Review Implications of research on endocrine disruption for the environmental risk assessment, regulation and monitoring of chemicals in the European Union Peter Matthiessen a, * , Ian Johnson b a NERC Centre for Ecology and Hydrology, Environmental Chemistry and Pollution Section, Lancaster Environment Centre, Library Avenue, Bailrigg, Lancaster LA1 4AP, UK b WRc-PLC, Frankland Road, Blagrove, Swindon, Wiltshire SN5 8YF, UK Received 2 December 2005; received in revised form 24 May 2006; accepted 27 May 2006 The challenges associated with the environmental risk assessment and regulation of endocrine disrupting chemicals are discussed. Abstract We assess the implications which research on endocrine disrupting chemicals (EDCs) has for the regulation of synthetic substances and for the protection of the environment, particularly under the forthcoming European Union (EU) REACH legislation. EDCs present regulatory prob- lems inter alia because they can act additively at concentrations which are individually harmless, and they may have non-classical dose (con- centration)-response relationships at low exposure levels. Furthermore, current in vivo testing routines were not specifically designed to assess the endocrine disrupting properties of chemicals, whilst in silico and in vitro methods have only limited applicability and availability for this purpose. We need to ensure that the assessment approaches specified in the draft REACH legislation and Technical Guidance are able to evaluate EDCs efficiently. However, it must also be recognised that environmental monitoring procedures in Europe will need to be improved to detect EDCs that have evaded identification, and where appropriate, control, under REACH. Ó 2006 Elsevier Ltd. All rights reserved. Keywords: Endocrine disruption; Risk assessment; Chemicals; Regulation; REACH 1. Introduction This paper is concerned with the issue of endocrine disrupt- ing chemicals (EDCs) and the implications of recent research with these substances for the regulation of chemicals in the European Union (EU). The intention is to provide a summary of current scientific advances in this field, and to give an opin- ion on how this new knowledge may need to inform the way in which the environmental risks of chemicals are predicted and managed. This is particularly important given the proposal published in 2003 for new European legislation on the regulation of industrial chemicals produced in excess of 1 tonne per annum, the Registration, Evaluation and Authorisa- tion of Chemicals (REACH) Regulation (CEC, 2003a; http:// ecb.jrc.it/REACH/). REACH, which is expected to be passed into law before the end of 2006, is designed to create a level playing field for ‘existing’ and ‘new’ substances by simpli- fying EU-level regulation, replacing 40 existing pieces of leg- islation and creating a single system for all chemicals (other than those covered by more targeted legislation such as the Plant Protection Products Directive e PPPD, and the Biocidal Products Directive e BPD). It is envisaged that by closing the knowledge gap for more than 30 000 existing substances, REACH will provide information on both the short-term and some of the longer-term effects of these substances in humans and wildlife. It is also hoped that the demand for higher safety * Corresponding author. Tel.: þ44 1524 595 867; fax: þ44 1524 61 536. E-mail address: pmatt@ceh.ac.uk (P. Matthiessen). 0269-7491/$ - see front matter Ó 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.envpol.2006.05.036 Environmental Pollution 146 (2007) 9e18 www.elsevier.com/locate/envpol