ABSTRACTS BOOK SURFBIO POLICY WORKSHOP 30 JUNE, 2023 ONLINE EVENT Surfbio project has received funding under the European Union’s Horizon 2020 research & Innovation programme under grant agreement Nº 952379 SURFBIO POLICY WORKSHOP 20 June. Online. 1 www.surfbio.eu BOOK OF ABSTRACTS POLICY WORKSHOP Online event June 20, 2023 SURFBIO POLICY WORKSHOP 20 June. Online. 2 www.surfbio.eu Book of Abstracts: SURFBIO Policy Workshop 20 June, 2023 - online event Organising committee: Jožef Stefan Institute, ICCRAM University of Burgos, AXIA Innovation, Wageningen University & Research, Helmholtz-Zentrum Dresden-Rossendorf. Editors: Prof. Dr. Aleš Lapanje, Jožef Stefan Institute; Beatriz Lapuente, University of Burgos; Daniel Canas, University of Burgos; Raquel Moreno, AXIA Innovation; Dr. Tomaz Rijavec, Jožef Stefan Institute. Published by: Jožef Stefan Institute Press. Issued by: Jožef Stefan Institute. Fort the issuer: Prof. Dr. Boštjan Zalar, director. Design: SurfBio Project - ICCRAM University of Burgos Ljubljana, 2023 First edition This publication is free of charge. Kataložni zapis o publikaciji (CIP) pripravili v Narodni in univerzitetni knjižnici v Ljubljani COBISS.SI-ID 159311107 ISBN 978-961-264-273-0 (PDF) SURFBIO POLICY WORKSHOP 20 June. Online. 3 www.surfbio.eu CONTENT PREFACE ...................................................................................................................................... 5 ORGANISING COMMITTEE ............................................................................................................ 6 SPEAKERS .................................................................................................................................... 7 ABSTRACTS ........................................................................................................................................... 13 LEGO MICROBES: THE COLLOID BIOLOGY APPROACH TO BUILDING A MICROBIAL COMMUNITY FOR SUCCESSFUL REMEDIATION OF THE ENVIRONMENT ........................................................................... 14 RUN-EU IS AN ALLIANCE ....................................................................................................................... 15 HORIZON EUROPE. OPPORTUNITIES AND STRATEGIES FOR PARTICIPATION ...................................... 16 SAFE AND SUSTAINABLE BY DESIGN (SSbD) ......................................................................................... 17 SAFE AND SUSTAINABILITY BY DESIGN FRAMEWORK BIO-SUSHY ....................................................... 18 USE OF NANOMATERIALS FOR GROUNDWATER REMEDIATION .......................................................... 19 FROM IDEA TO THE MARKET APPROVAL – REQUIREMENTS OF EU LEGAL FRAMEWORK FOR MEDICAL DEVICES, TISSUE AND CELLS, MEDICINAL SUBSTANCES ....................................................................... 20 INTRODUCTION TO STANDARDIZATION SYSTEM AND THE ROLE OF STANDARDS IN RESEARCH ........ 22 BIONANOPOLYS JOINT ENTITY SET UP TO SUPPORT COMPANIES IN BRINGING BIONANOMATERIALS TO MARKET ........................................................................................................................................... 23 UNLOCK, A LARGE-SCALE INFRASTRUCTURE FOR RESEARCH ON MICROBIAL COMMUNITIES ............ 24 SURFBIO POLICY WORKSHOP 20 June. Online. 4 www.surfbio.eu PREFACE This policy proceedings book captures the references of a dynamic and collaborative policy workshop organized as part of the “SurfBio Innovation Hub for Surface and Colloid biology research”, European funded project under grant agreement Nº 952379. Through close collaboration with national and international policymakers, industries, and stakeholders, we aim to shape material design solutions with (geo)political challenges, creating safe, sustainable, and cost-efficient applied developments and products and fostering excellence in science. The goal of this multi-collaborative approach is to establish an Innovation Hub in this pioneered field, providing high-quality research services and guidance to material designers, biotechnology researchers, academia, industry, and policymakers. The policy workshop targeted three main topics: i) Education, ii) Safety and Safe and Sustainable by Design (SSbD), and iii) Standardisation and Intellectual Property Rights (IPR). The discussions lasted over 4 hours and embraced visions of the policy and strategy tendencies to tackle the existing global challenges. The outcomes and recommendations served to form a comprehensive framework for the establishment and future procedures of the SurfBio Colloid Biology Innovation Hub. The attendees involved professionals from academia, research institutions, industry, and policymaking bodies, from public and private organisations at national and global levels. They engaged in vibrant debates and knowledge exchange to identify the key components that will boost the cell-surface discipline and position the Innovation Hub as an avant-garde platform, ensuring that the activities drive scientific excellence and applied advancements which are aligned with policies and strategies, in Slovenia and internationally. The final part included success stories, sharing fruitful initiatives and accomplishments, intended at inspiring the SurfBio partners and all the attendees and seek guidance, exchange knowledge and stimulate future collaboration. The policy proceedings book serves as a comprehensive record of the workshop, including the presenters and the summaries of each session. SURFBIO POLICY WORKSHOP 20 June. Online. 