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Chemicals are used to make virtually every man-made regard to their production, formulation, use and disposal. product and play an important role in the everyday life It will provide a high level of protection of human health of people around the world. The chemical industry is the and the environment and, at the same time, enhance the third largest industrial sector in the world and employs competitiveness of the EU chemicals industry. millions of people. Since 1930, global production of chemicals has risen from 1 million tonnes to over 400 Successful implementation of REACH will be a million tonnes annually. In 2004 the global sales were challenge. It will involve 30,000 chemicals, 30,000 estimated at € 1776 billion. The EU accounts for companies, a newly created European Chemicals approximately 33% of global sales. This gradual increase Agency and many other stakeholders. REACH will also in the production and widespread use of chemicals was be a scientific challenge. It will boost further scientific not without “cost”. While chemicals play an important research into sustainable chemistry. It will also make us role in products for health and well-being, they may also aware of the scarce human resources currently available pose risks to human health and the environment. to meet these challenges.



1. General Introduction

Over the last few decades there has been considerable activity in the field of risk assessment. This has mainly taken place in international bodies such as the Organization for Economic Co-operation and Development (OECD), the World Health Organization (WHO) - especially in the context of its International Programme on Chemical Safety (IPCS) - the European and Mediterranean Plant Protection Organization (EPPO), the Council of Europe and the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) [1-10]. Various directives and regulations in which risk assessment plays a crucial part have been issued by the European Community [11-14] and similar activities are taking place in other parts of the world, e.g., the U.S., Canada and Japan.
C.J. Van Leeuwen

2. Emissions of Chemicals to The Environment

The essence of risk assessment of chemicals (Chapter 1) is the comparison of exposure (the concentration of the substance to which organisms are exposed) with effects (the highest concentration at which no effects are expected on organisms or ecological systems).
P. Van Der Poel, D.N. Brooke, C.J. Van Leeuwen

3. Transport, Accumulation and Transformation Processes

This chapter will deal with the phenomena which determine the concentration of substances in the environment as well as within organisms. Knowing the concentrations of chemicals in different compartments as well as their further fate within these compartments is one of the key issues in a chemicals’ risk assessment procedure. Once the concentrations in the various relevant environmental compartments are known or estimated, they can be compared with information on the hazards of a substance in that compartment. The relevant environmental compartments may be water, sediment, soil, air, or biota.
D.T.H.M. Sijm, M.G.J. Rikken, E. Rorije, T.P. Traas, M.S. Mclachlan, W.J.G.M. Peijnenburg

4. Environmental Exposure Assessment

Organisms, man included, are exposed to chemicals through environmental media. Assessment of exposure concentrations can be done by measurement or by other means of estimation, e.g. model-based computation. For the risk assessment of existing situations, both measurement and modelling can be used; to assess the risks posed by new chemicals or new situations, modelling is the only option. Although it may seem natural to assume that measurement yields more certainty, this is not necessarily so. Chemical analyses are usually carried out on samples, taken at specific locations and times.
D. Van De Meent, J.H.M. De Bruijn

5. Human Exposure Assessement

Humans may be exposed to a variety of substances from multiple exposure routes. In Chapter 5 we will distinguish between exposure through the environment (Section 5.2), exposure from use of consumer products (Section 5.3), and exposure at the workplace (occupational exposure; Section 5.4). In this chapter information is provided on how to perform an exposure assessment for each of these human populations. This information pertains to the general principles, the data needed and how to perform the actual quantitative assessment, based on either measured or modelled data.
J.G.M. Van Engelen, P. J. Hakkinen, C. Money, M.G.J. Rikken, T.G. Vermeire

6. Toxicity Testing for Human Health Risk Assessment

Research into the toxic effects of substances on humans can be traced back to the ancient centres of civilization in Egypt, Greece and China, where toxic chemical substances were used as poisons and sometimes as medicines. “Toxicology is the scientific discipline involving the study of actual or potential danger presented by the harmful effects of substances in living organisms and ecosystems, of the relationship of such harmful effects to exposure and of the mechanism of action, diagnosis, prevention and treatment of intoxications” [1]. Paracelsus’ saying: “Dosis sola facit ” (it is the dose which makes the poison) is well-known and depicts a property inherent to almost every chemical: at a certain dose, effects are inevitable.
T.G. Vermeire, A.J. Baars, J.G.M. Bessems, B.J. Blaauboer, W. Slob, J.J.A. Muller

7. Ecotoxicological Effects

Ecotoxicology is the study of toxic effects of substances on species in ecosystems and involves knowledge of three main disciplines: toxicology, ecology and chemistry (Figure 7.1). Truhaut [2] coined the term ecotoxicology and included effects on humans in his definition, man being part of ecosystems. The current tendency is to include the effects of chemicals on all species in the biosphere in the definition of ecotoxicology [3]. However, in this section, we will not consider effects on man. Environmental risk assessment (ERA) shares many methodological aspects with human health risk assessment (HRA). However, there are a number of fundamental differences between ERA and HRA related to the scope of ERA which covers ecosystems and the biosphere. Fundamental aspects of ERA are discussed in the next section.
T.P. Traas, C.J. Van Leeuwen

