REACH assessment of humans exposed to chemicals indirectly via the environment: screening modeling in EUSES versus state of the science.

The assessment of humans indirectly exposed to chemicals via the environment (HvE) is an assessment element of the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation. The European Union System for the Evaluation of Substances (EUSES) is the default screening tool, aimed at prioritizing chemicals for further refinement/higher tier assessment. This review summarizes the approach used in EUSES, evaluates the state of the science in human exposure modeling via the environment, and identifies areas for further research to strengthen the confidence and applicability of EUSES for assessing HvE.

Assessment of the contribution of surfactants to mixture toxicity in French surface waters.

Surfactants are widely used 'down-the-drain' chemicals with the potential to occur at high concentrations in local water bodies and to be part of unintentional environmental mixtures. Recently, increased regulatory focus has been placed on the impacts of complex mixtures in aquatic environments and the substances that are likely to drive mixture risk. This study assessed the contribution of surfactants to the total mixture pressure in freshwater ecosystems.

Assessment of human exposure to environmental sources of lead arising from the lead battery manufacturing and recycling sector in Europe: demonstration of a tiered approach in a case study.

Background: Standard approaches for the assessment of Man via the Environment exposure are designed to be conservative. However, propagating these exposures into health impact assessment might lead to questionable socio-economic costs.

Objective: The objective of this study was to develop a novel tiered modelling approach to assess human exposure to lead (Pb) via the environment.

Assessment of exposure determinants and exposure levels by using stationary concentration measurements and a probabilistic near-field/far-field exposure model.

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requires the establishment of Conditions of Use (CoU) for all exposure scenarios to ensure good communication of safe working practices. Setting CoU requires the risk assessment of all relevant Contributing Scenarios (CSs) in the exposure scenario. A new CS has to be created whenever an Operational Condition (OC) is changed, resulting in an excessive number of exposure assessments.

Demonstrating the Reliability of bio-met for Determining Compliance with Environmental Quality Standards for Metals in Europe.

The importance of considering the bioavailability of metals in understanding and assessing their toxicity in freshwaters has been recognized for many years. Currently, biotic ligand models (BLMs) are being applied for the derivation and implementation of environmental quality standards (EQS) for metals under the Water Framework Directive in Europe. bio-met is a simplified tool that was developed for implementing bioavailability-based EQS for metals in European freshwaters.

MeClas: An online tool for hazard identification and classification of complex inorganic metal-containing materials.

MeClas is a web-based tool to generate (eco)toxicity hazard categories and corresponding classification & labelling information of inorganic metal-containing complex materials such as ores, concentrates, intermediates or alloys for which the manual application of the GHS/CLP rules is very complex and requires a high level of consistency. The tool comprises several tiers, aimed at the progressive refinement of classification through recognition of specific mineral content, speciation/mineralogy up to bio-availability corrections. Where relevant in a regional jurisdiction (EU and US), mandatory classification references are used complementary to high quality (eco)toxicity reference values (ERV/TRV) and self-classifications.

Potential for MERLIN-Expo, an advanced tool for higher tier exposure assessment, within the EU chemical legislative frameworks.

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.

Can Ingestion of Lead Shot and Poisons Change Population Trends of Three European Birds: Grey Partridge, Common Buzzard, and Red Kite?

Little is known about the magnitude of the effects of lead shot ingestion alone or combined with poisons (e.g., in bait or seeds/granules containing pesticides) on population size, growth, and extinction of non-waterbird avian species that ingest these substances.

SPERCS-A tool for environmental emission estimation.

The European Union (EU) chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires a hazardous substance registration to identify the uses of a substance and the corresponding conditions of safe use. This requirement includes a human and an environmental safety assessment. Exposure scenarios are developed and employed for estimating emissions resulting from the uses of hazardous substances.

Development of realistic environmental release factors based on measured data: approach and lessons from the EU metal industry.

The assessment of environmental exposure and risks associated with the production or use of a substance on an industrial site includes the estimation of the releases to the environment. In the absence of measured release data on the specific substance, a risk assessor would rely on default release factors to the environmental compartments as developed in international, national, or regional context. Because a wide variety of substances, processes, and uses has to be covered, default release factors are as a rule conservative, usually leading to significant overprediction of releases and hence to overpredicted environmental exposure concentrations and risks.

Improving sediment-quality guidelines for nickel: development and application of predictive bioavailability models to assess chronic toxicity of nickel in freshwater sediments.

Within the framework of European Union chemical legislations an extensive data set on the chronic toxicity of sediment nickel has been generated. In the initial phase of testing, tests were conducted with 8 taxa of benthic invertebrates in 2 nickel-spiked sediments, including 1 reasonable worst-case sediment with low concentrations of acid-volatile sulfide (AVS) and total organic carbon. The following species were tested: amphipods (Hyalella azteca, Gammarus pseudolimnaeus), mayflies (Hexagenia sp.

Development and validation of a quantitative structure-activity relationship for chronic narcosis to fish.

Vertebrate testing under the European Union's regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) is discouraged, and the use of alternative nontesting approaches such as quantitative structure-activity relationships (QSARs) is encouraged. However, robust QSARs predicting chronic ecotoxicity of organic compounds to fish are not available. The Ecological Structure Activity Relationships (ECOSAR) Class Program is a computerized predictive system that estimates the acute and chronic toxicity of organic compounds for several chemical classes based on their log octanol-water partition coefficient (K(OW)).

