Scientifically unfounded precaution drives European Commission's recommendations on EDC regulation, while defying common sense, well-established science and risk assessment principlest

摘要

We, the undersigned editors of prominent journals of pharmacology and toxicology, are drawing your attention to the imminent decisions by the European Commission to enforce a regulatory framework for so-called endocrine disrupting chemicals (EDCs). The currently drafted framework is based on virtually complete ignorance of all well-established and taught principles of pharmacology and toxicology, of opinions raised by the European Commission's own competent expert authority,1 and of critical statements made by member countries, while avoiding asking for support from the European Commission's own scientific expert committees.As a statement, and as emphasized by others before, "endocrine disruption" is not a toxicologically defined endpoint but a mode-of-action that may or may not result in adverse effects. In itself, the mode-of-action concept implies the necessary existenceof a threshold as experimentally proven for numerous other non-genotoxic agents including EDCs. Moreover, endocrine systems play a fundamental role in the physiological response to changes in the environment with the aim of keeping an organism's biologywithin the homeostatic space. It is the task of toxicologists to make the distinction between those effects that are within this adaptive range and effects that go beyond the boundaries of this space and thus can be called adverse.Such adverse effects can be observed in adequately designed and performed toxicity studies.