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European Union Risk Assessment Report - Human Health Addendum of April 2008 - 4,4'-ISOPROPYLIDENEDIPHENOL (BISPHENOL-A) - Part 2 Human Health

A risk assessment of 4,4'-isopropylidenediphenol (Bisphenol-A, BPA) produced in accordance with Council Regulation (EEC) 793/93 was published in 2003 . This Addendum (2008) has been prepared by the UK in the frame of Council Regulation (EEC) No. 793/93 on the evaluation and control of the risks of existing substances, following the principles for assessment of the risks to man and the environment, laid down in Commission Regulation (EC) No. 1488/94. The evaluation considers the emissions and the resulting exposure to the environment and the human populations in all life cycle steps. Following the exposure assessment, the environmental risk characterisation for each protection goal in the aquatic, terrestrial and atmospheric compartment has been determined. This Addendum of environmental risk assessment for Bisphenol-A, concludes that there is concern to the freshwater and marine aquatic compartments (including sediment, since the equilibrium partitioning approach has been used). Although no risks are indicated using the freshwater and marine PNEC for any scenario, there are still some uncertainties over the potential effects of bisphenol-A on snails, despite the thorough testing undertaken as part of the conclusion (i) programme. The human health risk assessment for Bisphenol-A concludes that there is concern forworkers. This conclusion is reached in relation to repeated dose systemic effects and for reproductive toxicity during the manufacture of BPA and the manufacture of epoxy resins. In addition, there are concerns for skin sensitisation in all occupational exposure scenarios where there is the potential for skin contact with high concentrations (>30%) of BPA. The format of the report is broadly in line with that of the original (2003) risk assessment. Significant new information is summarised in this updated (2008) risk assessment and a comment is added to indicate how this affects the findings from the original risk assessment.