On a Sustainable Chemicals Policy: The Significance of Risk Assessment and REACH

2016 ◽  
pp. 127-146
2003 ◽  
Vol 31 (3) ◽  
pp. 353-364 ◽  
Author(s):  
Robert Combes ◽  
Jennifer Dandrea ◽  
Michael Balls

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.


elni Review ◽  
2005 ◽  
pp. 22-37
Author(s):  
Lars Koch ◽  
Nicholas A. Ashford

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.


2003 ◽  
Vol 75 (11-12) ◽  
pp. 2563-2574 ◽  
Author(s):  
A. Gies

Like hardly any other issue in ecotoxicology, endocrine disruption has given rise to public concern. Reproductive, behavioral, and immunological effects in wildlife were publicly not only understood as possible threats to wildlife populations, but also as early warning signals that human health could be at risk. Above all, the public has been concerned about negative outcomes in reproductive health, and effects like feminization in fish were regarded as evidence for the biological plausibility of the hypothesis that environmental levels of hormonally active chemicals are high enough to affect human reproductive health. Public concern has been mirrored by several parliamentary and governmental decisions emphasizing the need for extensive research and rapid measures to reduce the risk associated with endocrine-disrupting substances. Endocrine disruption in wildlife is clearly a priority issue. At least in densely populated areas like Europe, symptoms of endocrine disruption in wildlife cannot only be detected in areas with abnormally high levels of pollution, but have also occurred in main river systems, estuaries, and even in the open sea. Imposex in mollusks and feminization in fish that were clearly related to disturbances in the hormonal system of these organisms by exogenous substances have been used as markers in monitoring programs. Though symptoms of endocrine disruption can be clearly identified, it is much more difficult to link these outcomes to causative chemicals or mixtures of substances. Natural and pharmaceutical hormones, phytoestrogens, pesticides, and industrial chemicals may all play a role to a different degree depending on the site under study. This means that several different risk-reduction strategies have to be applied, including bans of substances, use restrictions, and installation and optimization of sewage treatment works embedded in a strategy for the overall reduction of chemical input into the environment. It should be noted that, in addition to national and international regulatory actions taken by state authorities, a considerable reduction of the environmental input could be achieved in several countries by voluntary actions taken by industry. Regulatory bodies are still facing major problems in the field of risk assessment and risk reduction. Association between effects and causative agents or mixtures are in many cases weak. Important tools for risk assessment such as dose-response relationships or the existence of thresholds are not yet agreed on. These uncertainties are the reason that many national governments and the European Commission have identified precaution as the main element in chemicals policy for the management of endocrine disruptors. This paper is based on documents of the German Federal Environmental Agency, but solely represents the view of the author from a regulatory perspective and emphasizes the wildlife aspects of endocrine disruption.


1998 ◽  
Vol 62 (10) ◽  
pp. 756-761 ◽  
Author(s):  
CW Douglass
Keyword(s):  

2006 ◽  
Vol 175 (4S) ◽  
pp. 531-532
Author(s):  
Matthew R. Cooperberg ◽  
Stephen J. Freedland ◽  
David J. Pasta ◽  
Eric P. Elkin ◽  
Joseph C. Presti ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document