TY - JOUR
T1 - Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food
AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)
AU - Schrenk, Dieter
AU - Bignami, Margherita
AU - Bodin, Laurent
AU - Chipman, James Kevin
AU - del Mazo, Jesus
AU - Grasl-Kraupp, Bettina
AU - Hogstrand, Christer
AU - Hoogenboom, Laurentius (Ron)
AU - Leblanc, Jean Charles
AU - Nebbia, Carlo Stefano
AU - Nielsen, Elsa
AU - Ntzani, Evangelia E.
AU - Petersen, Annette
AU - Sand, Salomon
AU - Schwerdtle, Tanja
AU - Wallace, Heather
AU - Benford, Diane
AU - Fürst, Peter
AU - Rose, Martin
AU - Ioannidou, Sofia
AU - Nikolic, Marina
AU - Ramos Bordajandi, Luisa
AU - Vleminckx, Christiane
N1 - Panel members: Margherita Bignami, Laurent Bodin, James Kevin Chipman, Jesus del Mazo, BettinaGrasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Jean-Charles Leblanc, Carlo StefanoNebbia, Elsa Nielsen, Evangelia Ntzani, Annette Petersen, Salomon Sand, Dieter Schrenk, TanjaSchwerdtle, Christiane Vleminckx and Heather Wallace
Requestor: European Commission
Question number: EFSA‐Q‐2018‐00433
Acknowledgements: The Panel wishes to thank the hearing experts: Cathy Fernandes and Henri Schroeder, and EFSA staff members: Kelly Niermans and Federico Cruciani, for the support provided to this scientific output. The Panel wishes to acknowledge all European competent institutions and Member State bodies that provided consumption and occurrence data for this scientific output.
Data: All annexes on occurrence and exposure data, as well as the protocol used to produce this Scientific opinion, cross‐referenced in the text, are available on the EFSA Knowledge Junction at: https://doi.org/10.5281/zenodo.4475651
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
KW - hexabromocyclododecanes
KW - HBCDDs
KW - occurrence
KW - food
KW - toxicology
KW - human exposure
KW - risk assessment
UR - http://www.scopus.com/inward/record.url?scp=85103652164&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2021.6421
DO - 10.2903/j.efsa.2021.6421
M3 - Article
C2 - 33732387
VL - 19
JO - EFSA Journal
JF - EFSA Journal
SN - 1831-4732
IS - 3
M1 - e06421
ER -