EU Chemicals Policy Research Articles

Mapping the Dawn of Nanoecotoxicological Research

Some researchers consider nanotechnology the next industrial revolution, and consumer products and a variety of industries increasingly use synthetic nanoparticles. In this Account, we review the initial accomplishments of nanoecotoxicology, a discipline that is just a decade old. This new subdiscipline of ecotoxicology faces two important and challenging problems: the analysis of the safety of nanotechnologies in the natural environment and the promotion of sustainable development while mitigating the potential pitfalls of innovative nanotechnologies. In this Account, we provide a snapshot of the publicly available scientific information regarding the ecotoxicity of engineered nanoparticles. We pay special attention to information relevant to aquatic freshwater species commonly used for risk assessment and regulation. Just as the development of ecotoxicology has lagged behind that of toxicology, nanoecotoxicological research has developed much more slowly than nanotoxicology. Although the first nanotoxicolology papers were published in 1990s, the first nanoecotoxicology papers came out in 2006. A meta-analysis of scientific publications covering different environmental impacts of nanomaterials showed that the importance of research into the environmental impact of nanotechnology has gradually increased since 2005. Now the most frequently cited papers in the environmental disciplines are often those that focus on synthetic nanoparticles. The first nanoecotoxicology studies focused on adverse effects of nanoparticles on fish, algae and daphnids, which are ecotoxicological model organisms for classification and labeling of chemicals (these model organisms are also used in the EU chemical safety policy adopted in 2007: Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)). Based on our experience, we propose a multitrophic battery of nanoecotoxicological testing that includes particle-feeding and a priori particle-"proof" prokaryotic and eukaryotic organisms at different food-chain levels. Using this battery of selected test organisms, we demonstrated that TiO₂ nanoparticles were toxic to algae and that ZnO and CuO nanoparticles were toxic to several aquatic invertebrate test species. Thus, one single biotest cannot predict the ecotoxicological effects of chemicals/nanoparticles, and researchers should use several tests instead. Moreover, produced nanoparticles usually vary in features such as size, shape, and coating; therefore, a single nanoparticle species may actually include many entities with different physicochemical properties. An ecotoxicity analysis of all these variants would require a huge number of laboratory tests. To address these issues, high throughput bioassays and computational (QSAR) models that serve as powerful alternatives to conventional (eco)toxicity testing must be implemented to handle both the diversity of nanomaterials and the complexity of ecosystems.

Regulating the Use of Bisphenol A in Baby and Children's Products in the European Union: Current Developments and Scenarios for the Regulatory Future

Parents of newborns and small children have recently been confronted with labels indicating that their purchases of a baby bottle, teethers or sippy cups are now ‘Bisphenol A-free’ (BPA). A synthetic chemical used in the production process of polycarbonate (plastics), Bisphenol A is currently making headline news in the US and the EU. Its questioned safety in food plastics, baby bottles and children's toys has turned plastics into a political issue as it is systematically framed as a risk in media coverage.Apart from regulatory exposure limits (Tolerable Daily Intake levels (TDI), Bisphenol A is currently not subject to any restrictions in use yet (although BPA will be subject to a ban on the EU level from spring 2011 onwards). However, with the REACH framework (Registration, Evaluation, Authorisation of Chemicals), a new regulatory framework for EU's chemical policy in place since June 2007, these exposure limits may be reviewed and BPA may face regulatory action. This article aims to analyse the regulatory process of Bisphenol A in the EU as an example of an uncertain risk dossier. On the basis of document and media analysis and interviews, the main aim is to gain an understanding of how uncertain risks are being regulated in the European Union. To that end, the self-regulatory behavior of industry is also considered. On the basis of the current regulatory tools in place and the current state of affairs, as well as developments in the controversy around BPA, the paper concludes by presenting four scenarios that illustrate the dynamics of the case and its possible regulatory outcomes.

Input and output legitimacy: synergy or trade-off? Empirical evidence from an EU survey

Since the breakdown of the ‘permissive consensus’ in the early 1990s we have witnessed an input turn in the debate on EU legitimacy. Many scholars have been arguing for enhancing the input legitimacy of the EU through promoting stakeholder participation and deliberation on important European issues. Yet, others warn that this strategy might not help in increasing overall legitimacy of the EU, since increased input legitimacy could be thought to undermine its output legitimacy by making decision-making less efficient. This article assesses, empirically, the relationship between input and output legitimacy within the context of the EU chemicals policy overhaul. Contrary to what some scholars suggest, we find evidence from a survey that measures aimed at increasing the input legitimacy of the EU also hold the promise of increasing its output legitimacy.

