On February 4, 2021, the Food Packaging Forum (FPF) participated in the public consultation on the European Food Safety Authority’s (EFSA) “Scientific Committee’s Scientific Opinion draft on the biological plausibility of non-monotonic dose response (NMDR) for the risk assessment” (FPF reported). FPF also sent an open letter to Dr. Bernhard Url, Executive Director, EFSA, and Prof. Simon More, Chair of EFSA’s Scientific Committee, highlighting several severe shortcomings in the draft Scientific Opinion:
- Biological Plausibility: “The term “biological relevance” in the title of this Scientific Opinion implies that for any NMDR observed in a scientific experiment the underlying mode of action, or even mechanism of action, must be known to validate an observation that is statistically significant.” Such a requirement is unnecessary and “it is a logical fallacy to make the assessment of biological observations dependent on already available biological knowledge, when further scientific experiments are still needed to advance said knowledge.”
- Bias: Throughout the Scientific Opinion there is commentary that is unscientific and indicates a bias of the authors (who are not named). The work of authors with known conflicts of interest is cited repeatedly, further indicating that the Scientific Opinion is not scientifically excellent.
- Funding: “The issue of NMDR is critically important because it may require that the basic assumptions of chemical risk assessments are revised. The EFSA Scientific Opinion inadequately addresses this important topic, allegedly due to insufficient funding.”
Non-monotonic dose responses are common in biology. A presentation given by Prof. Ana Soto at the 2019 FPF workshop entitled “Non-monotonic dose-responses: Useful to organisms, challenging for regulators” explains how NMDR are common and what is known about underlying mechanisms for some observations of NMDR after chemical exposures.
Overall, in FPF’s opinion, the EFSA Scientific Opinion is not useful in its present state. FPF recommends a complete overhaul and inclusion of experts with the relevant knowledge in the process. This opinion is shared by the Endocrine Society, the largest scientific society in the world, in their comments on the Scientific Opinion that they shared in an open letter to the members of EFSA’s Scientific Committee.
Endocrine Society (February 2, 2021). “ES Comments on EFSA Draft NMDR Opinion.”