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The European Chemicals Agency (ECHA) is evaluating the function of the European Union (EU) Observatory for Nanomaterials (EUON). As part of its evaluation, ECHA is conducting a survey to collect responses from EUON website visitors and stakeholders. The survey includes questions concerning evaluation criteria such as use, effectiveness, coherence, EU-added value, and utility. The survey notes that under an ongoing legislative proposal, the European Commission (EC) foresees setting up a common...

On June 12, 2024, the European Chemicals Agency (ECHA) announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas where scientific research is needed to protect human health and the environment from hazardous chemicals. The report addresses micro- and nano-size materials, stating: Why further research is needed: Critical test methods to address the human and environmental hazard and risk assessment of nanomaterials are still missing....

The European Union (EU) Observatory for Nanomaterials (EUON) announced on February 5, 2024, that the European Chemicals Agency (ECHA) has published two new ex-ante publicity notices for two service contracts: “Survey on state of the art of carbon-based nanomaterial detection and quantification in environmental and biological matrices”: ECHA expects to launch a call for tender to initiate an EUON systematic survey on the current state of the art for carbon-based nanomaterial detection and...

POSTED IN INTERNATIONAL, LEGAL/REGULATORY ISSUES, OECD The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on...

The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. ECHA notes that the Partner Expert Group (PEG) members...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on December 7, 2022, publication of a June 2022 report by the European Chemicals Agency (ECHA) entitled Assessment of the potential impact of graphene, graphene oxide and other 2D materials on health, and the environment. Commissioned by EUON, the report provides a systematic review and critical assessment of the health and environmental effects of graphene, graphene oxide, and other two-dimensional (2D)...

The European Chemicals Agency (ECHA) has made recent improvements to its chemicals database. For nanomaterials on the European Union (EU) market, the details page of the database now includes information on the nanomaterial form characterization. According to ECHA, the results page also has an improved display, allowing better access to the data and improved user interaction options. Other improvements to the database include: Properties of concern on infocards now link to more information...

The European Chemicals Agency (ECHA) announced on March 22, 2022, that the Committee for Risk Assessment (RAC) recently adopted ten opinions on harmonized classification and labeling (CLH), including an opinion for multi-walled carbon nanotubes (MWCNT). According to the annex to ECHA’s announcement, MWCNTs possess properties that make them useful for industrial applications in new or enhanced materials and products (e.g., tensile strength, electrical and thermal...

The European Chemicals Agency (ECHA) has published a January 2022 update to the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification (version 2.0). The main changes to the document include additional guidance on the joint submission of data, clarifications regarding the need for one data set per nanoform or set of nanoforms, and information on the registration of sets of nanoforms versus single nanoforms. Changes to the Appendix are limited to...

The European Chemicals Agency (ECHA) has posted a new set of questions and answers (Q&A) for downstream users of nanoforms. The new Q&As, posted under Section I, include: What are my obligations as a downstream user purchasing, modifying or creating nanoforms? How do I know when I have created a new nanoform from a supplied substance? How do I know whether the nanoform I have created is covered by my supplier if I received [a safety data sheet (SDS)] with an exposure scenario...

On July 15, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “The ECHA Nanomaterials Expert Group (NMEG)” by Frank Le Curieux, Scientific Area Leader for Genotoxicity at the European Chemicals Agency (ECHA). Le Curieux provides a brief summary of the creation of NMEG and its history. NMEG’s current mandate is to provide informal and non-binding scientific and technical advice on questions related to nanomaterials or nanoforms of substances...

The European Chemicals Agency (ECHA) has launched a call for tenders to perform a study “Assessment of the potential impact of graphene, graphene oxide and other 2D materials on health, and the environment” as part of the European Union (EU) Observatory for Nanomaterials (EUON). According to the description, the goal of the study is to conduct a systematic literature review of the health and environmental effects of graphene, graphene oxide, and other two-dimensional (2D) materials, based on...

The European Chemicals Agency (ECHA) has begun a public consultation on a harmonized classification and labeling (CLH) proposal for multi-walled carbon tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nanometers (nm) to < 3 micrometers (μm) and a length ≥ 5 μm and aspect ratio > 3:1, including multi-walled carbon nanotubes (MWC(N)T). The dossier submitted by Germany’s Federal Institute for Occupational Safety and Health (BAuA) states that the...

On June 26, 2019, the Council of the European Union (EU) announced that it adopted conclusions on chemicals intended to “offer political guidance on the development of a sustainable EU chemicals policy strategy.”  The June 26, 2019, press release notes that the conclusions address in particular the topics of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, endocrine disruptors, nanomaterials, and pharmaceuticals.  According to the...

The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have received a draft assessment of glyphosate carried out by four European Union (EU) member states and have begun to consider the findings. According to ECHA’s June 15, 2021, press release, the national authorities of France, Hungary, the Netherlands, and Sweden -- known as the Assessment Group of Glyphosate (AGG) -- examined all the evidence submitted by the companies that are seeking renewed approval to...

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...

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...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 20th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in September 2020.  Below are highlights from the Tour de Table: Canada: Canada is developing a nanomaterial...

