Proposal of how to update the standard information requirements in REACH, PPPR and BPR – a testing strategy for identification of endocrine disruptors

This presentation is based on a project prepared by the Danish Centre on Endocrine Disrupters (CEHOS) for the Danish EPA. The project aim to provide a science based input to the on-going work in EU with regard to endocrine disruptors, i.e. the development of criteria for identification, REACH review on EDs and the revised strategy for the future work on endocrine disruptors, focusing on adequate detection of substances with endocrine disrupting properties under various legislative frameworks, including REACH (EC No 1907/2006), the Plant Protection Products Regulation (PPPR) (EC No 1107/2009) and the Biocidal Products Regulation (BPR) (EC No 528/2012). There are currently no specific information requirements or testing strategies with regard to endocrine disruption in REACH and other relevant legislations. However, in relation to biocides and recently also to plant protection products, indications of endocrine disrupting properties of a substance trigger additional information/testing requirements. With regard to plant protection products a new regulation from 1 March 2013 (EU 283/2013 (active substances) + EU 284/2013 (products)) sets out the general data requirements from 1 January 2014. According to these, new test methods that include endocrine sensitive endpoints have been included with regard to human health and the environment. Similar data requirements and new test methods that include endocrine sensitive endpoints are included in the guidance on Regulation (EU) No 528/2012 on how to fulfil data requirements for biocides. To a limited extent in vivo test methods that include endocrine sensitive endpoints have also been included in the standard information requirements for substances regulated under REACH. The existing information/data requirements in REACH, PPPR and BPR are not sufficient to adequately detect substances with endocrine disrupting properties. Proposals for changes in the existing REACH, PPPR and BPR information/data requirements are therefore provided. The proposals include enhancement of standard test methods as well inclusion of new methods and recommendations are given for a testing strategy. For all substances (prioritized by tonnage and exposure scenario), QSAR studies and testing using in vitro assays for interaction with different ED modalities e.g. ER, AR and steroidogenesis interference, should be conducted to elucidate whether there are alert(s) for further testing for ED effects