- The European Commission Proposals and Legal Requirements Concerning the Determination of Scientific Criteria to Identify Endocrine Disruptive Properties of Active Substances
The EU Regulatoin on Biocides and Pesticides obliges the European Commission to define scientific criteria identifying endocrine disrupting properties of active substances.On 15 June 2016, the Commission presented legislative proposals. The proposal with regard to the Plant Protection Products Regulation also provides for amendments to the authorization procedure for active substances with endocrine disrupting properties. The sofia study, commissioned by ClientEarth, examines whether the Commission's proposals are compatible with the requirements of EU law.
Download of the sofia-studies...
- Biopatents in Animal Breeding
Applicability of patent law and recommendations for the future development of the regulatory and legislative framework
This projects aims to generate scientific evidenceto support policy decisions on biopatenting in animal breeding. The project analysis the applicability of patent law in animal breeding and creates recommentdations for the future development of the regulatory and legislative framework, giving particular attentiont to how patent law concepts can be reconciled with the realities of conventional animal breeding. Based on legal analysis and the model of interdisciplinary institutional analysis, possible conflicts between patent law concepts and the practices of animal breeding are identified. In order to clarify needs for action and possible alternatives, regulatory and legislative options (including the status quo), their pre-conditions and implicationsare identified and pathways for action are developed.The research cooperation consists of Cardiff University, the Technical University of Munich and the Society for Institutional Analysis (sofia) of the University of Applied Sciences. The project is funded by the Federal Agency of Agriculture and Food(BLE).
Developing instruments to improve the business cooperation of German enterprises in terms of environmental and climate protection projects in developing and newly industrializing countries.
The central focus of the research project is analysis of the legal, administrative and economic requirements of market access. For this purpose, Morocco and the United Arab Emirates have been selected as target countries. The cultural aspects that could be important to economic success shall also be considered.
The project concentrates on three industry sectors: energy, waste and water. Opportunities based on the trade of emission certificates (CDM projects) shall also be taken into account.
Information Flyer, english (pdf, 93 KB)
Information Flyer, french (pdf, 62 KB)
The research cooperation consists of the Institute for Environmental Studies and Applied Research (IESAR) of the University of Applied Sciences in Bingen (Germany) and the Society for Institutional Analysis (sofia) of the University of Applied Sciences in Darmstadt (Germany).
The Research project is within the scope of FHprofUnd-Programms , supported by the Federal Ministry of Education and Research. Project management by AIF. For further information see the german site of sofia or the official website www.clima-pro.de (german website).
- Improving the Integrated European Impact Assessment?
On behalf of the German Federal Environment Agency (UBA) the international workshop "Improving the Integrated European Impact Assessment", Berlin, 15-17 September 2008, explored means and possibilities to strengthen the environmental aspects within the EU Impact Assessment System.
- Guidance for the implementation of a successful risk management under REACH
Study on behalf of the German Federal Environmental Agency (UBA)
(FKZ 205 67 462/05)
Short description in German
- Legal appraisal of the proposed REACh-Annex XIII revision
Führ, Martin on behalf of WWF European Policy Office
- The question how PBT/vPvB properties are defined and identified is crucial for many parts of the REACh Regulation. The definition is relevant for other sectoral environ-mental legislation (e.g. protection of water and soil). The definitions in Annex XIII and the procedural context thus is one of the pivotal parameter within the whole regula-tory framework established by REACh; both for the protection goals of the regulation and the legal certainty of registrants and downstream users.
- The current review process has a clear normative mandate: The revision clause and the recital 76 are providing a definite normative orientation for the amendment of An-nex XIII: What is asked for is an improvement ensuring a high level of protection for human health and the environment.
- The revision of Annex XIII as proposed by the Commission is not deemed adequate for the following reasons:
- The PBT/vPvB criteria remain the same as in the current Annex XIII and it is unclear how the information mentioned in the other parts relates to section 1.
- The proposal introduces legal uncertainty because the introduction speaks of a weight of evidence approach which is contradictory to the rigid criteria in section 1.
- With the still limited PBT definition, many PBT chemicals are likely to stay un-identified. This will undermine the flow of information in the supply chain as well as health and environment protection because companies do not undertake the subse-quent consequences for PBT chemicals (i.e. emission characterization, information in supply chain and better controls)
- Companies may challenge Member State and ECHA PBT identifications using infor-mation from section 3 on the basis of the restrictive definition in section 1.
- If the text as proposed by the European Commission is adopted the “Guidance on PBT Assessment” is confronted with the question to which extent the analysis fore-seen in the guidance is covered by legally binding provisions of the regulation.
