data provided, does SCCS consider titanium dioxide (nano) safe when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent; and
  2. Does SCCS have any further scientific concerns regarding the use of titanium dioxide (nano) when used as a UV-filter in sunscreens and personal care spray products.

SCCS reviewed data submitted by industry in July 2015 and concluded that “the information provided is insufficient to allow assessment of the safety of the use of nano-TiO2 in spray applications that could lead to exposure of the consumer’s lungs.”  According to the final opinion, the dossier provides exposure studies that were conducted with water-based sprayable products with low alcohol content, which according to the market overview currently represent around 80 percent of the sprayable sunscreen products on the European Union (EU) market.  For the non-water-based formulations or formulations that contain alcohol >10 percent per weight, which currently may represent around 20 percent of the sprayable sunscreen products on the EU market, no exposure data were submitted, so these products could not be evaluated.  The final opinion states that the submission “also does not provide adequate toxicological evaluation of nano-TiO2 relevant to the inhalation route, which would allow deriving a point of departure for the safety evaluation using worst-case assumptions.”  During the comment period on SCCS’s preliminary opinion, the applicant provided a new submission.  SCCS states that its analysis “showed that it has also not addressed the SCCS concerns over the safety of titanium dioxide (nano) when used as UV-filter in sunscreen and personal care sprayable products.”  SCCS notes that it has been made aware by the applicant’s new submission that there are already sprayable products on the market containing nano forms of titanium dioxide.  SCCS cautions that “[s]uch uses need to be carefully evaluated so that the chance of harmful effects through consumer’s lung exposure by inhalation is avoided.”

NNI Will Hold Meetings in 2018

Posted in Federal, Legal/Regulatory Issues, United States

The Office of Science and Technology Policy published a Federal Register notice on January 23, 2018, announcing that the National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), “will facilitate stakeholder discussion of targeted nanotechnology topics through workshops, webinars, and Community of Interest meetings between the publication date of this Notice and December 31, 2018.”  According to the notice, these public meetings address the charge in the 21st Century Nanotechnology Research and Development Act for NNCO to provide “for public input and outreach . . . by the convening of regular and ongoing public discussions.”  The notice states that workshop and webinar topics may include technical subjects; environmental, health, and safety issues related to nanomaterials (nanoEHS); business case studies; or other areas of potential interest to the nanotechnology community.  Areas of focus for the Communities of Interest may include research on nanoEHS; nanotechnology education; nanomedicine; nanomanufacturing; or other areas of potential interest to the nanotechnology community.  Meeting information will be posted on the National Nanotechnology Initiative (NNI) website

ECHA Management Board Reviews Strategy on Substances in Nanoforms

Posted in International, Legal/Regulatory Issues

During its December 14-15, 2017, meeting, the Management Board of the European Chemicals Agency (ECHA) discussed ECHA’s strategy on substances in nanoforms.  According to the strategy, following recent rulings of the Board of Appeal, the “possibility for using dossier and substance evaluation under the current legal text of [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation] to verify safe use of nanomaterials on the EU market has become increasingly challenging and resource intensive,” making revision of the REACH annexes “even more urgent than before.”  As reported in our March 6, 2017, blog item, in March 2017, the Board of Appeal annulled a contested decision that would have required the lead registrant to provide detailed substance identity information on the crystal phases, nanoforms, and surface treatment of nanoforms covered by its registration of titanium dioxide.  On June 30, 2017, the Board of Appeal published two decisions related to nanomaterials, largely upholding the appeals and annulling most of the requests for information, as reported in our July 5, 2017, blog item.  In the strategy, ECHA states that in the current situation, it “cannot effectively and systematically verify whether safe use of nanomaterials in the supply chain is demonstrated, and whether additional regulatory risk management measures are needed.”  ECHA notes that “[t]hese developments, however, do not eliminate the responsibility of industry in ensuring the safe use of substances, in whatever form.”  The preliminary conclusions for the meeting state that the Management Board welcomed ECHA’s progress and invited the EC “to conclude as a matter of urgency the revision of the annexes to REACH on the information requirements of nanomaterials.”

