TRAAC framework to improve regulatory acceptance and wider usability of tools and methods for safe innovation and sustainability of manufactured nanomaterials
Tài liệu tham khảo
Aerts, 2017
Beaudrie, 2011, Horses for courses: risk information and decision making in the regulation of nanomaterials, J. Nanopart. Res., 13, 10.1007/s11051-011-0234-1
Cicchetti, 1994, Guidelines, criteria, and rules of thumb for evaluating normed and standardized assessment instruments in psychology, Psychol. Assess., 6, 284, 10.1037/1040-3590.6.4.284
Dekkers, 2016, Towards a nanospecific approach for risk assessment, Regul. Toxicol. Pharmacol., 80, 46, 10.1016/j.yrtph.2016.05.037
Delmaar, 2013, First tier modeling of consumer dermal exposure to substances in consumer articles under REACH: a quantitative evaluation of the ECETOC TRA for consumers tool, Regul. Toxicol. Pharmacol., 65, 79, 10.1016/j.yrtph.2012.10.015
2012, Communication from the Commission to the European Parliament, the council, and the European economic and Social Committee, Sec. Regulat. Rev. Nanomater EUR-Lex COM., 572, 1
2018, Re-finding industry. Report from the high-level strategy group on industrial technologies, Conf. Doc. Directorate Gen. Res. Innov. Ref. Ares(2018)1067811 - 26/02/2018, 5
EC
EC, 2019
EC
EC, 2022
ECHA
ECHA, 2016
ECHA, 2016
ECHA, 2020
EFSA Scientific Committee, 2009, Scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety, EFSA J., 7
EFSA Scientific Committee, 2018, Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: part 1, Human Anim. Health EFSA J., 16
EPA US, 2017
EU
EUON, 2020
Fadeel, 2018, Advanced tools for the safety assessment of nanomaterials, Nature Nanotech, 13, 537, 10.1038/s41565-018-0185-0
Franken, 2020, Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria, NanoImpact, 17, 10.1016/j.impact.2019.100191
Franken, 2020, Experimental assessment of inhalation and dermal exposure to chemicals during industrial or professional activities in relation to the performance of ECETOC TRA, Ann. Work Exposures Health, 64, 944, 10.1093/annweh/wxaa070
Gomez-Diaz, 2019, On the evaluation of research software: the CDUR procedure. F1000Research, 8, 1353
Gottardo, 2017
Gruenpeter, 2020
Halamoda Kenzaoui, 2019
Hasselbring, 2020, From FAIR research data toward FAIR and open research software, Information Technol., 62, 39
Hesse, 2015, Evaluation of tier 1 exposure assessment models under REACH (ETEAM) project- substudy report on gathering of background information and conceptual evaluation
Hristozov, 2012, Risk assessment of engineered nanomaterials: a review of available data and approaches from a regulatory perspective, Nanotoxicology, 6, 10.3109/17435390.2011.626534
Hristozov, 2016, Frameworks and tools for risk assessment of manufactured nanomaterials, Environ. Int., 95, 10.1016/j.envint.2016.07.016
IOMC
Isigonis, 2019, Risk governance of nanomaterials: review of criteria and tools for risk communication, evaluation, and mitigation, Nanomaterials, 9, 10.3390/nano9050696
Jeliazkova, 2021, Towards FAIR nanosafety data, Nat. Nanotechnol., 16, 644, 10.1038/s41565-021-00911-6
JRC
Jung, 2016
Kirkegaard, 2020, Risk perceptions and safety cultures in the handling of nanomaterials in academia and industry, Ann. Work Expo. Health, 24, 479, 10.1093/annweh/wxaa022
Lamb, 2015
Lamprecht, 2020, Towards FAIR principles for research software, Data Science, 3, 37, 10.3233/DS-190026
Linkov, 2021
Marquart, 2017, Validation of the dermal exposure model in ECETOC TRA, Ann. Work Expo. Health, 61, 854, 10.1093/annweh/wxx059
Morris, 2010, Science policy considerations for responsible nanotechnology decisions, Nat. Nanotechnol., 6, 10.1038/nnano.2010.191
Musuamba, 2014, Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility. CPT Pharmacometrics Syst Pharmacol. 2021 NRC
Nymark, P., Grafström R., Noorlander C., Catalán J., Rodríguez-Llopis I., Suárez-Merino B., Hjorth R., Oosterwijk T., Vilchez A., Bakker M., Jensen K.A., 2017. Document on quality criteria for data. EU H2020 caLIBRAte project report. Ref. Ares(2017)4606075 - 21/09/2017. URL https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b53990b3&appId=PPGMS.
OECD, 2005, Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment, Ser. Testing Assess., No. 34
OECD, 2016, OECD Science, Technol. Innov. Outlook, 2016
OECD, 2020, Moving towards a safe(r) innovation approach (SIA) for more sustainable nanomaterials and Nano-enabled products, Ser. Safety Manuf. Nanomater., No. 96
OECD
OECD, 2021
Porcari, 2019, From risk perception to risk governance in nanotechnology: a multi-stakeholder study, J. Nanopart. Res., 21
Porcari, 2020, State-of-the-art review on existing data on stakeholder needs in regard to support tools for safer-by-design and the overall nano-risk governance, Gov4Nano D4.2, Grant Agreement Number, 814401
Riedmann, 2015, Sensitivity analysis, dominant factors, and robustness of the ECETOC TRA v3, Stoffenmanager 4.5, and ART 1.5 occupational exposure models, Risk Anal., 35, 211, 10.1111/risa.12286
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks)
Schinkel, 2014, Reliability of the advanced REACH tool (ART) Ann, Occup. Hyg., 58, 450
Shandilya, 2020, Review of existing and near-future next generation tools and models to support the nano-risk governance council and industrial safer-by-design
Shandilya, 2020, Perspective on a risk-based roadmap towards the implementation of the safe innovation approach for industry, NanoImpact, 20, 10.1016/j.impact.2020.100258
Soeteman-Hernandez, 2019, Perspective on how regulators can keep pace with innovation: outcomes of a European Regulatory Preparedness Workshop on nanomaterials and nano-enabled products, NanoImpact, 14, 10.1016/j.impact.2019.100166
Soeteman-Hernandez, 2019, Safe innovation approach: towards an agile system for dealing with innovations, Mater. Today Commun., 20
Sørensen, 2019, Evaluating environmental risk assessment models for nanomaterials according to requirements along the product innovation Stage-Gate process, Environ. Sci. Nano, 6, 10.1039/C8EN00933C
Teunenbroek, 2017, Towards a more effective and efficient governance and regulation of nanomaterials, Particle Fibre Toxicol., 14, 10.1186/s12989-017-0235-z
Tewari, 2021, Nanotechnology Market By Type (Nanosensor and Nanodevice) and Application (Electronics, Energy, Chemical Manufacturing, Aerospace & Defense, Healthcare, and Others): Global Opportunity Analysis and Industry Forecast (2021-2030). Emerg. Next Gen. Technol., 1
Trump, 2018, Risk associated with engineered nanomaterials: different tools for different ways to govern, Nano Today, 21, 10.1016/j.nantod.2018.03.002
van Tongeren, 2017, Validation of lower tier exposure tools used for REACH: comparison of tools estimates with available exposure measurements, Ann. Work Expo. Health, 61, 921, 10.1093/annweh/wxx056
Wilkinson, 2016, The FAIR Guiding Principles for scientific data management and stewardship, Scientific Data, 3, 10.1038/sdata.2016.18