Ethical aspects of research involving the use of human embryos in the context of the Fifth Framework Program: report to the European Commission.
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Advisory Committees↗
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European Commission sets up a European Group on Ethics in Science and New Technologies.
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Advisory Committees↗
European commission proposes a European food authority.
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European Union↗
European Commission--Directorate General DG XXIV Consumer Policy and Consumer Health Protection. Notes of Guidance for testing of cosmetic ingredients for their safety evaluation (Second Revision). Adopted: 20 December 1996. Revised: 16 January 1997. The Scientific Committee on Cosmetology of the European Commission.
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Consumer Product Safety↗
The prospects for using (Q)SARs in a changing political environment--high expectations and a key role for the European Commission's joint research centre.
Recent policy developments in the European union (EU) and within the Organisation for Economic Cooperation and Development (OECD) have placed increased emphasis on the use of structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs), collectively referred to as (Q)SARs, within various regulatory programmes for the assessment of chemicals and products. The most significant example within the EU is the European commission's proposal (of 29 October 2003) to introduce a new system for managing chemicals (called REACH), which calls for an increased use of (Q)SARs and other non-animal methods, especially for the assessment of low production volume chemicals. Another development within the EU is the Seventh Amendment to the Cosmetics Directive, which foresees the phasing out of animal testing on cosmetics, combined with the imposition of marketing bans on cosmetics that have been tested on animals after certain deadlines. At the same time, the Existing Chemicals programme within the OECD is investigating ways of increasing the use of chemical category approaches, which depend heavily on the use of (Q)SARs, activity-activity relationships and read-across. Such developments are placing an enormous challenge on industry, regulatory bodies, and on the European commission's Joint Research Centre (JRC), which is responsible for providing independent scientific advice to policy makers in the European Commission and the Member States. This paper reviews the different scientific and regulatory purposes for which reliable (Q)SARs could be used, and describes the current work of the JRC in providing scientific support for the development, validation and implementation of (Q)SARs.
Animal Experimentation↗
A critical assessment of the European Commission's proposals for the risk assessment and registration of chemical substances in the European Union.
In May, 2003, the European Commission published detailed proposals relating to its 2001 White Paper--Strategy for a Future Chemicals Policy. The White Paper described a new registration system called the REACH (Registration, Evaluation and Authorisation of Chemicals) system, for both new and existing chemicals. Subsequently, these detailed proposals were available for an eight-week consultation period for stakeholders to voice their views and concerns. In this paper, we describe our reactions to the Commissions more-detailed proposals. These include the creation of a European Chemicals Agency to implement the REACH system in conjunction with Competent Authorities (CAs) in Member States and the Commission itself. Unfortunately, many of our concerns and suggestions, previously voiced and shared with several other key stakeholders, remain unanswered, but are as relevant as when the White Paper was published. In particular, we are concerned about the lack of a clear and coherent strategy. There is no guidance for registrants on intelligent testing to maximise the use of non-animal approaches to safety testing, based on a combination of factors for estimating exposure levels, rather than mainly on production volumes. We are also concerned about the absence of a clear programme for the development, improvement and validation of new alternative methods, in conjunction with the Commissions own unit, the European Centre for the Validation of Alternative Methods, as well as other organisations with relevant expertise and experience, including FRAME. Finally, we explain why such measures should be introduced, together with clearer guidelines for the respective roles of the Agency, the CAs and the Commission in implementing and harmonising the REACH system at the European Union and Member State levels. A series of recommendations are made, to improve the situation and to improve the risk assessment process.
Journal Article↗
Summary of environment-related research areas developed in the frame of the 5th Framework Programme of the European Commission.
Following the decision of the European Parliament and of the Council of 22 December 1998, The European Commission has launched its Fifth Framework Programme for Research, Technological Development and Demonstration (RTD) which will run from 1999 to 2002. The activities will be carried out in the frame of four thematic programmes and three horizontal ones. The first calls for proposals were published in March 1999. Detailed information on the work programme of each activity is available through the Internet at the following address http://www.cordis.lu/fp5 and through direct contact with the programme's help-desks. The present summary gives an outline of environment-related research activities covered by 5th FWP.
