Scientific Opinion on Brominated Flame Retardants (BFRs) in Food: Brominated Phenols and their Derivatives

Abstract

EFSA was asked by the European Commission to deliver a scientific opinion on brominated phenols and their derivatives, other than tetrabromobisphenol A (TBBPA) or its derivatives, in food. Brominated phenols and their derivatives comprise a complex group of brominated flame retardants, used as reactive as well as additive flame retardants in a large range of resins and polyester polymers. A call for data was issued by EFSA in December 2009. No data on brominated phenols or their derivatives were submitted to EFSA. A limited number of occurrence data, covering the food group "Fish and other seafood", was identified in the literature. Data from European sampling showed that 2,4,6-tribromophenol (2,4,6-TBP) predominates over the other brominated phenols. Toxicity studies are scarce and mostly relates to 2,4,6-TBP. The main targets are liver and kidneys. In a limited repeated dose oral toxicity study a no-observed-adverse-effect level (NOAEL) for 2,4,6-TBP of 100 mg/kg b.w. per day was identified. 2,4,6-TBP was not genotoxic in bacterial tests in vitro, and not in vivo, but induced chromosomal aberrations in mammalian cells in vitro. No long-term toxicity or carcinogenicity studies with 2,4,6-TBP were identified. The CONTAM Panel concluded that due to the limitations and uncertainties in the current database, the establishment of a health based guidance value for 2,4,6-TBP was not appropriate. Therefore, the Panel derived a margin of exposure to assess the level of possible health concern for high consumers of fish, molluscs and crustaceans. The CONTAM Panel concluded that it is unlikely that current dietary exposure to 2,4,6-TBP in the European Union would raise a health concern. Also exposure of infants to 2,4,6-TBP via breast feeding is unlikely to raise a health concern. Due to lack of data a risk assessment of the other brominated phenols or their derivatives is not possible. for the support provided to this scientific opinion.The limited toxicokinetics data suggest that, following oral administration to rats, 2,4,6-TBP is rapidly absorbed, distributed in different tissues such as kidney, lung and liver and eliminated, mainly via urine, within 48 hours. No information was found on metabolic pathways of 2,4,6-TBP. No data on the other brominated phenols considered in this opinion were identified.Data on the toxicity of brominated phenols are generally lacking and most of the sparse information available relates to 2,4,6-TBP. In a few short-term oral toxicity studies in rats, liver and kidneys were the main targets. In a repeated dose oral toxicity study, which was combined with a reproduction/developmental toxicity screening test, a no-observed-adverse-effect level (NOAEL) for 2,4,6-TBP of 100 mg/kg b.w. per day was identified. In the reproduction/developmental phase of this study, reduced neonatal viability and reduced neonatal body weights were observed at a dose of 1 000 mg/kg b.w. per day. The NOAEL for developmental toxicity was 300 mg/kg b.w.2,4,6-TBP did not induce gene mutations in bacterial cells, but in...

Genotoxic Mechanism of Action of TBBPA, TBBPS and Selected Bromophenols in Human Peripheral Blood Mononuclear Cells

“…In vitro , in Chinese hamster lung cells (CHL/IU) 2,4,6-TPB in very high concentrations up to 1.6 mg/mL, induced chromosomal aberrations with and without metabolic activation ( 27 , 54 ). Similarly, 2,4,6-TBP in high concentrations from 400 to 500 μg/mL was able to induce chromosomal aberrations in human peripheral blood lymphocytes both in the absence and the presence of metabolic activation (S9-mix) ( 20 ). More recently, in vivo , Lebaron et al.…”

“…There are limited and inconsistent results concerning genotoxic potential of bromophenolic FRs ( 20 , 23 , 25 , 27 ). Moreover, according to our best knowledge, no study has been conducted to describe genotoxic mechanism of action of these substances in any cell type or organism.…”

Anthropogenic and Naturally Produced Brominated Phenols in Pet Blood and Pet Food in Japan

“…are approximately one-eighth that of U.S. pet dogs (860 pg/g wet wt. ). , 2,4-DBPh, 2,4,6-TBPh, and PBPh have been identified as flame retardants; therefore, these compounds are commonly found in the indoor environment where humans and pet animals spend long hours. In fact, indoor air collected from Japanese modern houses contained larger amounts of 2,4,6-TBPh than higher-brominated PBDEs (penta-BDEs to deca-BDE) and hexabromocyclododecanes (HBCDs) .…”

Gas Purge Microextraction Coupled with Stable Isotope Labeling–Liquid Chromatography/Mass Spectrometry for the Analysis of Bromophenols in Aquatic Products

“…European Food Safety Authority (EFSA) identified a no-observed-adverse-effect level (NOAEL) of 100 mg/kg bw per day for 2,4,6-tribromophenol (2,4,6-TBP) . Because of the lack of BPs level and toxicity data, at present there is no regulation on BPs concentrations in aquatic product . However, BPs were still under supervision in many countries.…”

“…For example, BPs in aquatic products were monitored in the form of volatile phenols in China . The information on BPs levels in seafood is useful for the comprehensive safety evaluation of BPs and is demanded by food authorities such as EFSA . In this study, 5 BPs which were detected in high frequency were chosen as analytes.…”