5 www.surfbio.eu ORGANISING COMMITTEE Aleš Lapanje, Jožef Stefan Institute. Beatriz Lapuente, Universidad de Burgos. Rocío Barros, Universidad de Burgos. Raquel Moreno, AXIA Innovation. Stefan Schymura, Helmholz-Zentrum Dresden-Rosendorf María Suarez Diez, Wageningen University & Research SURFBIO POLICY WORKSHOP 20 June. Online. 6 www.surfbio.eu SPEAKERS ELENA BARBERO CÁRMEN SÁNCHEZ - elena.barbero@urv.cat - Carmen.sanchez@itene.com - LinkedIn - ITENE. Centro Tecnológico. Embalaje, Transporte y Logística POSITION Project Manager at ITENE. POSITION Technical Director of ITENE. EDUCATION AND WORK EXPERIECE Elena Barbero Colmenar is leading the EDUCATION AND WORK EXPERIECE nanomaterials projects at ITENE. Before, she has She has more than 20 years of experience in the been working in a research laboratory at Rovira I management of R+D+i projects aimed at Virgili University, where did her Ph.D under the increasing the competitiveness of companies supervision of Prof. Joan Rosel (Director of DEW through innovation in packaging, transport and group - Droplets intErfaces & floWs, URV, mobility, as well as in the design and Tarragona). Her research focused on nanoparticle implementation of strategies. innovation engineering, in particular, she worked in the management and models for transferring research production of smal polymeric particles by results to the business environment. She has a electrohydrodynamic atomization, also known as technical background as an Agricultural Engineer electrospray. As a visiting researcher, she worked and a Degree in Food Science and Technology with Supercritical carbon dioxide technologies, from the Polytechnic University of Valencia, an under the supervision of Prof. Ernesto Reverchon entity in which she received her PhD Cum Laude in and Dr. Lucia Baldino (Universitat degli Studio di 2015. Additionally, she has completed various Salerno). Elena has a bachelor’s degree in Master's degrees, such as the MBA at ESTEMA or chemical engineering and a Master’s in the Program of General Directorate of IESE. She Renewable Energies and Green Technologies. leads the Technical Secretariat of the Spanish Technology Platform for Packaging and Packaging (PACKNET) and is the Coordinator of Group 1 of the Technical Committee for Standardization CTN49 – Packaging and Packaging. She is the coordinator of the European project Bionanopolys. SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 7 ILEANA MARÍA GRECA LYDIA GONZÁLEZ - imgreca@ubu.es - lydia.gonzalez@cdti.es - UBU research - Twitter: @LydiaGlezF_CDTI POSITION POSITION Ful Professor of Specific Didactics Spanish delegate at Horizon Europe EDUCATION AND WORK EXPERIECE EDUCATION AND WORK EXPERIECE Director of an international and interdisciplinary Spanish delegate at Horizon Europe – Cluster 5 consolidated Research Unit, recognized by the programme committee, in the area of Climate, Junta de Castilla y León, focusing on the didactics and National Contact Point (NCP) in Cluster 6 of natural and social sciences and Art and “Food, Bioeconomy, Natural Resources, heritage. Since 2021, she is Vice-Chancel or for Agriculture and Environment”, with a main focus Internationalisation and Cooperation at the on Natural Resources and Environment. University of Burgos and responsible for the RUN- In relation with the European Missions within EU Al iance at UBU. Her research interests include Horizon Europe, she is the Spanish delegate in the teacher professional development, integrated SPC subgroup for the Mission on “Adaptation to STEM approaches, the use of history and Climate Change” and the NCP as wel . philosophy of science, and contemporary science Ph.D. in Physics and with a Master in topics. Environmental Engineering and Management, after developing their scientific work at CSIC (Spanish National Research Council), she moved to work into industry. To highlight her experience working in LUCENT Microelectronics for 11 years. In 2003 she joined CDTI, the Spanish Innovation Agency answering to the Ministry of Science and Innovation, being linked to different international programmes that CDTI is managing (e.g. Eureka, Iberoeka) and from 2013 she has been working on the EU Research and Innovation Framework Programmes, Horizon 2020 and now Horizon Europe. SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 8 MARJETKA KRALJ MARTA SENDRA - marjetka.kralj@timian.si - msendra@ubu.es - LinkedIn - UBU research POSITION POSITION Quality and Regulatory Affairs Professional PostDoc at ICCRAM Toxicology research group EDUCATION AND WORK EXPERIECE EDUCATION AND WORK EXPERIECE Postgraduate interdisciplinary doctoral study In 2016 she moved to the University of Algarve to programme in Biomedicine, Faculty of Medicine, conduct research on the nanoplastics effects. In University of Ljubljana, Slovenia. Undergraduate 2018, she got a Juan de la Cierva Formación study Microbiology at Biotechnical Faculty Postodoctoral contract in Immunology and (University in Ljubljana, Slovenia). Genomics group from IIM-CSIC (Vigo). During this Experiences gained with > 12 years employment stage, she learnt new immunology and genomic at manufacturer of medical devices (Tosama) as a approaches which she incorporated in her Microbiologist – establishment of microbiological research field. She also got a Juan de la Cierva laboratory, Project Manager – leading & Incorporación contract in the ICCRAM-UBU management of research and development University. projects, Head of Quality Control / Regulatory In the past ten years, Marta Sendra evolved into an compliance Dpt. international y recognized expert in ecotoxicology Recent role as a Lead auditor of Quality and this is supported by publications with more Management Systems according to ISO than 25 international institutions from 13 different 13485:2016 and ISO 9001:2015, as wel as countries. Currently she is participating in three knowledge on FDA QSR 21 CFR 820, expert for European projects and three Spanish National hygiene, cleanliness, sterilization, biocompatibility projects. Following Scopus index, she published 39 Font: Calibri, 11 pt, normal style and justified. publications (35 articles and 4-chapter books), Recent role as a Lead auditor for MDD 93/42/EEC being first author of 23 of them al of them Q1 and and MDR 2017/745, more than 10 first decile. Founder & owner of Timian consulting – a consulting company. Co-owner of LegiRep d.o.o., Authorized representative company. SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 9 PHILIP MAURER ROBERT HARRISON - pmaurer@cencenelec.eu - rob@robharrison.eu - LinkedIn - LinkedIn POSITION POSITION Project Manager for Innovation – CEN and CENEL Sonnneberg Harrison Partnergesellschaft mbH EDUCATION AND WORK EXPERIENCE EDUCATION AND WORK EXPERIENCE Philip has worked for CEN and CENELEC at the Dr. Robert Harrison holds a B.A. in Physics from Brussels Management Centre since 2021. He Oxford University and a M.Sc. in Solid State Physics works as Innovation Project Manager, where he is from Sheffield University in the UK, he later responsible for different activities aimed at obtained his doctorate in Electronic Engineering facilitating the integration of the standardization with a thesis in the field of Indium Arsenide system with the research and innovation Phosphide Antinomide. He was also European IP community. These include exploring new Counsel for W.L.Gore & Associates from 1995 to technologies ripe for standardization, supporting 2001. and developing European research framework He worked for the European Patent Office as an projects, and interacting with researchers and examiner before joining the intellectual property innovators through events and workshops to department of IBM where he trained as a German, propose opportunities for standardization. and European Patent and Trademark Attorney. He holds a Bachelor’s degree in European Studies Robert Harrison is a member of the German from Maastricht University, the Netherlands and a Association of Engineers (VDI), the Institute of Master’s degree in International Administration Engineering and Technology (IET), the Institution and Global Governance from the University of of Electrical Engineers (IEEE) and the Institute of Gothenburg, Sweden. Previously he has been Physics. employed by the German Academic exchange service where he provided a supporting role to international education projects. SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 10 PETER J. SCHAAP ALEŠ LAPANJE - peter.schaap@wur.nl - ales.lapanje@ijs.si - LinkedIn - LinkedIn POSITION POSITION Associate Professor at Wageningen University & Head of Col oid Biology Lab at Jožef Stefan Research Institute. SURFBIO project coordinator. EDUCATION AND WORK EXPERIENCE EDUCATION AND WORK EXPERIECE Peter J. Schaap research Bioinformatics, Genetics, Dr. Lapanje has a degree in biology and a PhD in Genomics, Microbiology, Mycology, Microarrays, Microbiology. He is the PI of the colloid biology Transcriptomics, Fungi, Systems biology, group at Jožef Stefan Instiute, with more than 15 Proteomics, Synthetic biology, Metabolic years of experience in environmental model ing, Big data, Digital twins in Wageningen micorbiology and biotechnology. He has extended University & Research (Netherlands) at Faculty of his expertise with training in phycial chemistry and Agrotechnology