Table 2.

(Risk) Assessments on HBCDDs since the publication of the EFSA CONTAM Panel (2011a) Opinion, including details about the latter for comparison

Reference	Country	Compounds	NOAEL/LOAEL/BMD	HBGV/MOE	Dietary exposure (ng/kg bw per day)	Conclusion
EFSA CONTAM Panel (2011a)	Europe	Sum of α‐, β‐ and γ‐HBCDD	BMDL10 = 0.93 mg/kg bw (based on neurodevelopmental effects, single dose at PND10, Eriksson et al., 2006) Associated chronic intake = 0.003 mg/kg bw per day (related to the body burden at the BMDL10)	MOE An MOE larger than 8 was considered to imply no health concern, based on UFs of 2.5 for interspecies differences on toxicodynamics and 3.2 for intraspecies differences for toxicokinetics	Mean exposurea: Children: 0.15–1.85 Adults: 0.09–0.99 Very Elderly: 0.06–0.54 P95 exposurea: Children: 0.80–4.46 Adults:0.39–2.07 Very Elderly: 0.27–1.26 Specific population groups: High consumers of fish: 2.76b Consumers of fish liver (once a week): 1.94b	‘The CONTAM Panel concluded that current dietary exposure to HBCDDs in the European Union does not raise a health concern’
Rivière et al. (2014)	France	Sum of α‐, β‐ and γ‐HBCDD	Did not review new literature on toxicity. Used EFSA CONTAM Panel (2011a) chronic dietary intake associated with the body burden at the BMDL10 (see above)	MOE	Total Diet Study Adults: 0.211 Children: 0.320	‘The exposure levels are deemed to be of no public health concern (i.e. MOEs higher than 1000 for children and adults for the 95th percentiles)’
Petersen et al. (2013)	Denmark	Sum of α‐, β‐ and γ‐HBCDD	Did not review new literature on toxicity. Used EFSA CONTAM Panel (2011a) chronic dietary intake associated with the body burden at the BMDL10 (see above)	MOE	Fish Adults mean exposure = 0.19 95th percentile = 0.75 Children (4–14 years old): Mean exposure = 0.23 95th percentile = 1.28	‘The estimated MOEs are of no food safety concern’
COT (2015)	UK	Sum of α‐, β‐ and γ‐HBCDD	Reviewed new toxicity data since EFSA CONTAM Panel (2011a): ‘Overall, the new data did not demonstrate a mode of action for HBCDDs or provide an improved basis for extrapolation of experimental animal data to the human situation. Thus, they did not offer an alternative approach to the reference point identified by EFSA from the study by Eriksson et al. ( 2006 ), which remained the best available starting point for risk assessment’ Reference Point = 3 μg/kg bw per day BMDL10 body burden = 0.79 mg/kg bw (based on neurodevelopmental effects, Eriksson et al., 2006)	MOE	Breast milk, food for infants Breastfed infants (median): Average consumers (800 mL/day) 0–4 months: 0.018 > 4–6 months: 0.014 High consumers: 0–4 months: 0.027 > 4–6 months: 0.021 Infants: 4–6 months: 1.39 6–9 months: 1.62 9–12 months: 1.74	‘Overall the analysis indicated that estimated exposures via breast milk and food are not a cause for concern, but that high levels found in some samples of domestic dust are’
ANSES (2017)	France	Sum of α‐, β‐ and γ‐HBCDD	Reviewed new toxicity data since EFSA CONTAM Panel (2011a). Used EFSA CONTAM Panel (2011a) chronic dietary intake associated with the body burden at the BMDL10 (see above).	MOE	Mean UB: Infants (1–4 months): 8.27 Infants (1–3 years): 0.505 Children (3–17 years): 0.320 Adults: 0.211 P90 UB: Infants (1–4 months): 43.2 Infants (1–3 years): 0.880 P95 UB: Adults: 0.448 Children (3–17 years): 0.734	‘Based on current knowledge and the available data, exposure via food of the children population to the sum of HBCDD is considered tolerable’
Environment Canada/Health Canada (2011)	Canada	HBCDDs	To assess the risk for the adult population: NOAEL = 10 mg/kg bw per day (based on a two‐generation reproductive toxicity study, Ema et al., 2008). To assess the risk for infants and children: LOAEL = 0.9 mg/kg bw per day (based on altered behaviour in mice, Eriksson et al., 2006).	MOE	UB exposure = 0.042 μg/kg bw per day (including food, ambient air and dust) Breastfed infants = 0.089 μg/kg bw per day	‘Comparison with the NOAEL of 10 mg/kg bw per day resulted in a margin of exposure of 240,000. For breastfed infants, the margin was 10,000. These margins were considered by Environment Canada to be protective for breastfed children and adequate to address uncertainties in the exposure and health effects database.’
NICNAS (2012)	Australia	HBCDDs	NOAEL = 10.2 mg/kg bw per day (based on a two‐generation reproductive toxicity study, Ema et al., 2008)	MOE	Food consumption Typical exposure: Toddlers = 24 Children = 6 Adults =5.9 Reasonable worst‐case: Toddlers = 50 Children = 12 Adults =12	‘low risk from exposure through food’
NITE (2019)	Japan	HBCDDs	NOAEL = 10 mg/kg bw per day (based on a two‐generation reproduction toxicity study, Ema et al., 2008)	Hazard assessment valuef for general toxicity (increase absolute and relative liver weight) = 0.050 mg/kg bw per dayc Hazard assessment value for reproductive and developmental toxicity (reduction of the number of primordial follicles in the ovary of F1 females) = 0.10 mg/kg bw per dayd	–e	–

BMDL₁₀: benchmark dose lower confidence limit for a benchmark response of 10%; HBGV: health‐based guidance value; LOAEL: lowest observed adverse effect level; MOE: margin of exposure; TDS: total diet study; NOAEL: no observed adverse effect level; PND: postnatal day.

^aMean exposure across dietary surveys in European countries.

^bMaximum UB across European surveys.

^cWas derived by dividing the NOAEL by an UF of 200 (10 for animal‐to‐human extrapolation, 10 for human variability and 2 in consideration of the use of NOAEL as well as the test period (NITE, 2019).

^dWas derived by dividing the NOAEL by an uncertainty factor of 100 (10 for animal‐to‐human extrapolation and 10 for human variability) (NITE, 2019).

^eNo dietary exposure was estimated.

^fAccording to the authors (NITE, 2019), the hazard assessment values were derived by dividing the NOAEL by an uncertainty factor of 200 (10 for animal‐to‐human extrapolation, 10 for human variability and 2 in consideration of the use of NOAEL as well as the test period).