European Chemicals Legislation Research Articles

Mono-n-hexyl phthalate: exposure estimation and assessment of health risks based on levels found in human urine samples

Mono-n-hexyl phthalate (MnHexP) is a primary metabolite of di-n-hexyl phthalate (DnHexP) and other mixed side-chain phthalates that was recently detected in urine samples from adults and children in Germany. DnHexP is classified as toxic for reproduction category 1B in Annex VI of Regulation (EC) 1272/2008 and listed in Annex XIV of the European chemical legislation REACH; thereby, its use requires an authorisation. Health-based guidance values for DnHexP are lacking and a full-scale risk assessment has not been carried out under REACH. The detection of MnHexP in urine samples raises questions about the sources of exposure and concerns of consumer safety. Here, we propose the calculation of a provisional oral tolerable daily intake value (TDI) of 63 µg/kg body weight/day for DnHexP and compare it to intake levels corresponding to levels of MnHexP found in urine. The resulting mean intake levels correspond to less than 0.2% of the TDI, and maximum levels to less than 5%. The TDI was derived by means of an approximate probabilistic analysis using the credible interval from benchmark dose modelling of published ex vivo data on reduced foetal testosterone production in rats. Thus, for the dose associated to a 20% reduction in testosterone production, a lower and upper credible interval of 14.9 and 30.0 mg/kg bw/day, respectively, was used. This is considered a conservative approach, since apical developmental endpoints (e.g. changed anogenital distance) were only observed at higher doses. In addition, we modelled various scenarios of the exposure to the precursor substance DnHexP from different consumer products, taking measured contamination levels into account, and estimated systemic exposure doses. Of the modelled scenarios including the application of sunscreen (as a lotion or pump spray), the use of lip balm, and the wearing of plastic sandals, and considering conservative assumptions, the use of DnHexP-contaminated sunscreen was highlighted as a major contributing factor. A hypothetical calculation using conservative assumptions for the latter resulted in a margin of safety in relation to the lower credible interval of 3267 and 1007 for adults and young children, respectively. Most importantly, it was found that only a fraction of the TDI is reached in all studied exposure scenarios. Thus, with regard to the reported DnHexP exposure, a health risk can be considered very unlikely.

Practical Evaluation of Ionic Liquids for Application as Lubricants in Cleanrooms and under Vacuum Conditions

As part of a publicly funded cooperation project, novel high-performance lubricants (oils, greases, assembly pastes) based on ionic liquids and with the addition of specific micro- or nanoparticles are to be developed, which are adapted in their formulation for use in applications where their negligible vapor pressure plays an important role. These lubricants are urgently needed for applications in cleanrooms and high vacuum (e.g., pharmaceuticals, aerospace, chip manufacturing), especially when the frequently used perfluoropolyethers (PFPE) are no longer available due to a potential restriction of per- and polyfluoroalkyl substances (PFAS) due to European chemical legislation. Until now, there has been a lack of suitable laboratory testing technology to develop such innovative lubricants for extreme niche applications economically. There is a large gap in the tribological test chain between model testing, for example in the so-called spiral orbit tribometer (SOT) or ball-on-disk test in a high-frequency, linear-oscillation test machine (SRV-Tribometer from German “Schwing-Reib-Verschleiß-Tribometer”), and overall component testing at major space agencies (ESA—European Space Agency, NASA—National Aeronautics and Space Administration) or their service providers like the European Space Tribology Laboratory (ESTL) in Manchester. A further aim of the project was therefore to develop an application-orientated and economical testing methodology and testing technology for the scientifically precise evaluation and verifiability of the effect of ionic liquids on tribological systems in cleanrooms and under high vacuum conditions. The newly developed test rig is the focus of this publication. It forms the basis for all further investigations.

The implementation of the substitution principle in European chemical legislation: a comparative analysis

BackgroundThe 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.ResultsWe 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.ConclusionsThe 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.