and Food Sciences. col oid physics and has been involved in several national and international projects (FP7, H2020, Era). Curretly, he is the SURFBIO project coordinator and is establishing colloid biolgy as a new interdisciplinary field, connecting col oid chemistry and physics with biology and microbiolgy, genetics and biotechnology. SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 11 ALFREDO PÉREZ DE MORA - alfredo.perezdemora@tauw.com - LinkedIn POSITION Project Manager Dept. of Soil and Groundwater EDUCATION AND WORK EXPERIECE Dr. Pérez de Mora has over 15 years of experience in environmental chemistry, microbiology and engineering. At TAUW he is leading multiple remediation projects for decontamination of soil and groundwater both for the private and public sector. Dr. Pérez de Mora is strongly involved in R&D, sustainability and innovation activities within TAUW. He is part of the international Environmental Risk Assessment Team and is currently coordinating TAUW’s participation in two 2020 RIA Horizon projects (Greener and Biosysmo). SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 12 ABSTRACTS SURFBIO POLICY WORKSHOP 20 June. Online. 13 www.surfbio.eu LEGO MICROBES: THE COLLOID BIOLOGY APPROACH TO BUILDING A MICROBIAL COMMUNITY FOR SUCCESSFUL REMEDIATION OF THE ENVIRONMENT Ales Lapanje, Tomaz Rijavec, Maja Zugan, Dmitrii Deev, Iaroslav Rybkin Colloid biology group, Department of Environmental Sciences, Jozef Stefan Institute Contact: ales.lapanje@ijs.si SURFBIO project’s basis In the environment, multimicrobial structures such as flocs, mats or biofilms are extremely wel spatial y organized in terms of microenvironmental conditions and metabolite exchange that allow the establishment of different niches within. However, structures are formed by chance and it is extremely valuable to develop a synthetic approach where structures can be manipulated in a way that are acting as catalytic cores. If they can be tailor assembled and maintained in biotechnological processes such as bioaugmentation during the bioremediation. To assemble spatial y oriented microbial cells within the consortium composed of different cel s we need at least four components (4S): (i) Stickiness, a special "glue" to attach one cell to another and then promote their mutual interaction, (i ) Spatial, cel s should be spatial y oriented according to the design to exchange metabolites, (ii ) Stable, structures should not disintegrate in the solution or solid matrix (e.g. soil) after the initiation of microbial growth and (iv) Scalable, a method must be upscaled for the use in the biotechnological systems. To develop such synthetic structures we treated bacterial cel s as colloidal particles to which we can approximate a zeta potential of about -40mV by the Smoluchowski equation. According to DLVO theory if we change the surface potential of one cell it will attach to the cell with opposite charge. By careful manipulation using a top-down approach we were able to prepare special structures enabling the combining of different bacterial cells, including strict anaerobes, forming stable planar or 3D structures. Until now we have successfully applied the “LEGO” approach in the preparation of catalytic structures for organic wastewater processing, metal precipitation from mine tailings, removal of micropol utants, prevention of biocorrosion and revalorisation of lignin wastes from the paper pulp industry. Figure 1. Biocolloid structure synthetically prepared using electrostatic approach to bring different strains in close interaction. SURFBIO POLICY WORKSHOP 20 June. Online. 14 www.surfbio.eu RUN-EU IS AN ALLIANCE Ileana María Greca Dufranc Universidad de Burgos: C. Prta Romeros, 09001 Burgos, Spain Contact: imgreca@ubu.es Education, EU funds: strategies & opportunities RUN-EU is an alliance of seven like-minded higher education institutions from all regions of Europe, established in 2020 under the European Universities Initiative. Together, they are creating a regional development-oriented European University that embodies the values of sustainability, multiculturalism, and inclusiveness in al its work. University of Burgos recently joined this RUN-EU Alliance, what seeks to stimulate and create joint interregional education, research, innovation, and regional stakeholder engagement activities across the al iance around the Innovation Hubs of Future and Sustainable Industries, Bioeconomy, and Social Innovation. The academic entities involved have been producing regional y relevant and globally impactful knowledge for over 50 years. In 2020, RUN-EU brought together researchers from across Europe to create unique inter-university research spaces. SURFBIO POLICY WORKSHOP 20 June. Online. 