Die Umsetzung des EU Weißbuches zur Chemikalienpolitik

Background

Aim and Scope. Implementation of the European Union White Paper on chemicals policy shall provide more safety and more transparency in chemicals use. In the past, when assessing existing commercial substances there was often a lack of information in the fields of application of the chemicals and the exposures arising in those contexts. The White Paper therefore calls for ‘shared responsibility’. Processors and commercial users of substances are to be involved much more closely in the risk evaluation process than has hitherto been the case. They are to provide data on substance applications and exposures, and, to some extent, they are also to carry out exposure assessments and risk assessments themselves. By analysing case studies, the paper highlights the consequences of this approach.

Results and Discussion

Fear has often been voiced that these new tasks will completely overburden small and medium-sized enterprises. It is assumed that many chemicals are no longer available for smallvolume applications, as — for cost reasons — producers do not include these applications in their registration. The wording of the White Paper is not precise enough to be able to appraise the costs that will be associated with the required intensified communication. In this situation, it is essential to analyse prototypical substances and their applications in order to gain an improved understanding of the principle of shared responsibility.

Conclusions

The concrete study of several product chains has shown that the flow of information required between producers and users is very likely feasible within the context of the REACH system. For the producers of chemicals, the intensified communication will presumably make it simpler to procure information in the fields of application and exposures. However, in order to avoid users being overburdened, it will be important that registration requirements and focuses are shaped in a manner doing justice to practical realities. Users will need to undertake community-wide efforts on an industry federation and branch level. In this context, the protection of company know-how also needs to be ensured.

Recommendation and Outlook

In practice, implementation of the principle of shared responsibility can lead to intensified communication among the producers and users of chemicals. This can greatly facilitate exposure assessments and risk assessments. There is a need to develop manageable procedures that can also be implemented by small and medium-sized enterprises. Numerous proposals have been made in this context, and extensive reference material is now available.     

REACh im praxistest

In October 2003, the EU Commission presented the proposal for a new Chemicals Regulation. In late autumn 2005, Parliament and Council were working on finding their position on the Commission’s proposal. From November 2004 to April 2005, a simulation was carried out at EU level aiming to test the workability of registration under REACh. Based on a strategic partnership, the European Chemical Industry Council together with other industry associations, the EU Commission and a number of Member States had launched this project. 53 manufacturers or users of chemicals and competent authorities of 13 EU Member States took part in the simulation: eight registration cases were dealt with in parallel. The participants had to conduct the registration of a substance (including preparatory work) and the dossier evaluation by the authorities. The simulation was performed in a ’free-flow mode’, which means, that the participants worked without any guidance on how to practically implement the duties and tasks as laid down in the draft regulation. In the final phase of the project, the three strategic parners worked towards a common understanding on potential workability problems and suitable options for solutions. This process resulted in a report including a set of agreed recommendations on 12 identified workability issues The recommendations are mostly related to the co-operation between registrants, the sharing of responsibilities and communication between manufactures and down-stream users as well as technical and scientific aspects of dossier compilation., In addition, the recommendations address the need to develop a common understanding across Europe regarding the role of authorities in evaluating the registration dossiers and developing suitable tools for the evaluation. In addition to the set of practical recommendations, SPORT has demonstrated that useful insights in the workability of a new piece of legislation can be gained from simulating the key processes in practise already during the legislative process. Such pilot trials could be seen as a contribution toBetter Regulation, one of the strategic goals of the EU Commission.     

Systemic risks of genetically modified crops: the need for new approaches to risk assessment

Background

European chemicals legislation (registration, evaluation, authorisation and restriction of chemical substances (REACH)) requires a broad assessment of chemicals with respect to, inter alia, their health-relevant properties. Due to the extreme number of substances to be assessed and the limited current toxicological knowledge on their respective properties, REACH implicitly requires a paradigm change: away from knowledge generated mainly from costly animal experiments towards the use of mechanistic findings. Moreover, effect mechanisms at the biochemical or cellular level are essential when conclusions shall be drawn about "new" endpoints and mixtures of xenobiotics. This study (funded by the German Federal Environment Agency) describes examples of biochemical processes in the mammalian organism and how xenobiotics interfere with them. Interference with physiological processes expected to lead to adverse health effects is characterised as "toxicity pathway". The study describes toxicological endpoints not usually covered in routine animal testing and the respective toxicity pathways.