Can cost‐effectiveness analysis of control measures for persistent chemicals be improved? A critical evaluation of approaches for assessing “effectiveness”

AbstractPersistence, that is the ability of a chemical to accumulate in the environment over time, is a core concern triggering regulatory action under the European chemicals legislation REACH. Due to lacking quantitative information about environmental impacts and damage costs, cost‐effectiveness analysis (CEA) has been applied for evaluating the performance of regulatory control measures. Different indicators for assessing the effectiveness of a control measure have been used, (i) the expected aggregate emission reduction, (ii) the change of the environmental mass at steady‐state, and (iii) the change of the cumulative environmental stock. This paper examines the conceptual characteristics of these indicators when being used in CEA. The analysis elaborates on an illustrative example of three persistent chemicals with different intrinsic properties. We find that estimates of aggregate emission reduction and of the change of steady‐state mass misrepresent the environmental pollution burden of persistent chemicals because they ignore the time path of pollution in the environment. This can induce misleading conclusions on the relative cost‐effectiveness of control measures and can lead to an erroneous prioritization of measures. Cumulative stock estimates, while not being equivalent to quantitative risk or impact assessment, capture the time path of pollution in environmental media and, therefore, provide an approximation of the environmental impact potential of persistent chemicals. This is a prerequisite for a concern‐driven evaluation of risk‐management measures for persistent chemicals.

Repeated dose toxicity study to assess the safety and reproductive/developmental safety of 7-methyl-2H-1,5-Benzodioxepin-3(4H)-One (Calone®) and the read across approach to its biodegradation metabolite 7-methyl-2H-1,5-benzodioxepin-3-ol (Calol).

7-Methyl-2H-1,5-benzodioxepin-3(4H)-one (Calone®) is used in fragrances to impart a marine note. It is produced industrially at volumes requiring repeated dose and developmental/reproductive toxicology data (OECD TG 422) under European chemicals legislation (i.e., REACH). Additionally, Japanese chemicals legislation requires evaluation of Calone® biodegradability and identification of metabolites in an environmental biodegradation test. 7-Methyl-2H-1,5-benzodioxepin-3-ol (Calol) was the sole metabolite identified following biodegradation and a 28-day repeated dose toxicity study (OECD TG 407) would normally be required to support registration in Japan. The current paper presents results showing no adverse effects in the parental, reproductive, or developmental phases of an OECD TG 422 study following dietary administration of Calone® to rats at targeted doses of up to 1000mg/kg/day. The No Observed Adverse Effect Level (NOAEL) was the highest administered dose of 791 and 922mg/kg/day for males and females, respectively. An in vitro metabolism study conducted with rat and human liver microsomes demonstrated that greater than 90% of Calone® was metabolically reduced into Calol, the same metabolite observed in the environmental biodegradation test. Accordingly, the results from the OECD TG 422 study with Calone® are directly applicable to Calol and it would be expected to have the same NOAEL.

Who are engaging in the nano-specific partner expert groups? An analysis of partner expert groups vs. expert groups

BackgroundConsultation with partner expert groups (PEGs) is an important step in updating guidance under European chemical legislation concerning nanomaterials. Here, we briefly review the differences between PEGs and the broader use of expert groups in general, and scrutinise the five closed - and one ongoing-nano-specific PEGs to investigate stakeholder composition, level of engagement and the extent to which stakeholder comments resulted in revisions being implemented in ECHA’s draft guidance.ResultsThirty-six different stakeholders were identified as having been involved in the closed PEG consultations, and an additional nine are currently involved in an ongoing PEG. For the closed PEG consultations, industry and trade associations (I&Ts) and member or associated member states (MSCAs) were the most represented groups, accounting for 15 and 13 members, respectively, whereas non-governmental organisations (NGOs) and European Union bodies (EUB) accounted for four members each. Interestingly, Academia was not represented. A total of 2700 comments were provided to ECHA’s draft guidance updates. Of these, MSCAs, I&Ts, EUB and NGOs accounted for 924, 876, 771 and 126 comments, of which 678, 494, 547 and 70 were adopted by ECHA, respectively. Eight stakeholders did not provide a comment.ConclusionsEven though EGs and PEGs are not fully comparable, we find that they hold many similarities. The nano-specific PEGs are influenced by a few very active stakeholders that have the time, resources and motivation to engage extensively while some stakeholder groups are partly or completely missing. We recommend that ECHA provides funding opportunities for less resourceful stakeholders, in order to minimise the effects of scarce funding on engagement. Furthermore, we recommend broadening the list of accredited stakeholder organisations, thereby allowing for more diversity among stakeholders involved, e.g. Academia, and that ECHA provides a justification for inclusion of the PEG members.