15 www.surfbio.eu HORIZON EUROPE. OPPORTUNITIES AND STRATEGIES FOR PARTICIPATION Lydia González Fernández CDTI, Dir. European Programmes and Territorial Cooperation, Cid 4, 28001-Madrid, Spain Contact: lydia.gonzalez@cdti.es Education, EU funds: strategies & opportunities Horizon Europe is the current EU Research and Innovation Framework Programme (2021-2027). Covering almost any research area, it is key to know the different opportunities that can appear in the annual work programmes identifying those cal s and topics of greater interest, considering that col oid biology is an interdisciplinary field and the results of the research activities have many possible applications in different areas. KEYWORDS Horizon Europe. Research and Innovation. Circular Economy. SURFBIO POLICY WORKSHOP 20 June. Online. 16 www.surfbio.eu SAFE AND SUSTAINABLE BY DESIGN (SSbD) Marta Sendra1,2, Carlos Rumbo, Sonia Martel-Martín, Laura Gómez-Cuadrado1*, Rocío Barros 3 1 International Research Center in Critical Raw Materials and Advanced Industrial Technologies, Universidad de Burgos, Burgos, 09001, Spain 2 Department of Biotechnology and Food Science, Faculty of Sciences, University of Burgos, Plaza Misael Bañuelos, 09001 Burgos, Spain Contact: msendra@ubu.es Safe and sustainable by design Last December the European Commission published the first draft about Safe and Sustainable by Design (SSbD). In this document the European Green Deal and the Chemicals Strategy for Sustainability (CSS) have identified several actions to reduce the negative impacts on human and environment associated with chemicals, materials, products, and services commercialised or introduced onto EU market. The ambition of the CSS is to limit under regulation the most harmful substances and substitute them. Applying a SSbD methodology of chemicals and products will minimize the environmental footprint with safer, more sustainable, and functional new products. The principles of this framework are: green chemistry, green engineering, sustainable chemistry and circularity. In this presentation wil be identified and collected the bottlenecks in the step 1, 2 and 3 of the present framework. These three steps belong to the safety phase of the products: identifying the hazard properties of the products over the production, processing and application stages in consumer, workers, and environment. The first step looks at the intrinsic properties of the chemical or material to understand their hazard potential before further assessing the safety during use. In the step 2 the health and safety aspects related to chemicals/materials production and processing wil be addressed. It covers all processes: from raw materials extraction, production, processing, recycling and waste management; therefore, an Occupational Safety and Health (OSH) assessment wil be addressed. In relation to step 3 the application/use-specific exposure to chemicals and the associated risks (human and environment) wil be assessed identifying the exposure pathways according to a Chemical Safety Assessment. KEYWORDS Safety; Circularity; Functionality REFERENCES Caldeira C., Farcal R., Garmendia Aguirre, I., Mancini, L., Tosches, D., Amelio, A., Rasmussen, K., Rauscher, H., Riego Sintes J., Sala S. Safe and Sustainable by Design chemicals and materials - Framework for the definition of criteria and evaluation procedure for chemicals and materials. EUR 31100 EN, Publications Office of the European Union, Luxembourg, 2022, ISBN 978-92-76-53264-4, doi:10.2760/487955, JRC128591. ACKNOWLEDGMENTS Marta Sendra wishes to acknowledge her contract Juan de la Cierva Incorporación (IJC2020-043162-I) funded by MCIN/AEI/10.13039/501100011033 and European Union NextGenerationEU/PR SURFBIO POLICY WORKSHOP 20 June. Online. 17 www.surfbio.eu SAFE AND SUSTAINABILITY BY DESIGN FRAMEWORK BIO-SUSHY Elena Barbero1,2, Benjamine Belloncle1* 1Instituto Tecnológico del Embalaje, Tranporte y Logística; Carrer d'Albert Einstein, 1, 46980 Paterna, Valencia, Spain 2Materia Nova; Avenue Copernic, 3, 7000 Mons, Belgium Contact: elena.barbero@urv.cat Safe and sustainable by design The European Green Deal has established four interlinked policy goals for the transition to a sustainable economy and society: climate neutrality, biodiversity protection, circular economy and a zero-pollution ambition for a toxic-free environment. To achieve these objectives, the Chemicals Strategy for Sustainability (CSS) cal s for the transition to a Safe and Sustainable by Design (SSbD) approach for chemicals. The transition to chemicals and materials that are ‘safe and sustainable by design’ requires a common understanding of safety and sustainability aspects to be successful. Therefore, it is necessary to develop a European assessment framework for ‘safe and sustainable by design’ chemicals and materials, that can assist in the definition of safety and sustainability criteria. The proposed SSbD framework can be applied to the development of new chemicals and materials or to the re-assessment of existing ones. This safety and sustainability assessment is composed of four steps and fol ows a hierarchical approach in which safety aspects are considered first, before