Results and conclusions

Screening for chemicals which exert effects via common toxicity pathways and subsequently conducting targeted short-term tests may generate new information about the toxicity of chemicals without performing extensive substance-by-substance animal experiments. Information on common toxicity pathways may also provide input for the assessment of mixture effects. The U.S. Environmental Protection Agency is working intensely on this concept. It involves the use of enormous amounts of data on relevant biochemical and cellular processes, which are generated by "high-throughput screening" methods, and then are combined with substance-specific kinetic data, experimental apical test outcomes and modelling. Current limitations in the regulatory use of this integrated approach on risk assessment will be outlined.     

Expositionsszenarien nach REACH

Object and Background

Production and use of substances and formulations can result in exposures on humans and the environment. In October 2003, the European Commissions presented a proposal for the registration, evaluation, assessment and restriction of chemicals (REACH). Assessment of exposures will become an essential element of REACH for certain substances. For many manufacturers and users of substances and formulations these tasks are new. Pilot projects to REACH have shown so far that solutions and instruments for these tasks which meet the requirements of real life situations have yet to be developed.

Discussion and Conclusions

Within the REACH proposal, exposure scenarios are a main element of the chemical safety assessment. This article outlines the contents of exposure scenarios. It reflects experiences with exposure scenarios and discusses possibilities of standardization. It covers exposure steps/categories and possibilities to build product groups. Non-branch specific types of exposure situations are an important element of exposure scenarios. Therefore, exposure steps/categories should be contained in exposure scenarios. Nevertheless, these elements structure only a specific part of the information contained in exposure scenarios. Hence they cannot replace exposure scenarios. Exposure categories do not reveal the uses, the processes and the activities connected with the intended use of substances. These information are important parts of a complete exposure scenario. They are the basis for the following step of risk characterisation. In addition, they provide the necessary transparency regarding the use patteern of substances.     

Risikobewertung von Perfluortensiden als Beitrag zur aktuellen Diskussion zum REACH-Dossier der EU-Kommission

Background

The analysis of the intrinsic effects of perfluorinated organic surfactants shows the group to have a characteristic overall picture:

-high polarity

-high thermal and chemical stability

-ubiquitous distribution

-non-biodegradability

-multiple toxicity

In addition, certain substances belonging to this group (e.g. PFOS) exhibit a very long retention time in the human body. Toxic properties vary and, like the mechanisms for global distribution, have not been fully clarified. In the meantime, individual members of this substance group have been (are being) removed from the market. This report shows that in future the planned EU chemicals law (REACH) can be used to prevent such substances being regulated after they have been distributed in the environment and thus after damage has already occurred. To this end, however, the requirements for registration for low tonnage substances (1–10 tonnes/a) must be supplemented with specific tests (in particular on biodegradability)

Aim and Scope

The aim of the work was to analyse the intrinsic properties and risks of a subgroup of fluorinated organic substances.

Results

A summarising article describes the toxic effects and properties of a group of substances selected from the approximately 30,000 existing substances. With regard to the ongoing debate on revising the European regulations of existing substances (REACH). it is apparent that standardised test requirements cannot be applied to impact and risk analyses which are at times highly complex. For governments, REACH only provides the starting points for this process in the form of prescribed standard tests. If a substance (or a substance group) draws attention, more detailed tests must be carried out by the industry itself in the framework of responsible care and in the framework of the evaluation step of REACH. It is therefore important that the standard requirements of REACH are selected appropriately. In this respect, the study reveals some serious deficiencies in the Commission proposal.

Conclusion

The standard information for low tonnage substances (1–10 tonnes/a) must be supplemented in particular with an obligatory test on biodegradability. The possibility provided by the REACH dossier to evaluate substances on the basis of group observarions (SAR, QSAR e.g.) is to be welcomed.     

Schadstoffbelastete Erzeugnisse im Verbraucherbereich: Wird REACH zu Verbesserungen führen?