On January 20, 2021, Health Care Without Harm (HCWH) Europe and 12 other health, environment, and justice organizations sent a letter to Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA) “seeking clarifications on both the applicable legal framework and risk management measures in place, for nano/biocidal-treated articles in the context of the current COVID-19 pandemic.”  The letter states that “[a]s a result of laboratory tests supposedly showing...

The European Union (EU) Observatory for Nanomaterials (EUON) is conducting a web satisfaction survey.  EUON provides information on the safety, innovation, research, and uses of nanomaterials on the EU market.  It is intended for stakeholders developing policies in the area, consumers, industry representatives, and non-governmental organizations.  EUON is funded by the European Commission (EC) and hosted and maintained by the European Chemicals Agency (ECHA).  Information from the survey...

Beginning November 2, 2020, following the next release of the International Uniform Chemical Information Database (IUCLID), companies will be required to provide a name for the nanoforms or sets of nanoforms of their substance when registering nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  According to an item in the European Chemicals Agency’s (ECHA) September 30, 2020, weekly news, companies that have already...

The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA) substance evaluation conclusion document for multi-walled carbon nanotubes (MWCNT), synthetic graphite in tubular shape and tangled.  The conclusion provides a summary of how the information on the substance can be used for the purposes of regulatory risk management. Concern(s) Subject to Evaluation MWCNTs were originally selected for substance evaluation to...

The Nanotechnology Industries Association (NIA) will hold a webinar on July 7, 2020, on “Introducing the NanoHarmony project.”  Funded through Horizon 2020, NanoHarmony began on April 1, 2020.  NanoHarmony brings together 14 expert partners from ten European countries and will work alongside the Organization for Economic Cooperation and Development (OECD) and European Chemicals Agency (ECHA) to support the development of test guidelines and guidance documents for...

On May 5, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “NanoApp helps navigate legal obligations under REACH.”  Olivier de Matos, Secretary General of the European Center for Ecotoxicology and Toxicology (ECETOC), describes the web-based app that was designed to help registrants follow the European Chemicals Agency’s (ECHA) guidance on sets of nanoforms.  According to de Matos, the app primarily covers the “Appendix for...

The European Union (EU) Observatory for Nanomaterials (EUON) posted an article on April 6, 2020, announcing the availability of a study that found a lack of data on female fertility.  The study, A critical review of studies on the reproductive and developmental toxicity of nanomaterials, was commissioned by the European Chemicals Agency (ECHA) and carried out by DHI A/S and the Danish National Research Center for the Working Environment.  The scope of this project was to...

The European Chemicals Agency (ECHA) issued a press release on February 24, 2020, stating that it has received a low number of registration dossiers for nanomaterials.  ECHA states that it has received only 95 unique submissions for 36 substances covering nanoforms according to the updated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements.  ECHA expected to receive updated registrations for approximately 300 substances, based...

On February 24, 2020, the European Chemicals Agency (ECHA) will hold a webinar on “Registering nanoforms:  practical advice.”  As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Beyond this date, companies must have a registration compliant with these requirements to manufacture or import...

As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA organized a webinar on November 12, 2019, on the revised annexes and how companies can prepare to meet the new requirements.  ECHA states that the first part of the webinar explained what a nanoform is and how to build a set of similar...

The European Chemicals Agency (ECHA) announced on December 3, 2019, that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification.  According to ECHA, it aligns ECHA’s guidance with the amended annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation that will apply to nanomaterials and enter into force on January 1, 2020.  The new guidance document explains the term nanoform,...

The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH.  As...

On November 12, 2019, the European Chemicals Agency (ECHA) will hold a webinar on the amended information requirements for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  As reported in our December 4, 2018, blog item, the European Commission (EC) announced on December 3, 2018, that it adopted amendments to several REACH Annexes to clarify the information requirements for nanomaterials.  The amended...

On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges.  The objectives of the study were to: Collect existing definitions of generations of...

The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market.  The first item, posted on September 16, 2019, is “EUON:  past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA).  As reported in our...

The European Chemicals Agency (ECHA) announced on July 3, 2019, that several new features and improvements are now publicly available in its chemicals database, including new information in substance Infocards.  ECHA has updated the substance Infocards with a new nanomaterial form section that shows whether the substance is placed on the European Economic Area (EEA) market in nanoform and provides links to the European Union (EU) Observatory for Nanomaterials (EUON).  As...

The European Chemicals Agency (ECHA) has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification.  The draft guidance is being reviewed by a Partner Expert Group (PEG).  The draft Appendix has been developed to provide advice to registrants preparing registration dossiers that cover nanoforms.  It states that the advice provided covers nanospecific advice for issues related with registration and...

The February 2019 issue of the European Chemicals Agency’s (ECHA) Newsletter includes an interview with Eva Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham and leader of the European Union (EU) NanoSafety Cluster Coordination Team, on research on the safety of nanomaterials.  The NanoSafety Cluster coordinates the funding of research projects at the European level that address the safety aspects of nanomaterials and the related...