moving on to sustainability aspects. In this manner, the first three steps mainly cover different aspects of the safety of chemicals or materials. The fourth step covers the environmental aspect of sustainability. Moreover, depending on how the SSbD framework is applied, it might also be beneficial to evaluate socio-economic sustainability factors, for example as a supplementary component to the major safety and sustainability assessments in the framework's use in the future. In the BIO-SUSHY project, we consider this framework as a guide for the design and development of safe and sustainable novel coatings but, in addition to this, BIO-SUSHY wil contribute to the definition of the criteria in terms of safety and sustainability needed for the development of SSbD strategies applied to novel PFAs free coatings. ACKNOWLEDGEMENT BIO-SUSHY Horizon Europe Project, funded by the European Union under Grant Agreement 101091464. “Views and opinion expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HaDEA). Neither the European Union nor the granting authority can be held responsible for them”. More information: https://www.bio-sushy.eu SURFBIO POLICY WORKSHOP 20 June. Online. 18 www.surfbio.eu USE OF NANOMATERIALS FOR GROUNDWATER REMEDIATION Alfredo Pérez de Mora TAUW GmbH, Landsbergerstr. 404, 81241 Munich, Germany Contact: alfredo.perezdemora@tauw.com Safe and sustainable by design The use of nanomaterials for treatment of contaminated groundwater has gained significant relevance in the last 10 years. The applications include direct injection into the targeted contaminated section of the aquifer or incorporation to build a reactive permeable barrier downstream of the contamination source or plume. The ultimate goal is to create a reactive zone for transformation of the contaminants to non-toxic products or removal from the groundwater. Particularly, the use of nano zero valence iron (nZVI) and colloidal activated carbon has found significant commercial application for removal of toxic organic contaminants such as chlorinated compounds, mineral hydrocarbons or even per- and polyfluorinated compounds from groundwater. Utilization of nanomaterials for groundwater applications at contaminated sites requires the obtention of a water permit from the local environmental authorities. For this purpose appropriate documentation on the nanomaterials has to be presented regarding their purpose and mobility within the aquifer as wel as their proven effectiveness and ecotoxicological information. General y, successful performance of treatability studies with site materials at lab scale in batch reactors and/or in packed columns is a pre-requisite to show the feasibility of the nanomaterials for groundwater treatment and provide a solid basis for scaling-up to a field setting. In addition, a monitoring concept to fol ow the fate of the nanoparticles in the aquifer in space and time is needed. Due to their col oidal nature nanomaterials offer unique characteristics to provide a higher treatment efficiency (higher radius of influence and surface to volume ratio) than micromaterials. Yet, the production costs for nanomaterials need to be improved to successful compete against other non-nano technologies. Furthermore, standardized methods for detection and monitoring of nanomaterials in the environment are needed to evaluate their impact at large scale and increase their acceptance by stakeholders and regulators. Col aborations at early developmental stages with industrial partners is an important milestone to facilitate future applicability and commerciality of the nanotechnology and obtain additional funding support. SURFBIO POLICY WORKSHOP 20 June. Online. 19 www.surfbio.eu FROM IDEA TO THE MARKET APPROVAL – REQUIREMENTS OF EU LEGAL FRAMEWORK FOR MEDICAL DEVICES, TISSUE AND CELLS, MEDICINAL SUBSTANCES Marjetka Kralj Kunčič1 1TIMIAN, Marjetka Kralj Kunčič s.p., Begunje na Gorenjskem 98a, 4275 Begunje na Gorenjskem, Slovenia Contact: marjetka.kralj@timian.si Standardisation, Metrology, IP and Registration Regulatory requirements for medical devices and other regulated products, such as tissue or medicinal products, are demanding and impact the path to the market. This one is long and exhaustive, of course. All begin with an idea, which is usual y followed by a basic research and can turn into a real project journey. But it is not an easy one, as a path is narrow and goes up. Up in a way of years to market the product, and also to hundreds of thousands (sometime mil ions) of euros. One of the significant challenges in such a project represents regulatory requirements. These are similar in a global aspect, but also different and specific, as the products differ. For a medical devices and in vitro medical devices in EU area applies the Regulation (EU) 2017/745 and 2017/746, respectively. Tissue safety is assured with Directive 2004/23/EC of the European Parliament. This directive sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cel