Aim and Background Currently, the protection from hazardous substances occurring in consumer articles is often insufficient. In this paper, we discuss whether this situation will improve relevantly in the course of the implementation of the new European regulation on chemical substances (REACH). Changes under REACH may be heterogeneous. Therefore, differential effects depending on the tonnage as placed on the market, on the amount of substances contained in an article, and depending on timelines and exemptions for meeting the legal requirements, are discussed in this paper, together with a presentation of some uses of substances serving as examples. Discussion and Conclusions If substances are adequately registered, all identified and supported uses including their use in articles should be assessed. Therefore, where the full implementation of the registration conditions applies a substantial improvement may be expected due to REACH. Usually, producers or importers of articles are not required to register substances contained in these articles. Instead, the manufacturer or importer of the respective substance is usually responsible for registration, if exposure to the substance cannot be excluded and emission of the substance from an article is not the intended purpose. This may differ for substances intentionally released from articles. Additional obligations for substances not intentionally released mainly apply to substances of very high concern (SVHC). For the latter, the producer or importer of articles has to notify the European Chemicals Agency (ECHA) on the occurrence of the respective SVHC in articles. This information is important, especially because substances in imported articles may not be registered in advance. Authorisation within REACH is a very far reaching and effective tool of the legislation. However, authorisation is not required for SVHC imported as components of articles. Therefore, one main effect intended by REACH, i.?e. the substitution of SVHC, may possibly be undermined by importers of SVHC in articles. Restrictions, as specified in Annex XVII of REACH, offer a powerful opportunity to improve health and environmental safety with respect to hazardous substances. We support an extended understanding of what is defined as a “substance of concern” in the context of restrictions. This definition should be broader than just what is currently covered by the term SVHC. Consequences of restrictions may equally apply to European producers and importers of articles from outside of Europe, which contain such substances of concern. Another instrument currently closely linked to SVHC (in its more restricted definition), is the obligation of the producer or importer of articles to provide information according to article 33 (REACH). The downstream recipient of an article has to be informed on the content of SVHC in this article and how its safe use is ensured. Warehouses, wholesalers and other traders may therefore be aware of the SVHC contained in articles and may look for substitutes without such ingredients. Also, consumers may request this information on SVHC (just provided on demand) and are thus enabled to decide to buy other articles with less hazardous properties.     

Erfahrungen des Umweltbundesamtes mit der EU-Biozid-Richtlinie

Biocides are active substances and products which are intended to destroy (…) any harmful organism by chemical or biological means. Typical applications are for instance wood preservatives, antifouling products or disinfectants. In the European Union the use of biocidal products is regulated since 1998 by the Biocidal Product Directive 98/8/EG (BPD). The BPD was transposed into German law in 2001 by the “Biozid-Gesetz”. The Federal Environment Agency is responsible for the environmental risk assessment of biocidal active substances and products under the “Biozid-Gesetz” in Germany. The European Commission has to evaluate the BPD seven years after endorsement and if necessary, has to submit a proposal for the revision of the directive. It is expected that the European Commission will publish soon a review of the enforcement of the BPD together with suggestions for the revision of the directive. In this article the German Federal Environment Agency summarises suggestions for the revision of the BPD based on its ten years experience with the directive: The scope of the BPD needs an exact clarification of borderlines in order to avoid confusion with other legislation. Food and feeding stuff together with natural products like lavender branches and cedar wood, which are used as attracting or repellent agents, have to be excluded from the scope of the BPD. Special data requirements for natural oils and pheromones should be developed to take the complex composition of these substances into account. The advantages of a centralised and decentralised authorisation procedure are discussed for biocidal products in special product types. Furthermore we stipulate that biocidal active substances which are nano particles are treated as separate active substances with own identities. Due to animal welfare reasons it should be obligatory to share data from vertebrate animal studies as it is already mandatory under the REACH regulation. The import of articles treated with biocidal active substances into the European market should only be allowed, if the active substance is approved for their biocidal use within the EU. Finally we suggest to implement an obligation to report the market shares or consumption rates of biocidal active substances and products. Together with procedural simplifications and adaptation in the scope of the directive, changes of the data requirements will be the key issues during the revision of the BPD. Most important, these changes should not reduce but ideally increase the level of protection for human health and the environment.     