Regulatory and Scientific Barriers to The Safety Evaluation of Medical Nanotechnologies

Nanotechnology has permeated several key markets, with its fastest and highest rate of incorporation found in the development of medicinal products, medical device and other healthcare products. This has been achieved without reform of regulatory testing guidelines that were developed before nanotechnologies were even conceptualized. A number of medicinal products containing nanomaterials have already been authorized both in the EU and the USA. These nanotechnology-based products incorporate nanoscale liposomes (e.g., Caelyx/Doxil and MyocetTM), lipid micelles (e.g., Estrasorb), virosomes (e.g., Epaxal Berna) and pegylated proteins (e.g., Neulasta, Pegasys, PegIntron, Macugen and Somavert). Other products include CALAA-01 with its proprietary siRNApolymer delivery system, the synthetic amino acid polymer in Copaxone, protein conjugates (e.g., Abraxane), microemulsions (e.g., of cyclosporine) and nanocrystalline suspensions (e.g., Rapamune, Emend and Megace ES). Additional organic nanomaterials being investigated for drug delivery include carbon fullerenes and nanotubes, whilst inorganic nanoparticles are already incorporated into a number of in vivo diagnostic products (iron nanoparticles), wound care products (nanosilver) or dental and bone restoratives (calcium nanoparticles and composites) [1]. The fact that novel characteristics of nanomaterials, such as SilcrystTM and NanoOss, are conferred by their size, shape, surface and core chemistry have been long since recognized by organizations such as the US and European Patent and Trademark Offices and regulatory agencies such as the European Medicines Agency (EMEA) and the US FDA. These novel characteristics have met important medical needs, such as the ability to deliver therapeutic agents across biological membranes, improve their solubility, reduce their toxicity or allow their localized concentration at tumor sites. However, in spite of a growing body of evidence that many of the desirable properties of nanomaterials can also translate to risks, to date there is no specific guidance pertaining to the safety evaluation of nanotechnology-based products. One such risk is the ability of nanomaterials to cross biological barriers impervious to larger particles. In some cases, this may trigger neurotoxicity [2]. Furthermore, chemical composition does not necessarily correlate with risk. Indeed, last year it was reported that engineered carbon nanotubes, once thought to be no more toxic than graphite, trigger the formation of lesions akin to those seen in asbestosis in mice [3]. In light of such evidence, in April 2009, the EU Parliament called the Commission to task over its decision to allow single registration of nano and bulk equivalent materials under the EU Chemicals Policy after having already come to the conclusion that existing test methods are not adequate for assessing the risks associated with nanomaterials in foods and having earlier this year called upon the Commission to compile a database of nanomaterials used in the EU by 2011 and to review legislative measures to ensure the safety of nanomaterials for all uses.

The EU Chemicals Policy: Towards Inclusive Governance?

This paper investigates to what extent contemporary EU risk regulation responds to demands for inclusive governance. To this end, the paper examines the new EU regulatory framework for the control of chemicals, better known as the REACH Regulation. It identifies and evaluates opportunities for public participation during the negotiation of the REACH proposal (the 'input' stage), in decision-making processes under the REACH Regulation ('throughput'), and at the stage of reviewing decisions taken in compliance with REACH ('output'). The paper argues that formal opportunities for public participation exist and are reasonably satisfactory, but that their significance is eroded by the institutional and functional context in which participation must take place.

An evaluation of selected valid and mechanistically based SARs for skin sensitisation

Skin sensitisation which clinically is manifested as allergic contact dermatitis is an important health endpoint to be taken into account in the risk assessment of chemicals. In the new EU chemical policy REACH, information on skin sensitisation potential will have to be provided for chemicals manufactured or imported equal to or above 1 tonne/year and it is estimated that the highest number of substances will need to be tested for skin sensitisation. Within REACH, the use of (Q)SARs and other alternative methods is strongly encouraged in order to reduce the number of animal tests. The goal of this project was to test the applicability of SARs and structural alerts for skin sensitisation in the REACH framework. SARs and structural alerts which were found in the literature were analysed and further refined by using a number of examples (substances) that had not been previously used in the derivation of the published SARs. For substances which fit within the boundaries of the proposed alerts, it is assumed that they would be classified as sensitising in accordance with EU classification and labelling rules.

The Consideration of the Supply Chain Management for the Forthcoming EU Chemical Policy Restriction

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Animal testing and alternative approaches for the human health risk assessment under the proposed new European chemicals regulation.

During the past 20 years the EU legislation for the notification of chemicals has focussed on new chemicals and at the same time failed to cover the evaluation of existing chemicals in Europe. Therefore, in a new EU chemicals policy (REACH, Registration, Evaluation and Authorization of Chemicals) the European Commission proposes to evaluate 30,000 chemicals within a period of 15 years. We are providing estimates of the testing requirements based on our personal experiences during the past 20 years. A realistic scenario based on an in-depth discussion of potential toxicological developments and an optimised "tailor-made" testing strategy shows that to meet the goals of the REACH policy, animal numbers may be significantly reduced below 10 million if industry would use in-house data from toxicity testing, which are confidential, if non-animal tests would be used, and if information from quantitative structure activity relationships (QSARs) would be applied in substance-tailored testing schemes. The procedures for evaluating the reproductive toxicity of chemicals have the strongest impact on the total number of animals bred for testing under REACH. We are assuming both an active collaboration with our colleagues in industry and substantial funding of the development and validation of advanced non-animal methods by the EU Commission, specifically in reproductive and developmental toxicity.

