A Critical Assessment of the European Commission's Proposals for the Risk Assessment and Registration of Chemical Substances in the European Union

2003 ◽  
Vol 31 (3) ◽  
pp. 353-364 ◽  
Author(s):  
Robert Combes ◽  
Jennifer Dandrea ◽  
Michael Balls
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
White Paper ◽  
Assessment Process ◽  
Alternative Methods ◽  
The European Union ◽  
Registration System ◽  
Safety Testing ◽  
Key Stakeholders ◽  
Chemicals Policy

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.

Introduction to the EU REACH Legislation

2008 ◽  
Vol 36 (1_suppl) ◽  
pp. 1-6 ◽  
Author(s):  
Christina Grindon ◽  
Robert Combes
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Animal Welfare ◽  
European Parliament ◽  
White Paper ◽  
European Council ◽  
The European Union ◽  
Safety Testing ◽  
The Eu

FRAME initiatives on the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals, first proposed as a White Paper in 2001, are summarised. These initiatives considered the scientific and animal welfare issues raised by the REACH proposals, and resulted in a number of suggestions for improvement, many of which seem to have been adopted during the current progress of the legislation through the European Council and European Parliament.

scholarly journals Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

2020 ◽  
Vol 137 ◽  
pp. 109515
Author(s):  
Ermolaos Ververis ◽  
Reinhard Ackerl ◽  
Domenico Azzollini ◽  
Paolo Angelo Colombo ◽  
Agnès de Sesmaisons ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
European Food Safety Authority ◽  
Assessment Process ◽  
The European Union ◽  
Risk Assessment Process ◽  
Novel Foods

An Overall Strategy for the Testing of Chemicals for Human Hazard and Risk Assessment under the EU REACH System

2003 ◽  
Vol 31 (1) ◽  
pp. 7-19 ◽  
Author(s):  
Robert Combes ◽  
Martin Barratt ◽  
Michael Balls
Keyword(s):  
Risk Assessment ◽  
Expert Systems ◽  
Toxicity Testing ◽  
White Paper ◽  
Assessment Process ◽  
Laboratory Animals ◽  
Production Volume ◽  
The European Union ◽  
Essential Information ◽  
Large Numbers

In its White Paper, Strategy for a Future Chemicals Policy, published in 2001, the European Commission (EC) proposed the REACH (Registration, Evaluation and Authorisation of CHemicals) system to deal with both existing and new chemical substances. This system is based on a top-down approach to toxicity testing, in which the degree of toxicity information required is dictated primarily by production volume (tonnage). If testing is to be based on traditional methods, very large numbers of laboratory animals could be needed in response to the REACH system, causing ethical, scientific and logistical problems that would be incompatible with the time-schedule envisaged for testing. The EC has emphasised the need to minimise animal use, but has failed to produce a comprehensive strategy for doing so. The present document provides an overall scheme for predictive toxicity testing, whereby the non-animal methods identified and discussed in a recent and comprehensive ECVAM document, could be used in a tiered approach to provide a rapid and scientifically justified basis for the risk assessment of chemicals for their toxic effects in humans. The scheme starts with a preliminary risk assessment process (involving available information on hazard and exposure), followed by testing, based on physicochemical properties and (Q)SAR approaches. (Q)SAR analyses are used in conjunction with expert system and biokinetic modelling, and information on metabolism and identification of the principal metabolites in humans. The resulting information is then combined with production levels and patterns of use to assess potential human exposure. The nature and extent of any further testing should be based strictly on the need to fill essential information gaps in order to generate adequate risk assessments, and should rely on non-animal methods, as far as possible. The scheme also includes a feedback loop, so that new information is used to improve the predictivity of computational expert systems. Several recommendations are made, the most important of which is that the European Union (EU) should actively promote the improvement and validation of (Q)SAR models and expert systems, and computer-based methods for biokinetic modelling, since these offer the most realistic and most economical solution to the need to test large numbers of chemicals.

scholarly journals Rethinking the Role of Information in Chemicals Policy: Implications for TSCA and REACH

elni Review ◽  
2005 ◽  
pp. 22-37
Author(s):  
Lars Koch ◽  
Nicholas A. Ashford
Keyword(s):  
United States ◽  
Risk Assessment ◽  
European Union ◽  
Risk Management ◽  
Risk Reduction ◽  
The United States ◽  
Sequential Process ◽  
The European Union ◽  
Chemicals Policy

