REACH and CLP. Its Role in Regulatory Toxicology

Abstract

This chapter intends to illustrate the general framework of the European Chemical Regulation “REACH” (Registration, Evaluation, Authorization, and Restriction of Chemicals). Special focus will be on the aspects which are important for a regulatory toxicologist. Objectives, scope, and basic rules are explained. The most famous REACH principle is “no data – no market.” So-called “Klimisch reliability criteria” are decisive to determine whether data are suitable for a hazard assessment under REACH. Non-animal-testing approaches such as in vitro methods or weight-of-evidence approaches are encouraged by the regulation. Registration entails broad-scale derivation of no effect levels for Man and the environment. Exposure scenarios serve as standardized communication tools along the supply chain to convey information on chemical safety under intended use.

Since its implementation more than 10 years ago REACH continued to adjust dynamically to new developments in regulatory toxicology. Several new alternative methods became part of the registration package. They aim at reducing, refining, and replacing animal tests. However, a reverse trend can be observed as well: a reduced acceptance of weight-of-evidence assessments by evaluating authorities. This could lead to even more animal tests in the future for hazard identification.

The 2006 European REACH regulation set a precedence for the world. It established a standard which is increasingly taken as a role model for the chemical regulation in other countries and economic areas.