Suchergebnisse

AbstractCurrent approaches for the prospective regulatory assessment of chemicals do not account sufficiently for elevated mixture risks. The Mixture Assessment Factor (MAF, better labeled a Mixture Allocation Factor) has been suggested for mixtures of industrial chemicals in the EU's Chemicals Strategy for Sustainability, as a pragmatic tool to account for potential mixture risks already during the risk and safety assessment of individual chemicals. The MAF is to be applied in scenarios in which specific mixture risk assessments are not possible, due to a lack of data and/or the complexity of the relevant exposure scenarios. Several approaches and algorithms for calculating a MAF have been suggested in the literature. The MAFexact, which is a member of the larger MAFceiling class, is defined as the maximum fraction of the risk quotient of each chemical that is still acceptable to occur in a mixture, without the sum of risk quotients exceeding 1. This paper provides a comparative overview of the different MAF types discussed in the literature. It argues that the MAFexact is the most promising approach in the context of chemical registration and authorization under regulatory frameworks such as REACH because this approach ensures a protection level that is similar to the protection level used in the current safety assessment of individual chemicals under REACH. Other MAF approaches either disproportionally impact low-risk substances, without leading to any appreciable risk reduction, or hamper risk communication because they lead to fluctuating residual risks after the MAF application. The paper also presents a case study comparing the different MAF approaches and finally discusses the MAF concept in the wider context of chemical regulation.

AbstractThe EU Commission published on the 26th of October 2022 its proposal for amending three central water management Directives, the Water Framework Directive, the Groundwater Directive, and the Directive on Environmental Quality Standards. The proposal introduces a series of amendments and changes to remedy shortcomings that were identified in the previous fitness check of the European water legislation and to align the legal framework with the scientific and technical progress of the last decades. This commentary briefly summarizes and evaluates the new elements that are most relevant from a toxicological and ecotoxicological perspective.The Commission proposal substantially extends the list of WFD priority substances and now includes 68 substances and substance groups. It also identifies five substances and substance groups as a priority for groundwater management. In several instances, generic sum-EQS values are suggested for selected substance groups, an approach that lacks scientific underpinning and might not always be sufficiently protective. EQS values for substances groups are certainly needed, but are better set using relative potency factors or other implementations of the Concentration Addition concept. The Commission proposal employs this approach for setting groupwise EQS values for PFAS chemicals and PAHs and it should be systematically applied also to other groups of priority substances.Effect-based methods (EBMs) are now included in the legal text of the WFD, which is highly welcome. However, the Commission proposal limits EBMs to explorative studies and does not include the setting of EQS values based on EBM-methods.Revising the major legislative frameworks offers opportunities to streamline water pollution management in the spirit of the "one substance, one assessment" idea. Further details on how substance evaluations performed in the context of water management can be harmonized with those performed by EFSA, ECHA and EMA during substance registration and authorization would have been welcome.

Abstract
Background
The substitution of hazardous chemicals with safer alternatives is an important objective in European chemical policy, but implementation has been slower than expected. We conduct a comprehensive analysis and comparison of the implementation of the substitution principle in European regulations for pesticides, biocides, and industrial chemicals. Specifically, we examine and compare the criteria and processes associated with the identification of candidates for substitution and the assessment of alternatives.

Results
We find only minor differences in the criteria applied to identify candidates for substitution amongst pesticides, biocides, and industrial chemicals, but larger differences concerning the processes used. While all substances that are to be approved as a pesticide and biocide are systematically evaluated against the established criteria for substitution, the substitution process for industrial chemicals only focuses on those substances identified as substances of very high concern. The main reason candidates for substitution remain on the market is the lack of identified safer chemical alternatives and the insufficient consideration of non-chemical alternatives, caused, at least to a large extent, by the comparatively weak incentives provided by current regulations.

Conclusions
The systematic approach for the identification of industrial substances of very high concern (SVHC) under ECHAs "Integrated Regulatory Strategy" is much welcome. However, no final conclusion on SVHC properties or the need for regulatory action has been drawn for approximately 90% of the REACH-registered substances, as often even basic hazard and exposure data are missing. Hence, at least a screening-level evaluation of SVHC properties should become a mandatory part of the substance registration under REACH. To reduce the risk of strategic behaviour in the search for alternatives to industrial chemicals identified as SVHC, a setup in which regulatory authorities play a larger role as information and knowledge brokers should be considered. Investments in innovation as well as improved sharing of information and a better distribution of the workloads amongst European authorities might also improve the identification of safer alternatives. However, without stronger incentives, making it more costly for companies to continue using hazardous substances relative to safer alternatives, initiatives to promote substitution are likely to have limited success.

Abstract

Background
The substitution principle has been included in the EU pesticides legislation as a new element. Comparative assessments will have to be conducted for all uses of plant protection products (PPPs) that contain active substances with certain hazardous properties, the so-called candidates for substitution (CFS). This study investigated the resulting workload in terms of the number of cases for comparative assessments that regulatory authorities may have to face. The analysis was carried out for Germany as an example.


Main text
In Germany, the requirement for comparative assessments may affect up to 25% of all PPPs and around 50% of all uses of PPPs. In absolute terms, these are around 350 candidate products with 1,850 different uses. Alternative products without CFS may be available for around 40% of these uses. On average, a candidate product is authorised for around 18 different uses. For 11 of these uses, no alternatives are authorised. For the remaining seven uses, slightly more than seven alternatives are available on average. Multiplication of these factors gives an indicative figure of around 18,500 possible pairwise comparisons of candidate products with alternative products for every common use.


Conclusions
The high number of expectable cases poses a formidable challenge for the efficient conduct of the new task of comparative assessments by competent Member States authorities. To this end, new data handling systems, assessment procedures, and decision rules need to be established.

