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 Posts Comments Received on Draft Regulation to Amend REACH Annexes to Address Nanomaterials

Posted in International, Legal/Regulatory Issues

As reported in our October 11, 2017, blog item, on October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances.  Comments were due November 6, 2017.  The EC has posted the comments online.  In all, 36 comments were submitted.  The comments received fall into the following categories:

  • Business associations, including the Nanotechnology Panel of the American Chemistry Council; Fachverband der chemischen Industrie (FCIO); the Association of Synthetic Amorphous Silica Producers (ASASP); the Japan Business Council in Europe (JBCE); the European Council of the Paint, Printing Ink and Artists’ Colors Industry (CEPE); the Nanotechnology Industries Association (NIA); the German Paint and Printing Ink Association (VdL); the Japan Chemical Industry Association; Eurometaux; PlasticsEurope Deutschland e.V.; the German Chemical Industry Association (VCI); Verband der Mineralfarbenindustrie e.V. (VdMi); and the European Chemical Industry Council (Cefic);
  • Public authorities, including the French Agency for Food, Environmental and Occupational Health and Safety (ANSES); and the Federal Public Service (FPS) Health, Food Chain Safety and Environment, DG Environment — Risk Management of Chemical Substances;
  • Non-governmental organizations, including Association de veille et d’information civique sur les enjeux des nanosciences et des nanotechnologies (Avicenn); the European Environmental Bureau (EEB); Eurogroup for Animals; ZERO — Associação Sistema Terrestre Sustentável; and the PETA International Science Consortium Ltd.;
  • Company/business organizations, such as Evonik Industries AG; BASF SE; SwedNanoTech; Eckart GmbH; Merck KGaA; the European Association of Craft, Small and Medium-Sized Enterprises (UEAPME); and Dane Color UK Ltd.;
  • Environmental organizations, including GRACE GmbH; Inter-Environnement Wallonie (IEW); the European Environmental Citizens Organization for Standardization (ECOS); and the Center for International Environmental Law (CIEL);
  • Academic/research institutions such as the Society for Institutional Analysis (sofia); and
  • Other, such as Graphene Flagship; and Wirtschaftskammer Österreich (WKÖ).

ECHA Will Hold Webinar on Updated REACH Guidance for Nanomaterials

Posted in International, Legal/Regulatory Issues

On November 30, 2017, the European Chemicals Agency (ECHA) will hold a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  ECHA states that the main focus will be on the registration and read-across of nanoforms, but the webinar will also cover updates for information requirements for human health and the environment.  According to the agenda, time will be reserved at the end to answer questions.

Presentations and Report Posted for Conference on Standardization for Nanotechnologies and Nanomaterials

Posted in International, Research

In October 2017, the presentations and report for the June 20, 2017, Second European Conference on “Standardization for Nanotechnologies and Nanomaterials:  Reliable data for an effective management of nanomaterials” were posted.  The European Committee for Standardization (CEN)/Technical Committee (TC) 352 “Nanotechnologies,” together with the CEN-European Committee for Electrotechnical Standardization (CENELEC) Management Center, the European Commission (EC), and the European Free Trade Association, organized the Conference as part of its coordinating role in the implementation of Mandate M/461, “Standardization activities on nanotechnology and nanomaterials.”  Round tables were held on nanosafety; nanoparticle aerosol measurements; quality/relevance of data in nanomaterial databases and registries; identification of nanomaterials; nanomaterial exposure and risk assessment; and the impact of research projects on standardization.  According to the Conference report, an additional conference within the M/461 framework will be held by the end of 2018.

NSF NSE Will Hold Grantees Conference on Progress in Nanotechnology

Posted in Federal, Research, United States

Nanotechnology

 

The National Science Foundation (NSF) Nanoscale Science and Engineering (NSE) grantees conference on progress in nanotechnology will be held December 12-13, 2017.  The conference will highlight the research and education activities of ongoing NSE grant projects.  It will include a combination of keynotes, panels, posters, program information sessions, discussions of research trends, and principal investigator meetings with NSF program directors.  The conference will address the following themes:

  • Day 1: Progress in foundational nanotechnology and infrastructure — Nanoscale modeling and simulation and use of big data, nanotechnology based-devices and systems by design, two-dimensional materials and quantum phenomena in nanoscale systems, nano-research centers, and the National Nanotechnology Coordinated Infrastructure (NNCI) and nanoHUB; and
  • Day 2: Progress in grand challenges and convergence — Advanced nanomanufacturing (convergence with bio, cyber, cogno, and artificial intelligence), brain-like cognitive engineering systems, education challenges, and societal aspects.

Germany Holds Expert Dialogue on Nanotechnologies in the Automotive Sector

Posted in EU Member State, International

On September 26-27, 2017, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) held an Expert Dialogue regarding the opportunities and risks of the application of nanotechnologies in the automotive sector.  The Expert Dialogue provided an overview of current and future applications of nanomaterials in automobiles.  A number of the presentations are available online, in German.  Since 2006, the NanoDialogue has been conducted as part of the German government’s Nano Action Plan, and BMUB has the lead responsibility for it.  The goal is to support an exchange of ideas among stakeholders on the opportunities and risks of nanotechnologies to help promote the responsible and sustainable use of nanomaterials.  Information on the Expert Dialogue on the opportunities and risks of the application of nanotechnologies in the construction sector is available in our June 26, 2017, blog item.

