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Q: Neither the REACH regulations nor the technical guidance document on Identification (RIP 3.10) offers any guidance on identifying nanoforms of the same molecular structure as their bulk substance, nor on how to analyze hazard levels for nanoforms. However, the REACH FAQs state that the European Commission is funding research projects into risk assessment methodologies for nanoforms under FP7. Where can we find information on the * types of programs the Commission is funding in that area, and * resource allocation to risk assessment of nanoforms, in relation to the resources dedicated to research into the benefits of nanoscience and nanotechnologies ?
A: In line with the European Commission's comprehensive and responsible approach to nanotechnology and nanosciences laid out under the Commission's Action plan, Action Plan "Nanosciences and nanotechnologies: An action plan for Europe 2005-2009" (COM(2005) 243) activities related to health and enviromental impact of nanomaterials are funded alongside other nanotechnology research. In previous FP, several research projects in those areas have been funded for an amount of over 25 million €. Please, bear in mind that the figure stands only for projects with specific focus on investigating the potential risk of nanomaterials and does NOT include (i.e.) projects related to Nanomedicine applications where part of the research may have been dedicated to assessing the toxicological properties of new nanoparticles. In addtion, under the first call of FP7 NMP, the following five topics in the Work Programme directly related to health, safety and environmental impacts in the area of nanosciences - please see text from the NMP Work Programme cited below. Additional activities in the area of nano-metrology have also been addresed in the call. It is the intention of the Commission to continue with activities related to the evaluation of potential risks under the NMP programme. 4.1.3. Health, Safety and Environmental Impacts The main objective is to support the scientific assessment of the potential health, safety and environmental risks associated with nanotechnology-based materials and products at the earliest possible stage. This involves the generation of quantitative data on toxicology and ecotoxicology and methodologies for generating data. Test methods, exposure assessment and risk assessment methods may need to be developed or modified to be applicable to nanomaterials, as well as methodologies for life cycle analysis. In addition, analytical methods might not be fully suitable and therefore also the development of suitable devices and instruments for measurement are addressed. Research activities will thus contribute to close the knowledge gap, providing the basis for meeting regulatory requirements and, if need be, developing new requirements, conducive to a safe, responsible and sustainable development.NMP-2007-1.3-1 Specific, easy-to-use portable devices for measurement and analysis Technical content / scope: Risk assessment is based on appropriate characterisation of materials, hazard and monitoring and assessment of exposure. At present, there are few relevant studies on exposure to engineered nanoparticles, but it is believed that the greatest potential for human exposure over the next few years will be in the workplace. Gathering relevant and objective data on real exposure by allowing for background distinction at the workplace for industrial processes (e.g. production of nanoparticles, particularly when present in aerosols) represents a challenge and needs the development of appropriate personal measurement systems. The objective of the expected collaborative projects would be to develop and validate affordable, portable, adequate sampling and measurement equipments for monitoring working environments (i.e. quantification and characterisation of airborne nanoparticles in particular). These devices and methodologies for routine and non-routine exposure measurements should show an adequate degree of specificity, accuracy, user-friendliness and moderate production costs and produce data suitable for their use in exposure modelling systems. Funding scheme: Large scale integrating collaborative projectsSpecific features: Additional activities other than research should be included as appropriate, such as safety issues, specific education modules or the analysis of existing and required regulations. In line with the objectives of this topic, adequate industrial and SME participation is recommended. Expected impact: (i) Safety of new nano-materials and -systems, and of nanotechnology-based products and services; (ii) safe and cost-effective minimisation of the exposure of workers when manufacturing nano-scale entities; (iii) sustainable and responsible development; (iv) support to research and regulation; (v) implementation of the European Commission’s Action Plan for Nanotechnology.NMP-2007-1.3-2Risk assessment of engineered nanoparticles on health and the environmentTechnical content / scope: The understanding of the safety, environmental and human health implications of nanotechnology-based materials and products is important worldwide. Reinforced cooperation has been initiated on this matter with the USA and in particular between the European Commission and the USA Environmental Protection Agency. It is advantageous to share and harmonize the research effort to increase efficiency and prevent any duplication of effort, also since it addresses pre-competitive questions. This research will create a reliable and sound foundation for the assessment of the safety of nanotechnology-based products and encourage nanotechnological advances that can address the needs of citizens and contribute to sustainable development objectives. Projects under this call should be related to engineered nanoparticles and should address one or more topics in the following areas: hazard characterisation, exposure, toxicology, main endpoints of and health effects of engineered nanoparticles; testing; monitoring/detection of engineered nanoparticles in the various environments (excluding the development of equipment); environmental and biological fate, transport, and transformation of nanoparticles. The interdisciplinary research should contribute to better understanding of toxicokinetics, cellular and molecular mechanisms, behaviour and fate, bio-persistence, biokinetics, to understand fundamentally the exposure, behaviour, mechanisms, consequences and potential effects to various endpoints of nanoparticle-biological entities interactions. Funding scheme: Small or medium-scale focused research projectsSpecific features: Cooperation with the USA research teams is strongly recommended, possibly through balanced participation EU-USA in each project. EU funding for US participants is not foreseen within the present call. Gender issues should be considered, where appropriate. Expected impact: (i) Better in vitro or in vivo methodologies for the regulatory demands for the safety assessment of nanotechnology products, (ii) better understanding of the impact of the nanoparticles on health, safety and the environment; (iii) future definition of appropriate measures, where needed; (iv) safe and cost-effective minimisation of the exposure of workers; (iv) sustainable and responsible development; (v) support to research and regulation; (vi) implementation of the European Commission’s Action Plan for Nanotechnology; (vii) reinforcement of the international dimension of European research within the 7th Framework