In light of the expected increase in the application of nanotechnologies to medical devices, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is requested to provide a risk assessment of medical devices containing nanomaterials. This evaluation shall take into account different categories of medical devices such as:
a. Non-invasive medical devices, e.g. devices coming into contact with the intact skin,
b. Invasive devices (surgical or not), e.g.:
- woundcare materials,
- implantable medical devices,
- dental and bone fillings and cements,
- injectable nanomaterials.
In this assessment, where relevant, the SCENIHR is invited to differentiate between free, fixed, and encapsulated nanomaterials. Deadline is March 2013.
Three new draft appendices for guidance on information requirements and chemical safety assessment regarding nanomaterial have been sent to the Competent Authorities for REACH and CLP (CARACAL), the expert group which advises the European Commission and ECHA on questions related to REACH and CLP.
The three appendices concerning information requirements (appendices to R7a, R7b and R7c) have been developed in order to provide advice to registrants for use when preparing registration dossiers for nanomaterials. The content of the appendices implements the advice provided by the REACH Implementation Project on Nanomaterials 2 (RIP-oN2) on specific aspects of information requirements concerning materials in nano form...
On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects...
Scientists from the University of Limerick (UL) have joined a European Commission (EC) funded project, SANOWORK that aims to assess and manage potential risks associated with nanomaterials. SANOWORK involves collaboration between 8 academic and public research bodies and 5 industrial manufacturers of nanomaterials from across Europe who will participate in the € 4.7 M EC FP7-NMP research project...
(...) researchers in Taiwan and the U.S. have developed what they say is the first personal sampler to collect nano- and microparticles. Chuen-Jinn Tsai at the National Chiao Tung University and his colleagues linked sampling technologies in series. First, a tiny cyclonic vacuum, like those in bagless vacuum cleaners, catches particles over 4 µm wide, which are too heavy to follow the spinning air in the cylindrical cyclone. The cyclone pushes these microparticles to the side walls, where they fall and are collected. Next, particles bigger than 100 nm in diameter collect in the second part of the sampler, called a micro-orifice impactor. In it, air blows through 137 thin nozzles and pushes particles onto a collection plate. Finally the smallest nanoparticles, those that are too light to be pushed onto the impactor’s plate, blow through and get caught in a filter...
Jointly organized by the coordinators of four European FP7 Projects HINAMOX, NANOPOLYTOX, NEPHH and ENPRA, and by The Joint Research Centre (JRC) from the European Commission, the symposium "Safety issues and regulatory challenges of nanomaterials" will be held on the 3rd and 4th May 2012 at CIC biomaGUNE San Sebastián (Spain). Addressing the latest results and progress of the European FP7 Projects (HINAMOX, NANOPOLYTOX, NEPHH and ENPRA) the symposium aims to present the state of the art and recent developments in the legislation and regulations in the EU and the world concerning nanomaterials. The event will provide participants with the opportunity to share knowledge and experiences about the critical issues specific for the risk assessment and LCA of nanomaterials in a regulatory context, to identify the needs and challenges for policy making and regulation of nanotechnology based materials and to trigger discussion and networking among experts in the different fields of nanosafety. For more information, program and registration click here.
On May 9-11, 2012, the Organization for Economic Cooperation and Development (OECD) and Germany’s Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) will hold a workshop entitled “Safe Management of Nanowaste” in Munich (Germany). According to the draft agenda, the objectives of the workshop are to get a better understanding of the potential risks posed by nanowaste and waste containing nanomaterials; to exchange information about existing initiatives/approaches addressing nanowaste management; and to identify what OECD and member country governments can do to ensure safe management of such materials...
On June 8, the FP7 project HINAMOX proposes a Nanosafety Training course on Metal Oxides at the Finnish Institute of Occupational Health, Helsinki (Finland). HINAMOX offers a complete approach to understanding the safety and human health implications of metal oxide nanoparticles (NPs) and nanotechnology-based materials. The course will highlight the experiences and discoveries of the HINAMOX project and experts from HINAMOX will share their latest knowledge and practices regarding health effects, toxicology testing, exposure assessment, risk assessment and management of manufactured nanosized metal oxides. For more information click here.