On June 28, 2021, Gov4Nano will hold a workshop on the GRACIOUS approach to the quality assessment of nanosafety data. GRACIOUS, a European Union (EU) H2020 project, has proposed a methodology to facilitate the evaluation of quality and completeness for sets of nanomaterial physicochemical and (eco)toxicological data based on established criteria, i.e., completeness, reliability, relevance, and adequacy. Gov4Nano states that this approach “is unique in the sense that it can automatically assess data quality and completeness starting from the available (meta)data, thus minimising the reliance on expert judgment.” The goal is to advance further the methodology in the H2020 Gov4Nano project and implement it as a functionality of the eNanoMapper database to enable real-time analysis of each included dataset. Gov4Nano is organizing the workshop to present its approach and collect opinions on key aspects of the quality assessment methodology. According to Gov4Nano, the workshop will cover:

  • The background and purpose of the GRACIOUS approach for data quality assessment;
  • The detailed methodology for assessing data quality and completeness of physicochemical and hazard data sets;
  • How the approach can help to address stakeholder needs; and
  • How certain aspects of the methodology and its implementation in the eNanoMapper database can be improved.

Nano4Gov states that data experts and risk assessors from industry, regulation, and academia should attend.

On June 3, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published an interview with Aurélie Niaudet, who is in charge of assessing the risks associated with physical agents. Niaudet states that nanomaterials have novel properties that “are highly sought after and increasingly exploited, but can also induce specific types of behaviour when interacting with humans or the environment.” After the human body is exposed, “there is then the question of the distribution and possible accumulation of these nanomaterials in the various organs.” According to Niaudet, “assessing the risks associated with nanomaterials involves three steps: agreeing on criteria for defining them, describing the main types of exposure, and understanding their behaviour and effects.” As reported in our previous blog items, ANSES’s work on nanomaterials has addressed titanium dioxide and nano silver, and recently included a review of the presence of engineered nanomaterials in food. ANSES also manages the R-Nano register and published an analysis in 2020 that “highlighted the poor quality of the reported data and led ANSES to issue recommendations to declaring companies and to the ministries to consolidate this register and increase its usefulness.” ANSES also coordinates the National Research Program for Environmental and Occupational Health, funding research on the effects and environmental fate of nanomaterials, as well as on monitoring population exposure.

To protect people, Niaudet recommends that, in addition to strengthening the regulatory framework, “it is also important to limit exposure of the population and the environment as a precautionary measure, by choosing safe products that are equally effective but free of nanomaterials.” Niaudet states that ANSES “reiterates its recommendation to restrict the use of products containing nanomaterials that are of little benefit to the population.”

On May 31, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Updating our language: why we should not paint all nanoforms with the same brush” by Chiara Venturini, Director General of the Nanotechnology Industries Association (NIA). Venturini reviews how the EU’s language has evolved. In 2011, the European Commission (EC) adopted a definition that describes a nanomaterial as a material at the nanoscale. In 2020, the EC amended Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and introduced the use of the term “nanoform” in safety data sheets (SDS). Venturini states that describing a specific “nanomaterial” only provides information about its elemental composition and size, but at the nanoscale, “that substance can adopt more than one different form (i.e. a nanoform), and, most importantly, those nanoforms can behave differently in terms of their physico-chemical properties.” According to Venturini, as explained in a recent NIA position paper, the EC’s transition from nanomaterial to nanoform “is a welcome development: the increased granularity in the information collected on nanoforms supports safe manufacturing; helps build up the knowledge base to identify the safest and most efficient forms of a substance to be used in products; and continuously improves the transparency required to gain end-user trust and foster confidence in nanotechnology.” Bergeson & Campbell, P.C. is a proud NIA member.

The European Chemicals Agency (ECHA), as part of the activities of the European Union (EU) Observatory for Nanomaterials (EUON), is conducting a stakeholder survey on the substances available as nanomaterials in the EU market. The survey includes a market study of the nanomaterials, including substances, uses, volumes, and key operators in the EU. According to EUON’s May 21, 2021, news item, the survey aims to provide an overview of the substances that are available as nanomaterials on the EU market, as well as insight into their main areas of application and approximate volumes. Stakeholders are invited to complete a short questionnaire on the nanomaterial substances they produce, trade, or use. Respondents can also indicate their willingness and consent to participate in upcoming focus groups that are intended to provide a “realistic” projection of the growth of the nanomaterials market over the next five years.

Registration has opened for a June 8, 2021, webinar held by the U.S. National Nanotechnology Initiative on “What We Know about NanoEHS: Human Health.” The webinar will feature experts from diverse disciplines who will share their perspectives on key findings on the effects of engineered nanomaterials on human health. Janet Carter, Senior Scientist, Occupational Safety and Health Administration (OSHA), will moderate. The panel will include:

  • Leanne Gilbertson, Assistant Professor, Department of Civil and Environmental Engineering, University of Pittsburgh;
  • Bruce Lippy, Nanomaterial research, The Center for Construction Research and Training (CPWR);
  • Christie Sayes, Associate Professor, Department of Environmental Science, Baylor University; and
  • Gavin West, Director, Nanomaterials Research, CPWR.

NNI has posted videos with closed captioning for two of its earlier webinars in the series, “What We Know about NanoEHS: How It All Began” and “What We Know about NanoEHS: Human Exposure.”