Concept of Essential Uses: An Exploration

European chemicals legislation – while among the most advanced in the world – still needs tools for bringing greater consistency to the substance evaluation processes. This article explores the elements of the ‘essential use’ concept – as proposed by the Montreal Protocol – in the European framework. The Treaty on the Functioning of the European Union provides context to understanding ‘health’, ‘safety’, and ‘functioning of society’ in order to then view how these elements are reflected within Union legislation and case law. In the balancing of EU priorities, examples exist where importance is given through exemptions and derogations to sectors within the categories of health, safety, and societal advancement. This demonstrates the possibility of the concept to help define essentiality and to determine specific uses that may be deemed essential. Essential Use, Chemicals, Chemicals Legislation, European Law, Environmental Law, Montreal Protocol

Nanomaterials in the European chemicals legislation – methodological challenges for registration and environmental safety assessment

Analysis of the availability and suitability of methods needed to comply with the new legal requirements to nanomaterials.

Health Friendly Materials for Use in Taphole and Runner

High-temperature coal tar pitch (CTPht) is an excellent binder in materials for use in the metallurgical industry. Due to the content of polycyclic aromatic hydrocarbons (PAH), CTPht (EC/List no. 266-028-2) has been defined as a ’substance of very high concern’ under the European Chemicals Legislation (European Chemicals Agency. 2017). Authorization has been required in Europe for use of CTPht, since October 4th, 2020, but exception has been granted for use in self-baking electrodes, as Soderberg. Several new products have been developed to substitute products containing CTPht in addition to already existing CTPht free materials. These materials contain binders which with a health friendly view, range from modified CTPht to bio binders with no harmful components. For some of these the change of properties during curing has been measured, together with high temperature properties. Different materials are compared to show strength and weaknesses both for curing and baked properties. Conditions during use of materials for tap hole and runners, have been measured on several furnaces and for plugging guns. The measured conditions are combined with the measured properties of different CTPht materials to find working solutions for ferroalloy furnaces.

Choosing the best for preventing the worst: A structured analysis of the selection of risk management options in REACH restriction dossiers

Under the European chemicals legislation REACH (Registration, Evaluation, Authorisation and restriction of CHemicals), the use of chemicals posing an unacceptable risk for humans and the environment can be restricted. This requires that regulatory authorities of EU member states, or the European Chemicals Agency on request of the Commission, submit a restriction proposal in which they suggest one or multiple risk management options (RMOs). The options are recommended to be evaluated in a socio-economic analysis (SEA) using defined criteria. This paper explores the drivers of the selection of the preferred RMO in 32 restriction dossiers. Applying principal component analysis reveals that the selection of the preferred RMO, and the evaluation of possible trade-offs between alternative RMOs, is determined by criteria characterizing a measure's effectiveness and practicality, in particular its risk reduction capacity (R) and proportionality. A logistic regression using quantitative estimates provided in SEA suggests that the probability for an RMO to be selected is the higher the higher its R and the lower the costs of the restriction. Based on our analysis we conclude that the selection process of RMOs in REACH restriction dossiers could be strengthened by defining a limited but unambiguous set of criteria, conducting a score-based evaluation as a default, and by defining transparent decision rules.

Vitamin K antagonist rodenticides display different teratogenic activity

Vitamin K antagonists (VKA) are not recommended during pregnancy because warfarin (a first-generation VKA) is associated with a malformation syndrome “the fetal warfarin syndrome” (FWS). VKA are also used for rodent management worldwide. Recently, the Committee for Risk Assessment responsible for the European chemical legislation for advances on the safe use of chemicals had classed 8 anticoagulant used as rodenticides in the reprotoxic category 1A or 1B. This classification emerges from a read-across prediction of toxicity considering the warfarin malformation syndrome. Herein, our study explores the teratogenicity of warfarin at the human therapeutic dose and that of bromadiolone, a second-generation anticoagulant rodenticide. Using a rat model, our study demonstrates that warfarin used at the therapeutic dose is able to induce teratogenicity, while in the same conditions bromadiolone does not induce any teratogenic effect, challenging the classification of all VKA as reprotoxic molecules.

International Conference on Green Chemistry on 5th /6th November 2018 in Vienna

Under the Austrian EU presidency, the Austrian Ministry for Sustainability and Tourism (BMNT) organised a conference on Green Chemistry on 5th/6th November 2018 in Vienna. This article outlines key findings of the conference. The conference aimed to gather chemical as well as policy experts, stakeholders and various practitioners of green chemistry to discuss the current scientific status in this field, but also the need and opportunities for integrating the principles of green chemistry in European chemicals legislation. The event discussed perspectives how to foster and better integrate into the legal frameworks the principles of ‘Green Chemistry’, which guide the design of chemical substances, products and processes to avoid hazards and reduce resource use – thus offering potentials for industries to ensure their compliance and also for ‘Circular Economies’.