On February 18, 2019, the European Union (EU) NanoSafety Cluster (NSC) announced that it is supporting the Malta Initiative by linking various projects with activities developed within the Malta Initiative.  According to NSC’s website, the Malta Initiative began in 2017, when Germany approached the EU Directorate-General (DG) for Research and Innovation to request political and financial support to develop and amend Organization for Economic Cooperation and Development...

The February 2019 issue of Computational Toxicology includes an article entitled “Grouping of multi-walled carbon nanotubes to read-across genotoxicity:  A case study to evaluate the applicability of regulatory guidance.”  The article describes a case study, performed by scientists at the European Commission’s (EC) Joint Research Center (JRC), to explore and illustrate read-across of genotoxicity data by following the “Recommendations for nanomaterials applicable to the Guidance on...

The European Chemicals Agency (ECHA) announced on January 30, 2019, that it has submitted a restriction proposal for microplastic particles that are intentionally added to mixtures used by consumers or professionals.  According to ECHA, if adopted, the restriction could reduce the amount of microplastics released to the environment in the European Union (EU) “by about 400 thousand tonnes over 20 years.”  ECHA states that its assessment found that intentionally added...

The European Union (EU) Observatory for Nanomaterials (EUON) provides information on nanomaterials to a wide audience on subjects including safety, innovation, and research.  It also covers the existing EU legislation on nanomaterials and the presence and uses of specific substances on the EU market.  EUON is currently conducting a survey to allow stakeholders to express their views on how EUON is performing and how it could be developed to meet their needs better.  EUON is funded by the...

The European Chemicals Agency (ECHA) announced on December 19, 2018, that it published several new substance evaluation conclusion documents, including one for silver.  Silver was added to the Community Rolling Action Plan (CoRAP) list in 2014 and evaluated by the Netherlands.  According to the substance evaluation conclusion and evaluation report, silver was originally selected for substance evaluation to clarify concerns about nanoparticles/ecotoxicity of different forms of the...

The European Commission (EC) announced on December 3, 2018, that it adopted amendments to several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The EC notes that REACH “has always applied to nanomaterials, but did not contain specific provisions for them, which is why companies often did not know how to register these ‘substances in nanoform.’”...

The Swedish National Platform for Nanosafety (SweNanoSafe) has posted a report on the European Chemicals Agency’s (ECHA) November 8-9, 2018, workshop on the upcoming Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) information requirements for nanomaterials.  As reported in our April 26, 2018, blog item, the European Commission (EC) REACH Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements...

On September 12-13, 2018, the Organization for Economic Cooperation and Development (OECD), NanoReg2, and GRACIOUS hosted a “Scientific Workshop:  Grouping of Nanomaterials.”  The Workshop brought together 120 nanotechnology specialists from Europe, North America, and Asia to discuss a bottleneck in nanomaterials development and testing.  The agenda and the following slides from the workshop have been posted online: Welcome slides. Session 1: Nanomaterial Grouping: ...

On September 21, 2018, the Organization for Economic Cooperation and Development (OECD) announced four new case studies on integrated approaches for testing and assessment (IATA), including a Case Study on Grouping and Read-Across for Nanomaterials — Genotoxicity of Nano-TiO2.  The European Union (EU) Joint Research Center (JRC) developed the case study for the genotoxicity of nano-titanium dioxide (TiO2) for illustrating the practical use of IATA.  The case study applies the...

The September 2018 issue of the ECHA Newsletter includes an article entitled “Are the new REACH information requirements for nanos relevant for you?” written by Jenny Holmqvist, Coordinator for Nanomaterials for the European Chemicals Agency (ECHA).  As reported in our April 26, 2018, blog item, the European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to...

On July 17, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) announced the availability of a study that it commissioned, Critical review of the relevance and reliability of data sources, methods, parameters and determining factors to produce market studies on manufactured nanomaterials on the EU market.  The study presents the results of a critical review of the relevance and reliability of data sources, methods, parameters, and determining factors to...

The Organization for Economic Cooperation and Development (OECD) published a May 17, 2018, document entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The document compiles information provided by delegations for the February 2018 OECD Working Party on Manufactured Nanomaterials (WPMN) meeting on current developments on the safety of manufactured nanomaterials.  It aims to summarize relevant information on activities related to...

The May 2018 ECHA Newsletter includes an interview with Robert Johansson, Head of the Swedish Chemicals Agency’s (KEMI) Chemical Statistics and Registries Unit.  As reported in our December 7, 2017, blog item, KEMI has established a mandatory reporting scheme to obtain information on the quantities and types of nanomaterials used in Sweden, with the first reports due in February 2019.  According to Johansson, “[t]his information can then provide a basis for...

The European Union Observatory for Nanomaterials (EUON) has posted the workshop report from the March 9, 2018, Stakeholder Dialogue meeting.  According to the report, the annual meeting focused on providing an update on EUON and allowing stakeholders an opportunity to share their views on expectations on the future development of EUON.  During his welcome address, Jukka Malm, European Chemicals Agency (ECHA), acknowledged that some stakeholders preferred a mandatory register...