Programme.NMP-2007-1.3-3Scientific review of the data and studies on the potential impact of engineered nano-particles on health, safety and the environmentTechnical content / scope: Data on environment, safety and health effects of engineered nanoparticles need to be periodically reviewed in order to exploit the results and duly orient future research and risk management actions. In particular, a focus on nanomaterials that are likely to be produced and used in higher quantities is needed. Specific attention should be paid to carcinogenic, mutagenic or reprotoxic (CMR) properties, as well as problematic properties for the environment (like persistence or bioaccumulation). The support action(s) should collect and assess published scientific and technical data, perform a critical review to provide a state-of-the-art overview of current knowledge, produce detailed report(s) on the toxicological profiles and identify remaining uncertainties. Dynamic processes could also be considered e.g. agglomeration or de-agglomeration and other unintended reactions or interactions with surrounding media. The nanoparticles addressed with the present call are: (i) fullerene and derivates, (ii) nanotubes and derivates, (iii) metals and (iv) oxides. Conclusions should be drawn and recommendations should be issued, for research or for other initiatives.Funding scheme: Coordination and support actions aiming at supporting research activities.Specific features: Maximum duration: 12 months. Consortia are encouraged to be multidisciplinary, including expertise in areas of toxicology and eco-toxicology. Gender issues should be considered, where appropriate.Expected impact: (i) Better understanding of the impact of nanoparticles on health and the environment, and definition of future actions; (ii) sustainable and responsible development.; (iii) support to research and (iv) support to regulatory measures and implementation of legislation.NMP-2007-1.3-4Creation of a critical and commented database on the health, safety and environmental impact of nanoparticlesTechnical content / scope: A free access database (including tools) established at European level is needed to allow a comprehensive analysis of published data. This support action aims at creating a database on environment and health effect, which should include physicochemical characterization and properties of nanomaterials, explosion risks, hazard information like acute and chronic toxicity, toxicokinetics, ecotoxicity, bioaccumulation, exposure information throughout the life cycle of nanomaterials, environmental fate of nanoparticles, results from in vitro studies (such as cell and tissue penetration, potential circulatory effects, mutagenicity and genotoxicity, where the case), in vivo studies and occupational epidemiological studies. The database should be useful to identify potential risks with nanomaterials for workers, consumers or public at large. It should contain structured information from research papers and provide tools for text mining,. The database could serve the needs of users with different profiles (general public, scientific community, regulators) and also contain a collection of research papers with their metadata (paper source, authors, date, etc.). The database should be at European level and allow integration with other European related databases such as those related to chemicals, food or pharmaceutical and medical products. Moreover, it could also serve as interface with similar non-EU databases. A balanced "governing board" encompassing representatives of all main EU stakeholders should be established. Activities should take into account existing and ongoing EU projects of a similar nature, and be complementary to them or based upon them. Access to the database and consolidated information of the results of the analyses, updates and methodology should be provided appropriately. Funding scheme: Coordination and support actions aiming at supporting research activities. Only one database and support action will be funded.Specific features: Main elements should be created within 12 months and the database should be made available. It should be regularly updated within a total indicative duration for this action of 4 years. Activities should take into account existing and ongoing relevant initiatives involving the creation of databases. Gender issues should be considered, where appropriate.Expected impact: (i) Better understanding of the impact of nanoparticles on health and the environment, and definition of future actions; (ii) safe and responsible development and use of nanotechnology; (iii) support to research and regulation; (iv) support to regulatory measures and implementation of legislation; (v) implementation of the European Commission’s Action Plan for Nanotechnology; (vi) support to good governance in nanotechnology.NMP-2007-1.3-5Coordination in studying the environmental, safety and health impact of engineered nanoparticles and nanotechnology based materials and products Technical content / scope: Knowledge regarding the toxicological and ecotoxicological profile of nanomaterials as well exposure data should be integrated to the rapid development of the technology and sufficient data should be available for a proper risk assessment. Existing standard test methods have been developed under current regulatory regimes for traditional chemicals and may need adjustment to be applied to nanomaterials. An effort is therefore needed to develop adequate methodologies, taking advantage of the latest scientific and technical evidence across all relevant disciplines. Collaboration among research groups and coordination of research efforts will increase efficiency, which may more rapidly lead to adoption of standardised and validated methods essential for regulatory activities. The expected coordination action should address amongst others but not exclusively, the following activities: Coordination in establishing and performing test strategies and methods for toxicity and ecotoxicity with a view to develop efficient test systems and tiered testing approaches for nanomaterials; Coordination in studying possibilities to develop quick screening methods for (eco)toxicity, in vitro models and predictive models for (eco)toxicity for nanomaterials, in particular focussing on properties like carcinogenicity, mutagenicity, reprotoxicity, bioaccumulation and persistence; Coordination in approaching risk assessment tools for nanotechnology-enabled products, including modelling, exposure scenario development and life-cycle analysis; Coordination in developing risk assessment methodology for assessing environmental and health effects of nanomaterials and for performing impact assessments. Funding scheme: Coordination and support actions aiming at coordinating research activities. Specific features: None Expected impact: (i) Synergy, increased efficiency and effectiveness in the European research activities in this field; (ii) better understanding of the impact of nanoparticles on health and the environment, and definition of actions; (iii) safe and responsible development and industrial use of nanotechnology; (iv) support to regulatory measures and implementation of legislation (v) support to industrial decision making, to EU research and to other EU policies; (vi) implementation of the European Commission’s Action Plan for Nanotechnology; (vii) creation of one (or more) leading pole(s) of excellence that will be able to support industrial activities, in particular benefiting high-technology SMEs.
Category : FP7 (Seventh Framework Programme) ( NMP )