Die externen Kosten der Stromerzeugung aus erneuerbaren Energien im Vergleich zur fossilen Stromerzeugung

Aim and Background

The supply and use of energy is related to environmental impacts, which cause significant economic damage. As these costs are not reflected in the price of energy, there is little incentive for the polluter to reduce the pressure on the environment. From an economic point of view, environmental resources and services are used beyond the optimal level. The quantification of external costs has been an area of intensive research, in particular within the series of ExternE projects funded by the European Commission. Although external cost estimates have been successfully used to support European environmental legislation, the assessment of external costs is still a matter of significant uncertainties — in particular in areas were potential large environmental impacts are expected. In spite of uncertainty and limited knowledge, policy needs to require guidelines for the evaluation of energy and environmental policy measures.

Main Features

Based on a critical review of the current literature, recommendations for the quantification of external costs from renewable electricity generation in comparison to fossil nuclear technologies are derived.

Results and Discussion

Current electricity market prices do not reflect the total costs of electricity generation. Quantifiable external costs from fossil electricity generation are in the same order as private generation costs. The internalisation of external costs will improve the competitiveness of renewable energy technologies. To avoid market distortion, policy shall implement framing conditions supporting the further internalisation of external costs.

Conclusions

Costs for supporting renewable energy via the German feed-in tariffs are compensated for by external costs avoided.

Perspectives

Fossil and nuclear energies are more expensive than is teflected by economical quantification. In contrast, the costs for renewable energies tell the truth even today. The sooner the external costs are integrated in the pricing, the sooner the relaunch of energy supply will attract interest, also from the economic point of view.     

Where are the SVHCs?

Background

The European chemicals regulation REACH includes the legal duty for suppliers to inform consumers on request about the presence of substances of very high concern (SVHCs) in articles. Since this requirement has been in force now for 10 years, the intention of this study was to find out whether information on SVHCs is adequately communicated to the consumer today. Data on the presence of SVHCs in articles were collected as a prerequisite for the subsequent requests for a targeted choice of articles to examine the operability of the ‘right to know.’

Results

Literature data show that SVHCs have been measured and described in a large variety of commodities. 32% of 334 information requests for articles which were suspected to contain SVHCs were answered by suppliers and a minor number of these answers were of good quality. Only two respondents indicated the presence of SVHCs in their articles. Suppliers are not legally obliged to respond to requests if their articles are free of SVHCs. Therefore, the absence of a response might be interpreted as an indication that SVHCs are present below 0.1% in the articles in question. However, there are certain doubts that only two out of 334 articles suspected contain SVHCs.

Conclusions

The data question whether the ambitious aims of the SVHC regime can be achieved under the present conditions. Measures are proposed on how to improve implementation of the information requirement and to amend the legal criteria in the upcoming REACH revision.

     

化学品健康风险评估过程中的数据质量评估技术概述

自1938年美国首先颁布管控化学品的法律以来,健康风险评估逐步发展,各个国家和地区相继颁布文件,并已形成较为完善的评估框架.由于在化学品健康风险评估的过程中,存在大量收集引用的数据及信息,因此数据质量评估是保证风险评估结果可信的关键.目前为止美国环保署(environmental protection agency,EPA)和欧盟《化学品的注册、评估、授权和限制》(regulation concerning the registration,evaluation,authorization and restriction of chemicals,REACH)法规均对数据质量评估方法进行了详细的规定.两个地区均采用数据评分(1—4)与证据权重(weight of evidence,WOE)(1/2)相结合的评估方法,不同之处在于欧盟更侧重于对数据整体的相关性、可靠性和充分性进行评估和打分,U.S EPA则更为细致具体,其侧重于不同情境下的数据分组分析,根据不同的评分领域和指标,规定高置信度、中置信度、低置信度和数据不可接受的标准.通过总结对比欧盟及美国的数据质量评估方法,建议我国采用数据打分与证据权重相结合的定量评估方法,并明确规定不同情景下不同数据来源的打分规则和标准,使数据质量评估过程系统化.     

