NANoREG – A common European approach to the regulatory testing of Manufactured Nanomaterials
The innovative and economic potential of Manufactured Nano Materials (MNMs) is threatened by a limited understanding of the related EHS (Environmental Health and Safety) issues. While toxicity data is continuously becoming available, the relevance to regulators is often unclear or unproven. The shrinking time to market of new MNM drives the need for urgent action by regulators. NANoREG aims to deliver the answers needed by regulators and legislators on EHS by linking them to a scientific evaluation of data and test methods.
The EU NanoSafety Cluster is a DG RTD NMP initiative to maximise the synergies between the existing FP6 and FP7 projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure assessment, mechanisms of interaction, risk assessment and standardisation.
Participation in the NanoSafety cluster is voluntary for projects that commenced prior to April 2009, and is compulsory for nano-EHS projects started since April 2009.
The EU FP7 large-scale integrating project NanoValid (contract: 263147) has a main objective to develop a set of reliable reference methods and materials for the fabrication, physicochemical (pc) characterization, hazard identification and exposure assessment of engineered nanomaterials (EN), including methods for dispersion control and labelling of ENs. Based on newly established reference methods, current approaches and strategies for risk and life cycle assessment will be improved, modified and further developed, and their feasibility assessed by means of practical case studies.
MARINA stands for integrated and intelligent testing, integrated assessment, and modular interconnection of knowledge and information for validated science-based risk management methods. The approach is to shift from toxicology studies of specific individual nanomaterials towards developing tools for a more integrated systematic health and environmental safety assessment and management that can handle the overall risks for types or classes of ENM based on their physico-chemical properties.
QualityNano: A pan-European infrastructure for quality in nanomaterials safety testing.
QualityNano is a Research Infrastructure for nanosafety assessment. QualityNano’s core aim is the creation of a ‘neutral’ scientific & technical space in which all stakeholder groups can engage, develop, and share scientific best practice in the field.
BIORIMA – Risk Management of Biomaterials
The new EU Horizon 2020 BIORIMA project aims to develop an Integrated Risk Management (IRM) framework for nanobiomaterials (NBM) used in advanced therapy medicinal products (ATMP) and medical devices (MD). The BIORIMA IRM framework is a structure upon which the validated tools and methods for materials, exposure, hazard and risk identification/assessment and management are allocated plus a rationale for selecting and using them to manage and reduce the risk for specific NBM used in ATMP and MD.
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Founder of the NanoDefine website. Doctor of Medicine, author of many books on nutrition and neuroscience research. Lecturer at the Medical University of Paris.