By Carla N. Hutton and Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn July 12, 2019, the European Food Safety Authority (EFSA) published in the EFSA Journal its “Scientific opinion on the proposed amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution.” The opinion addresses the assessment of data provided by interested… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesThe Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Nano-registries: Country-specific Solutions for Nano-regulation.” While the European Union (EU) has declined to create an EU-wide nano-registry, several EU Member States have adopted their own nano-registries. Belgium and France created stand-alone nano-registries, but Norway and Sweden added a… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn July 5, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) released an ex-post evaluation report prepared by the Evaluation Working Group of the European Chemicals Agency (ECHA) with the support of PricewaterhouseCoopers. The ex-post evaluation assessed EUON against the following criteria: effectiveness; coherence; EU added-value; and utility. The recommendations by the external evaluators… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Union (EU) Observatory for Nanomaterials (EUON) announced on July 3, 2019, that it has added a new search tool for nanomaterials to its website. According to EUON, it will enable regulators to form a better view of available data and give consumers access to chemicals safety information. The search tool combines data submitted… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn 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… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn June 25, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two requests for scientific opinions: hydroxyapatite (nano) and copper (nano) and colloidal copper (nano). According to the mandate for hydroxyapatite (nano), the EC received 17 notifications for cosmetic products containing hydroxyapatite in nano form. The EC states that according to… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,OECD,ResearchThe European Commission’s (EC) Joint Research Center (JRC) published a press release on June 6, 2019, regarding its contribution to the Organization for Economic Cooperation and Development’s (OECD) development of Test Guidelines for the safety assessment of nanomaterials. According to the press release, scientists from JRC have actively participated in discussions of the OECD’s Working… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesThe Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Safe-by-Design — The Early Integration of Safety Aspects in Innovation Processes.” The Dossier presents an overview of the concepts behind the idea of integrating health or environmental safety considerations in the design of materials, products, or processes, focusing… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Commission (EC) published on June 11, 2019, a call for data on the following ingredients used in cosmetic products: gold (nano); colloidal gold (nano); platinum (nano); colloidal platinum (nano); copper (nano); and colloidal copper (nano). The EC states that it has concerns about the use of nano forms of gold, colloidal gold, platinum,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchThe International Organization for Standardization (ISO) has published standard ISO/TS 20660:2019, “Nanotechnologies — Antibacterial silver nanoparticles — Specification of characteristics and measurement methods.” The standard provides guidance for the specification of characteristics and relevant measurement methods for silver nanoparticles in powder or colloidal forms that are intended for antibacterial applications in nanotechnology. ISO states that… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,OECDAs reported in our May 30, 2019, blog item, the Organization for Economic Cooperation and Development (OECD) recently published several reports in its Series on the Safety of Manufactured Nanomaterials, including Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. The Tour de Table compiles information provided by delegations on the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,OECD,ResearchThe Organization for Economic Cooperation and Development (OECD) has posted the following reports in its Series on the Safety of Manufactured Nanomaterials: 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 19th meeting of the OECD Working… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn May 16, 2019, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of eREACHNano, “a new web tool focused on helping small and medium-sized companies that may lack sufficient in-house expertise on the regulation covering nanomaterials.” The web tool explains the data requirements for nanoforms according to the guideline documents of the Registration,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Research,United StatesThe European Commission’s (EC) Joint Research Center (JRC) announced on May 10, 2019, publication of an article entitled “Measuring particle size distribution of nanoparticle enabled medicinal products, the joint view of EUNCL and NCI-NCL. A step by step approach combining orthogonal measurements with increasing complexity” in the April 10, 2019, issue of the Journal of… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe Nanotechnology Industries Association (NIA), a “cross-sectoral, responsible voice for nanotechnology value chains and the global commercial eco-system,” hosts frequent webinars and then posts the webinars on its YouTube channel. On May 7, 2019, NIA held a webinar on “Nano in Action: Nanosafety.” Participants heard about the latest research and support tools intended to advance… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,ResearchOn April 29, 2019, the German Federal Institute for Risk Assessment (BfR) announced InnoMat.Life, a joint research project to establish criteria for an efficient assessment of the human health and environmental risks of novel (nano) materials. The Federal Ministry of Education and Research is providing 2.22 million euro to fund the project, which will be… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,OECD,ResearchThe Organization for Economic Cooperation and Development’s (OECD) April 2019 issue of its Chemical Safety and Biosafety Progress Report includes an update on OECD’s work to determine the safety of manufactured nanomaterials. The Report notes that the applicability of OECD Test Guidelines for nanomaterials continues to be a major concern of the work of the… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Occupational Health and Safety Issues,ResearchThe International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies — Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range in a mixed dust manufacturing environment.” The standard provides guidelines to quantify and identify particles of carbon black and/or amorphous silica in air samples collected in… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesAn Advisory Group of 29 scientists from 18 countries met on March 25-27, 2019, to recommend priorities for the International Agency for Research on Cancer (IARC) Monographs program during 2020-2024. The Advisory Group assessed the response to a public call for nominations and considered more than 170 unique candidate agents, including the recommended priorities remaining… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in EU Member State,International,Legal/Regulatory IssuesOn April 17, 2019, the Ministry of Ecological and Solidarity Transition issued a press release announcing that France will prohibit foods containing food additive E171 (titanium dioxide) from being placed on the market beginning January 1, 2020. The press release cites the April 15, 2019, opinion from the Agence nationale de sécurité sanitaire de l’alimentation,… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,ResearchOn January 22-24, 2019, a Mexico-European Union (EU) workshop on nanosafety was held in Mexico. The aim of the workshop was to establish a stronger connection between the Mexican and European research communities within the context of bringing scientific information to the risk assessment, risk management, and policy levels. According to the workshop report, Mexico… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Food Safety Authority (EFSA) held a stakeholder workshop on April 1-2, 2019, on the implementation of its guidance on the risk assessment of applications of nanosciences and nanotechnologies in the food and feed chain. As reported in our July 5, 2018, blog item, “EFSA Publishes New Guidance on Nanotechnologies in Food and Feed,”… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Occupational Health and Safety Issues,United StatesTechConnect World Innovation Conference and Expo will be held June 17-19, 2019. It will include the third installment of a panel started three years ago, “Tools and Techniques: Applying the Best Health, Safety, and Environment Practices to Advanced Manufacturing.” The Symposium Co-Chairs include: Sally Tinkle, Senior Strategy and Policy Advisor, IDA/Science and Technology Policy Institute;… Continue Reading
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
