The Scope of the Exposure Assessment within the Chemical Safety Assessment under REACH

The REACH Regulation (EC) No. 1907/2006 established a new legal framework for chemical substances. The idea behind REACH is to regulate the risks resulting from chemical substances which may affect the environment and/or the health of humans if they are exposed to chemicals as consumers, workers or indirectly via the environment. The scheme of REACH to regulate the risks resulting from substances rests on four pillars: registration, evaluation, authorization and restriction. Within those pillars REACH contains a differentiating approach to regulate the risks in an appropriate, adequate end efficient way. In respect of the registration phase there are several examples for this approach: the submission of a registration is only necessary for substances which are manufactured or imported in quantities of one tonne or more per year (Article 6 of the REACH Regulation), there are specific registration requirements for intermediates (Articles 17, 18 of the REACH Regulation), the data requirements rise if specific tonnage thresholds are crossed (Article 12 of the REACH Regulation), and exemptions exist for specific substances, such as non-isolated intermediates (Article 2(1)(c) of the REACH Regulation), waste (Article 2(2) of the REACH Regulation) or substances within PPORD (Article 9 of the REACH Regulation).