Technical Report 130

5.CONCLUSION

In response to the publication of the ECHA and EFSA (2016) Outline of draft Guidance Document for the implementation of the hazard-based criteria to identify endocrine disruptors, ECETOC provides guidance on how the strategy described in ECHA and EFSA (2016) can be put into practice. This has resulted in the development of the ECETOC 7SI-ED. The ECETOC 7SI-ED focuses on how to use a step-wise WoE approach to gather and assess available information, to integrate it and determine its sufficiency to identify the presence or absence of endocrine disrupting properties of a substance in accordance with the three components of the WHO/IPCS (2002) definition of an endocrine disruptor and the criteria set out in the ongoing revisions of the EU plant protection products and biocidal products legislations.

The ECETOC 7SI-ED is envisioned to cover human and environmental health, and it applies existing relevant scientific concepts and established best practice frameworks and methodologies. By following the ECETOC 7SI-ED, the data for any regulated substance can be transparently organised and evaluated to reveal the WoE available, its strengths and uncertainties, to compare with the regulatory definition for an endocrine disruptor. This enables a conclusion to be drawn on whether, or not, a substance meets this definition. However, the seven-step tool to identify the endocrine disrupting properties of a substance forms only the first step of the actual hazard and risk assessment of endocrine disrupting substances. The next step for any substance that meets the definition criteria is to undergo a comprehensive hazard and risk assessment. ECETOC Reports are available that provide guidance on how to conduct the hazard and risk assessment of endocrine disrupting substances (ECETOC, 2009a, b, 2011; Bars et al., 2011, 2012; Weltje et al., 2013). Substance hazard and risk assessment entails the determination of safety thresholds, exposure assessment, potency assessment and the determination whether acceptable risk can be demonstrated. By comparison, the seven steps outlined in Section V of ECHA and EFSA (2016) are restricted to the identification of endocrine disrupting properties. Boobis et al. (2016, 2017) provide an in-depth discussion of the limitations of hazard identification-based classification schemes.

The ECETOC 7SI-ED is recommended as a tool to assess whether, or not, a substance meets the regulatory definition of an endocrine disruptor. It is based on robust scientific principles and has been designed to be practical and transparent in its utility with the framework being presented as a series of discrete logical steps, each of which is supported by a clear set of questions and considerations to guide decision-making.