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 March 13, 2018, the European Commission (EC) Ombudsman issued its recommendation in a case concerning the EC’s refusal to grant access to its catalog of nanomaterials used in cosmetics, as well as to related notification from cosmetics manufacturers. As reported in our August 8, 2017, blog item, ClientEarth announced on July 31, 2017, that… 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 IssuesThe European Environmental Bureau (EEB) announced on December 22, 2017, the availability of its assessment of the environmental performance of the Estonian Presidency of the European Union (EU). The assessment is based on the results of “Ten Green Tests” laid out at the beginning of Estonia’s Presidency. The eighth test is protecting the public from… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory Issues,ResearchThe European Commission (EC) Environment Directorate General (DG) published an August 2017 report entitled Assessing the environmental safety of manufactured nanomaterials. The report “shows that, despite early fears, nano-sized particles are not inherently more toxic than larger particles; however, differences between them may be notable and new insights are still being provided by research.” The… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn June 8, 2017, the European Commission (EC) published eight NanoData Landscape Compilation reports. The EC states that the reports offer a snapshot of the environment for nanotechnology in different application fields: NanoData Landscape Compilation: Health: This report offers a snapshot of the status of the environment for nanotechnology in the context of health. Analysis… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesOn June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles. The petition summary states: “Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer. Because the precautionary… Continue Reading
By Lynn L. Bergeson and Carla N. Hutton on Posted in International,Legal/Regulatory IssuesThe European Commission (EC) Joint Research Center (JRC) announced on July 10, 2015, the publication of its third report in its review of the EC recommendation on the definition of a nanomaterial. The report is the last in a series of three, and provides scientific support to the EC in its review of the definition… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,ResearchOn October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established a… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn October 30, 2012, the European Chemicals Agency (ECHA) will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH Part I: Characterisation of nanoforms of substances in registration dossiers.” According to ECHA, the webinar will provide information to registrants on the type of information to be included in a Registration, Evaluation, Authorization… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has posted an opinion on zinc oxide, nano-form. SCCS approved the opinion for adoption and it is now open for comment by applicants, national authorities, and other interested parties. SCCS considered whether zinc oxide in its nano-form is safe for use as a UV-filter with a concentration… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn August 31, 2012, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials: Carbon nanotubes… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesThe Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn July 4, 2012, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,StateThe European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (EC) discussed how nanomaterials in general have been characterized in… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,OtherOn April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn February 29, 2012, the European Chemicals Agency (ECHA) announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) substance evaluation process. For each substance, ECHA notes the initial grounds for concern. For two substances, silicon dioxide and silver, the… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory IssuesOn November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be… Continue Reading