s. The most known and complex is legislation relating to medicinal products for human use – in Europe the requirements are compiled in Directive 2001/83/EC. This directive covers different medicinal substances: form biologics, which are derived from living sources, including humans, other animals, bacteria, and viruses to vaccines and monoclonal antibodies, other therapeutic chemical substances. Al the mentioned legal framework are demanding and enable marketing the products only after approval of regulatory authorities. The success awaits only the most persistent research teams. But it is very helpful, when academic centres and research institutions in the early development phase acquire the knowledge on regulatory aspects, as such an approach may help speed the whole process. KEYWORDS Medical Device Regulation; Tissue; Medicinal substances Market approval; Product Compliance REFERENCES Corr P., Wil iams D. (2009) . E, The Pathway from Idea to Regulatory Approval: Examples for Drug Development. Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Conflict of Interest in Medical Research, Education, and Practice. Washington (DC): National Academies Press (US). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. SURFBIO POLICY WORKSHOP 20 June. Online. 20 www.surfbio.eu Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cel s. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. SURFBIO POLICY WORKSHOP 20 June. Online. 21 www.surfbio.eu INTRODUCTION TO STANDARDIZATION SYSTEM AND THE ROLE OF STANDARDS IN RESEARCH Philip Maurer European Committee for Standardization and European Committee for Electrotechnical Standardization 1CEN and CENELEC, Rue de la Science 23, 1000 Brussels, Belgium Contact: pmaurer@cencenelec.eu Standardisation, Metrology, IP and Registration Innovation is paramount in the world of today and tomorrow: the ability to develop new technologies and have them quickly access the market determines who wins or loses in the global economy. In this rapidly changing technological environment, standardization has a fundamental role to play. Standards and standardization are recognized as tools for promoting innovation for both policymakers and businesses, as standards al ow codifying knowledge and making it accessible to a wide range of stakeholders. This presentation wil first offer an introduction to standardization as a whole and the European Standardization system and the role of the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). The speech wil also explain the benefit of integrating standardization with research and innovation activities, showing how standardization creates a foundational framework for innovative and impactful solutions to support the implementation of EU Research and Innovation programmes, as well as recommendations for project partners on how to best implement standardization into their research project. KEYWORDS Standardization; Interoperability; CEN and CENELEC; Norm SURFBIO POLICY WORKSHOP 20 June. Online. 22 www.surfbio.eu BIONANOPOLYS JOINT ENTITY SET UP TO SUPPORT COMPANIES IN BRINGING BIONANOMATERIALS TO MARKET Carmen Sanchez Instituto Tecnológico del Embalaje, Transporte y Logística: Carrer d'Albert Einstein, 1, 46980 Paterna, Valencia Contact: Carmen.sanchez@itene.com Success stories The international association that wil manage the Single-Entry-Point (SEP) of the BIONANOPOLYS project has been formally constituted and wil be able to support companies across the European Union in the market introduction of bionanomaterials through technical, legal, regulatory, safety, economic and financial support services. The SEP was established as an AISBL (non-profit entity) on 17 February 2023 in the framework of the European project BIONANOPOLYS, funded by the Horizon 2020 programme. The BIONANOPOLYS SEP will reduce the risks and barriers to the commercial exploitation of bio-based materials and polymeric bionanocomposites with nanotechnology and accelerate market penetration and innovation processes. SMEs, large companies, and potential customers who are users of the BIONANOPOLYS OITB (Open Innovation Test Bed) wil be able to access the services offered by the project partners through this entity, which will act as a one-stop shop, at affordable costs and conditions. The test bed consists of 14 enhanced pilot plants and complementary services to support technological and commercial breakthroughs. Col aboration between al the partners that make up BIONANOPOLYS and access through the SEP allows joint access to all the services offered by the partners and helps to drive col aborative open innovation. The SEP governance model will be validated in the Open Call: project partners will be in charge of evaluating the projects submitted to the BIONANOPOLYS platform once the open cal launched last February to select five projects from different European countries that will be able to access its services free of charge to develop, test or scale-up bionanomaterials in the BIONANOPOLYS OITB closes. For more information a catalogue of al the services has been developed and a clear and solid applicants guide has been drawn up to boost the dissemination and explain the Open Cal procedures. SURFBIO POLICY WORKSHOP 20 June. Online. 