Mixture risks threaten water quality: the European Collaborative Project SOLUTIONS recommends changes to the WFD and better coordination across all pieces of European chemicals legislation to improve protection from exposure of the aquatic environment to multiple pollutants

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.

Hygiene and legal aspects of occupational exposure assessment to cytostatics

The employers responsibilities for the assessment of occupational exposure to cytostatics in the workplace were analyzed in the light of existing legal regulations. Cytostatics may pose a threat to health and life of workers taking care of patients treated oncologically, i.e., pharmacists, physicians, nurses and other personnel. The significant scale of occupational exposure to cytostatics in Poland is confirmed by the data collected in the Central Register of Data on Exposure to Carcinogenic or Mutagenic Substances, Mixtures, Agents or Technological Processes, maintained by the Nofer Institute of Occupational Medicine, Łódź, Poland. The issue of occupational risk assessment of exposure to cytostatics gives raise to numerous concerns. Polish regulations concerning health protection of employees occupationally exposed to cytostatics are not unequivocal, as they are derived from different areas of the law, especially those applying to hazard classification, labeling and preparation of safety data sheets for cytostatics. There are neither binding occupational exposure limits legally set for active compounds of antineoplastic drugs nor methods for monitoring of these substances concentrations in a worker's breathing zone and biological material. This prevents the employer to carry out the correct assessment of occupational exposure, the results of which are the basis for preparing the proper preventive strategy. In this article the consequences of amendments to the European chemical legislation for employers responsible for adequate protection of health and life of employees exposed to cytostatics, were discussed, as well as some legal changes aimed at a better health and life protection of workers exposed to cytostatics in a workplace were proposed. Med Pr 2018;69(1):77-92.

OMNIITOX - Operational Life-Cycle Impact Assessment Models and Information Tools for Practitioners.

This article is the preamble to a set of articles describing initial results from an on-going European Commission funded, 5th Framework project called OMNIITOX, Operational Models aNd Information tools for Industrial applications of eco/TOXicological impact assessments. The different parts of this case study-driven project are briefly presented and put in relation to the aims of contributing to an operational life cycle-impact assessment (LCIA) model for impacts of toxicants. The present situation has been characterised by methodological difficulties, both regarding choice of the characterisation model(s) and limited input data on chemical properties, which often has resulted in the omission of toxicants from the LCIA, or at best focus on well characterised chemicals. The project addresses both problems and integrates models, as well as data, in an information system- the OMNIITOX IS. There is also a need for clarification of the relations between the (environmental) risk assessments of toxicants and LCIA, in addition to investigating the feasibility of introducing LCA into European chemicals legislation, tasks that also were addressed in the project. Keywords: Case studies; characterisation factor; chemicals; environmental risk assessment; hazard assessment; information system; life cycle impact assessment (LCIA); potentially toxic substances; regulation; risk assessment; risk ranking

Time matters: A stock-pollution approach to authorisation decision-making for PBT/vPvB chemicals under REACH

A core aim of the European chemicals legislation REACH is to ensure that the risks caused by substances of very high concern (SVHC) are adequately controlled. Authorisation – i.e. the formal approval of certain uses of SVHC for a limited time - is a key regulatory instrument in order to achieve this goal. For SVHC which are, in addition to their toxicity, (very) persistent and/or (very) bioaccumulative (PBT/vPvB chemicals), decision-making on the authorisation is conditional on a socio-economic analysis (SEA). In a SEA companies must demonstrate that the gains from keeping a chemical in use outweigh expected damage costs for society.The current setup of the REACH authorisation process, including existing guidance on performing a SEA, ignores that PBT/vPvB chemicals are stock pollutants. This paper explores the implications of incorporating stock pollution effects of these chemicals into a SEA on authorisation decision-making. We develop a cost-benefit approach which includes stock dynamics of PBT/vPvB chemicals. This allows identifying the decision rules for granting or refusing an authorisation. Furthermore, we generalize the model to an entire set of damage functions. We show that ignoring stock pollution effects in a SEA may lead to erroneous decisions on the use of PBT/vPvB chemicals because long-term impacts are not adequately captured. Using a historic case of DDT soil contamination as an illustrative example we discuss information requirements and challenges for authorisation decisions on the use of PBT/vPvB chemicals under REACH.

Are natural compounds used in personal care products toxic for the aquatic environment?

