REACH—how is it going?

Abstract

REACH, the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (European Union (EU), 2006), is the greatest upheaval ever in European regulation of chemicals. Its implementation is now well under way. The European Chemical Agency (ECHA) in Helsinki administered much of the scheme and tried to restrict the number of chemicals in the first pre-registration stage to 10 000, but by the end of 2008, 165 000 substances had been pre-registered by 65 000 companies (ECHA 2008a, 2009). Registration must be complete by 30 November 2010 for chemicals supplied at .1000 tons year , with lower thresholds for chemicals that show certain serious effects. Registration will involve completion of a Chemical Safety Assessment, culminating in risk management measures (RMMs) for each application of each chemical, if it is classified for health or environmental effects (ECHA, undated). Eventually, all classified chemicals supplied at .10 tons year 1 will need such an assessment. The process is dominating the activity of many occupational hygienists in the European chemical industry and is affecting many others. The British and Dutch Occupational Hygiene Societies (BOHS and NVvA) convened a 2-day second European Conference and Workshop on REACH in Brussels at the beginning of October 2009, at which 180 delegates from 15 countries reviewed occupational hygiene aspects of the work in progress, especially exposure scenarios and safe handling advice. The presentations are available on the BOHS and NVvA websites http://www.bohs.org/eventDetails .aspx?event5164 and www.arbeidshygiene.nl. The central feature of REACH is that key responsibilities for specifying controls at the point of use are now placed on manufacturers, if in the EU, or importers of the chemicals. Manufacturers or importers (MoI) must estimate human exposure by all routes for each potential use and specify RMMs which will reduce exposure below an exposure limit. The user is obliged to implement these control measures. In the past, there have been EU supply regulations requiring central risk assessment of chemicals, but this has been very slow. EU legislation has generally made control in the workplace the responsibility of the employer, not the manufacturer, with control subject to risk assessment at the point of exposure. Now MoIs are the key people, although the earlier workplace legislation also remains in force. Most past EU regulation of the workplace has been by directives imposing minimum standards, which each member state is then responsible for implementing through its own legislation. REACH is a direct-acting regulation, not requiring national implementation of its main measures. The regulation covers not only the workplace but also consumers and the environment as well. It comes under enterprise and environment components of the Treaty of Rome, not the social provisions of the Treaty that are the usual basis for EU workplace legislation. To the outside observer, it looks as if concern for the consumer and the environment has overwhelmed lessons from good practice in the workplace. Present occupational health regulations, based on the Chemical Agents and Carcinogens Directives and others, remain in place (EU, 1998, 2004), and REACH will apply alongside them. They will obviously remain important for hazardous substances which are not supplied, such as welding fume, Author to whom correspondence should be addressed. Tel: þ44-1332-298101; fax: þ44-1332-298099; e-mail: editor@ogs.org.uk