NIOSH Will Use Experience in Managing Engineered Nanomaterials to Address Advanced Manufacturing

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

Charles Geraci, PhD, CIH, FAIHA, Associate Director for Nanotechnology and Advanced Materials at the National Institute for Occupational Safety and Health (NIOSH), and Laura Hodson, MSPH, CIH, FAIHA, Coordinator of the NIOSH Nanotechnology Research Center, co-authored an article entitled “From ‘Just in Time’ to ‘Just Next Door’:  21st-century Manufacturing Challenges and Opportunities for Industrial Hygienists.”  The American Industrial Hygiene Association (AIHA) published the article in the January 2018 issue of The Synergist.  The article notes that many new manufacturing and material technologies “are simply a natural progression of nanotechnology research.”  NIOSH has been an active contributor to the National Nanotechnology Initiative (NNI), contributing to the safe and responsible development of nanotechnology and focusing on protecting workers who manufacture and use engineered nanomaterials.  According to the article, NIOSH “intends to leverage its knowledge and experience in managing engineered nanomaterials to create a framework that supports safe and responsible development of advanced manufacturing in the U.S.”  The article states:  “The time is right for all industrial hygienists to consider the reapplication of good industrial hygiene practice to the next generation of manufacturing.  Industrial hygienists should follow the tried-and-true practice of protecting workers by hazard anticipation, recognition, evaluation, control, and confirmation.”  This includes determining the types and locations of hazards, identifying potential hazards or exposures, identifying the potentially exposed worker population, and developing a risk management plan.  The article recommends that the industrial hygiene community keep pace with the changes in processes and the continued introduction of new and more active materials, and leverage resources with others who have greater expertise.  NIOSH “will continue to utilize knowledge gained from promoting responsible development of nanomaterials as it seeks to promote responsible development of 21st-century manufacturing.”

EFSA Begins Public Consultation on Guidance for the Risk Assessment of Nanoscience and Nanotechnology Applications

Posted in International, Legal/Regulatory Issues

On January 12, 2018, the European Food Safety Authority (EFSA) opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnology applications in the food and feed chain.  The guidance covers the relevant areas within EFSA’s remit, such as novel foods, food contact materials, food and feed additives, and pesticides.  EFSA notes that the guidance takes account of scientific developments that have taken place since publication of the previous guidance in 2011, particularly studies that offer new insights into exposure assessment and hazard characterization of nanomaterials.  The guidance considers potential future developments suggested in the scientific literature for nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides, and food contact materials.  Therefore, EFSA states, the guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment, and hazard characterization of nanomaterials.  It specifically elaborates on physicochemical characterization of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterization of nanomaterials, and their determination in complex matrices.  It also details the aspects relating to exposure assessment and hazard identification and characterization. In particular, according to EFSA, the guidance discusses nanospecific considerations relating to in vivo/in vitro toxicological studies and outlines a tiered framework for toxicological testing.  Depending on the initial tier results, studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome, and endocrine activity.  The guidance touches upon the possible use of read across to fill data gaps, in vitro digestion, toxicokinetics, and genotoxicity, as well as general issues relating to in vitro testing of nanomaterials.  The guidance also discusses the potential use of integrated testing strategies and the knowledge of modes/mechanisms of action.  The guidance proposes approaches to risk characterization and uncertainty analysis, and provides recommendations for further research in this area.  Comments are due March 4, 2018.

IOSH Publishes Research Report and Industry Guidance on Nanotechnology in Construction and Demolition

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

On January 8, 2018, the Institution of Occupational Safety and Health (IOSH) announced the availability of a research report on nanotechnology in construction and demolition, as well as guidance for industry.  The aim of the research was to provide clarity regarding the current use of nanomaterials in the built environment and the potential benefits and risks arising for those working in the construction and demolition sectors.  Research included review of academic and manufacturers’ literature; interviews with individuals working in various parts of the construction, demolition, and materials supply sectors; and laboratory testing of samples of nano-enabled construction products.  The research findings include:

  • Use of nanomaterials in construction: The main nano-enabled products available are surface coatings, concrete, window glass, insulation, and steel.  There is a lack of evidence regarding which products definitely contain nanomaterials, and what these materials might be, however.  Current usage rates for nano-enabled products in construction are difficult to assess but appear to be relatively low;
  • Health risks from nanomaterials: According to the report, the potential health risks from nanomaterials are generally associated with the presence of nanoparticles and other nano-objects — the smaller particle size results in increased surface area and therefore increased reactivity.  The size of objects is not the only factor that influences risk, however, and there are wide variations between different materials in terms of their toxicity.  Information currently available about the health risks from nanomaterials is based on laboratory research rather than on cases of ill-health in workers.  The results of studies are often inconsistent or inconclusive due to variations in the methods and exact materials used;
  • Exposure to nanomaterials: Assessment of nanomaterial risk is difficult due to the uncertainties over the toxicity of particular nanomaterials and the lack of information on which nanomaterials are contained in which products.  There is some evidence that exposure to nanoparticles from engineered nanomaterials is likely to be low during demolition and construction processes as nanoparticles remain attached to fragments of the underlying matrix.  The evidence base is small, however, and material aging might also influence this, particularly in the demolition context.  Nanomaterial risk may not add substantially to existing construction health hazards (for example silica dust), and commonly used protective methods are likely to be appropriate in many cases;
  • Building on the findings of this research: Improved clarity will only occur if manufacturers take action to share information more readily and to follow voluntary guidance to provide greater detail in safety data sheets regarding any nano-objects.  Action by manufacturers to design products and materials that are intrinsically safer is the best route to minimize any risks to workers in the long term.   Further research is needed to assess the potential for worker exposure from nano-objects in construction and demolition and to consider the impact of secondary nanomaterials.

Germany Publishes Report on Scientific Stakeholder Meeting on Nanomaterials in the Environment

Posted in EU Member State, International, Legal/Regulatory Issues, Research

The German Environment Agency (UBA) has published a report summarizing the contents and outcomes of the October 2017 scientific stakeholder meeting on nanomaterials in the environment.  The meeting focused on the relevant regulatory results of recent German and European research projects on nanomaterials in the environment.  The stakeholder meeting provided a forum for participants to present the state of the knowledge on environmental nanosafety in a regulatory context, as well as to discuss the scientific results and their regulatory relevance between affected stakeholders.  The meeting included key note talks, platform presentations, and poster presentations.  A Knowledge Café provided the opportunity for participants to discuss selected topics with regard to environmental safety of nanomaterials in smaller groups.  The meeting closed with a discussion on the lessons learned highlighting the outcomes of the meeting from the perspectives of different stakeholders.

EEB Finds Estonian EU Council Presidency Failed to Fill Regulatory Gaps on Nanomaterials

Posted in International, Legal/Regulatory Issues

The European Environmental Bureau (EEB) announced on December 22, 2017, the availability of its assessment of the environmental performance of the Estonian Presidency of the European Union (EU).  The assessment is based on the results of “Ten Green Tests” laid out at the beginning of Estonia’s Presidency.  The eighth test is protecting the public from hazardous chemicals, including mercury.  The test includes encouraging the European Commission (EC) “to develop a new strategy for a non-toxic environment that builds on a strengthened implementation of [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation], fills regulatory gaps such as on nanomaterials and mixture effects, and sets out a way forward following the fitness checks of REACH and all other EU Chemical safety legislation.”  EEB notes that while there were positive steps taken, “the Estonian Presidency did not work on the regulatory gaps on nanomaterials, but rather encouraged its development as a new revolutionary technology in several events.”  The Ten Green Tests for the Bulgarian Presidency include reminding the EC “of its obligation under the Seventh Environmental Action Programme to develop by 2018 a new strategy for a non-toxic environment and urge that this builds on a strengthened implementation of REACH, fills regulatory gaps such as on nanomaterials and mixture effects, and sets out a way forward following the fitness checks of REACH and all other EU Chemical safety legislation.”

B&C Publishes Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018

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

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 4, 2018, their “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018.”  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and Acta offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018.  This 38-page document is chock-full of insights, predictions, and useful information.

NIOSH Plans to Support Implementation of WHO Guidelines to Protect Workers from Nanomaterials

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

On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “WHO Guidelines to Protect Workers from Nanomaterials.”  As reported in our December 13, 2017, blog item, the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  NIOSH Director John Howard, MD, describes the WHO Guidelines as “an important step in protecting workers worldwide from the potential risks of manufactured nanomaterials.”  Vladimir Murashov, Ph.D., Senior Scientist, NIOSH Office of the Director, chaired the Guideline Development Group.  NIOSH also contributed one of the eleven systematic reviews (Eastlake A, Zumwalde R, Geraci C.  “Can Control Banding be Useful for the Safe Handling of Nanomaterials? A Systematic Review.”  J Nanoparticle Res.) and participated in the external expert review.  The blog item states that NIOSH “plans to continue supporting this WHO effort at the guideline implementation phase, which will focus on turning these guidelines into practice.”