European-wide spatial analysis of sewage treatment plants and the possible benefits to nature of advanced treatment to reduce pharmaceutical emissions.

Pharmaceuticals are known to widely occur in the environment and to affect the health of ecosystems. Sewage treatment plants (STPs) are main emission pathways for pharmaceuticals, which are often not sufficiently removed during wastewater treatment. In Europe, STP treatment requirements are specified under the Urban WasteWater Treatment Directive (UWWTD). The introduction of advanced treatment techniques, such as ozonation and activated carbon, under the UWWTD is expected to be an important option to reduce pharmaceutical emissions. In this study, we present a European-wide analysis of STPs reported under the UWWTD, their current treatment level and potential to remove a set of 58 prioritised pharmaceuticals. Three different scenarios were analysed to show 1) UWWTD present effectiveness, 2) the effectiveness at full UWWTD compliance, and 3) the effectiveness when advanced treatment is implemented at STPs with a treatment capacity of >100.000 person equivalents. Based on a literature study, the potential of individual STPs to reduce pharmaceutical emissions ranged from an average of 9% for STPs with primary treatment to 84% for STPs applying advanced treatment. Results of our calculations show that European-wide emission of pharmaceuticals can be reduced with 68% when large STPs are updated with advanced treatment, but spatial differences exist. We argue that adequate attention should also be paid with regards to preventing environmental impacts of STPs with a capacity <100.000 p.e. Circa 44% of total STP effluent is emitted near Natura2000 sites (EU nature protection areas). Of all surface waters receiving STP effluent for which the ecological status has been assessed under the Water Framework Directive, 77% have a status of less than good. Relatively often only primary treatment is applied to wastewater emitted into coastal waters. This analysis can be used to further model pharmaceutical concentrations in European surface waters, to identify STPs for which more advanced treatment might be required and to protect EU aquatic biodiversity.

Managing PMT/vPvM substances in consumer products through the concepts of essential-use and functional substitution: a case-study for cosmetics.

Measures are needed to protect water sources from substances that are mobile, persistent and toxic (PMT) or very persistent and very mobile (vPvM). PMT/vPvM substances are used in a diverse range of applications, including consumer products. The combined application of the essential-use and functional substitution concepts has been proposed to phase out substances of concern and support the transition to safer and more sustainable chemicals, a key goal of the European Commission's Chemicals Strategy for Sustainability. Here, we first identified the market share of PMT/vPvM containing cosmetic products. We found that 6.4% of cosmetic products available on the European market contain PMT or vPvM substances. PMT/vPvM substances were most often found in hair care products. Based on their high occurrence, the substances Allura red (CAS 25956-17-6), benzophenone-4 (CAS 4065-45-6) and climbazole (CAS 38083-17-9) were selected as case-studies for assessment of their functionality, availability of safer alternatives and essentiality. Following the functional substitution framework, we found that the technical function of Allura red was not necessary for the performance of some cosmetic products, making the use non-essential. For other applications of Allura red, as well as all applications of benzophenone-4 and climbazole, the technical function of the chemical was considered necessary for the performance. Via the alternative's assessment procedure, which used experimental and in silico data and three different multicriteria decision analysis (MCDA) strategies, safer alternatives were identified for all case-study chemicals. All assessed uses of PMT/vPvM substances were thus deemed non-essential and should consequently be phased out.

Safe and sustainable by design: A computer-based approach to redesign chemicals for reduced environmental hazards.

Persistency of chemicals in the environment is seen a pressing issue as it results in accumulation of chemicals over time. Persistent chemicals can be an asset in a well-functioning circular economy where products are more durable and can be reused or recycled. This objective can however not always be fulfilled as release of chemicals from products into the environment can be inherently coupled to their use. In these situations, chemicals should be designed for degradation. In this study, a systematic and computer-aided workflow was developed to facilitate the chemical redesign for reduced persistency. The approach includes elements of Essential Use, Alternatives Assessment and Green and Circular Chemistry and ties into goals recently formulated in the context of the EU Green Deal. The organophosphate chemical triisobutylphosphate (TiBP) was used as a case study for exploration of the approach, as its emission to the environment was expected to be inevitable when used as a flame retardant. Over 6.3 million alternative structures were created in silico and filtered based on QSAR outputs to remove potentially non-readily biodegradable structures. With a multi-criteria analysis based on predicted properties and synthesizability a top 500 of most desirable structures was identified. The target structure (di-n-butyl (2-hydroxyethyl) phosphate) was manually selected and synthesized. The approach can be expanded and further verified to reach its full potential in the mitigation of chemical pollution and to help enable a safe circular economy.