Conservation of Natural Resources↗
A critical assessment of the European Commission's proposals for the risk assessment and registration of chemical substances in the European Union.
In May, 2003, the European Commission published detailed proposals relating to its 2001 White Paper - Strategy for a Future Chemicals Policy. The White Paper described a new registration system called the REACH (Registration, Evaluation and Authorisation of Chemicals) system, for both new and existing chemicals. Subsequently, these detailed proposals were available for an eight-week consultation period for stakeholders to voice their views and concerns. In this paper, we describe our reactions to the Commission's more-detailed proposals. These include the creation of a European Chemicals Agency to implement the REACH system in conjunction with Competent Authorities (CAs) in Member States and the Commission itself. Unfortunately, many of our concerns and suggestions, previously voiced and shared with several other key stakeholders, remain unanswered, but are as relevant as when the White Paper was published. In particular, we are concerned about the lack of a clear and coherent strategy. There is no guidance for registrants on intelligent testing to maximise the use of non-animal approaches to safety testing, based on a combination of factors for estimating exposure levels, rather than mainly on production volumes. We are also concerned about the absence of a clear programme for the development, improvement and validation of new alternative methods, in conjunction with the Commission's own unit, the European Centre for the Validation of Alternative Methods, as well as other organisations with relevant expertise and experience, including FRAME. Finally, we explain why such measures should be introduced, together with clearer guidelines for the respective roles of the Agency, the CAs and the Commission in implementing and harmonising the REACH system at the European Union and Member State levels. A series of recommendations are made, to improve the situation and to improve the risk assessment process.
Animal Use Alternatives↗
Industrial platforms--a unique feature of the European Commission's biotechnology R&D programme.
The European Commission's research, technological development and demonstration programmes aim to strengthen European research and technological development, and to increase the competitiveness of European industries. The creation and development of Industrial Platforms play an important role in these processes by improving the transition from research to commercial application. Industrial Platforms are technology-based industrial groupings established by industry with the aims of enabling the exploitation or dissemination of research results, encouraging academic-industrial collaborations and providing their members with a means of voicing their opinion on present and future research policies.
Biotechnology↗
Environmental risk assessment of medicinal products for human use according to European Commission recommendations.
Presented here, based on new recommendations of the European Commission, is an environmental risk assessment (ERA) of a selected group of pharmaceuticals for Phase I, environmental exposure assessment, and Phase II Tier A, initial environmental fate and effect analysis. This pharmaceutical group is composed of the 111 highest-selling human drug substances that have annual sales in Germany of more than 5,000 kg. The data required for this ERA came from analyzing: (1) sales annually (in kg or IU) of the 2671 active pharmaceutical drug substances (2001) on the German market in all medicinal products sold by pharmacies (with and without prescriptions) and used in hospitals in 1996-2001; (2) the use pattern of drug substances as categorized according to Anatomical Therapeutic Chemical (ATC) classification indexes ATC3 and ATC7; (3) data for excretion, toxicity, and metabolites of the 111 selected human drug substances; (4) the physicochemical properties of these substances; and (5) the degradability of selected drug substances in sewage treatment plants (STPs) by using a validated and accredited liquid chromatography-electrospray ionization tandem mass spectrometry method. A correction factor for the pharmaceutical therapeutic (PT) activity of metabolites, the PT(Index) (excretion rate/100) for drug substances and PT active metabolites was established to refine the predicted environmental concentration (PEC(SURFACEWATER)). A refinement of the PEC(SURFACEWATER) was carried out with the market penetration factor of the human drug substances in Germany. In addition, for effect analysis the predicted no-effects concentration (PNEC) was calculated using assessment factors. The estimated PEC results were validated with the exposure results of effluents of the STPs. All results on ERA of drug substances have been documented in a Microsoft Access 2000 database.
Advisory Committees↗
The European Commission proposal for a marine strategy: lacking substance.