- The amendment of Annex XIII as proposed by the European Commission still links the PBT assessment strictly to the results of the tests which are listed in the current version of Annex XIII. No legal consequences are foreseen for substances where monitoring data or other scientific evidence are suggesting that PBT properties are on hand.
- This could be avoided by introducing an opening clause to the criteria themselves and thus integrating the procedural steps of the “PBT guidance” by ECHA to the wording of Annex XIII. It is recommended to integrate one of the two regulative options discussed in chapter D, page 6.
- International workshop "Improving the Integrated European Impact Assessment", Berlin, 15-17 September 2008
On behalf of the German Federal Environment Agency (Federal Environmental Research Programme, Project No. 37307 11 100) the international workshop "Improving the Integrated European Impact Assessment", Berlin, 15-17 September 2008, explored means and possibilities to strengthen the environmental aspects within the EU Impact Assessment System. Major obstacles for the adequate consideration of environmental aspects arise from methodological difficulties and the institutional design of the impact assessment procedure. Therefore, the introductory paper (Bizer/Lechner/Führ 2008) develops recommendations to address these problems. It suggests modifications of the Integrated Impact Assessment (IA) with a stronger emphasis on quantification and monetisation in order to obtain a comprehensive description of environmental impacts and in addition to strengthen the comparability of economic and environmental aspects. It also suggests enhancing the quality control mechanisms; e.g. the role of the Impact Assessment Board (IAB) and its power to intervene.
The workshop discussed these and other issues – including the consequences of the design of the impact assessment procedure in Germany – in four sessions with international experts. In the first session the problems and challenges of impact assessment were summed up by Steven White (European Commission, DG Environment), Dr. Klaus Jacob (Free University of Berlin) and Dr. Pendo Maro (EEB, Brussels). In sessions two and three different methodological approaches were discussed by Prof. Dr. Michael Schmidt (University of Brandenburg), Dr. Clive George (University of Manchester), Dr. Giles Atkinson (London School of Economics) and Dr. Martin Drechsler (Helmholtz Centre for Environmental Research - UFZ Leipzig). Session four focused on the institutional framework based on presentations by Steven White and Dr. Jochen Gebauer (Chancellery of the Federal Republic of Germany). A report of the workshop was published by Nicola Below in elni Review 2/2008. Download the article "International Workshop on Regulatory Impact Assessment with a focus on environmental aspects" by Nicola Below. An executive summary is also available: Improving the Integrated European Impact Assessment? Executive Summary of the International Workshop in Berlin by Kilian Bizer, Tobias Lechner and Martin Führ.
- New approaches for communicating risk factors with regards to REACh, GHS und Nanotechnology
The research project was supported by the German Federal Ministry of Economics and Technology. The project was concluded on 20 June 2008. A workshop was organised to present the findings of the project in the Federal Ministry od Economics and Technology in Berlin, Germany.
Many products which are dealt with, used or consumed in households contain substances which can lead to health impairments when they are inhaled, swallowed or come into contact with the skin. Dealing with such substances inappropriately can also be a source of pollution in the water, soil and air. While many of these substances used in the manufacturing process can be avoided or at least replaced by other substances which are not as harmful, it is not possible to do so in many cases. To avoid adverse affects to their health or the environment, consumers should be made aware of the potentially harmful properties which many commonplace products have.
The goal of dealing safely with chemical substances, preparations and products is being aspired to with the European Community Regulation on chemicals REACh which entered into force on 1 June 2007. To accomplish this, explicit reporting requirements throughout the supply chain have been defined legally. However, the reporting requirements do not include the end consumer (i.e. households or craftsmen). Neither of these are “REACh players”.
One of the main questions of this project are to determine how the gaps in communication which are opening up between the "REACh players" and consumers can be closed again. Furthermore, this project aims to determine which options would be available to inform consumers of the substances of which a product is made and to give consumers essential information on using these items safely. Between July 2007 and May 2008 a special research group examined these questions with an institutional analysis on the basis of three product groups. The three product groups were
2. paint and lack,
3. chemicals commonly found in hardware stores (e.g. methylated spirits, hydrochloric acid, paint remover, etc).
An executive summary can be downloaded here: New approaches for communicating risk factors with regards to REACh, GHS und Nanotechnology by Bernd Steffensen, Nicola Below and Stefanie Merenyi (pdf, 105 KB).
- Legal appraisal of nano technologies
Nano technology is regarded as a key technology of the 21st century, which will be used in a large number of industries and technical applications. On the one hand, completely new products are being developed, and on the other hand, existing technical solutions are being replaced with "nano solutions". Possible application fields for nano technology are interesting from an economic point of view, but they also have the potential to improve aspects of sustainability (for instance, increased efficiency and resource protection).
