A review of the state-of-the-art for stakeholder analysis with regard to environmental management and regulation.

Stakeholder analysis (SA) is a widely used decision-support tool. This paper reviews the state-of-the-art of SA within environmental management and regulation. In total, 48 SA studies from the peer-reviewed literature were investigated according to 7 aspects: Topic and purpose; Elements included; Geographical area; Definition of key terms; Methods used; Authors self-evaluation and Inclusion. We find that the SAs conducted cover a broad spectrum of environmental issues. The most applied data-collection methods are snowball-sampling (26 studies, 54%), interviews (30 studies, 63%) and literature reviews (26 studies, 54%). The most examined stakeholder attributes were interests (41 studies, 85%) and influence (34 studies, 71%). We find that there is a lack of clear definitions of key-terms such as "Stakeholder" (19 studies, 40%) and "Influence" (14 studies, 29%). SAs are often conducted by authors from other geographical areas than the case study, which could explain why marginalised stakeholders are only considered in 21 of the studies (44%). In only half of the studies (24 studies, 50%), the authors reflect upon limitations and biases of their own analysis. Among others, three important lessons learned from our study are: 1) Transparency with regard to methodology, results and decisions made is of paramount importance as it otherwise undermines the credibility of SA; 2) Definition of key-terms such as "stakeholder" and "influence" need to be provided in future SAs to avoid misunderstandings; and finally, 3) Clear guidelines on how to perform SA are needed, including how to determine interests and power, and how to document and report findings.

Proxy Measures for Simplified Environmental Assessment of Manufactured Nanomaterials.

Proxy measures have been proposed as a low-data option for simplified assessment of environmental threat given the high complexity of the natural environment. We here review studies of environmental release, fate, toxicity, and risk to identify relevant proxy measures for manufactured nanomaterials (MNMs). In total, 18 potential proxy measures were identified and evaluated regarding their link to environmental risk, an aspect of relevance, and data availability, an aspect of practice. They include socio-technical measures (e.g., MNM release), particle-specific measures (e.g., particle size), partitioning coefficients (e.g., the octanol-water coefficient), and other fate-related measures (e.g., half-life) as well as various ecotoxicological measures (e.g., 50% effect concentration). For most identified proxy measures, the link to environmental risk was weak and data availability low. Two exceptions were global production volume and ecotoxicity, for which the links to environmental risk are strong and data availability relatively decent. As proof of concept, these were employed to assess seven MNMs: titanium dioxide, cerium dioxide, zinc oxide, silver, silicon dioxide, carbon nanotubes, and graphene. The results show that none of the MNMs have both high production volumes and high ecotoxicity. Several refinements of the assessment are possible, such as higher resolution regarding the MNMs assessed (e.g., different allotropes) and different metrics (e.g., particle number and surface area). The proof of concept shows the feasibility of using proxy measures for environmental assessment of MNMs, in particular for novel MNMs in early technological development, when data is particularly scarce.

Development of Comparative Toxicity Potentials of TiO2 Nanoparticles for Use in Life Cycle Assessment.

Studies have shown that releases of nanoparticles may take place through the life cycle of products embedding nanomaterials, thus resulting in potential impacts on ecosystems and human health. While several life cycle assessment (LCA) studies have assessed such products, only a few of them have quantitatively addressed the toxic impacts caused by released nanoparticles, thus leading to potential biases in their conclusions. Here, we address this gap and aim to provide a framework for calculating characterization factors or comparative toxicity potentials (CTP) for nanoparticles and derive CTP values for TiO2 nanoparticles (TiO2-NP) for use in LCA. We adapted the USEtox 2.0 consensus model to integrate the SimpleBox4Nano fate model, and we populated the resulting model with TiO2-NP specific data. We thus calculated CTP values for TiO2 nanoparticles for air, water, and soil emission compartments for freshwater ecotoxicity and human toxicity, both cancer effects and noncancer effects. Our results appeared plausible after benchmarking with CTPs for other nanoparticles and substances present in the USEtox database, while large differences were observed with CTP values for TiO2 nanoparticles published in earlier studies. Assumptions, which were performed in those previous studies because of lack of data and knowledge at the time they were made, primarily explain such discrepancies. For future assessment of potential toxic impacts of TiO2 nanoparticles in LCA studies, we therefore recommend the use of our calculated CTP.

Meeting the Needs for Released Nanomaterials Required for Further Testing-The SUN Approach.

