Reach (and CLP). Its role in regulatory toxicology

Abstract

This chapter intends to illustrate the general framework of REACH and will specifically focus on the aspects which are important for a regulatory toxicologist. The principles of its individual elements Registration, Evaluation, Authorization, and Restriction are explained. The current progress is described and an outlook to the final stage of the transition period is given. In its 1999 “White paper” the European Union published the result of an analysis of the existing chemical legislation identifying a number of problems. The paper challenged the existing allocation of resources applying different approaches for new and existing substances. For new substances, even at low tonnage levels, a burdensome and expensive notification was required. On the other hand, producers were not obliged to submit similar data packages for existing substances. Moreover, the systematic evaluation of existing chemicals had turned out inefficient. After an intensive dialogue with all stakeholders, the REACH regulation was adopted in 2006. REACH stands for Registration Registration, Evaluation Evaluation, Authorization Authorization and Restriction Restriction of Chemicals. Since entering into force REACH is gradually replacing several directives such as the former Dangerous Substances Directive (DSD) (Council Directive 67/548/EEC), the Dangerous Preparations Directive (DPD) (Council Directive 1999/45/EC), the Restriction Directive, (Council Directive 76/769/EEC) and the Regulation on Existing Substances. (Council Regulation No 793/93 EEC) It is impossible to give a comprehensive overview in this chapter of all the aspects of REACH, because the regulation and the accompanying guidance documents cover over 20,000 pages. This chapter intends to illustrate the general framework of REACH and will specifically focus on the aspects which are important for a regulatory toxicologist.