01 May 2006

Registration of petroleum substances under REACH

In 1993 the Council adopted Regulation (EEC) 793/93 or the ‘ESR’ (Existing Substances Regulation), thus introducing a comprehensive framework for the evaluation and control of ‘existing’ chemical substances. The ESR foresaw comprehensive risk assessments and, where necessary, risk reduction measures for priority substances.

This Regulation complemented the existing rules governed by Directive 67/548/EEC for ‘new’ chemical substances, which required approval by the competent authorities of EU Member States prior to being put on the market. In the late 1990s legislators and industry alike concluded that chemicals safety legislation needed a fundamental overhaul. The notification of new substances within the European Community had declined, falling significantly below the number of new substances notified in the USA.

The risk assessment programme for existing chemicals under Regulation 793/93, the ‘Existing Substances Regulation’, was disappointingly slow. Since the adoption of the Existing Substances Regulation by the Council in 1993, work had started on 141 of the 2,700 or so high production volume chemicals produced within, or imported into the Community at volumes above 1,000 t/a, and risk assessments were completed for only a fraction of these 141 chemicals.

The comprehensive risk assessment approach had turned out to be too heavy and too slow. Moreover, since the Existing Substances Regulation had not foreseen an involvement of downstream users of chemical substances as such (or as used in preparations), it was notoriously difficult to obtain the use and exposure information needed to assess the risks over the full life cycle. In parallel, the view emerged among authorities that responsibility for demonstrating the safe use of chemical substances.