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Statement on EFSA Scientific Committee draft opinion on the biological plausibility of NMDRs and their impact on risk assessment

EFSA Scientific Committee: No indications of non-monotonic dose response (NMDR) detected for BPA

The European Food Safety Authority´s (EFSA) Scientific Committee has published its draft opinion on the biological plausibility of non-monotonic dose responses and their impact on the risk assessment. The Scientific Committee developed an approach to be applied in the risk assessment process when apparent non-monotonicity is observed; BPA is used as a case study. EFSA´s Scientific Committee concluded that there are “no indications of NMDR were detected for BPA”.

Assessment of non-monotonicity claims for BPA

The EFSA Scientific Committee evaluated the reliability of the NMDR claims in the BPA case study based on several publications including those identified by Beausoleil et al. (2016) external report on NMDR, those considered under EFSA targeted literature search and the studies based on data from the CLARITY-BPA Program. One aim was to support the EFSA risk assessment on BPA by EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel).

Overall, the Scientific Committee concluded that “the endpoints identified and consistency of findings across studies do not suggest that NMDR is of relevance for the risk assessment of BPA.

Next Steps

The draft opinion is open for feedback until February 4th, 2021. EFSA will assess all comments which will be further assessed by the relevant EFSA Panel and taken into consideration if found to be relevant.