and

Subscribe to and

The 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 Review on Nanomaterials. The Communication describes the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.…

Continue Reading NGOs Call for “Nano Patch” for REACH, and EC Responds

On 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…

On October 22, 2012, Safe Work Australia announced the availability of a report entitled Human Health Hazard Assessment and Classification of Carbon Nanotubes, as well as an information sheet on the report. The report recommends that multi-walled carbon nanotubes should be classified as hazardous unless toxicological or other data for specific types imply otherwise. The National…

On 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…

The Centers for Disease Control and Prevention (CDC) published a September 20, 2012, Federal Register notice seeking comment on a proposed National Institute for Occupational Safety and Health (NIOSH) exposure assessment and epidemiological study of U.S. workers exposed to carbon nanotubes (CNT) and carbon nanofibers (CNF). The notice states that the proposed research is a cross-sectional…

On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way…

On 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 in bone cements;
  • Nanopaste hydroyapatite powder for bone void filling;
  • Polymer setting material with nanoparticles in dental cements;
  • Polycrystalline nanoceramics in dental restorative materials;
  • Nanosilver or other nanomaterials used as coatings on implants and catheters; and
  • Nanosilver used as an antibacterial agent.

The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices. 

…
Continue Reading SCENIHR Issues Call for Information and Experts on Health Effects of Nanomaterials Used in Medical Devices

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the…

The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas…

The 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…