Technical Report 130

APPENDIX A: BACKGROUND INFORMATION

Introduction

ECETOC is an industry-funded, scientific, not-for-profit think tank that strives to enhance the quality and reliability of science-based chemical risk assessment. To assist in the development of practicable guidance to move regulatory application of criteria to identify endocrine disrupting properties forward in the EU, it is proposing the ECETOC Seven Steps for the Identification of Endocrine Disrupting Properties (ECETOC 7SI-ED).

Appendix A to this report provides relevant background information to substantiate the rationale and justification for the structure and contents of the ECETOC 7SI-ED:

  • Activities of the OECD related to endocrine disruptors;
  • Activities of the European Commission (in the following: the Commission) related to the establishment of legislative provisions on endocrine disruptors;
  • Summary of prior ECETOC work related to the establishment of a science-based framework for the identification and hazard and risk assessment of endocrine disruptors.

Generally, the ECETOC 7SI-ED follows the framework and the provisions outlined by the Commission in 2016. Specifically, provisions have been outlined in the Commission Communication on endocrine disruptors and the draft Commission acts setting out scientific criteria for the determination of endocrine disruptors in the context of the EU legislation on plant protection products [PPP] and biocidal products [BP] (Commission, 2016a) and the ECHA and EFSA Outline of draft guidance document for the implementation of the hazard-based criteria to identify endocrine disruptors (ECHA and EFSA, 2016). The Commission plans to implement scientific criteria concerning the hazard-based identification of endocrine disruptors in the context of Regulation (EU) No 528/2012 concerning the making available on the market and use of BP (EP and Council of the EU, 2012) and Regulation (EC) No 1107/2009 on the placing of PPP on the market (EP and Council of the EU, 2009).

As described in Commission (2016a) and ECHA and EFSA (2016), a conclusion on the identification of endocrine disrupting properties is based upon an evaluation of all available relevant data and information, and it encompasses three pillars, i.e. (1) an assessment of the evidence for endocrine MoA; (2) an assessment of the evidence for adverse effects in an intact organism, or its progeny, or (sub)populations; (3) an assessment of whether identified endocrine MoAs are causally related to the adverse effects.