The regulatory environment for endocrine disruptor (ED) testing varies around the world and is evolving. The EU has a well-established approach for ED testing which many other countries look to for guidance. The U.S. has completed a full round of testing under their Endocrine Disruptor Screening Program (EDSP) and U.S. strategy has now evolved to use a more flexible, substance-specific approach that promotes rapid screening methods as a 'first pass' assessment. Even in the absence of specific ED regulation, all regulators are sensitive to ED potential and are watchful for any such signals in safety data. For substance registrants however, this leaves a lot of ambiguity in terms of both scientific testing and regulatory requirements.
Labcorp has been at the forefront of ED testing and continues to innovate today through technical developments and regulatory advances. Partner with us and we can help you navigate the ED scientific and regulatory ambiguity round the globe.
Identifying the best testing approach for regulators can be complex
The OECD’s conceptual framework for ED testing is well established under guidance document 150(2018). It is the basis for ED assessment in the EU, which includes additional evidence requirements on key events and postulated modes of action. There are five levels:
- level 1: basic physiochemical properties of the substance
- level 2: in vitro mechanistic information
- level 3: in vivo mechanistic evidence
- levels 4 and 5: in vivo reproductive and developmental toxicity
Understanding how best to navigate through the levels and select applicable tests can be challenging as it is driven by both science and regulation.