The analysis of the potential risks of engineered nanomaterials (ENM) has so far been almost exclusively focused on the pristine, as-produced particles. However, when considering a life-cycle perspective, it is clear that ENM released from genuine products during manufacturing, use, and disposal is far more relevant. Research on the release of materials from nanoproducts is growing and the next necessary step is to investigate the behavior and effects of these released materials in the environment and on humans. Therefore, sufficient amounts of released materials need to be available for further testing. In addition, ENM-free reference materials are needed since many processes not only release ENM but also nanosized fragments from the ENM-containing matrix that may interfere with further tests. The SUN consortium (Project on "Sustainable Nanotechnologies", EU seventh Framework funding) uses methods to characterize and quantify nanomaterials released from composite samples that are exposed to environmental stressors. Here we describe an approach to provide materials in hundreds of gram quantities mimicking actual released materials from coatings and polymer nanocomposites by producing what is called "fragmented products" (FP). These FP can further be exposed to environmental conditions (e.g., humidity, light) to produce "weathered fragmented products" (WFP) or can be subjected to a further size fractionation to isolate "sieved fragmented products" (SFP) that are representative for inhalation studies. In this perspective we describe the approach, and the used methods to obtain released materials in amounts large enough to be suitable for further fate and (eco)toxicity testing. We present a case study (nanoparticulate organic pigment in polypropylene) to show exemplarily the procedures used to produce the FP. We present some characterization data of the FP and discuss critically the further potential and the usefulness of the approach we developed.

Aquatic Ecotoxicity Testing of Nanoparticles-The Quest To Disclose Nanoparticle Effects.

The number of products on the market containing engineered nanoparticles (ENPs) has increased significantly, and concerns have been raised regarding their ecotoxicological effects. Environmental safety assessments as well as relevant and reliable ecotoxicological data are required for the safe and sustainable use of ENPs. Although the number of publications on the ecotoxicological effects and uptake of ENPs is rapidly expanding, the applicability of the reported data for hazard assessment is questionable. A major knowledge gap is whether nanoparticle effects occur when test organisms are exposed to ENPs in aquatic test systems. Filling this gap is not straightforward, because of the broad range of ENPs and the different behavior of ENPs compared to "ordinary" (dissolved) chemicals in the ecotoxicity test systems. The risk of generating false negatives, and false positives, in the currently used tests is high, and in most cases difficult to assess. This Review outlines some of the pitfalls in the aquatic toxicity testing of ENPs which may lead to misinterpretation of test results. Response types are also proposed to reveal potential nanoparticle effects in the aquatic test organisms.

Review of microplastics and chemical risk posed by plastic packaging on the marine environment to inform the Global Plastics Treaty.

Plastic overproduction and the resulting increase in consumption has made plastic pollution ubiquitous in all ecosystems. Recognizing this, the United Nations (UN) has started negotiations to establish a global treaty to end plastic pollution, especially in the marine environment. The basis of the treaty has been formulated in terms of turning off the tap, signaling the will to prevent plastic pollution at its source. Based on the distribution of plastic production by sector, the plastic packaging sector consumes the most plastic. The volume and variety of chemicals used in plastic packaging, most of which is single-use, is a major concern. Single-use plastics including packaging is one of the most dominant sources of plastic pollution. Plastic waste causes pollution in water, air and soil by releasing harmful chemicals into the environment and can also lead to exposure through contamination of food with micro- and nano-plastic particles and chemicals through packaging. Marine life and humans alike face risks from plastic uptake through bioaccumulation and biomagnification. While the contribution of plastics ingested to chemical pollution is relatively minor in comparison to other pathways of exposure, the effect of plastic waste on marine life and human consumption of seafood is beyond question. To reduce the long-term impact of plastic, it is crucial to establish a global legally binding instrument to ensure the implementation of upstream rather than downstream solutions. This will help to mitigate the impact of both chemicals and microplastics, including from packaging, on the environment.

European nanomaterial legislation in the past 20 years - Closing the final gaps.

