Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food

Abstract

The European Commission asked EFSA to update its 2011 risk assessment on hexabromocyclododecanes (HBCDDs) in food. HBCDDs, predominantly mixtures of the stereoisomers α-, β- and γ-HBCDD, were widely used additive flame retardants. Concern has been raised because of the occurrence of HBCDDs in the environment, food and in humans. Main targets for toxicity are neurodevelopment, the liver, thyroid hormone homeostasis and the reproductive and immune systems. The CONTAM Panel concluded that the neurodevelopmental effects on behaviour in mice can be considered the critical effects. Based on effects on spontaneous behaviour in mice, the Panel identified a lowest observed adverse effect level (LOAEL) of 0.9 mg/kg body weight (bw) as the Reference Point, corresponding to a body burden of 0.75 mg/kg bw. The chronic intake that would lead to the same body burden in humans was calculated to be 2.35 μg/kg bw per day. The derivation of a health-based guidance value (HBGV) was not considered appropriate. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Over 6,000 analytical results for HBCDDs in food were used to estimate the exposure across dietary surveys and age groups of the European population. The most important contributors to the chronic dietary LB exposure to HBCDDs were fish meat, eggs, livestock meat and poultry. The CONTAM Panel concluded that the resulting MOE values support the conclusion that current dietary exposure to HBCDDs across European countries does not raise a health concern. An exception is breastfed infants with high milk consumption, for which the lowest MOE values may raise a health concern.

Keywords: HBCDDs; food; hexabromocyclododecanes; human exposure; occurrence; risk assessment; toxicology.

Figure 1

General structure of the three major HBCDD stereoisomers; α‐HBCDD, β‐HBCDD and γ‐HBCDD (molecular mass = 641.7)

Figure 2

Distribution of occurrence values reported on HBCDDs across different European countries

Figure 3

Distribution of occurrence values reported for HBCDDs by year

Figure 4

Percentage of analytical results below LOD, below LOQ and quantified values in the final data set across the different food categories (FoodEx Level 1)