ECHA Seeks Case Studies to Feature at SETAC Europe

Posted in International, Research

The European Chemicals Agency (ECHA) will have six sessions at the Society of Environmental Toxicology and Chemistry (SETAC) Europe, which will be held May 13-17, 2018, in Rome, Italy.  ECHA’s sessions will include one on recent developments in regulatory science and environmental risk assessment of nanomaterials.  To support the session, ECHA welcomes abstracts on experience gained in environmental hazard and risk assessment of nanomaterials illustrated by case studies.  Presentations may also cover the implementation of existing (or new) test methods, grouping and read-across approaches specific to nanomaterials, discussion on the further need for guidance and standard methods in relation to the regulatory needs, and available or innovative communication tools.  The session will focus on how to produce adequate and reliable information suitable for regulatory purposes and on innovative approaches to communicate the risks and benefits of nanomaterials beyond the scientific community.  Abstracts are due November 29, 2017.

OECD Publishes Analysis of Survey on Consumer and Environmental Exposures to Manufactured Nanomaterials

Posted in International, OECD, Research

The Organization for Economic Cooperation and Development published a November 7, 2017, report entitled Consumer and Environmental Exposure to Manufactured Nanomaterials — Information used to characterize exposures:  Analysis of a Survey.  The report provides a “light analysis” of the results of a Working Party on Manufactured Nanomaterials (WPMN) survey on consumer and environmental exposures to manufactured nanomaterials.  The survey, initiated in 2015, was designed to collect information used to characterize consumer and environmental exposures for human and ecological risk assessment.  WPMN intended the survey to be used as a tool to inform potential avenues for future research and collaboration in the area of exposure assessment as it relates to manufactured nanomaterials.  The survey collected data on the importance and availability of information and data in six broad categories:  (1) material characterization; (2) production, use, and market; (3) releases to the environment (direct, indirect, and via consumer use); (4) environmental fate and transport; (5) exposure assessment (direct and indirect); and (6) exposure control and mitigation.  The report presents an analysis of the survey data within each of these categories and highlights the importance of multiple types of information, ranging from material characterization to environmental release and exposure analysis.  The report also contains a more detailed analysis of the issues in each of the six categories, with respect to perceived importance, data availability, and framework.  The report recommends potential avenues for future work by the OECD; these are grouped into the following three themes, based on linkages identified by the survey:

  • Theme 1 includes projects related to the development and use of exposure models for manufactured nanomaterials. This includes information on production/import quantities, exposure pathways, and exposure measurement in the environment, for consumers and of emissions from consumer articles and products;
  • Theme 2 includes projects on issues related to environmental behavior and transformation, and includes information on nanomaterials released from the use of articles and products to the environment; and
  • Theme 3 includes projects related to the material characterization of manufactured nanomaterials and includes data on the physical form of nanomaterials in products.

According to the report, recommended next steps include obtaining feedback on the direction proposed for future OECD projects and identifying specific projects that can be undertaken by WPMN.  Follow up on selected survey responses is also recommended to determine the feasibility and applicability of data for future activities

BfR Publishes Q&A Regarding Study on Fate and Effects of Tattoo Pigments in Human Skin

Posted in EU Member State, International, Research

On October 12, 2017, the German Federal Institute for Risk Assessment (BfR) published questions and answers (Q&A) regarding a study on whether nanometric pigments from tattoo inks can permanently accumulate in lymph nodes.  BfR states that by using X-rays from a particle accelerator in Grenoble, it discovered where the pigments accumulate in the tissue.  According to BfR, until now, the accumulation of pigments from tattooed persons has been known by optical coloring of the lymph nodes only, as they often had been of the same color as the tattoo.  Both skin and lymph nodes have now been characterized in terms of their chemical composition, pigment identity, and size.  The study, “Synchrotron-based ν-XRF mapping and μ-FTIR microscopy enable to look into the fate and effects of tattoo pigments in human skin,” was published in September 2017.

UK Parliamentary Office Publishes Note on Risk Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues

On October 5, 2017, the United Kingdom’s (UK) Parliamentary Office of Science and Technology (POST) published a POSTnote entitled “Risk Assessment of Nanomaterials.”  According to POST, key points include:

  • Nanomaterial uses and benefits are diverse and increasing, such as in cosmetics, textiles, electronics, and medicine;
  • Current regulatory frameworks applicable to nanomaterials within the UK are mainly set at the European Union (EU) level;
  • There are some indications of potential health and environmental risks, but conclusions are limited by insufficient long-term evidence and difficulties in translating results from the laboratory to the real world;
  • Post-Brexit, the UK will need to establish regulatory frameworks for nanomaterials; and
  • The wide range of forms and uses of nanomaterials present many regulatory challenges, such as ensuring consistency in testing and finding valid ways of grouping nanomaterials so that their risks may be assessed more efficiently.

 

ISO Publishes Standard on Use and Application of Acellular In Vitro Tests and Methodologies to Assess Nanomaterial Biodurability

Posted in International, Research

In October 2017, the International Organization for Standardization (ISO) published standard ISO/TR 19057:2017, “Nanotechnologies — Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability.”  The standard reviews the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands in simulated biological and environmental media.  It is intended to focus more on acellular in vitro methodologies implemented to assess biodurability and, therefore, excludes the general review of relevant literature on in vitro cellular or animal biodurability tests.