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.

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.

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.

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.

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.

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.

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.

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.

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.

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.