以REACH为数据源进行生命周期影响评估

由于潜在生态毒理数据的限制，生态周期影响评估中的毒性模型仅仅描述了市场上的一小部分物质。改进现有的LCIA数据情况可以通过发现新的数据来源，比如欧盟化学品注册、评估、授权和限制(REACH)数据库。本研究通过对比记录在REACH数据库和UNEP/SETAC的科学统一模型USEtox中相同化学物质的生态毒理数据来探究REACH是否具有作为数据来源的潜力。数据根据数据点的个数，报道可靠性和测试时间评估，并将每种化学物质的50%涵盖物种的危险浓度与USEtox中的数据做对比。结果强调了REACH和USEtox之间不同的数据可用性。REACH和USEtox的生态毒理学数据对比表明REACH是一个LCIA毒性鉴别的潜在生态毒理学数据来源，也显示出REACH标准的数据存在着一致性的问题，以及REACH中监管风险评估的假设可能与LCIA所需数据有出入。因此，在考虑REACH标准下的数据在LCIA的运用之前，数据质量，预处理和可运用性需要进一步的研究。探究其他可用的数据来源，发表的研究与报告也需要更深入的调查。
精选自Nienke Müller, Dick de Zwart, Michael Hauschild, Ga?l Kijko, Peter Fantke. Exploring REACH as potential data source for characterizing ecotoxicity in life cycle assessment. Environmental Toxicology and Chemistry: Volume 36, Issue 2, pages 492–500, July 2017. DOI: 10.1002/etc.3542
详情请见http://onlinelibrary.wiley.com/wol1/doi/10.1002/etc.3542/full
     

Braucht Substitution mehr Staat oder mehr Markt?

Ziel und Hintergrund

In den bisherigen REACH-Verordnungsentwürfen wird als einer der wichtigen Gründe für die Gesetzes-initiative ‘die Schaffung von Anreizen für die Substitution gefährlicher durch weniger gefährliche Stoffe’ genannt (REACH 2003, 61). Damit wird die Frage aktuell, was denn Unternehmen als Wirtschaftssubjekte ‘anreizen’ oder eben auch ‘nicht anreizen’ kann, gefährliche chemikalien zu substituieren: Welche Marktkräfte wirken bereits positiv, die durch regulative Vorgaben eventuell verstärkt werden können, und welche die Substitution behindernden Marktkräfte sollten durch regulative Maßnahmen abgeschwächt werden?

Schwerpunkte

Die Autoren untersuchen auf Basis ihrer Vorarbeiten und Fallstudien zur Substitution die Rahmenbedingungen — Treiber und blockierende Faktoren — für Substitution. Dabei werden auch aktuelle Positionen zur Substitutionsproblematik einbezogen, so z.B. die Stellungnahme des Ausschusses für Umwelt, Gesundheit und Sicherheit der Royal Society of Chemistry (UK), des UK Chemicals Stakeholder Forums sowie die gegenwärtigen Kompromisse zwischen Europäischem Rat und Europäischem Parlament zur Regelung der Substitution unter REACH.

Ergebnisse und Schlussfolgerungen

Gegenwärtig fördern weder die Marktdynamik noch die Gesetzgebung Substitution effektiv genug. Die Unternehmen selbst sind zögerlich, wenn Kosten und Haftungsfragen sowie Kundenprioritäten der Substitution entgegenstehen. Substitution wird vom Gesetzgeber oft nur als Rahmengebot, als Generalklausel, als Anspruch, als Vorrangstrategie oder als Priorität gefordert. Dennoch gibt es sowohl in der Gesetzgebung als auch in der Marktentwicklung positive Ansätze, die regulativ unterstützt werden können.

Perspektive

Der entscheidende Punkt für die Frage der regulativen Substitutionsvorgaben ist, auf welche Weise der Staat die Marktdynamik durch Setzen von Innovationszielen befördern kann. Der Staat sollte in Kooperation mit den Stakeholdern in technischen Dossiers die bekannten Substitutionsmöglichkeiten und Risikominderungsmaßnahmen zusammen stellen, einen Realisierungszeitpunkt vorgeben, Mindeststandards vorschrieben und auch detaillierte Regulation androhen, falls nichts geschieht. Eine case-to-case-Beurteilungs-Methode ist der Substitutionsproblematik in der Regel angemessen, um den Aufwand und die erforderlichen Maßnahmen annähernd genau zu bestimmen.     

