DAVID J. ANDREW
TSGE Consulting Ltd.,
Knaresborough, United Kingdom

Abstract

Since the introduction of the REACH Regulation in 2007, a number of new test methods have been validated and adopted by the OECD and new guidance for registrants on meeting the data requirements has been provided by ECHA. As a consequence of these changes, chemical companies registering substances under the 2018 deadline are increasingly able to meet the REACH Annex VII and Annex VIII (eco)toxicological data requirements using non-animal testing methods. The impact of the changes is discussed and potential testing strategies are outlined, following the principle of REACH that animal testing should be performed only ‘as a last resort’.

INTRODUCTION

The REACH Regulation (Regulation (EC) No 1907/2006) concerning the registration, evaluation, authorisation and restriction of chemicals, came into force in 2007 and has had a significant impact on the chemicals industry in Europe. The aims of REACH include making manufacturers and importers responsible for both understanding and managing the risks associated with the use of their chemicals, thereby ensuring a high level of protection for human health and the environment. REACH affects companies manufacturing or importing chemical substances into the EU in quantities of 1 tonne or more per annum (tpa) and covers individual chemical substances, substances included in preparations or in articles (where release of the substance is intended). The first two REACH registration deadlines in 2010 and 2013 applied to substances manufactured or imported in quantities of ≥1000 tpa and 100-1000 tpa, respectively. The next (2018) registration deadline applies to substances manufactured or imported in quantities of 1-100 tpa and is therefore likely to affect a much larger number of chemical companies, including a large proportion of SMEs (1) with limited ...