On basis of an analysis of the present state of "nano technologies" and a review of existing national and European environmental legislation, including legislation that will come into force in the near future (in particular REACH) regarding nano technologies, it is the objective of this appraisal to identify gaps in legislation at both a national and a European level regarding nano technologies, to point out possible regulatory approaches, and to formulate recommendations for further regulatory action. Download the study: Legal appraisal of nano technologies (PDF, 440 KB). More information on Potential risks of Nanotechnologies.
- Smart labels and WEEE - Informations exchange along the added value chain
How can the exchange of information through the value chain be organised by use of "smartlabels", to render on the one hand the logistics more efficient and on the other hand to fulfil legal requirements concerning occupational health and safety, consumer protection, data protection, and electrical equipment provisions? The research project was concluded in March 2008. For further information on the project ELVIES see german version.
- Implementation of risk reduction measures under REACh
Toxic ignorance has become a major issue in the current debate on chemical policy both in the EU and the US. The term refers to a lack of knowledge of the health and environmental properties, as well as the mechanisms of action, of Existing Chemicals. There can be little doubt that this term also goes to the heart of the problem facing us today. However, the availability of such data – at any rate for individual substances – gives rise to a new problem, which is that such data must now be evaluated in light of the actions that need to be taken. Here the legal interface with other sector of environmental legislation are crucial.
"Interface problems between REACh and sector specific environmental legislation (IPPC/WFD)" is the titel of a study carried out on behalf of the German Federal Environmental Agency.
Download of the english version: UBA - Text 04/2005 (pdf, 1,5 MB).
German Version: UBA - Text 03/2005 (pdf, 1,5 MB).
- Risk management under REACh
Requirements upon technical and organisational guidance for producers, importers and downstream users.
Preparatory study carried out on behalf of the German Federal Environmental Agency.
The success of REACh will depend on whether or not the actors are willing and able to adopt the roles allocated to them under the new regime. Yet it would be naive to assume that the simple fact of enacting the Regulation will be sufficient to effect the necessary changes in the behaviour of the responsible parties.
The paradigm shift in chemicals regulation caused by REACh brings with it a clear requirement for more self-responsibility on the part of economic actors. The authorities’ monitoring and inspection strategies will need adjustments to this development – indeed, it is this which makes the new regulatory regime such a paradigm shift.
Against this background, the central issue which emerges is the extent to which the various actors are willing to work together. Here, more than with any other regulatory scheme, the starting point for all efforts to bring about change is ensuring that the responsible parties addressed by the regulation are motivated – motivation matters. Another question must therefore also be asked: what incentives are there for the actors, and what obstacles lie in their way?
The initial hypothesis in this preparatory study is that support, in the form of (technical and organizational) guidance specific to each type of economic actor, can help to push forward the necessary innovation and cooperation processes to implement REACh in the intended way. Thus transaction costs for each actor can be kept to a minimum and obstacles overcome. This also supports the central, structural objective of REACh to establish a “learning system”, particularly with regard to the interaction occurring between the producers and users of industrial chemicals. To this end, sufficient regulatory (dis)incentives are essential. The question of possible amendments to the current draft of the Regulation will therefore also be addressed.
Summary in english: here (pdf, 250 kB).
German Version: UBA - Text 05/2006 (pdf, 1,9 MB).
- Transnational Product Responsibility in View of the Free Rider Problem
Product Related Environmental Policy and Transboundary Electronic Commerce.
Study performed in the context of the INVERSI-Project in cooperation with Rheinisch-Westfälisches Institut für Wirtschaftsforschung (RWI), Essen, and Gesellschaft für Arbeits-, Reorganisations- und Ökologische Wirtschaftsberatung mbH (ARÖW), Duisburg, Germany.
Funded by the German Federal Ministry of Education and Research as part of the :[riw]-program:
Rahmenbedingungen für Innovationen zum nachhaltigen Wirtschaften
(Frameworks for Innovation towards Sustainability)
Martin Führ, Jaqui Dopfer, Stefanie Merenyi
A summary of the sofia results (pdf 0,2 MB).
The final report (pdf 1,2 MB).
- Contribution to the liber amicorum for Ludwig Krämer: Richard Macrory (Ed.): Reflections on 30 Years of EU Environmental Law - A High Level of Protection, Europa Law Publishing, Groningen (NL), 2006, p. 273 - 285:
Martin Führ: Transnational Law Making - The WEEE-Example pdf, 270 kB.
For further projects see also: german version.