Einstufung und Kennzeichnung: das Instrumentarium von GHS und REACH für das Risikomanagement

For the safe use of chemicals it is necessary to identify risks in different fields of application. Not until then harmful effects to man and the environment can possibly be reduced by adequate measures. Here the identification of intrinsic properties of chemicals is an important fundamental for evaluation. Broad examination of exposition follows. REACH and GHS deliver new instruments which, due to their requirements on information quality and transparency as well as on harmonization, contribute to the improvement of risk management measures (RMM). With the coming into force of the CLP-regulation and the implementation of the GHS within the EU on 20.?1.?2009, as suggested in the white book on European Chemicals policy in 2001, the new system of European chemical law has been completed at a regulatory level. This article shows the development so far from the first directive on the regulation on the labeling of chemicals, to the establishment of application and test procedures, and then to the instruments of risk communication and risk management introduced by REACH and the CLP-regulation.     

REP-LECOTOX: an example of FP 6 INCO project to strengthen ecotoxicological research in WBC (Western Balkan countries)

Background

In order to map exceedances of critical atmospheric deposition loads for nitrogen (N) surface data on the atmospheric deposition of N compounds to terrestrial ecosystems are needed. Across Europe such information is provided by the international European Monitoring and Evaluation Programme (EMEP) in a resolution of 50 km by 50 km, relying on both emission data and measurement data on atmospheric depositions. The objective of the article at hand is on the improvement of the spatial resolution of the EMEP maps by combining them with data on the N concentration in mosses provided by the International Cooperative Programme on Effects of Air Pollution on Natural Vegetation and Crops (ICP Vegetation) of the United Nations Economic Commission for Europe (UNECE) Long-range Transboundary Air Pollution (LTRAP) Convention.

Methods

The map on atmospheric depositions of total N as modelled by EMEP was intersected with geostatistical surface estimations on the N concentration in mosses at a resolution of 5 km by 5 km. The medians of the N estimations in mosses were then calculated for each 50 km by 50 km grid cell. Both medians of moss estimations and corresponding modelled deposition values were ln-transformed and their relationship investigated and modelled by linear regression analysis. The regression equations were applied on the moss kriging estimates of the N concentration in mosses. The respective residuals were projected onto the centres of the EMEP grid cells and were mapped using variogram analysis and kriging procedures. Finally, the residual and the regression map were summed up to the map of total N deposition in terrestrial ecosystems throughout Europe.

Results and discussion

The regression analysis of the estimated N concentrations in mosses and the modelled EMEP depositions resulted in clear linear regression patterns with coefficients of determination of r ² = 0.62 and Pearson correlations of r _p = 0.79 and Spearman correlations of r _s = 0.70, respectively. Regarding the German territory a nationwide mean of 18.1 kg/ha/a (standard deviation: 3.49 kg/ha/a) could be derived from the resulting map on total N deposition in a resolution of 5 km by 5 km. Recent updates of the modelled atmospheric deposition of N provided a similar estimate for Germany.

Conclusions

The linking of modelled EMEP data on the atmospheric depositions of total N and the accumulation of N in mosses allows to map the deposition of total N in a high resolution of 5 km by 5 km using empirical moss data. The mapping relies on the strong statistical relationship between both processes that are physically and chemically related to each other. The mapping approach thereby relies on available data that are both based on European wide harmonized methodologies. From an ecotoxicological point of view the linking of data on N depositions and those on N bioaccumulation can be considered a substantial progress.     

Wasserrahmenrichtlinie — Fortschritte und Defizite

Background

The water protection policy of the European Union sits on new footings since the end of 2000: The Water FrameworkDirective (WFD). By replacing, merging and renewing all parts of the European water protection policy from the 1970s, the WFD provides a consistent, transparent and comprehensive concept of what water management should be in the Europe of the coming decades. The new directive is aimed at a holistic approach towards integrated water protection. It sets ambitious high-quality goals to achieve a good status for European lakes and rivers primarily in ecological terms, gives details about the essential processes as well as instruments, and includes everything into a strict time schedule.

Aim

This article adresses progress and shortcomings at the implementation of the WFD in general and with reference to two selected case studies (Rivers Elbe and Upper Danube).

