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The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

The wine sector is paying more attention to sustainable wine production practices, but this topic is highly debated because organic viticulture aims to a reduction of environmental impacts, while conventional viticulture ensures an increase of yield. This work provides an economic and environmental comparison using different indicators whereas no previous studies on viticulture have faced on both aspects of sustainability. Two distinct vineyards within the same case study farm were considered, where conventional and organic viticulture practices were applied for 5 years. For each type of production, we calculated the economic benefit and environmental indicators such as the Water Footprint, Carbon Footprint, and an indicator of environmental performance associated with the vineyard phase (“Vineyard Management” or “Vigneto” indicator part of the Italian VIVA certification framework). This latter considers six sub-indicators investigating pesticides management, fertilizers management, organic matter content, soil compaction, soil erosion, and landscape quality. The multi criteria approach is a novel framework assessing sustainability on vineyard management using environmental indicators from VIVA calculator and the economic aspect. Main results showed that organic management in viticulture can be applied without having economic losses and with the benefit of better preserving the natural capital.

Based on the data gap analysis performed in the first step of MEDCIS, the Medcis team on contaminant proposed a road map associated with a time-schedule in order to improve harmonization in Mediterranean region for 2024 GES assessment. Partner countries shared information on monitored substances and biological effects, thresholds used, matrix/matrices used for the monitoring of each substance/family of substances, the limit of quantification (LQ) of each chemical measurement, and the proportion of censored data

Based on the data gap analysis performed in the first step of MEDCIS, the Medcis team on contaminant proposed a road map associated with a time-schedule in order to improve harmonization in Mediterranean region for 2024 GES assessment. Partner countries shared information on monitored substances and biological effects, thresholds used, matrix/matrices used for the monitoring of each substance/family of substances, the limit of quantification (LQ) of each chemical measurement, and the proportion of censored data

Based on the data gap analysis performed in the first step of MEDCIS, the Medcis team on contaminant proposed a road map associated with a time-schedule in order to improve harmonization in Mediterranean region for 2024 GES assessment. Partner countries shared information on monitored substances and biological effects, thresholds used, matrix/matrices used for the monitoring of each substance/family of substances, the limit of quantification (LQ) of each chemical measurement, and the proportion of censored data

The MERLIN-Expo tool was evaluated using a SWOT analysis, which was based on expert judgement and literature review. A list of criteria was set up containing the major model characteristics, which were divided in general model criteria and relevance model criteria. Relevance model criteria were defined as criteria, which are highly depending on the regulatory framework the model is used in. From the analysis presented above, it appeared that certain regulatory chemical frameworks (e.g. REACH, biocides) are stricter towards their requirements compared to others (e.g. site-specific/local regulatory frameworks). Based on expert judgement, the MERLIN-Expo tool was evaluated using the general and relevance criteria. MERLIN-Expo has many advanced functionalities (such as uncertainty analysis, modular approach, dynamic model, combines environmental fate with pharmacokinetics) and models (many fate processes and environmental compartments, different human populations). At the same time, the threat is that current (regulatory) applicability frameworks do not always require these advanced assessment functionalities. The MERLIN-Expo tool appeared to be most suitable for the site-specific assessment as this is the most flexible framework. Based on this analysis, weaknesses of the MERLIN-Expo tool for its use in a certain regulatory framework could also be identified. These weaknesses are at the same time further development opportunities for MERLIN-Expo. On general model characteristics, MERLIN-Expo was identified as a highly documented (both for novice and expert level), transparent, user-friendly tool with regular trainings. Its main treat now is to ensure continuing support and mechanisms for future developmental work and updates.

The assessment of bioaccumulation processes plays a significant role in the evaluation of chemical risks. The awareness of long-lasting and often irreversible effects of bioaccumulative chemicals on ecological and human targets encouraged the inclusion of bioaccumulation assessment in many national and international legislative frameworks. At the same time, various experimental and modelling approaches have been developed to estimate bioaccumulation metrics such as the bioaccumulation factor (BAF) or the biomagnification factor (BMF). In this chapter, the main processes governing bioaccumulation phenomena in selected aquatic organisms (phytoplankton, invertebrate and fish) and in terrestrial mammals are described, in particular those implemented in the corresponding models available in MERLIN-Expo tool for exposure assessment. The main objective is to describe the development of bioaccumulation models for organic and inorganic contaminants which takes into account recent progresses and which satisfactorily describes bioaccumulation of contaminants along food webs including phytoplankton, invertebrate and fish species for surface waters, and mammals for terrestrial systems, and also allowing dynamic and stochastic assessment according to MERLIN-Expo modelling features. The coupling of different aquatic biota models allows to recreate aquatic food web of different dimensions and complexity, while the coupling of terrestrial mammal model with plant models available in MERLIN-Expo permits to simulate the transfer of contaminants along simplified terrestrial food chains.

MERLIN-Expo merges and integrates advanced exposure assessment methodologies, allowing the building of complex scenarios involving several pollution sources and targets. The assessment of exposure and risks to human health from chemicals is of major concern for policy and ultimately benefits all citizens. The development and operational fusion of the advanced exposure assessment methodologies envisaged in the MERLIN-Expo tool will have a significant impact in the long term on several policies dealing with chemical safety management. There are more than 30 agencies in Europe related to exposure and risk evaluation of chemicals, which have an important role in implementing EU policies, having especially tasks of technical, scientific, operational and/or regulatory nature. The main purpose of the present paper is to introduce MERLIN-Expo and to highlight its potential for being effectively integrated within the group of tools available to assess the risk and exposure of chemicals for EU policy. The main results show that the tool is highly suitable for use in site-specific or local impact assessment, with minor modifications it can also be used for Plant Protection Products (PPPs), biocides and REACH, while major additions would be required for a comprehensive application in the field of consumer and worker exposure assessment.