Science-based decision matrix for the identification of endocrine disruptors for regulatory purposes

Recent EU legislation for chemical substances requires a particular assessment of endocrine disrupting properties that may cause adverse effects in humans. Especially for pesticidal active substances, measures concerning specific scientific criteria for the determination of endocrine disrupting properties should have been presented by the European Commission until December 2013. But presently, no specific science-based approach for the assessment of these substances has been agreed upon. This paper is discussing common scientific principles for the evaluation and grouping of substances with endocrine disrupting properties that may cause adverse effects in humans. A matrix-based approach is proposed to be applied in various fields of scientific evaluation of chemical substances, which is based on a scientific evaluation of all available data that may contribute to ensure a high level of protection of human health. This evaluation is expected to be proportionate, consistent and predictable to support administrative decisions in regulatory toxicology. However, a scientifically based categorisation in a decision matrix as a backbone for specific and legally binding rules should be performed according to the relevant EU regulations for the aforementioned groups of substances. Considering the complexity of the matter, it appears appropriate to base possible categorisation on considerations in a decision matrix, which take into account severity, reversibility, potency and consistency of an adverse effect. Based on this decision matrix it should be possible to allocate substances falling under the WHO/IPCS definition to categorise as endocrine disruptors (EDs) or even dispense such substances from categorisation.