Natural substances are frequently used ingredients in personal care products. As the discharge of rinse-off products, like shampoos or soap, is mainly via the aquatic environment, the question is, whether these natural substances pose an environmental risk. More than a quarter of the natural substances which are listed in the “Inventory …… of ingredients employed in cosmetic products” (INCI list) are classified as dangerous for the environment with long lasting effects according to the European regulation on classification and labelling, e.g. various Citrus preparations, Cupressus sempervirens extract, Picea excelsa extract or Pinus sylvestris leaf extract. Some of the components responsible for the classification of natural substances as dangerous for the environment are e.g. limonene, pinenes or benzyl benzoate. Classification and labelling is a trigger for the registration requirements for natural substances according to the European regulation on chemicals (REACH), but so far only 5% of natural substances classified are registered. It must be assumed that there are more substances that should undergo the REACH process among the 703 natural substances that do not yet turn up in the data base of substances classified and labelled as hazardous (C&L inventory). Natural substances and personal care products receive special treatments in the European chemical legislation. The compilation of the classifications might question whether this special treatment is justified.

Natural personal care products-analysis of ingredient lists and legal situation.

BackgroundMany natural substances are classified as dangerous substances according to the European regulation on classification and labelling. Are they used in natural personal care products today? One hundred ingredient lists were analyzed to find this out.ResultsAll products with natural substances contained dangerous natural substances or they contained natural substances, for which the information about their classification as dangerous substances is not available. 54 natural substances quoted in the ingredient lists were found to be classified, with 37 substances being classified due to hazardous effects for skin and eyes. However, the most frequently used natural substances are not classified as dangerous. Natural substances are multi-constituent compounds, leading to two main problems in personal care products: the potential interactions of a multitude of substances and the fact that dangerous constituents are not disclosed in the ingredient lists. For example, the fragrance allergens citral, farnesol, limonene, and linalool are frequent components of the natural substances employed. In addition, 82 products listed allergenic fragrance ingredients as single substances in their ingredient lists. Recommendations for sensitive skin in a product’s name do not imply that the ‘26 fragrance allergens’ are omitted. Furthermore, 80 products listed ‘parfum’/‘aroma’, and 50 products listed ethanol.ConclusionsThe data show that the loopholes for natural substances and for personal care products in the present European chemical legislation (e.g. the exception for classification and labelling of cosmetic products and the exception for information transfer in the supply chain) are not in line with an adequate consumer and environmental protection.

The German Environmental Specimen Bank

The main objective of the German Environmental Specimen Bank (ESB) is the long-term storage of environmental and human samples under stable deep-freeze conditions for future research. The ESB is unique in providing a continuous historical record of environmental and human exposure to chemicals in Germany. ESB was started parallel to the development of the first German Chemicals Legislation in the late 1970s. In 1979, the ESB test operation began. After the Chemicals Law came into force in 1982, the ESB was established as a permanent facility in 1985. With the new European Chemicals Legislation, REACH, in 2007 responsibility for the safety of commercial chemicals and risk assessment was assigned to the industry. Since then, the ESB has become even more important in verifying the self-assessment of the industry, in evaluating the effectiveness of regulations, thus ensuring the protection of humans and the environment against adverse effects caused by exposure to chemicals. These objectives are pursued by the regular monitoring of contaminations and the assessment of temporal trends. Demonstrating the necessity of deriving exposure reduction measures, ESB results serve as key information for policy-makers. Information on preventing exposure to chemicals is available to the general public and to the public health services. The ESB is thus an important monitoring instrument of the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety. The Federal Environment Agency operates the ESB based on its own concepts, heads the scientific data evaluation and transfers results into the environmental policy arena and to the general public.

The OSIRIS Weight of Evidence approach: ITS for skin sensitisation

Within the EU FP6 project OSIRIS approaches to Integrated Testing Strategies (ITSs) were developed, with the aim to facilitate the use of non-test and non-animal testing information in regulatory risk assessment of chemicals. This paper describes an analytical Weight-of-Evidence (WoE) approach to an ITS for the endpoint of skin sensitisation. It specifically addresses the European chemicals legislation REACH, but the concept is readily applicable to ITS and WoE procedures in other regulatory frameworks, and for other toxicological endpoints. Bayesian statistics are applied to estimate the reliability of a conclusion on the sensitisation potential of a chemical, combining evidence from different information sources such as QSAR model predictions, in vitro and in vivo test results. The methodology allows for adaptation of the weight of individual information sources to account for the different levels of reliability of the individual ITS components. The calculated reliability of the WoE conclusion gives an objective, transparent and reproducible measure to decide if the information requirements for data evaluation are satisfied. Furthermore, in case the WoE is not sufficient, it gives the possibility to evaluate a priori if and how it will be possible to fulfil the information requirements with additional tests and/or model predictions.