Monitoring micropollutants in marine waters, can quality standards be met?

The environmental risks of 33 micropollutants occurring in Belgian coastal zone were assessed as single-substances and as mixtures. Water and sediment samples were taken in harbors, coastal waters and the Scheldt estuary during 2007-2009. Measured environmental concentrations were compared to quality standards such as Predicted No Effect Concentrations (PNECs), Environmental Quality Standards (EQSs), and Ecotoxicological Assessment Criteria (EAC).

A scenario analysis for reducing organic priority pollutants in receiving water using integrated dynamic urban fate models.

The Water Framework Directive (WFD) has the objective of a catchment-oriented water quality protection for all European waters with the purpose of achieving a good ecological and chemical quality status by the year 2015. To that end, necessary measures should be identified and implemented, with the aim of progressively reducing pollution from priority substances. The objective of this paper is to demonstrate how a dynamic model of the integrated urban wastewater system (IUWS) can be used to test different emission reduction strategies for organic priority pollutants (PPs) in a semi-hypothetical case study on di(2-ethylhexyl)phthalate (DEHP).

Evaluating the usefulness of dynamic pollutant fate models for implementing the EU Water Framework Directive.

The European Water Framework Directive (WFD) aims at achieving a good ecological and chemical status of surface waters in river basins by 2015. The chemical status is considered good if the Environmental Quality Standards (EQSs) are met for all substances listed on the priority list and eight additional specific emerging substances. To check compliance with these standards, the WFD requires the establishment of monitoring programmes.

Probabilistic intake assessment of polybrominated diphenyl ethers and omega-3 fatty acids through fish consumption.

Food intake is one of the principal exposure routes of polybrominated diphenyl ethers (PBDEs) in humans. This study focuses on fish consumption as a PBDE exposure route. A probabilistic intake assessment of PBDEs and healthy long chain omega-3 PUFAs (LC n-3 PUFAs) was conducted for Belgian fish consumers in order to study the balance of the intake of LC n-3 PUFAs and PBDEs.

Fish consumption is a safe solution to increase the intake of long-chain n-3 fatty acids.

Objectives: Dietary intake of long-chain (LC) n-3 PUFA in developed countries is low compared with recommendations. Fish is naturally rich in LC n-3 PUFA, but is also a dietary source of heavy metals and organic pollutants. We investigated whether the recommendation for LC n-3 PUFA could be reached through fish consumption, without exceeding the provisional tolerable weekly intake of methylmercury (MeHg) and the tolerable weekly intake (TWI) of dioxin-like compounds.

Probabilistic intake assessment of multiple compounds as a tool to quantify the nutritional-toxicological conflict related to seafood consumption.

Seafood represents a natural source of valuable nutrients (e.g., long chain omega-3 poly-unsaturated fatty acids (LC n-3 PUFAs), vitamin D, and iodine), but the favourable health perception is troubled by the presence of contaminants (e.

An intelligent data collection tool for chemical safety/risk assessment.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the new European chemical legislation which aims to assess risk or safety of tens of thousands of chemicals to improve the protection of human health and the environment. The chemical safety assessment process is of an iterative nature. First, an initial, worst-case assessment is conducted after which refinements are made until no risk has been estimated or the risk is adequately controlled.

Improving uncertainty analysis in European Union risk assessment of chemicals.

Handling uncertainty in curren European Union (EU) risk assessment of new and existing substances is problematic for several reasons. The known or quantifiable sources of uncertainty are mainly considered. Uncertainty is insufficiently, explicitly communicated to risk managers and decision makers but hidden and concealed in risk quotient numbers that appear to be certain and, therefore, create a false sense of certainty and protectiveness.

Variability and uncertainty assessment of patulin exposure for preschool children in Flanders.

The objective of the present study was to evaluate the patulin exposure of children consuming organic, handcrafted or conventional apple juice through a probabilistic approach and to evaluate the effectiveness of several risk management options aiming to reduce the risk for children due to patulin exposure. However, a large part of the data on patulin contamination of apple juice fell under the limit of detection (LOD). Different methods were tested to deal with these so-called left censored data and a uniform distribution with uncertain bounds was selected to handle this censorship.

Parameter sensitivity and uncertainty of the forest carbon flux model FORUG: a Monte Carlo analysis.

The Monte Carlo technique can be used to propagate input variable uncertainty and parameter uncertainty through a model to determine output uncertainty. However, to carry out Monte Carlo simulations, the uncertainty distributions or the probability density functions (PDFs) of the model parameters and input variables must be known. This remains one of the bottlenecks in current uncertainty research in forest carbon flux modeling.

A rule-based screening environmental risk assessment tool derived from EUSES.

Within the context and scope of the forthcoming European Union chemical regulations (REACH), there is a need to be able to prioritise the chemicals for evaluation. Therefore, a simple, pragmatic and adequately conservative approach for the identification of substances of very low or no immediate concern at an early stage is presented. The fundamental principles and basic concepts are derived from the EU Technical Guidance Document and EUSES, and are translated into an easy-to-use rule-based system.