This article analyzes the role of different kinds of information for minimizing or eliminating the risks due to the production, use, and disposal of chemical substances and contrasts it with present and planned (informational) regulation in the United States and the European Union, respectively. Some commentators who are disillusioned with regulatory approaches have argued that informational tools should supplant mandatory regulatory measures unflatteringly described as “command and control.” Critics of this reformist view are concerned with the lack of technology-innovation forcing that results from informational policies alone. We argue that informational tools can be made more technology inducing – and thus more oriented towards environmental innovations – than they are under current practices, with or without complementary regulatory mechanisms, although a combination of approaches may yield the best results. The conventional approach to chemicals policy envisions a sequential process that includes three steps of (1) producing or collecting risk-relevant information, (2) performing a risk assessment or characterization, followed by (3) risk management practices, often driven by regulation. We argue that such a sequential process is too static, or linear, and spends too many resources on searching for, or generating information about present hazards, in comparison to searching for, and generating information related to safer alternatives which include input substitution, final product reformulation, and/or process changes. These pollution prevention or cleaner technology approaches are generally acknowledged to be superior to pollution control. We argue that the production of risk information necessary for risk assessment, on the one hand, and the search for safer alternatives on the other hand, should be approached simultaneously in two parallel quests. Overcoming deficits in hazard-related information and knowledge about risk reduction alternatives must take place in a more synchronized manner than is currently being practiced. This parallel approach blurs the alleged bright line between risk assessment and risk management, but reflects more closely how regulatory agencies actually approach the regulation of chemicals. These theoretical considerations are interpreted in the context of existing and planned informational tools in the United States and the European Union, respectively. The current political debate in the European Union concerned with reforming chemicals policy and implementing the REACH (Registration, Evaluation and Authorization of Chemicals) system is focused on improving the production and assessment of risk information with regard to existing chemicals, although it also contains some interesting risk management elements. To some extent, REACH mirrors the approach taken in the U.S. under the Toxics Substances Control Act (TSCA) of 1976. TSCA turned out not to be effectively implemented and provides lessons that should be relevant to REACH. In this context, we discuss the opportunities and limits of existing and planned informational tools for achieving risk reduction.

Scrutinizing Three Trichloroethylene Carcinogenicity Classifications in the European Union—Implications for the Risk Assessment Process

2002 ◽  
Vol 21 (6) ◽  
pp. 441-450 ◽  
Author(s):  
Christina Rudén
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Assessment Process ◽  
The European Union ◽  
Risk Assessment Process ◽  
Chlorinated Solvent ◽  
European Union Commission

In this paper, carcinogenicity classifications of the chlorinated solvent trichloroethylene (TCE) made by the European Union Commission Expert Groups in 1976, 1988, and 2001 are scrutinized and alternative classifications are proposed. It is argued that the TCE database at these three points in time could have been interpreted to fulfill the criteria for stricter classifications than those actually made. Implications of this for the classification process are discussed.

scholarly journals Protecting women with multiple and complex needs from gendered violence: impediments to obtaining and maintaining safe and secure accommodation in a European context

2020 ◽  
Vol 4 (2) ◽  
pp. 157-171
Author(s):  
Morag MacDonald ◽  
David Kane ◽  
James Williams
Keyword(s):  
European Union ◽  
Phenomenological Approach ◽  
The European Union ◽  
Gendered Violence ◽  
Complex Needs ◽  
European Context ◽  
Key Stakeholders ◽  
Funded Project ◽  
Forms Of Violence ◽  
To Receive

The aim of this article is to identify the key impediments to accessing and sustaining safe and secure accommodation by women with multiple and complex needs within a European context. Women with multiple and complex needs are particularly vulnerable to various forms of violence against them and homelessness is often one of their particular needs. The European context is important because ending violence against women is a key priority of the European Union, yet this particularly vulnerable group has largely been overlooked in key strategy. This research was part of a European Union-funded project and a pragmatic, phenomenological approach was taken to the research, employing interviews with key stakeholders (women and professionals who work with them) from five European countries. Using Maslow’s hierarchy of needs as a framework of analysis, the key findings were that accommodation is a key requirement for women with multiple needs to receive the treatment they need. However, simply providing safe and secure accommodation is not enough; rather, a coordinated, wraparound service is required to ensure that women successfully address their multiple needs and are empowered to sustain their tenancies and, ultimately, become self-actualised.

scholarly journals National Food Safety Systems in the European Union: A Comparative Survey

2013 ◽  
Vol 2 (1) ◽  
Author(s):  
Andreas Hadjigeorgiou ◽  
Elpidoforos S. Soteriades ◽  
Anastasios Philalithis ◽  
Anna Psaroulaki ◽  
Yiannis Tselentis ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Comparative Survey ◽  
Safety Systems ◽  
Central Level ◽  
The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

scholarly journals DERMAL ABSORPTION OF DIQUAT AND POTENTIAL OCCUPATIONAL RISK

2020 ◽  
Vol 73 (7) ◽  
pp. 1459-1464
Author(s):  
Tatyana O. Yastrub ◽  
Sergii T. Omelchuk ◽  
Andrii M. Yastrub
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Plant Protection ◽  
Plant Protection Products ◽  
Dermal Absorption ◽  
The European Union ◽  
Association Agreement ◽  
Food And Agriculture ◽  
Food And Agriculture Organization ◽  
High Level

The aim: The toxicological-hygienic assessment of dermal absorption of diquat in terms of potential risk of its bioavailability in professional use. Materials and methods: The object of the study was cutaneous exposure of diquat, determined in toxicological experiments of different duration (data of scientific literature) and at the stage of state testing of pesticide preparations based on diquat dibromide (data of a full-scale hygiene experiment, prognostic model of risk assessment), the technical concentrate of diquat dibromide (active substance content not less than 377 g / kg) contains relevant supplements, the content of which is regulated by the Food and Agriculture Organization. Results and conclusions: Due to the high risk of the diquat adverse effects affecting the personnel, general public and environment, the European Union has introduced administrative decisions to forbid plant protection products containing the diquat. Fulfillment of the conditions of the Association Agreement between Ukraine and the European Union indicates the need to develop common regulations and risk assessment methods aimed at ensuring high level of protection of human health and the environment.

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