Results and Discussion

After introducing the WFD, its aims and exceptions, a policy summary and background document ‘Environmental objectives und the Water Framework Directive’ and the use of Environmental Quality Standards (EQS) for single ‘priority substances’ as well as ‘hazardous priority components’ is discussed. The initial characterization undertaken by the German states revealed that only about 14% of all surface waters are considered to meet the WFD objectives by the year of 2015. Approximately 60% of the water bodies assessed are at risk of failing the WFD objectives, if not systematic efforts are made to improve the quality. Screenings of sources and paths of exposure for ‘priority substances’ and ‘priority hazardous substances’ according WFD identified one distinct pollution source for surface waters: ‘Historical pollution from sediments’. Because of industrial emissions in the past several river catchment areas are expected to fail the standards demanded by the WFD, due to a risk of remobilization of contaminants from sediments. This holds true for the Rhine river with high loads of hexachlorobenzene (HCB) as well as for Elbe river, where contaminated sediments can be a severe problem. Therefore, integration of sediments into the holistic river basin management approach and their consideration within the ‘programmes of measures’ scheduled for 2009 is highly recommended. At present, a comprehensive weight-of-evidence study verifies whether the observed fish decline at the Upper Danube. River is caused by ecotoxicological hazard potentials of contaminated sediments.

Outlook

Combined investigations of sediment contamination and mobility as well as acute and mechanism specific biotests in effect directed analyses/weight-of-evidence studies show grent potential for the assessment of chemically polluted rivers and should be included into the ‘programmes of measures’ within future management concepts.

     

Interoperable web GIS services for marine pollution monitoring and forecasting

This paper presents services and systems developed in the FP6 InterRisk (Interoperable GMES Services for Environmental Risk Management in Marine and Coastal Areas of Europe) project, which addresses the need for better access to information for risk management in Europe, both in cases of natural hazards and industrial accidents. The overall objective of the project is to develop a pilot system for interoperable GMES monitoring and forecasting services for environmental management in marine and coastal areas. This pilot system is based on established and widely adopted web-GIS standards, in line with INSPIRE recommendations. The pilot is comprised of, among other things, a portal and a web-GIS map viewer, both developed using open source tools. Providers using commercial tools adhering to the adopted standards, however, can also deliver products to the InterRisk pilot. The InterRisk services and system are based on a combination of free and commercial software, and have been demonstrated to end-users in three European areas: Norwegian, UK and Irish waters, and German and Polish waters. Products and services offered in these areas are presented, along with an outline of the technical development of web-GIS clients and portals.

Umwelteigenschaften von Produkten Die Rolle der Ökobilanz in ISO Typ III Umweltdeklarationen

Goal and Scope

Type III Environmental declarations (Environmental product declarations, EPD) are intended to inform interested parties about the environmental performance characteristics of products. They are based mainly on LCA according to ISO 14040ff, provide its results as inventory or impact category indicators and thus describe the product system under investigation. ISO 14025 is out for ballot as FDIS. The concept of EPD has found a market in particular in the construction sector. It has a considerable part in the European Integrated Product Policy, e.g. documentation of improvement in design for environment, documentation of compliance with green procurement requirements.

Main Features

EPD are a means to communicate the results of a LCA-study according to ISO 14040ff in a comparable and harmonised way. ISO (FDIS) 14025 describes how to develop and document consistent and comparable data sets. This report exemplifies three levels in the development of EPD for which the standard provides requirements. 1. Framework for the development of an EPD program including verification procedures for EPD. 2. Defining the rules for conducting the LCA according to ISO 14040ff as well as additional information for defined product categories (product category rules). 3. Development and documentation of EPD according to the PCR.

Results and Conclusions

After quite a few years of standardisation work the new standard ISO (FDIS) 14025 will provide a systematic approach to documenting and communicating LCA results in an EPD. This will support propagating LCA from its academic origin to a practical tool for the assessment of the environmental performance of a product system. An essential part will be the participation of LCA experts in EPD programs.

Recommendations and Outlook

An enormous effort for developing appropriate conventions will have to be taken by all interested parties to come up with consistent and comparable EPD in different branches. In some areas defining such conventions has been shown to be possible. An important part is the development of quality criteria for modelling as well as for the databases used to calculate the LCA. To find sufficient credibility at economically acceptable conditions with a minimum of bureaucratic effort more practical experience will have to be gained. This holds especially for the trust in the EPD results based on the independence of the review, transparency of procedures and the participation of interested parties. There is a demand on education for SME developing EPD for their products as well as for the users of EPD on how to document EPD transparently and apply them properly.     