The U.S. National Nanotechnology Initiative (NNI) will hold a webinar on June 2, 2021, on nanosensors for food and agriculture. NNI states that nanotechnology-enabled sensors (nanosensors) “are promising tools to advance precision agriculture and support a safe and robust food supply chain, from farm to fork.” Panelists will discuss how the development and deployment of nanosensors could transform agriculture and food safety. They will highlight the state of the science, discuss community needs to push the science forward, and explore the challenges associated with bringing these technologies to market. Hongda Chen, National Program Leader, National Institute of Food and Agriculture (NIFA), U.S. Department of Agriculture (USDA), will moderate. The panel will include:

  • Evangelyn Alocilja, Professor, Biosystems and Agricultural Engineering, Michigan State University;
  • Jonathan Claussen, Associate Professor, Mechanical Engineering, Iowa State University;
  • Sam Nugen, Associate Professor, Food Science, Cornell University; and
  • Michael S. Strano, Carbon P. Dubbs Professor in Chemical Engineering, Massachusetts Institute of Technology.

The National Institute for Occupational Safety and Health (NIOSH) has published Current Intelligence Bulletin 70: Health Effects of Occupational Exposure to Silver Nanomaterials. According to the Current Intelligence Bulletin (CIB), NIOSH assessed potential health risk from exposure to silver nanomaterials by evaluating more than 100 studies of silver nanomaterials in animals or cells. The CIB states that recent studies in animals have demonstrated that biologic activity and potential adverse health effects are related to particle size. Adverse health effects of nanoscale silver particles, including early stage lung inflammation and liver hyperplasia, have been observed in rats following inhalation exposure. NIOSH considers these responses relevant to workers and estimated the risks to workers based on these animal data. NIOSH derived a recommended exposure limit (REL) for silver nanomaterials (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration. The CIB notes that NIOSH continues to recommend a REL of 10 μg/m3 as an eight-hour TWA for total silver (metal dust, fume, and soluble compounds, as Ag). NIOSH further recommends the use of workplace exposure assessments, engineering controls, safe work procedures, training and education, and established medical surveillance approaches to protect workers.

NIOSH “recommends that employers disseminate this information to workers and customers and requests that professional and trade associations and labor organizations inform their members about the potential hazards of occupational exposure to silver nanomaterials.” NIOSH RELs are non-mandatory occupational exposure limits (OEL), unlike the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL), which are codified and are legally enforceable.

The European Chemicals Agency (ECHA) is in the process of updating its guidance on the information requirements and chemical safety assessment (IR&CSA) for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA has developed three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R.7a, R.7b, and R.7c) to provide advice to registrants for use when preparing REACH registration dossiers that cover nanoforms. ECHA is updating two of the appendices, Appendix R7-1 to Chapter R.7a and Appendix R7-2 to Chapter R.7c. The draft update states that the advice provided focuses on specific recommendations for testing materials that are nanoforms of substances. Annex VI defines the terms “nanoform” and “set of similar nanoforms” and establishes the requirements for characterization of the identified nanoforms/sets of similar nanoforms of the substance. According to the draft update, part of the advice provided is not strictly nanoform specific and may also be applicable to other particulate forms of substances (e.g., relevance of dissolution rate). The draft update notes that when such advice has been included, “it is because it is considered especially relevant for nanoforms and should be part of the nanoform specific guidance.” In the absence of any suitable specific provision (either because the endpoint is not relevant for nanoforms, because the guidance already provided is considered to be equally applicable to nanoforms as to non-nanoforms, or because more research or adaptation is needed before developing advice), no additional guidance for the information requirement has been included.

The appendix intends to provide advice specific to nanoforms and does not preclude the applicability of the general principles given in Chapter R.7a (i.e., the parent guidance). When no advice has been given for a specific endpoint, the advice provided in the parent guidance should be followed. ECHA notes that the appendix and its parent guidance provide specific guidance on meeting the information requirements set out in REACH Annexes VI to XI. General information for meeting the information requirements, such as collection and evaluation of available information and adaptation of information requirements, is available in Chapters R.2 to R.5 of the Guidance on IR&CSA.

ECHA states that when considering the use of data already available, the Guidance on information requirements and chemical safety assessment — Appendix R.6-1 for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals “may be useful as it provides an approach on how to read-across the hazard data between nanoforms (and the non-nanoform) of the same substance.”

On May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive.  The European Commission (EC) asked EFSA to update its safety assessment of the food additive titanium dioxide (E171).  EFSA states:  “Taking into account all available scientific studies and data, the Panel [on Food Additives and Flavorings] concluded that titanium dioxide can no longer be considered safe as a food additive.  A critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles.  After oral ingestion, the absorption of titanium dioxide particles is low, however they can accumulate in the body.”  According to EFSA, the Panel applied for the first time the 2018 EFSA Scientific Committee guidance on nanotechnology to the safety assessment of food additives.  EFSA states that “[t]itanium dioxide E 171 contains at most 50% of particles in the nano range (i.e. less than 100 nanometres) to which consumers may be exposed.”  EFSA notes that its evaluation is related to the risks of titanium dioxide used as a food additive, not to other uses.  EFSA has not banned E171.  Any legislative or regulation decisions on the authorizations of food additives are the responsibility of the EC and member states, who will now “reflect on EFSA’s scientific advice and decide upon any appropriate regulatory measures or advice for consumers.”

In 2011, the European Commission (EC) adopted a Recommendation on the definition of a nanomaterial.  The Recommendation invites member states, European Union (EU) agencies, and economic operators to use the definition “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies.”  The EC is now reviewing its Recommendation.  It has launched a targeted stakeholder consultation to update, test, and verify the preliminary findings of this comprehensive review, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the EU.  The EC states that the consultation aims to:

  • Verify or complement the findings of the review;
  • Gather precise and structured technical feedback on the identified technical elements of the definition that could be addressed by changes to the definition; and
  • Gather input on the impact of the changes under consideration: would they influence (different) classification of specific materials placed or emerging on the market?

The consultation includes a summary of the interim findings and links to relevant documents and reports, and provides a short rationale with every question.  The online consultation is open until June 30, 2021.