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Bisphenol A : Part 1. Facts and figures on human and environmental health issues and regulatory perspectives


Various organisations have raised concerns about the possible adverse effects of BPA on human health. Scientific studies have associated BPA with adverse immune effects, obesity, ADHD, diabetes and prostate cancer, which may be related to its possible interaction with the estrogen receptor. To date, scientific studies have not found conclusive evidence of possible adverse effects caused by BPA and a causal relationship between BPA exposure and endocrine-mediated effects is still uncertain. Debates are ongoing about possible adverse effects of BPA at low doses that may lead to endocrine disruption, and about the presence (or absence) of a possible non-monotonic dose response (NMDR) relationship. Although this issue raises a lot of concern, there is still no conclusive evidence available that proves a low-dose effect. BPA has been shown to have endocrine disrupting effects on environmental organisms like fish and snails, leading to problems with reproduction and development of offspring. Over the years, BPA has been the topic of many different regulatory and scientific initiatives. It is still the topic of study in a vast number of ongoing initiatives. Consequently, the state of knowledge on BPA is a fast-developing field, especially regarding its possible endocrine-mediated effects. This report summarises the hazard and risk assessments on BPA and regulatory aspects available through 20 March 2014. The present data indicate a possible risk for a number of environmental compartments and for some occupational settings (EC, 2008). Knowledge about adverse effects, low-dose effects, NMDR and possible endocrine-mediated effects on human health is developing quickly. As of 20 March 2014, the available data do not indicate a risk for most groups of consumers and patients (EFSA draft, 2014; SCENIHR draft, 2014). However, some studies have expressed concern about the possible exposure of infants and young children in light of the present uncertainties and the higher sensitivity of people in these age groups (SCENIHR draft, 2014; GR, 2011). In March 2014, ECHA's Risk Assessment Committee (RAC) adopted the opinion to strengthen the current classification of BPA to a harmonised classification as a category 1B reproductive toxicant (Repro Cat. 1B). This opinion has to be officially established via a REACH Comitology decision before it can be included in Annex VI of the CLP Regulation (1272/2008/EC). This decision making process will take place within the next one to two years. It should be noted that this Part 1 report only gives an overview of the state of knowledge about BPA. It does not include an appraisal of the available information by the RIVM. That will follow in Part 2, which is expected to be published in 2015. Part 2 will evaluate the available scientific knowledge, discuss the possible health risks of BPA, include further support for policy considerations and, if relevant, propose further risk management measures.

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