According to a report published by the Danish Centre on Endocrine Disruptors intended as an input for the REACH review on EDCs, REACH is not able to identify EDCs under its current methodology and requires revisions to achieve effective regulation of EDCs.
The report discusses that EDCs are unlikely to have thresholds as they act on top of already present and active endogenous hormones. Secondly, the authors state that the effect of EDCs seem to decrease with decreasing dose, but never become zero. EDCs are of particular concern as they may cause irreversible developmental damage. Yet, the authors point out, REACH is not capable of identifying EDCs effectively as only some endpoints relevant for EDCs are included in current testing. It is therefore suggested that the two generation study should be replaced with the extended one generation study (OECD GD 443) and further endpoints added to the other screening and toxicity studies (OECD TG 414/421/422). In order to improve the detection of non-monotonic dose-responses (NMDRs), the number of dose levels in animal studies should be increased. The authors also point at the possibility to use benchmark approaches, rather than a no observed adverse effect level (NOAEL) to estimate exposures with low risk. Such approach can however only be applied if sufficient data to detect NMDRs is available.
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Danish Centre on Endocrine Disrupters (2013). “Input for the REACH-review in 2013 on endocrine disrupters.”
