EFSA Cites Significant Data Gaps in Risk Assessment for Emerging Brominated Flame Retardants in Food
The European Food Safety Authority (EFSA) has published an updated scientific opinion on emerging and novel brominated flame retardants (BFRs) in food, concluding that dietary exposure to three compounds does not raise a health concern while emphasizing that insufficient data prevented full risk assessments for most of the 27 chemicals evaluated.
The opinion updates EFSA's 2012 assessment at the request of the European Commission and incorporates newly available occurrence, toxicological, and biomonitoring data for emerging and novel BFRs. The assessment is the fifth in a series of updated EFSA opinions on different classes of brominated flame retardants.
BFRs are synthetic chemicals used in plastics, textiles, electronics, and other products to reduce flammability. Although the use of several BFRs has been restricted or banned in the EU, the chemicals persist in the environment and can enter the food chain through contaminated air, soil, and water. They are most commonly detected in foods of animal origin, including fish, meat, milk, and dairy products.
Based on available evidence, EFSA's Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that dietary exposures to bis(2-ethylhexyl) tetrabromophthalate (BEH-TEBP), 2-ethylhexyl 2,3,4,5-tetrabromobenzoate (EH-TBB), and decabromodiphenyl ethane (DBDPE) do not raise health concerns. However, the panel noted that these conclusions relied on limited dietary exposure data from one or two European countries.
For most of the remaining BFRs, EFSA determined that available data were insufficient to complete risk characterization. No health-based guidance values could be established for any of the 27 substances assessed due to limited toxicological information.
The Panel also identified several compounds with significant toxicological concerns. It concluded that tris(2,3-dibromopropyl) phosphate (TDBPP), dibromoneopentyl glycol (DBNPG), and tribromoneopentyl alcohol (TBNPA) should be considered genotoxic and carcinogenic, while 4-(1,2-dibromoethyl)-1,2-dibromocyclohexane (DBE-DBCH) was considered genotoxic based on positive in vitro mutagenicity data. In contrast, EFSA concluded that EBTEBPI, DBDPE, pentabromobenzyl acrylate (PBB-Acr), and TTBP-TAZ are not genotoxic.
Evidence of reproductive, developmental, or neurodevelopmental toxicity was identified for several compounds, including DBNPG, BEH-TEBP, EH-TBB, DBDPE, and TDBP-TAZTO.
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Although occurrence data in food were submitted for eight BFRs, EFSA determined that only hexabromobenzene (HBB) and BTBPE had sufficient occurrence data to estimate dietary exposure. However, because toxicological data were inadequate to establish reference points for those substances, risk characterization could not be performed.
EFSA identified several research priorities to address remaining uncertainties, including additional occurrence data in food, human biomonitoring data, genotoxicity testing, and toxicological studies capable of establishing reference points for risk assessment. The authority also recommended improving access to original regulatory study data to support more consistent chemical risk assessments under the EU’s One Substance, One Assessment initiative.
The CONTAM Panel reported a certainty level of 90 percent or greater for most of its conclusions but emphasized that substantial evidence gaps remain for many emerging and novel brominated flame retardants.