The European Commission's proposed Marine Strategy constitutes a highly inadequate approach to long-term protection of the European Seas. The main problem with the strategy is the restriction to a proposed directive in which only EU Member States are placed under obligation to develop their own environmental objectives and marine protection activity programmes. This 'renationalisation' results in the exclusion of key policy areas like Common Agricultural Policy (CAP) and Common Fishery Policy in which the EU has centralised powers. Furthermore, there is no plan to refine EU environmental law relevant to marine protection and nor are there any provisions for the linking of EU-level action with the international conventions for the protection of the oceans.
Conservation of Natural Resources↗
Table of cases relating to sexual and reproductive rights--European Commission on Human Rights and the European Court of Human Rights.
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Europe↗
Uncertainties and data needs in risk assessment of three commercial polybrominated diphenyl ethers: probabilistic exposure analysis and comparison with European Commission results.
Some environmental monitoring programs have reported increasing levels of certain polybrominated diphenyl ether (PBDE) isomers in aquatic biota and in human breast milk. The commercial PBDE products are known as penta-, octa-, and deca-brominated diphenyl ethers (PeBDE, OBDE and DBDE, respectively). Aside from the current European Commission's risk assessment initiative and efforts underway in Sweden, Canada and elsewhere to evaluate environmental levels, little is understood about sources of exposure and risks to humans. In this study, a multi-pathway human health risk assessment was performed to predict theoretical chronic daily intakes (CDIs) of PeBDE, OBDE, and DBDE by five different age groups: 0-2, 2-6, 6-12, 12-18, and 18-70 years. Sources of exposure included air, drinking water, consumption of fish, vegetables, meat and dairy products, and ingestion of breast milk by infants. In addition to a deterministic analysis, the risk assessment included a probabilistic analysis to derive the probability density functions describing the range of plausible exposures associated with eight different pathways, as well as aggregate lifetime exposures for each age group. The results were compared to CDI point estimates calculated by the European Chemicals Bureau as part of the European Commission's Existing Substances Programme. The major sources of uncertainties are discussed, including environmental sources, levels in different environmental compartments, toxicity, and human exposure. This paper also discusses the limitations in the current state-of-the-science and provides recommendations for improving the scientific relevance and accuracy of future environmental risk assessments of PBDEs.
Adolescent↗
[Environmental and occupational exposure to vitreous fibers: the initiatives of the European Commission].
The recent classification of a certain number of glass fibres by the European Commission within the framework of the Council Directive 67/548/CEE has reopened the debate on the carcinogenicity of these fibres at the level of the European Union. There is the risk of a law suit being field before the Court of Justice in Luxembourg against Germany, "guilty" of not having observed Community regulations. As regards worker protection, the recent Council Directive on chemical agents reviews the legal aspects concerning both preventive measures and the setting of limit values of occupational exposure.
Air Pollutants, Occupational↗
European Commission activities in eHealth.
Health-care is an information-intensive and knowledge-demanding sector, which is why eHealth solutions are so important in this field. The European Commission (EC) has been initiating and funding research and development activities regarding Information and Communication Technologies (ICT) for health, or "eHealth", since 1988. These programmes covered priority topics like electronic health-care records, regional and national health networks, telemedicine in homecare and care-at-the-point-of-need to support continuity of care concepts, systems to support people to stay healthy, and systems and tools to support health professionals to work more efficiently and safely on patients. During the 15-year span of the programmes, the European Union (EU) has contributed about 500 million Euro to approximately 400 R&D projects, support activities, best practice and studies covering technical, clinical, ethical, legal, organisational and market issues. eHealth has shown proven benefits in application fields like improved access to care, care at the point-of-need, citizen-centred care, improved quality and cost containment. Such applications were on show at the EU High Level eHealth Conferences in Brussels, Belgium, in 2003, and in Cork, Ireland, in 2004. eHealth is now on the governmental agenda of EU Member States to be implemented on a broader scale. In line with this development, the Commission has taken a number of policy initiatives. A European Union Action Plan for a European eHealth Area was published by the Commission in April 2004 and endorsed by the EU health ministers in June 2004. This means that, for the first time, Europe has a coherent agenda for the implementation of eHealth. This report will concentrate on eHealth activities initiated by the Information Society Directorate-General of the European Commission.