The EU Green Deal's ambition for a toxic-free environment: Filling the gap for science-based policymaking.

Around the world, many ambitious environmental conventions and regulations have been implemented over recent decades. Despite this, the environment is still deteriorating. An increase in the volume and diversity of chemicals is one of the main drivers of this deterioration, of which biodiversity loss is a telling indicator. In response to this situation, in October 2020, a chemicals strategy for sustainability (CSS) was published in the EU. The CSS is the first regional framework aiming to address chemical pollution in a holistic manner. The CSS covers the complete lifecycle of a chemical, including the design of better substances and remediation options, to remove chemicals from the environment. The strategy contains terms, such as a "toxic-free environment," for which no clear definition exists, potentially hampering the implementation of the CSS. In this paper, a definition for a "toxic-free environment" is proposed on the basis of a survey and a discussion held at the 2020 SETAC Europe Annual Meeting. In addition, key issues that are absent from the CSS but are considered to be key for the realization of a toxic-free environment are identified. To achieve the policy goals, it is recommended to align the definition of risk across the different chemical legislations, to establish a platform for open data and data sharing, and to increase the utility and use of novel scientific findings in policymaking, through the development of a strong science to regulation feedback mechanism and vice versa. The paper concludes that environmental scientists have the tools to address the key challenges presented in the CSS. However, an extra step is needed by both policymakers and scientists to develop methods, processes and tools, to increase the robustness and transparency of deliberation processes, and the utility of science. Integr Environ Assess Manag 2021;17:1105-1113. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

ECORISK2050: An Innovative Training Network for predicting the effects of global change on the emission, fate, effects, and risks of chemicals in aquatic ecosystems.

By 2050, the global population is predicted to reach nine billion, with almost three quarters living in cities. The road to 2050 will be marked by changes in land use, climate, and the management of water and food across the world. These global changes (GCs) will likely affect the emissions, transport, and fate of chemicals, and thus the exposure of the natural environment to chemicals. ECORISK2050 is a Marie Sklodowska-Curie Innovative Training Network that brings together an interdisciplinary consortium of academic, industry and governmental partners to deliver a new generation of scientists, with the skills required to study and manage the effects of GCs on chemical risks to the aquatic environment. The research and training goals are to: (1) assess how inputs and behaviour of chemicals from agriculture and urban environments are affected by different environmental conditions, and how different GC scenarios will drive changes in chemical risks to human and ecosystem health; (2) identify short-to-medium term adaptation and mitigation strategies, to abate unacceptable increases to risks, and (3) develop tools for use by industry and policymakers for the assessment and management of the impacts of GC-related drivers on chemical risks. This project will deliver the next generation of scientists, consultants, and industry and governmental decision-makers who have the knowledge and skillsets required to address the changing pressures associated with chemicals emitted by agricultural and urban activities, on aquatic systems on the path to 2050 and beyond.

Towards 'one substance - one assessment': An analysis of EU chemical registration and aquatic risk assessment frameworks.