Dioxinähnliche polychlorierte Biphenyle (PCB) in der Umwelt

Goal and Scope

The state of the art on sources, transport and environmental fate, human exposure and toxicological risk assessment of dioxin-like polychlorinated biphenyls (PCB), and non dioxin-like PCB is described and summarized with focus on Germany and neighbouring countries.

Methods

Presentations and discussions of a two-days symposium in Germany are the primary source of information. The significance of dioxin-like PCB is evaluated in relation to polychlorinated dibenzo-p-dioxins (PCDD) and dibenzofurans (PCDF). For that purpose, toxicity equivalent concentrations (TEQ) of both groups of contaminants in environmental matrices are compared.

Results and Conclusions

TEQ values of dioxin-like PCB are comparable to those of PCDD/PCDF in many environmental media; in food of animal origin PCB-TEQ is even higher. In most media, the non-ortho substituted PCB 126 has by far the highest contribution to the PCB-TEQ due to its high toxicity equivalency factor of 0.1. Atmospheric (long-range) transport obviously plays the major role for the diffuse PCB contamination of the environment. The transfer atmosphere-plant is apparently the key process for the entrance of dioxin-like PCB into terrestrial food chains.

Recommendation and Perspective

In spite of the decline of environmental contamination with PCB and PCDD/PCDF, a significant part of the general population in Germany and other European countries currently exceeds the tolerable intake of dioxin-like substances. However, also the results of a new toxicological risk assessment of non dioxin-like PCB implicate the need of further reduction of PCB exposure.     

Entwicklung und Einsatz eines standardisierten Labortests für Dungkäfer (Aphodius constans) zur Prüfung der Ökotoxizität von Veterinärpharmaka

Goal, Scope, and Background

According to European legislation, an environmental risk assessment of veterinary pharmaceuticals for dung beetles is required if the substance is a parasiticide for the treatment of pasture animals. However, the demonstration of the environmental safety of those substances for dung beetles is strongly hampered by the fact that no standardized test system is available so far. Therefore, starting with recommendations from the SETAC advisory group DOTTS (Dung Organism Toxicity Test Standardization), a test system using the widespread temperate dung beetle species Aphodius constans was developed.

Methods

Using experiences gained at the University of Montpellier (e.g. in field studies) and in other terrestrial tests, details of culturing and testing of A. constans were investigated in a project sponsored by the German Environment Protection Agency (UBA). Basically, the survival of young larvae of A. constans exposed to the test substance spiked into formulated (i.e. dried, grounded and re-wetted) or fresh dung is measured over a period of three weeks. Using the model substance dimethoate (an insecticide required as positive control in tests with the predatory mite Hypoaspis aculeifer) the suitability of the new test was checked. Afterwards, the new test method was used to determine the toxicity of four common veterinary pharmaceuticals (ivermectin, dicyclanil, moxidectin, praziquantel) in formulated and fresh dung. Finally, the effects of ivermectin on the dung beetles were determined in a test using fresh dung from treated cattle.

Results and Conclusions

For Dmethoate LC₅₀-values were found in a range of 1–3 mg a.s./kg dung (dew.), depending on the dung type. Praziquantel did not show eirecis in the tested concentration range (i.e. up to 1000 mg a.s./kg Dung (DW). The LC₅₀-values of the other three pharmaceuticals were very low (<6 mg a.s./kg dung (DW)). With the exception of Dicyclanil no differences between formulated and fresh dung were identified. In the case of ivermectin the LC₅₀-value were even lower: about 0.5 mg a.s./kg dung (DW). No differences between the results of test in which the substance was spiked into dung and those tests which were performed with dung from treated cattle were found. These results prove the sensitivity as well as the robustness of this test method.

Recommendations and Perspectives

Based on the experiences reported here, it is recommended to standardize this test in an international ring test so that it can be incorporated in the risk assessment process for veterinary pharmaceuticals as described in the currently developed international registration guidelines.