8. Data:Needs, Availability, Sources and Evaluation

The recognition that a core set of data is needed for prioritization and risk assessment of chemicals goes back to the 1970’s. Among other things, this resulted in the OECD Council Act on the Minimum Premarketing Set of Data (MPD) for new chemicals [1] and the equivalent Screening Information Data Set (SIDS) for high production volume chemicals (see also Chapter 16). It is equally important to remember that it is not feasible to conduct complete and comprehensive testing on every chemical and therefore tiered approaches are needed to identify those chemicals which require further testing to guarantee safe use (see Chapter 11).
P.G.P.C. Zweers, T.G. Vermeire

9. Predicting Fate-Related Physicochemical Properties

The environmental fate of chemical substances is determined by partitioning between environmental compartments, and by transport and degradation processes. In this context, long range transport potential and persistence are important characteristics of the compound behaviour [1-7]. Besides specialized models to address the compound fate in individual environmental compartments, multimedia fate models have become popular in exposure and fate assessment on global and regional scales. A main application of such models is the screening-level prediction of the fate of environmental chemicals under standardized emission scenarios, and more recently the focus has shifted to more detailed process descriptions including time-dependent concentration levels of compounds and consideration of spatial resolution.
G. Schüürmann, R.-U. Ebert, M. Nendza, J.C. Dearden, A. Paschke, R. Kühne

10. Predicting Toxicological and Ecotoxicological Endpoints

In the last few decades, society has become increasingly concerned about the possible impacts of chemicals to which humans and environmental organisms are exposed. In many industrialised countries, this has led to the implementation of stringent chemicals legislation and to the initiation of ambitious risk assessment and management programmes (see Chapter 1). However, it has become increasingly apparent that the magnitude of the task exceeds the availability of resources (experts, time, money) if traditional test methods are employed. This realization, coupled with increasing attention to animal welfare concerns, has prompted the development and application of various (computer-based) estimation methods in the regulatory assessment of chemicals.
A.P. Worth, T.I. Netzeva, G. Patlewicz

11. Intelligent Testing Strategies

In the context of regulatory programs for the safety evaluation of chemicals, there is a need for a paradigm shift. The challenge is to move in a scientifically credible and transparent manner from a paradigm that requires extensive hazard (animal) testing to one in which a hypothesis- and risk-driven approach can be used to identify the most relevant in vivo information [1]. Socalled Intelligent or Integrated Testing Strategies (ITS) are a significant part of the solution to the challenge of carrying out hazard and risk assessments on large numbers of chemicals. ITS (Figure 11.1) are integrated approaches comprising multiple elements aimed at speeding up the risk assessment process while reducing costs and animal tests [1].
C.J. van Leeuwen, G.Y. Patlewicz, A.P. Worth

12. The Management of Industrial Chemicals in the Eu

Chemicals are used to make virtually every man-made product and play an important role in the everyday life of people around the world. The chemical industry is the third largest industrial sector in the world. It is also a major economic force. Worldwide, it employs some ten million people and generates billions of euros in shareholder value and tax revenue for governments. Eighty percent of the production takes place in 16 countries, primarily in the OECD member countries.
C.J. Van Leeuwen, B.G. Hansen, J.H.M. De Bruijn

13. The Management of Industrial Chemicals in the USA

Within the United States Environmental Protection Agency (EPA), the Office of Pollution Prevention and Toxics (OPPT) is responsible for implementing the Toxic Substances Control Act (TSCA) of 1976 and the Pollution Prevention Act (PPA) of 1990 [1,2]. Before TSCA was passed, it was not known how many chemicals were in commerce in the U.S., where they were being produced and/or imported, and in what quantities they were being produced and/or imported.
C. Auer, J. Alter

14. The Management of Industrial Chemicals in Japan

Like many other countries, Japan has developed a number of systems for the assessment and management of different types of chemicals. While pharmaceuticals, food additives, pesticides, acutely toxic substances and other specific types of chemicals have a longer history of regulation, the general regulation on industrial chemicals started in the 1970’s. It was in the 1970’s that industrialized countries were confronted with severe pollution affecting human health and the environment (see also Chapter 1), and Japan was no exception. As a result of pollution caused by PCBs the first regulations in Japan focused on persistent, bioaccumulative and toxic substances.
E. Toda

15. The Assessment and Management of Industrial Chemicals in Canada

The chemical industry is one of the largest manufacturing sectors in Canada and employs more than 90,000 people; nearly every major global chemical company in the world has production or research and development facilities. In 2003, more than two thousand companies, including 21 of the 25 world’s largest manufacturers, had operations in this country.
M.E. Meek, V.C. Armstrong

16. The Oecd Chemicals Programme

The Organization for Economic Cooperation and Development (OECD) is an intergovernmental organization. Its principal aim is to promote policies for sustainable economic growth and employment, a rising standard of living, and trade liberalisation. By “sustainable economic growth” the OECD means growth that balances economic, social and environmental considerations. At the time of writing, the OECD groups 30 member countries: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, the Slovak Republic, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States.
R. Diderich


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