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Metal-Specific Risk Assessment—The European Perspective

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.