The New EU Chemicals Policy: Challenges and Chances for Animal-free Test Methods

As a first step toward preparing new chemicals legislation, in February 2001, the European Commission adopted a White Paper on a Strategy for a Future Chemicals Policy. Its main goals are to better protect humans and the environment from unknown risks through chemicals. The "promotion of non-animal testing" is one of the key elements of the proposed strategy. For low production volume chemicals, only data from in vitro tests are to be requested. The data requirements for higher production volume chemicals will be designed flexibly, so that only data relevant for the respective chemical are collected. From the point of view of animal welfare risk management, strategies should be defined before test batteries are put together. The test catalogues currently listed in the Dangerous Substances Directive, Council Directive 67/548/EEC, are to be replaced by flexible, tiered-testing strategies, and concrete waiving strategies are to be designed. The avoidance of duplicate testing should become mandatory. In order to fill prevailing knowledge gaps, the funding of alternative method research should be given priority by the EU Commission, and thus should receive a concrete budget. It should have been formulated as a key action in the European Sixth Research Framework Programme.

42 The new EU chemicals policy

42 The new EU chemicals policy

Ecopa: actual status and plans

Ecopa, the European Consensus Platform on alternatives, is an international not-for-profit organization, based in Belgium and complying with Belgium law. It is the only quadripartite organization at EU level, which is promoting the 3R-Alternatives at the European level. Ecopa brings together National Consensus Platforms on alternative methods. Consensus means that all parties concerned are represented: animal welfare, industry, academia and governmental institutions. Ecopa actually counts 14 National Platforms of Member States (or future Member States), (8 full members, platforms of Austria, Belgium, Finland, Germany, The Netherlands, Spain, Switzerland and United Kingdom and six associate members being Czech Republic, Denmark, Italy, Norway, Poland and Sweden) and has three working groups. The fields of interest of these working groups change according to the needs and were until now concerned with (i) the 6th Framework Programme of the EC for Research, Technological Development and Demonstration Activities, (ii) the EC White Paper Strategy for a Future EU Chemicals Policy and (iii) the formation & educational programmes on alternative methods. Ecopa is thus uniquely placed and has huge expertise to offer to the debate around scientific and politically-linked topics. It has to be considered a key stakeholder by the European Commission and Parliament ( http://ecopa.vub.ac.be) or http://ecopa.tsx.org).

Concern on EU chemicals policy

Concern on EU chemicals policy

The Commission White Paper on a Strategy for a Future EU Chemicals Policy: the view of European companies of American parentage.

After years of good service, EU legislation on chemicals is currently subject to a major review. This process, initiated by the Council of Ministers at Chester in April 1998, will soon lead to new legislative proposals. In the meantime, a review of the Commission's White Paper on "Strategy for a Future Chemicals Policy," published in February 2001, clearly shows that the regulatory landscape in this area will be significantly reshaped and that a new burden will be imposed on industry to demonstrate that the production and use of chemicals indeed conform to high standards of protection of human health and the environment. In the view of industry, on both sides of the Atlantic, while the objectives of the proposed reform can be supported, the measures proposed in the White Paper to implement these objectives are not properly balanced and will lead to substantial societal and economic drawbacks, unless significant adjustments are made. The purpose of this article is to present the pitfalls and difficulties of the reform as they are perceived by the EU Committee of the American Chamber of Commerce in Brussels, an organization that regroups about 150 European companies of American parentage, belonging to a broad range of European business sectors, including producers and users of chemicals. In view of the transatlantic and cross-business character of its membership, the EU Committee offers a different perspective on the debate.

ECVAM, ECETOC and the EU chemicals policy.

ECVAM's initiatives in validation have received significant support from the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), especially through the provision of reference chemical data banks, which contain peer-reviewed, high-quality in vivo data on commercially available chemical substances. Chemicals have been selected from these ECETOC data banks for validation studies on alternative methods for skin corrosion and irritation and for eye irritation and, in addition, an ECETOC task force peer-reviewed the selection and classification, on the basis of in vivo data, of chemicals used in the validation of three alternative methods for developmental toxicity. More recently, ECVAM and ECETOC have been pursuing parallel initiatives on the proposed new EU chemicals policy, with the common goals of ensuring that industry and European Commission resources are used to investigate only those chemicals that pose a significant risk to human health and the environment, and that the Policy requires that any testing which is required follows the Three Rs principles of reduction, refinement and replacement.

