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GSRS19 JRC Technical Report 1FSTQFDUJWFTPO OBOPUFDIOPMPHZBOE OBOPQMBTUJDT (?AOSCJGLCȩ#ȩ+ȩJJ?Lȩȩ GPEGRȩ1MISJJ )JSCRRECLȩ LGJȩ)ȩ.?RPG ȩ #30ȩȩ#, This publication is a aims to provide evidence-based scientific support to the European policymaking process. The scientific output expressed does not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of this publication. For information on the methodology and quality underlying the data used in this publication for which the source is neither Eurostat nor other Commission services, users should contact the referenced source. The designations employed and the presentation of material on the maps do not imply the expression of any opinion whatsoever on the part of the European Union concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Contact information Birgit Sokull-Kluettgen, European Commission, Joint Research Centre Anil K. Patri, U.S. Food and Drug Administration [email protected] EU Science Hub https://ec.europa.eu/jrc JRC120318 EUR 30195 EN PDF ISBN 978-92-76-18435-5 ISSN 1831-9424 doi:10.2760/517689 Luxembourg: Publications Office of the European Union, 2020 © European Union, 2020 The reuse policy of the European Commission is implemented by the Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Except otherwise noted, the reuse of this document is authorised under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated. For any use or reproduction of photos or other material that is not owned by the EU, permission must be sought directly from the copyright holders. All content © European Union, 2020 How to cite this report: Allan J., Sokull-Kluettgen B., and Patri A.K., Gobal Summit on Regulatory Science 2019 Nanpotechnology and Nanoplastics, EUR 30195 EN, Publications Office of the European Union, Luxembourg, 2020, ISBN 978-92-76-18435-5, doi:10.2760/517689, JRC120318. JRC TECHNICAL REPORT Global Summit on Regulatory Science 2019 Nanotechnology and Nanoplastics Perspectives on nanotechnology and nanoplastics Jacqueline E M Allan Birgit Sokull-Kluettgen Anil K Patri JRC120318 2020 Contents Foreword ...........................................................................................................................................................................................................................................................3 Summary and Conclusions ................................................................................................................................................................................................................5 1 Introduction ......................................................................................................................................................................................................................................... 11 1.1 GSRS19 Programme Overview ................................................................................................................................................................................. 11 1.2 Committees and Attendance ..................................................................................................................................................................................... 12 2 Global regulatory science perspectives on nanotechnology and nanoplastics ........................................................................ 15 3 Regulatory research needs for new and follow-on nanomedicines .................................................................................................. 23 4 Safety assessment of Nanomaterials ......................................................................................................................................................................... 33 5 Nanotechnology in the agri/food/feed sector ....................................................................................................................................................... 43 6 Documentary standards and reference materials ............................................................................................................................................ 53 7 Challenges concerning Nanoplastics ............................................................................................................................................................................ 63 8 Poster session ................................................................................................................................................................................................................................... 71 Annexes ........................................................................................................................................................................................................................................................... 79 Annex 1. Agenda ............................................................................................................................................................................................................................. 80 Annex 2. Biographies of speakers and session chairs ................................................................................................................................... 87 Annex 3. List of participants ............................................................................................................................................................................................. 107 1 2 Foreword The Global Summit on Regulatory Science (GSRS) is organised yearly by the Global Coalition for Regulatory Science Research (GCRSR). This international coalition was established in 2013, with the aim of facilitating education, scientific training, and scientific exchanges in the field of regulatory science with an impact on public health. Partner organisations of the GCRSR come from Argentina (ANMAT), Australia / New Zealand (TGA/FSANZ), Brazil (ANVISA), Canada (HC), China (CFDA), European Union (EFSA, EMA & JRC), Japan (MHLW & FSCJ), Republic of Korea (MFDS), Singapore (AVA), and the USA (FDA). The 2019 Global Summit on Regulatory Science (GSRS19) on Nanotechnology and Nanoplastics was co- and the GCRSR, and hosted by the JRC at Ispra and Stresa (Italy), from 24-26 September 2019. The GSRS19 attracted almost 200 scientists from 36 countries around the world, representing regulatory agencies, academia and industry, to discuss global regulatory science perspectives on medical products, food, and standards related to nanotechnology with a special session on emerging challenges with nanoplastics. This summit provided a venue for regulators, policy makers, and scientists to exchange views on innovative technologies, methods and regulatory assessments, as well as harmonising strategies to address emerging challenges via global collaborations. The organisers thank those that contributed to the success of the GSRS19, in particular, the invited speakers and poster presenters for their excellent scientific contributions, the session chairs and panellist for the fruitful discussions, and participants coming from all over the world that brought diverse perspectives of global importance. The organisers recognise the contributions and dedication of the Scientific Programme Committee and the immense amount of planning and hard work by the Local Organising Committee from the JRC in Ispra that contributed to the success of the summit. We also thank the professional and friendly staff from Hotel La Palma in Stresa (Italy) for their excellent hospitality. scheduled to be held 28-30 September 2020, at NIH Campus in Bethesda, Maryland, USA (more information: http://aralliance.org/gsrs/). We hope to see you at this summit and contribute to its success. 3 4 Summary and Conclusions The 2019 Global Summit on Regulatory Science (GSRS19) on Nanotechnology and Nanoplastics at Ispra and Stresa (Italy), 24-26 September 2019, was co-organised by the European Commission's Joint Research Centre (JRC) and the Global Coalition for Regulatory Science Research (GCRSR). The GSRS19 attracted almost 200 scientists from around the world, and provided a platform for interaction between those researching, producing and regulating nanomaterials, to exchange views and experiences on policies and practices in regulation, standards, definitions and methodologies for nanomaterials and nanoplastics. Global regulatory science perspectives on nanotechnology and nanoplastics Nanotechnology is an area of product innovation that is developing to enhance properties, reduce consumption of materials, alleviate waste, and help the environment, etc. faster than regulatory frameworks. Participants in GSRS19 stressed the importance of discussion, collaboration and mutual learning in regulatory science for nanotechnology. International and national forums are helping to bring stakeholders together in dialogues to address areas of shared interest and concern. Sharing of research results and research facilities is strengthening the science base for regulation of nanomaterials and nanotechnology-based
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