With the Green Deal the EU aims to achieve a circular economy, restore biodiversity and reduce environmental pollution. As a part of the Green Deal a 'one-substance one-assessment' (OS-OA) approach for chemicals has been proposed. The registration and risk assessment of chemicals on the European market is currently fragmented across different legal frameworks, dependent on the chemical's use. In this review, we analysed the five main European chemical registration frameworks and their risk assessment procedures for the freshwater environment, covering 1) medicines for human use, 2) veterinary medicines, 3) pesticides, 4) biocides and 5) industrial chemicals. Overall, the function of the current frameworks is similar, but important differences exist between the frameworks' environmental protection goals and risk assessment strategies. These differences result in inconsistent assessment outcomes for similar chemicals. Chemicals are also registered under multiple frameworks due to their multiple uses, and chemicals which are not approved under one framework are in some instances allowed on the market under other frameworks. In contrast, an OS-OA will require a uniform hazard assessment between all different frameworks. In addition, we show that across frameworks the industrial chemicals are the least hazardous for the freshwater environment (median PNEC of 2.60E-2 mg/L), whilst biocides are the most toxic following current regulatory assessment schemes (median PNEC of 1.82E-4 mg/L). Finally, in order to facilitate a successful move towards a OS-OA approach we recommend a) harmonisation of environmental protection goals and risk assessment strategies, b) that emission, use and production data should be made publicly available and that data sharing becomes a priority, and c) an alignment of the criteria used to classify problematic substances.

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted.

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the co-rapporteur Member State the Czech Republic for the pesticide active substance sulfoxaflor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of sulfoxaflor as an insecticide on fruiting vegetables (field and greenhouse application), cucurbits (field and greenhouse application), spring and winter cereals (field application) and cotton (field application). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. For the field and non-permanent structure greenhouses, a high risk to honeybees and bumble bees was identified related to some pertinent scenarios (treated crop scenario except after flowering period, weed scenario, field margin scenario). A low risk was concluded for honeybees, bumble bees and solitary bees in case of permanent structure greenhouse provided the low exposure in such scenarios.

Peer review of the pesticide risk assessment of the active substance ethoprophos.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co-rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethoprophos as a nematicide and an insecticide on potatoes. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted.

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions were reached on the basis of the evaluation of the representative uses of flumioxazin as a herbicide on winter wheat and sunflower (pre- and post-emergence). The reliable endpoints, derived from the studies and the literature data presented in the dossier and considered appropriate for use in regulatory risk assessment, are presented.

Peer review of the pesticide risk assessment of the active substance methiocarb.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co-rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of methiocarb as an insecticide and a bird repellent on maize. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance dimethoate.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co-rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimethoate as insecticide on wheat and sugar beet. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance (EZ)-1,3-dichloropropene.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)-1,3-dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)-1,3-dichloropropene as a nematicide in fruiting vegetables (tomato, pepper, eggplant, cucumber, zucchini, melon and watermelon). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance napropamide-M.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide-M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamide-M as a herbicide on winter oilseed rape and brassica vegetable crops. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop-propargyl).

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co-rapporteur Member State Germany for the pesticide active substance clodinafop-propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop-propargyl as a herbicide on wheat, rye and triticale. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance propanil.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of propanil as a herbicide on rice. MRLs were assessed in rice. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted.

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions were reached on the basis of the evaluation of the representative uses of bromoxynil as a herbicide on maize and straw cereals. The reliable endpoints, derived from the studies and the literature data presented in the dossier and considered appropriate for use in regulatory risk assessment, are presented.

Peer review of the pesticide risk assessment of the active substance dichlorprop-P and variant dichlorprop-P-2-ethylhexyl.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Ireland and co-rapporteur Member State Poland for the pesticide active substance dichlorprop-P and the variant dichlorprop-P-2-ethylhexyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop-P as a herbicide on cereals, grassland and grass seed crops and of the variant dichlorprop-P-2-ethylhexyl as a plant growth regulator on citrus. MRLs were assessed in mandarin and lemon. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance fosetyl.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State France and co-rapporteur Member State Estonia for the pesticide active substance fosetyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of fosetyl as a fungicide on grapes, citrus and pome fruits. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and the co-rapporteur Member State Portugal for the pesticide active substance 1-methylcyclopropene are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of 1-methylcyclopropene as a plant growth regulator on apples. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance BAS 750 F (mefentrifluconazole).

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance BAS 750 F (mefentrifluconazole) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use(s) of BAS 750 F (mefentrifluconazole) as a fungicide on cereals. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.