The future of ECVAM: a personal perspective.

Progress made in the practical application of the validation process is summarised, and some of the remaining problems are considered. Highlights of the first ten years of ECVAM are reviewed, andECVAM's activities as a route of communication on the Three Rs are discussed. Finally, some suggestions are made for maintaining ECVAM's momentum in the future, especially in relation to the challenge and opportunity for alternative methods afforded by the new EU Chemicals Policy.

Ecopa: a powerful concept in the way forward for alternative methods.

ecopa, the European Consensus-Platform on Alternatives, is an international not-for-profit organisation, based in Belgium and complying with Belgium Law. It is the only quadripartite organisation that promotes the Three Rs at the European level. Ecopa brings together national consensus platforms on alternative methods. Consensus means that all parties concerned are represented, including animal welfare, industry, academia and government. Ecopa currently includes the National Platforms of 14 EU Member State (or future Member State; eight full members, namely, Austria, Belgium, Finland, Germany, The Netherlands, Spain, Switzerland and the UK, and six associate members, being the Czech Republic, Denmark, Italy, Norway, Poland and Sweden). Ecopa also has three working groups, concerned with: a) the 6th Framework Programme of the EC for Research, Technological Development and Demonstration Activities; b) the EC White Paper Strategy for a Future EU Chemicals Policy; and c) the formation of educational programmes on alternative methods within the EU. Ecopa is thus uniquely placed and has huge expertise to offer to the debate around political topics, including the White Paper, the 6th Framework Programme, and the 7th Amendment of the EU Cosmetics Directive. Ecopa should be considered a key stakeholder by the European Commission and Parliament, and it is essential that the views of ecopa are fully incorporated into future legislation. Recently, the ecopa working groups made a strong common statement on the Chemicals Policy White Paper and made a number of recommendations to the Commission based on scientific, practical and realistic grounds. These are to be found on the ecopa Web site (http://www.ecopa.tsx.org/).

The EU Chemicals Policy Review from a Legal Perspective: For a Progressive, Coherent and Integrated Approach that Preserves the Internal Market

This paper analyses the Commission White Paper on a Strategy for New Chemicals Policy from a legal perspective. In concentrating its efforts towards resolving the “burden of the past”, the White Paper does not provide the fundamental justification of the choice of a single system applicable to both new and existing chemicals and many uncertainties remain as to the scope and functioning of this system. Ensuring the coherency of the future legislation will require clarifying the fundamental legal nature and consequences of each phase of the proposed “REACH” system, and streamlining the REACH processes on the basis of centralised, efficient, and transparent decision-making processes. The White Paper does not specify how the Commission intends to ensure that the new legislation preserves the internal market for chemicals, another fundamental objective of the reform. This will require that the new legislation be based on Article 95 of the EU Treaty, that it clarifies some of the grey zones of the existing chemical legislation, and that the Commission effectively enforces the internal market discipline with respect to those cases where national competencies remain. Finally, efficacy will require the prioritisation of the scope of the REACH system to avoid duplication of efforts and a fundamental reflection on the interactions between the different EU policies and legislation affecting chemicals to ensure that the future chemical legislation is integrated and coherent.

Government Watch: EU chemical policy

ADVERTISEMENT RETURN TO ISSUEPREVDepartmentsNEXTGovernment Watch: EU chemical policyCite this: Environ. Sci. Technol. 2001, 35, 9, 183A–185APublication Date (Web):May 1, 2001Publication History Published online1 May 2001Published inissue 1 May 2001https://doi.org/10.1021/es012222iRIGHTS & PERMISSIONSArticle Views71Altmetric-Citations-LEARN ABOUT THESE METRICSArticle Views are the COUNTER-compliant sum of full text article downloads since November 2008 (both PDF and HTML) across all institutions and individuals. These metrics are regularly updated to reflect usage leading up to the last few days.Citations are the number of other articles citing this article, calculated by Crossref and updated daily. Find more information about Crossref citation counts.The Altmetric Attention Score is a quantitative measure of the attention that a research article has received online. Clicking on the donut icon will load a page at altmetric.com with additional details about the score and the social media presence for the given article. Find more information on the Altmetric Attention Score and how the score is calculated. Share Add toView InAdd Full Text with ReferenceAdd Description ExportRISCitationCitation and abstractCitation and referencesMore Options Share onFacebookTwitterWechatLinked InReddit PDF (31 MB) Get e-Alerts Get e-Alerts

Balancing Trade and Environment in the European Union: Proportionality Substituted?

Free movement of goods—National general prohibition on the use of trichloroethylene—Article 30 EC Treaty (ex Article 36)—EU chemicals policy—risk assessment and management