In 2004, the potential societal implications related to nanotechnology were highlighted in an influential report by the Royal Society and the Royal Academy of Engineering (RS & RAE). It was made clear that legislation is an important tool to tackle the challenges related to nanomaterials and a list of recommendations were put forward. Shortly after, the European Commission also proposed a list of recommendations on how to handle nanomaterial challenges and adopted the so-called "incremental approach", describing that current legislations should be adapted, where relevant, to handle nanomaterials. Now almost 20 years have passed and it seems relevant to take stock and investigate how legislations have been adapted to tackle nano-specific challenges. In this review, we analyze key pieces of European legislations relevant to nanomaterials and assess to what extent these legislations compare with the original recommendations from 2004 by the RS & RAE and the European Commission. We uncover the cross-cutting challenges that remain and provide recommendations on next steps that should be taken to address the risks of nanomaterials. For each recommendation, we assessed whether it was met to a high, medium or low degree by conducting targeted literature searches at Web of Science, screening legislations, guidance documents, databases etc., and applying expert judgement. We found that >90% of the recommendations put forward in 2004 by the RS & RAE and the European Commission have been either met to a high degree (13 out of 29) or met to a medium degree (14 out of 29). This suggests important advancements in the field of nanosafety. At the same time, it is important to address the concerns still left partly or fully unsolved. Such efforts entail e.g. further development of measuring instruments and standardised characterization and risk assessment methods for nanomaterials, application of a uniform nanomaterial definition, maximization of containment of free nanomaterials until hazards assessed/handled and elimination/minimisation of unintentional nanomaterial emission. Furthermore, we recommend prioritising future efforts to ensure enforcement and implementation of existing nano-specific provisions, as well as revision, where needed, of legislations that currently do not account for nanomaterials, such as the Waste Framework Directive.

Effects of interactions between natural organic matter and aquatic organism degradation products on the transformation and dissolution of cobalt and nickel-based nanoparticles in synthetic freshwater.

Expanding applications and production of engineered nanoparticles lead to an increased risk for their environmental dispersion. Systematic knowledge of surface transformation and dissolution of nanoparticles is essential for risk assessment and regulation establishment. Such aspects of Co- and Ni-based nanoparticles including metals, oxides, and solution combustion synthesized metal nanoparticles (metal cores with carbon shells) were investigated upon environmental interaction with organic matter, simulated by natural organic matter (NOM) and degradation products from zooplankton and algae (eco-corona biomolecules, EC) in freshwater (FW). The presence of NOM and EC in FW results in negative surface charges of the nanoparticles reduces the extent of nanoparticles agglomeration, and increases concentration, mainly due to the surface adsorption of carboxylate groups of the organic matter. The dissolution of the Co-based nanoparticles was for all conditions (FW, FW with NOM or EC) higher than the Ni-based, except for Co3O4 being nearly non-soluble. The surface transformation and dissolution of nanoparticles are highly exposure and time-dependent, and surface- and environment specific. Therefore, no general correlation was observed between dissolution and, particle types, surface conditions, or EC/NOM adsorption. This underlines the importance of thorough investigations of nanoparticles adsorption/desorption, degradation, and exposure scenarios for developing regulatory relevant protocols and guidelines.

Unfolding the science behind policy initiatives targeting plastic pollution.

The intensive global plastic production, use and associated plastic pollution have caused concern for the potential risks to human health and the environment. This has led to the adoption of numerous regulatory initiatives aiming to combat plastic pollution. Despite the considerable regulatory activity in the field of plastic, it appears that there is still debate about the actual risks of plastic to humans and the environment. This raises the question of to what extent the current plastic regulation is evidence-based, a declared ambition in the European Union. Therefore, the aim of this study was to investigate to what extent key policy initiatives targeting plastic pollution are based on scientific evidence. Selection of initiatives was based on expert elicitation accounting for the opinions of persons involved in the development of the policy initiatives, and a thorough assessment of the historical development of plastic pollution regulation, with focus on their importance both with respect to regulation of plastics as well as their historical importance as drivers for societal actions on plastic pollution. We find that scientific evidence appears to be generally present in the scientific foundation for the policy initiatives analysed in this study. All the initiatives are supported by scientific articles and reports about among others plastic sources, ecological impacts of plastic production and consumption patterns. Marine litter monitoring data was found to contribute to the evidence base for 4 out of the 6 policy initiatives and thereby appears to be one of the central scientific drivers behind the societal actions on plastic pollution. Other scientific tools applied when shaping the policy initiatives include risk assessment, impact assessment and life cycle assessment. Despite the prevalent consideration and application of scientific evidence, there seems to be a broad recognition in the preparatory work of the initiatives that there is still a lot of uncertainty related to determining the harm of plastic pollution. In these cases, taking precautionary actions seems however to be justified, recalling not least the precautionary principle. As the issue of plastic pollution is complex and still subject to uncertainty, it seems important both that policy initiatives allow for flexibility and continuing adjustment to the on-going knowledge generation and that the scientific community provides the needed research to continue the science-informed policy development.

Prospective environmental risk screening of seven advanced materials based on production volumes and aquatic ecotoxicity.

