EU Issues Study on REACH Implementation

August 6, 2009
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported in late July that Eurostat, the Statistical Office of the European Communities, recently published a baseline study or the first snapshot of REACH policy in the preregistration phase.

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported in late July that Eurostat, the Statistical Office of the European Communities, recently published a baseline study or the first snapshot of REACH policy in the preregistration phase. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of pharmaceutical intermediates and active pharmaceutical ingredients.

REACH is the European Union (EU) regulation governing the registration, evaluation, authorization, and restriction of chemicals. The regulation was put into place to require registration of approximately 30,000 substances produced or imported within the EU. Substance registration is prioritized according to the phase-in timeline based on the volume and hazardous characteristics of the materials.

The Eurostat study, The REACH Baseline Study: A Tool to Monitor the New EU Policy on Chemicals-REACH, lays out a foundation for future studies using a set of indicators, in order to monitor the success of REACH, according to a SOCMA press release. The three main indicators most closely related to the main objectives of REACH were noted as administrative indicators, a risk and quality indicator system, and supplementary indicators.

The study will monitor changes to risk and the current information base on chemicals, including the quality of such information. The study noted the difficulty in tracking risk reduction and used a subset of chemicals taken out of the approximately 30,000 chemicals regulated under REACH.