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
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Chemicals Agency (ECHA) announced on September 27, 2017, that the Committee for Risk Assessment (RAC) concluded on ten opinions for harmonized classification and labeling (CLH), including titanium dioxide. In May 2016, France submitted a CLH proposal for titanium dioxide, stating that titanium dioxide should be considered as being potentially carcinogenic to humans when… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn June 30, 2017, the European Chemicals Agency (ECHA) Board of Appeal published two decisions related to nanomaterials. In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.” In Cases A-014-2015 and A-015-2015, registrants appealed the same… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,Occupational Health and Safety Issues,ResearchOn June 14, 2017, the European Chemicals Agency (ECHA) announced the launch of the European Union (EU) Observatory for Nanomaterials (EUON). ECHA states that EUON “offers a unique web-based information point with factual and neutral content about nanomaterials on the EU market.” EUON is targeted at a wide audience, including consumers, workers, regulators, and scientists. … Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn June 9, 2017, the European Chemicals Agency (ECHA) announced that the Committee for Risk Assessment (RAC) “concluded that the available scientific evidence meets the criteria in the [Classification, Labeling and Packaging (CLP)] Regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.” In May 2016, France submitted a… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA published two new guidance documents: Nano-specific appendix to Chapter R.6 of the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Chemicals Agency (ECHA) has created a web page for the Nanomaterials Expert Group (NMEP), which was created in October 2012. NMEP aims to seek common ground among experts on scientific and technical issues regarding the implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, the Classification, Labeling, and Packaging (CLP)… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn March 2, 2017, the European Chemicals Agency (ECHA) announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossier evaluation for titanium dioxide. In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human… Continue Reading
