Such is the nature (and challenge) of toxicology, that different groups of experts will not always agree about the interpretation of a particular data-set, a case in point being the interesting collection of data available on bisphenol A (BPA). A Norwegian Panel has now waded into the BPA debate, challenging the conclusions drawn in the April 2008 EU Risk Assessment Report (RAR). Whilst the RAR selected a no-observed-adverse-effect level (NOAEL) of 50 mg/kg bw/day for its subsequent risk characterization, the Nordic environmental agencies (Norway, Denmark and Sweden) that participated in the RAR discussions strongly disagreed with this, noting [in a footnote in the RAR] that “there is a possible risk for developmental neurotoxicity of BPA at very low exposure levels” (0.1-0.25 mg/kg bw/day). The VKM reiterated this view, but did not feel that the four key studies provided sufficient evidence for setting “a robust lower NOAEL for BPA than the current EFSA [European Food Safety Authority] NOAEL of 5 mg/kg bw/day”. (This NOAEL is based on liver effects at higher dose levels.) To resolve the issue, the VKM recommended that a GLP-compliant study be carried out in accordance with OECD Test Guideline 426 (the developmental neurotoxicity study), using “a broad range of concentrations from the very low doses up to those with known maternal effects.”

[Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food Safety. Assessment of four studies on developmental neurotoxicity of bisphenol A. 08/404-6 final. 18 June 2008 (available at {178452}

The above item was taken from the October 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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