The number and volume of advanced materials being manufactured is increasing. In order to mitigate future impacts from such materials, assessment methods that can provide early indications of potential environmental risk are required. This paper presents a further development and testing of an environmental risk screening method based on two proxy measures: aquatic ecotoxicity and global annual production volumes. In addition to considering current production volumes, this further developed method considers potential future production volumes, thereby enabling prospective environmental risk screening. The proxy measures are applied to seven advanced materials: graphene, graphene oxide, nanocellulose, nanodiamond, quantum dots, nano-sized molybdenum disulfide, and MXenes. Only MXenes show high aquatic ecotoxicity, though the number of test results is still very limited. While current production volumes are relatively modest for most materials, several of the materials (graphene, graphene oxide, nanocellulose, nano-sized molybdenum disulfide, and MXenes) have the potential to become high-volume materials in the future. For MXenes, with both high aquatic ecotoxicity and high potential future production volumes, more detailed environmental risk assessments should be considered. For the other materials with high potential future production volumes, the recommendation is to continuously monitor their aquatic ecotoxicity data. Based on the application of the proxy measures combined with future scenarios for production volumes, we recommend this environmental risk screening method be used in the early development of advanced materials to prioritize which advanced materials should be subject to more detailed environmental assessments.

The need for environmental regulation of tires: Challenges and recommendations.

The interest in tire wear particles (TWPs), generated from abrasion of tires, have gained traction over the past few years, both in regards to quantifying particulate emissions, leaching of different compounds, toxicity, and analytical methods. The life of a tire, from cradle to end-of-life, crosses over different scenarios during its lifetime and transcends environmental compartments and legislative areas, underlining the need for a collective approach. Sustainability for a tire encompasses the use of raw materials, recycling of raw materials, circular economy and material sourcing. The tire industry is currently making significant efforts towards a greener and more sustainable production considering reduction of CO2-emissions, recycling, material sources and implementing the use of biomass from plants rather than oil-derived alternatives. In this paper, we aim to analyze and discuss the need for environmental regulation of tires in order to provide a series of targeted recommendations for future legislation. Our study shows that the numerous regulations related to tires focus on chemicals, manufacturing, raw materials, use of tires on roads, waste handling, safety and polycyclic aromatic hydrocarbons (PAHs) in different life cycle stages of a tire. However, none directly addresses the contribution of TWPs to the environment. Despite the overall good intentions of the existing regulations, there is a lack of focus on the compounds that partition from the tire and disperse in the environment, their mixture effects, and the transformative products from the parent compounds in the environment. Therefore, a renewed focus is needed on risk assessment of complex mixtures like TWPs. Thus, transparency in regard to use of chemicals in TWP, mixtures, minimization of emissions, and capture of particulate pollution should be a priority.

Definition, categorization, and environmental risk assessment of biopharmaceuticals.

Biopharmaceuticals are associated with the revolutionary treatment of various diseases, and according to the European Medicines Agency, biopharmaceuticals derived from biological sources are perceived to not cause significant environmental risk. However, there is currently no broadly recognized definition or categorization of biopharmaceuticals despite the fact that improved technology has made it possible to modify them to obtain more efficient medicines, thereby raising questions about their biological origins and risks. The aim of this paper, based on a literature review, is to derive a clear definition of biopharmaceuticals and evaluate the European Union's regulation and environmental risk assessment (ERA) procedures for them. Nine different definitions were identified, and it is evident that the term "biopharmaceuticals" is used ambiguously. We therefore recommend that biopharmaceuticals are defined as complex molecules derived from a biological source, with the purpose to diagnose, prevent, treat, or cure diseases or conditions of human beings. Furthermore, we recommend that biopharmaceuticals should be categorized according to their biological structure: 1) amino acids, 2) nucleic acids, and 3) vaccines. Only 11 studies were identified as being relevant to ERA, and we lack useful data for hazard identification. More research is needed to examine the ecotoxicity, fate, and stability of most biopharmaceuticals-and categorical regulatory exclusion seems unfavorable in this regard.

Monitoring and modelling of influent patterns, phase distribution and removal of 20 elements in two primary wastewater treatment plants in Norway.

