By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn May 23, 2018, the European Union Observatory for Nanomaterials (EUON) published an article entitled “Nordic information campaign on REACH-relevant regulation for nanomaterials.” According to EUON, Norway, Sweden, Finland, and Denmark are coordinating an information campaign through the N-Nano project group of the Nordic Chemical Working Group of the Nordic Council of Ministers. The goal… 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 EU Member State,International,Legal/Regulatory IssuesThe Belgian Federal Public Service for Public Health, Food Chain Safety and Environment has published the first annual report for nano substances registered for placement on the market in 2016. Although the report is available only in French and Dutch at this time, each contains an executive summary in English. Of the 475 registrations submitted,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesBelgium published in the January 15, 2018, Official Gazette an amendment to the Royal Decree regarding the placement on the market of substances manufactured at the nanoscale. Under the amendment, cosmetic products as defined by the July 2012 Belgian Royal Decree on cosmetic products are exempt from registration, and provisions regarding the registration of mixtures… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory Issues,ResearchThe German Environment Agency (UBA) has published a report summarizing the contents and outcomes of the October 2017 scientific stakeholder meeting on nanomaterials in the environment. The meeting focused on the relevant regulatory results of recent German and European research projects on nanomaterials in the environment. The stakeholder meeting provided a forum for participants to… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Occupational Health and Safety IssuesOn November 23, 2017, the French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) published a report summarizing studies and research completed in 2016 and in progress in 2017. According to the report, INRS action on manufactured nanomaterials has three objectives: (1) making knowledge on hazards available to the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products. The announcement, available in Swedish, states that the requirement will enter into force on January 1, 2018, and the first reports will… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory Issues,ResearchGermany’s Federal Environment Agency (UBA) published a November 2017 report entitled Considerations about the relationship of nanomaterial’s physical-chemical properties and aquatic toxicity for the purpose of grouping. The report notes that, based on the variety of existing nanomaterials with numerous modifications, “the effort of investigating environmental fate and effects will be tremendous.” As a result,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,InternationalOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,ResearchOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,Legal/Regulatory IssuesOn June 15, 2017, the European Commission (EC) published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market. Regulation (EC) No. 1223/2009 on cosmetic products requires the EC to publish a catalog of all nanomaterials used in cosmetics placed on the market, indicating the categories of products and the reasonably… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn June 7, 2017, Sweden notified the European Commission (EC) that it intends to amend the information requirements concerning the Swedish Chemicals Agency’s (KEMI) product register to require notifiers to provide information on nanomaterials contained in the product. Under the draft regulation, the requirement will apply to nanomaterials that have been intentionally added to the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesThe Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products to the Swedish products register by February 28, 2019. According to KEMI, the proposal is the same as presented in its 2015 report. Although the report… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory Issues,ResearchThe Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020. Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years. Action Plan Nanotechnology 2020 is geared towards the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,Legal/Regulatory IssuesOn October 13, 2016, the European Chemicals Agency (ECHA) announced that the Biocidal Products Committee adopted three opinions supporting the approval of active substances for use in biocidal products, including its first opinion on a nanomaterial. The Committee supports the use of pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated for insecticides, acaricides, and products… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesIn cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance. As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory Issues,ResearchGermany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials: Application safety and environmental compatibility. The report… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn June 1, 2016, the German Environment Agency (UBA) published a report entitled Nanomaterials in the environment: Current state of knowledge and regulations on chemical safety. The aim of the report is to outline the necessary further development of chemicals regulations for nanomaterials with regard to the environment from UBA’s perspective. The report is addressed… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,Legal/Regulatory IssuesThe Ministry for the Environment, Energy, and the Sea has posted a report, available only in French, entitled Éléments issus des déclarations des substances à l’état nanoparticulaire: Rapport d’etude 2015. The report analyzes nanomaterial registrations received in 2015 for reporting year 2014. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,Legal/Regulatory Issues,ResearchOn February 16, 2016, the Danish Environmental Protection Agency (Danish EPA) posted a report entitled Assessment of Nano-enabled Technologies in Cosmetics. The report reviews the available literature on nano-enabled technologies for cosmetic products, specifically addressing soluble nano-transporters. Accompanying the report is an appraised database summarizing the literature that formed the basis of the review. The… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn January 25, 2016, the Netherlands National Institute for Public Health and the Environment (RIVM) published a report that describes the content of a computer program that can be used for a risk assessment. According to RIVM, the NanoCosmetics tool will need to cover all aspects of the risk assessment, including: the physicochemical characterization of… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesThe Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices. RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years. … Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,InternationalThis month the Danish Environmental Protection Agency (Danish EPA) published the following publications, in English, concerning nanomaterials: Better control of nanomaterials — summary of the 4-year Danish initiative on nanomaterials: The “Better control of nanomaterials” initiative intended to create an overview of the possible risks of using nanomaterials, focusing on consumers and the environment. The… Continue Reading