Europe↗
The European Commission's White Paper "strategy for a future chemicals policy": a review.
The European Commission has proposed a radical new policy for the regulation of chemicals in the EU in the form of a White Paper. The current system has separate regulatory provisions for "new" chemicals (introduced to the market since September 18, 1981) and "existing" chemicals (on the market before September 18,1981). The proposed future policy will have a single unified regulatory system for all chemicals, which should result in better regulation of chemicals in the EU single market. It will be better because risk assessments will be targeted at the chemicals of greatest concern. Furthermore, the system will be streamlined, making regulatory decisions faster, and thus reducing the so-called burden of the past (the large number of chemicals that have never been assessed for their risks to human health or the environment). The new system incorporates the precautionary principle, which will be applied where there is an early indication of unacceptable risk or where there is undue delay in the regulatory process. Moreover, the new strategy is intended to promote greater transparency for all stakeholders.
Chemical Industry↗
Over the counter medicines and the need for immediate action: a further evaluation of European Commission recommended wordings for communicating risk.
A study examined people's interpretation of European Commission (EC) recommended verbal descriptors for risk of medicine side effects, and actions to take if they do occur. Members of the general public were presented with a fictitious (but realistic) scenario about suffering from a stiff neck, visiting the local pharmacy and purchasing an over the counter (OTC) medicine (Ibruprofen). The medicine came with an information leaflet which included information about the medicine's side effects, their risk of occurrence, and recommended actions to take if adverse effects are experienced. Probability of occurrence was presented numerically (6%) or verbally, using the recommended EC descriptor (common). Results showed that, in line with findings of our earlier work with prescribed medicines, participants significantly overestimated side effect risk. Furthermore, the differences in interpretation were reflected in their judgements of satisfaction, side effect severity, risk to health, and intention to take the medicine. Finally, we observed no significant difference between people's interpretation of the recommended action descriptors ('immediately' and 'as soon as possible').
Adolescent↗
Results of the European Commission Marina II study: part II--effects of discharges of naturally occurring radioactive material.
Enhanced levels of naturally occurring radioactive materials (NORM) are produced through various industrial operations and may lead to discharges to the marine environment. A recent study, called MARINA II, carried out for the European Commission considered discharges of radionuclides from the NORM industries to north European marine waters and their consequences. There are two main sources that were considered in the study. The use of phosphogypsum during the production of phosphoric acid by the fertiliser industry and the pumping of oil and gas from the continental shelf in the North Sea which produces large quantities of water contaminated with enhanced levels of naturally occurring radionuclides. Discharges of alpha emitting radionuclides from these two industries have contributed significantly to the total input of alpha emitters to north European waters over the period 1981-2000 (data were not available prior to 1981). Discharges due to the use of phosphogypsum have declined since the early 1990s and are now very low. Discharges from the oil and gas industries stabilised in the second half of the 1990s and are now the major contributor to alpha discharges to the region. As most European countries do not report discharges of radioactivity with the water produced during extraction, there is considerable uncertainty in the discharges used in the study. The impact of the discharges has been estimated both in terms of the effect on non-human biota and the radiological impact for people. In the 1980s the radiation dose rates to marine biota in the region around a phosphate plant on the north-west coast of England were as high due to the discharges from the phosphate plant as those near to the Sellafield reprocessing plant due to its discharges. In recent years the additional dose to marine biota in this region due to the past NORM discharges is of the same order of magnitude as the natural background. The collective dose rate was estimated to determine the radiological impact on people. The peak collective dose rate from the NORM industries occurred in 1984 and was just over 600 manSv y(-1). The collective dose rate fell with time as discharges from the phosphate industry reduced and was estimated as under 200 manSv y(-1) in 2000.
Chemical Industry↗