Industry remains convinced that there is no basis to change the current classification of BPA. BPA is not a selective reproductive toxicant as indicated by guideline studies that cover a very wide dose range, from very low up to high doses. Effects on animal fertility only occur at high doses of BPA and are a consequence of systemic toxicity.
Industry provides background briefing on latest EFSA draft assessment on BPA.
SCENIHR preliminary opinion finds margin of safety for polycarbonate and epoxy resin medical devices. Within the constraints of the available data, SCENIHR generally found that exposure to BPA from all medical applications is low, often in the range of the very low consumer exposures through the diet.
Industry stresses that in its new draft opinion, EFSA did not conclude that BPA causes effects on the liver, kidney and the mammary gland at dose levels relevant to human exposure, but identified these areas to require risk assessment. Additionally it set a new temporary TDI (t-TDI) as a result of a highly conservative approach and not of increased uncertainty. Finally, industry points out that exposure to BPA for consumers remains extremely low and is well below the new t-TDI.
Industry provides a number of questions and answers on the latest EFSA draft health assessment of BPA.
EFSA’s draft opinion clearly confirms that BPA is not a concern for human health, including newborns and young children. This is consistent with the findings of other regulatory agencies across the globe.
The recent Lathi et al. study from Stanford University is incapable of establishing any causal link between Bisphenol A (BPA) exposure and miscarriage.
A recent study funded by the US Environmental Protection Agency (EPA) found that levels of free BPA in blood is unmeasurably low – and far below levels required to activate any reaction of the endocrine system. The study clarifies an ongoing controversy among scientists regarding BPA-blood levels and related internal exposure to BPA.
The results of the study recently published in the journal Pediatrics by Eng et al. fail to establish any meaningful connection between BPA and obesity.
The members of the PC/BPA-group support EFSA’s comprehensive and transparent science based evaluation of BPA and encourage all stakeholders interested in a science-based assessment process to participate, as the final opinion will benefit from this public consultation process.