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The assessment of environmental exposure and risks associated with the production or use of a substance on an industrial site includes the estimation of the releases to the environment. In the absence of measured release data on the specific substance, a risk assessor would rely on default release factors to the environmental compartments as developed in international, national, or regional context. Because a wide variety of substances, processes, and uses has to be covered, default release factors are as a rule conservative, usually leading to significant overprediction of releases and hence to overpredicted environmental exposure concentrations and risks. In practice, unrealistic and worst-case predictions do not support a more efficient management of releases and risk. The objective of this article is to propose a more realistic approach to characterize the environmental releases from manufacture, processing, and downstream uses of the metals and their compounds. Although developed in the European Union (EU), this approach can also be used in other regions and in other chemical management systems addressing metals. A database consisting of more than 1300 recent (1993-2010), site-specific measured release factors to air and water of 18 different metals from various EU Member States was compiled and used to calculate average and reasonable worst-case release factors for multiple metal manufacture and industrial use processes. The parameters influencing releases to water were found to depend predominantly on life cycle step (manufacture and/or use), the sector and/or the solid-water partition coefficient (K(d)). The release factors can be used as advanced tier instrument in environmental safety assessments, increasing the realism of the estimates while still keeping a sufficient level of conservatism., (© 2014 SETAC.)

This review considers the development of the regulatory process for metals in the European Union (Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals, REACH). The manner in which the REACH process was developed, its history, and the relative involvement of government and industry are examined. The problems involved in setting up the system and the steps in optimisation are considered. One of the major difficulties in the development of the REACH mechanism was incorporating the fact that many metals are essential elements, which is not a factor that most toxicological examinations consider. How the REACH process evolved to deal with these problems and how the mechanisms were put in place to overcome them is examined. Looking specifically at examples of industry working with academia, one needs to consider how a risk assessment can be developed and submitted in a timely and successful fashion.