Abstract
The present monitoring and assessment of water quality problems fails to characterize the likelihood that complex mixtures of chemicals affect water quality. The European collaborative project SOLUTIONS suggests that this likelihood can be estimated, amongst other methods, with improved component-based methods (CBMs). The use of CBMs is a well-established practice in the WFD, as one of the lines of evidence to evaluate chemical pollution on a per-chemical basis. However, this is currently limited to a pre-selection of 45 and approximately 300 monitored substances (priority substances and river basin-specific pollutants, respectively), of which only a few actually co-occur in relevant concentrations in real-world mixtures. Advanced CBM practices are therefore needed that consider a broader, realistic spectrum of chemicals and thereby improve the assessment of mixture impacts, diagnose the causes of observed impacts and provide more useful water management information. Various CBMs are described and illustrated, often representing improvements of well-established methods. Given the goals of the WFD and expanding on current guidance for risk assessment, these improved CBMs can be applied to predicted or monitored concentrations of chemical pollutants to provide information for management planning. As shown in various examples, the outcomes of the improved CBMs allow for the evaluation of the current likelihood of impacts, of alternative abatement scenarios as well as the expected consequences of future pollution scenarios. The outputs of the improved CBMs are useful to underpin programmes of measures to protect and improve water quality. The combination of CBMs with effect-based methods (EBMs) might be especially powerful to identify as yet underinvestigated emerging pollutants and their importance in a mixture toxicity context. The present paper has been designed as one in a series of policy briefs to support decisions on water quality protection, monitoring, assessment and management under the European Water Framework Directive (WFD).

Abstract
Evidence is mounting that chemicals can produce joint toxicity even when combined at levels that singly do not pose risks. Environmental Quality Standards (EQS) defined for single pollutants under the Water Framework Directive (WFD) do not protect from mixture risks, nor do they enable prioritization of management options. Despite some provisions for mixtures of specific groups of chemicals, the WFD is not fit for purpose for protecting against or managing the effects of coincidental mixtures of water-borne pollutants. The conceptual tools for conducting mixture risk assessment are available and ready for use in regulatory and risk assessment practice. Extension towards impact assessment using cumulative toxic unit and mixture toxic pressure analysis based on chemical monitoring data or modelling has been suggested by the SOLUTIONS project. Problems exist in the availability of the data necessary for mixture risk assessments. Mixture risk assessments cannot be conducted without essential input data about exposures to chemicals and their toxicity. If data are missing, mixture risk assessments will be biassed towards underestimating risks. The WFD itself is not intended to provide toxicity data. Data gaps can only be closed if proper feedback links between the WFD and other EU regulations for industrial chemicals (REACH), pesticides (PPPR), biocides (BPR) and pharmaceuticals are implemented. Changes of the WFD alone cannot meet these requirements. Effect-based monitoring programmes developed by SOLUTIONS should be implemented as they can capture the toxicity of complex mixtures and provide leads for new candidate chemicals that require attention in mixture risk assessment. Efforts of modelling pollutant levels and their anticipated mixture effects in surface water can also generate such leads. New pollutant prioritization schemes conceived by SOLUTIONS, applied in the context of site prioritization, will help to focus mixture risk assessments on those chemicals and sites that make substantial contributions to mixture risks.

Abstract
Present evaluations of chemical pollution in European surface and groundwater bodies focus on problem description and chemical classification of water quality. Surprisingly, relatively low attention has been paid to solutions of chemical pollution problems when those are encountered. Based on evaluations of current practices and available approaches, we suggest that water quality protection, monitoring, assessment and management of chemical pollution can be improved by implementing an early-stage exploration of the 'solution space'. This follows from the innovative paradigm of solution-focused risk assessment, which was developed to improve the utility of risk assessments. The 'solution space' is defined as the set of potential activities that can be considered to protect or restore the water quality against hazards posed by chemical pollution. When using the paradigm, upfront exploration of solution options and selecting options that would be feasible given the local pollution context would result in comparative risk assessment outcomes. The comparative outcomes are useful for selecting optimal measures against chemical pollution for management prioritization and planning. It is recommended to apply the solution-focused risk assessment paradigm to improve the chemical pollution information for river basin management planning. To operationalize this, the present paper describes a still-growing database and strategy to find and select technical abatement and/or non-technical solution options for chemical pollution of surface waters. The solutions database and strategy can be applied to help prevent and reduce water quality problems. Various case studies show that implementing these can be effective, and how solution scenarios can be evaluated for their efficacy by comparative exposure and effect assessment.

AbstractThe aim of the European Water Framework Directive is to ensure good ecological status for all European surface waters. However, although current monitoring strategies aim to identify the presence and magnitude of ecological impacts, they provide little information on the causes of an ecosystem impairment. In fact, approaches to establish causal links between chemical pollution and impacts on the ecological status of exposed aquatic systems are largely lacking or poorly described and established. This is, however, crucial for developing and implementing appropriately targeted water management strategies. In order to identify the role of chemical pollution on the ecological status of an aquatic ecosystem, we suggest to systematically combine four lines of evidence (LOEs) that provide complementary evidence on the presence and potential ecological impact of complex chemical pollution: (1) component-based methods that allow a predictive mixture risk modeling; (2) effect-based methods; (3) in situ tests; (4) field-derived species inventories. These LOEs differ systematically in their specificity for chemical pollution, data demands, resources required and ecological relevance. They complement each other and, in their combination, allow to assess the contribution of chemical pollution pressure to impacts on ecological structure and function. Data from all LOEs are not always available and the information they provide is not necessarily consistent. We therefore propose a systematic, robust and transparent approach to combine the information available for a given study, in order to ensure that consensual conclusions are drawn from a given dataset. This allows to identify critical data gaps and needs for future testing and/or options for targeted and efficient water management.