By Carla N. Hutton and Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe 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 The draft guidance is being reviewed by a Partner Expert Group (PEG).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. … Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,ResearchThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe Environment Council of the Council of the European Union (EU) met on October 9, 2018. According to the outcome of the Council meeting, the items debated under any other business included the “Berlin Declaration” on nanomaterials, submitted by the German delegation and supported by the French and Luxembourg delegations. The Berlin Declaration summarizes the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,OECD,ResearchOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,OECD,ResearchOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in Federal,International,Legal/Regulatory Issues,OECD,ResearchThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory Issues,ResearchThe 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,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials. According to the European Chemicals Agency’s (ECHA) press release, the amendments address the knowledge gap regarding which substances registered under REACH are placed on the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn April 4, 2018, the European Chemicals Agency (ECHA) announced that it has launched a public consultation on its draft Strategic Plan for 2019-2023. ECHA states that by 2023, it “aims to become the main source of scientific knowledge and technical know-how on chemicals, serving a wide range of [European Union (EU)] policies and stakeholders.” … Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in InternationalThe European Chemicals Agency (ECHA) announced on March 15, 2018, a new website, “Chemicals in our life.” The website is available in 23 European Union (EU) languages and “provides useful information on the benefits and risks of using chemicals and explains how the EU legislation on chemicals protects us.” In its press release, ECHA notes… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn March 5, 2018, the European Commission (EC) announced the availability of a Communication to the European Parliament (EP), the Council of the European Union (EU), and the European Economic and Social Committee on the operation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Communication includes proposals intended to facilitate further… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesAs reported in our June 19, 2017, blog item, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market. On February 5, 2018, the European Union Observatory for Nanomaterials (EUON) published a table linking nanomaterials listed in the catalog to their Registration, Evaluation, Authorization and Restriction… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesDuring 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn November 30, 2017, the European Chemicals Agency (ECHA) held 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. The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements… Continue Reading
