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

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Article
Panel on Contaminants in the Food Chain
EFSA Journal
EFSA Journal 2011;9(12):2477 [67 pp.].
doi
10.2903/j.efsa.2011.2477
Panel members at the time of adoption
Jan Alexander, Diane Benford, Alan Boobis, Sandra Ceccatelli, Bruce Cottrill, Jean-Pierre Cravedi, Alessandro Di Domenico, Daniel Doerge, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Metka Filipič, Johanna Fink-Gremmels, Peter Fürst, Thierry Guerin, Helle Katrine Knutsen, Miroslav Machala, Antonio Mutti, Martin Rose, Josef Schlatter and Rolaf van Leeuwen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Brominated Flame Retardants in Food: Åke Bergman, Alan Boobis, Sandra Ceccatelli, Jean-Pierre Cravedi, Metka Filipič, Peter Fürst, Niklas Johansson, Helle Knutsen, Miroslav Machala, Franco Merletti, Olaf Päpke, Dieter Schrenk, Rolaf Van Leeuwen, Stefan Van Leeuwen and Marco Zeilmaker for the preparatory work on this scientific opinion and EFSA staff: Alessandro Carletti, Gina Cioacata, Luisa Ramos Bordajandi and Elena Scaravelli for the support provided to this scientific opinion. The CONTAM Panel acknowledges all European competent authorities and other stakeholders that provided TBBPA occurrence data for food and supported the consumption data collection for the Comprehensive European Food Consumption Database.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2010-00219
Adopted
29 November 2011
Published in the EFSA Journal
19 December 2011
Corrected
6 December 2013. This version replaces the previous one/s.
Erratum/Corrigendum

Corrections were made to the abstract, summary, main body of the text and conclusions to include the data submitted by Ireland and the UK through the EFSA BFR call for data. The inclusion of these data does not change the approach taken by the CONTAM Panel, or the conclusions or recommendations.

Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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.

Keywords
Tetrabromobisphenol A, TBBPA, TBBPA derivatives, occurrence, food, toxicology, human exposure, risk assessment
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Number of Pages
67