23 www.surfbio.eu UNLOCK, A LARGE-SCALE INFRASTRUCTURE FOR RESEARCH ON MICROBIAL COMMUNITIES Schaap P1, Langenhoff A1, Kleerebezem R2, Koehorst J1, Atasoy M1, Stouten G2 and Smidt H1, UNLOCK Large Scale Infrastructure for Microbial Communities1,2. Wageningen University & Research1 and Delft University of Technology2, The Netherlands Contact: peter.schaap@wur.nl Success stories BACKGROUND Microbial communities perform vital roles affecting our health to global greenhouse gas emissions. Many of the key-microorganisms of these communities depend on symbiotic interactions for growth, which makes them difficult to study and explore in isolation. Efficient research on microbial communities is hampered by three major technical limitations: (i) the lack of high-throughput cultivation facilities for comparative analysis of microbial ecosystems in paral el, (ii) the effective integration of these cultivation studies with molecular systems characterizations, and (i i) a tight integration and transparent and uniform storage and processing of the generated data. THE UNLOCK INFRASTRUCTURE By addressing these limitations, UNLOCK enables research on mixed microbial communities at an unprecedented scale and efficiency. Wet lab experiments and computational simulations are both vital to the research and development process. The Unlock research infrastructure (Figure 1) is composed of three complementary experimental platforms for high-throughput discovery and characterization of microbial communities integrated with a FAIR data platform The FAIR data platform is equipped with an up-to-date computational ecosystem of robust state-of-the-art open-source tools for data handling, information retrieval, statistical analysis, and visualization of Omics data. The iRODS open-source data management system is used to manage data and metadata storage. Omics analysis pipelines are containerized and written in the Common Workflow Language (CWL) Semantic web techniques are used for automatic data handling and data FAIRification (Figure 2). SURFBIO POLICY WORKSHOP 20 June. Online. 24 www.surfbio.eu Figure 1. Overview of the Unlock Infrastructure. Figure 2. FAIR data platform technical details. Experiment metadata is used to program the iRODS DMS to store data in designated folders along with the metadata. Data transformation and analysis is done using containerized applications. Kubernetes is used manage container deployment. QR-code: https://m-unlock.nl REFERENCES Kleerebezem R, Stouten G, Koehorst J, Langenhoff A, Schaap P, Smidt H. Experimental infrastructure requirements for quantitative research on microbial communities DOI: 10.1016/j.copbio.2021.01.017 SURFBIO POLICY WORKSHOP 20 June. Online. 25 www.surfbio.eu SURFBIO POLICY WORKSHOP 20 June. Online. www.surfbio.eu 26 The Jožef Stefan Institute is the leading Slovenian From the Jožef Stefan Institute, Slovenia’s leading scientific research institute, covering a broad scientific research institute, together with five top spectrum of basic and applied research. The staff research & innovation partners across Europe, is made up of more than 850 specialists in natural SURFBIO project partners are creating an sciences, life sciences and engineering. Innovation Hub to study micro-be–surface by using high-tech methodologies and equipment . The mission of the Jožef Stefan Institute is the accumulation - and dissemination - of knowledge SURFBIO project aim to provide researchers, at the frontiers of natural science and technology academic institutions, industry and policy makers to the benefit of society at large through the with training services and assessments to pursuit of education, learning, research, and optimise novel materials for a variety of deve-lopment of high technology at the highest applications. Understanding the interactions of inter-national levels of excellence. the colloids (microorganisms and biomolecules) with surfaces and between themselves is a key The Laboratory for Colloid Biology is working on factor that can lead to improvements in several the new discipline focused on the study of the fields, such as the biotechnology industry or interaction between different microbial cells and the development of nano-carriers for drug between cells and surfaces. The research in this delivery. These interactions can be studied and field might give scientific community a analysed by applying different tools and completely new tool for manipulation of techniques, and this is the SURFBIO main structures of bacterial communities. objective. Surfbio project has received funding under the European Union’s Horizon 2020 research & Innovation programme under grant agreement Nº 952379