Many small- or medium-sized communities in Northern Europe employ only primary wastewater treatment plants (WWTPs) and effluent discharges can be a relevant source of pollution. The current study combines monitoring and modelling approaches to investigate concentrations, influent patterns, size distribution and removal of 20 elements for the two primary WWTPs (Ladehammeren, LARA; Høvringen, HØRA) serving Trondheim, the third largest city in Norway. Element concentrations were determined in raw influent wastewater, effluents and biosolids, and diurnal inflow patterns were assessed. The elemental distribution in particulate, colloidal and dissolved fractions of untreated wastewater was characterized using filtration separation and electron microscopy. An influent generator model and multivariate statistical analyses were used to determine release patterns and to predict the (co-)occurrence of selected elements. Raw influent wastewater concentrations for most elements were similar in the two WWTPs, with only Ca, Mn, Fe, Co and Ba being significantly higher (p < 0.05) in HØRA (which receives more household and hospital discharges). Removal efficiencies varied between elements, but in most cases reflected their association with particulates. Nanosized particles of several elements were detected, with Cu/Zn being most common. Measured concentrations of most elements followed typical diurnal wastewater discharge patterns and enrichment factors calculated for biosolids confirmed the importance of anthropogenic sources for P, Cu, Zn, Cd, As, Cr, Ni, Pb, V, Co and Fe. Elemental concentrations generally correlated well with total suspended solid (TSS) concentrations at HØRA, while this was less pronounced in LARA (possibly due to higher industrial contributions). In one of its first applications for WWTP influent pattern examination, principal component analysis was found to be instrumental for source identification of target elements, showing significant differences between LARA and HØRA influents. The combined experimental, statistical and modelling approaches used herein allowed for improved understanding of element sources, patterns of discharge and fate in primary WWTPs.

Stakeholder analysis with regard to a recent European restriction proposal on microplastics.

Stakeholder involvement is pivotal EU governance. In this paper, we complete a stakeholder analysis of the European Chemicals Agency's recent Annex XV restriction proposal process on intentionally added microplastics. The aim of this study is to map the interests, influence and importance of active stakeholders in order to understand the arguments being put forward by different stakeholders and provide recommendations to policy-makers on how to ensure a balanced consideration of all stakeholder perspectives. Stakeholders were identified through niche media analysis and by scrutinising comments from the public consultation on the restriction proposal. Their importance and influence were mapped using three approaches: "scale from low to high", "psychometric scale" and "qualitative ranking". We identified 205 different stakeholders out of which 77 were industry and trade associations, 25 were large companies and only four were small and medium-sized enterprises. National authorities and researchers did not comment on the restriction proposal, whilst large companies were very active providing comments. Industry trade associations and sports-related non-governmental organizations articulated anxiety about the costs associated with the implementation of the restriction proposal. Among environmental non-governmental organizations, there was consensus that plastics should be handled like other substances under EU's chemical regulation. Primary stakeholders identified exhibited high importance, but varying degrees of influence, while the opposite applied to the major European institutions. Based on our analysis, we recommend that: The European Chemicals Agency implement measures to include "silent" stakeholders and invite guest experts to participate in their committees on Risk Assessment and Socio-Economic Analysis; Researchers should be more active in the public consultation; and that special emphasis should be put on helping small and medium-sized enterprises. With regards to stakeholder consultation, we find that media analysis is a good supplement to stakeholder analysis and that a more objective top-down measure of stakeholder importance and influence is needed.

A nationwide assessment of plastic pollution in the Danish realm using citizen science.

Plastic pollution is considered one of today's major environmental problems. Current land-based monitoring programs typically rely on beach litter data and seldom include plastic pollution further inland. We initiated a citizen science project known as the Mass Experiment inviting schools throughout The Danish Realm (Denmark, Greenland and the Faeroe Islands) to collect litter samples of and document plastic pollution in 8 different nature types. In total approximately 57,000 students (6-19 years) collected 374,082 plastic items in 94 out of 98 Danish municipalities over three weeks during fall 2019. The Mass Experiment was the first scientific survey of plastic litter to cover an entire country. Here we show how citizen science, conducted by students, can be used to fill important knowledge gaps in plastic pollution research, increase public awareness, establish large scale clean-up activities and subsequently provide information to political decision-makers aiming for a more sustainable future.

Setting the limits for engineered nanoparticles in European surface waters - are current approaches appropriate?

The current widespread and diverse use of engineered nanoparticles (ENPs) in consumer products is expected to result in direct and indirect emissions to the aquatic environment. In Europe, the Water Framework Directive (WFD) is responsible for maintaining a good chemical and ecological status of surface waters. This review provides an insight to the likely scenarios if an engineered nanoparticle should be considered a "priority substance" in the WFD. Through a brief literature review of the aquatic toxicity of carbon- and metal-containing ENPs and in light of principles to establish environmental quality standards, we conclude that it is impossible to set limit values for ENPs in surface waters now and in the foreseeable future. This is due to the extensive lack of knowledge not only in relation to unknown toxic effects, degradability, and bioaccumulation of ENPs in the aquatic environment, but also due to the questionable validity of test systems and methods to establish environmental quality standards (EQS). From this, we also suggest some paths to follow to compensate for these knowledge gaps which include environmental monitoring and a closer look at the use of ENPs in consumer products.

Publisher Correction: On the issue of transparency and reproducibility in nanomedicine.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.