Scientific Opinion on Tetrabromobisphenol A (TBBPA) and its derivatives in food.

EFSA was asked by the European Commission to deliver a scientific opinion on tetrabromobisphenol A (TBBPA) and its derivatives in food. TBBPA and its derivatives are widely used as flame retardants. TBBPA is primarily used as reactive flame retardant covalently bound to epoxy and polycarbonate resins. TBBPA derivatives are used as either reactive or additive intermediates in polymer manufacture. Data from the analysis of TBBPA in 652 food samples were submitted to EFSA by four European countries (Ireland, Norway, Spain and the UK), covering the period from 2003 to 2010. All analytical results were reported as less than the limit of quantification (LOQ) and the majority of the samples were in the food group "Fish and other seafood" (n=465). Toxicological studies with TBBPA have been carried out using different experimental designs with single or repeated administration during gestation, postnatally or in adulthood. The main target is thyroid hormone homeostasis. TBBPA is not genotoxic. There are no indications that TBBPA might be carcinogenic. The Panel on Contaminants in the Food Chain (CONTAM Panel) identified a lower confidence limit for a benchmark response of 10 % (BMDL10) of 16 mg/kg b.w. reported for changes in thyroid hormones as the critical reference point. Due to the limitations and uncertainties in the database, the Panel concluded that it was inappropriate to use this BMDL to establish a health based guidance value, and therefore used a margin of exposure (MOE) approach for the health risk assessment of TBBPA. In view of the large MOEs, the Panel concluded that current dietary exposure to TBBPA in the European Union does not raise a health concern. Also exposure of infants via human milk does not raise a health concern. Additional exposure, particularly of young children, to TBBPA from house dust is unlikely to raise a health concern.