TY - RPRT
T1 - Scientific Opinion on the risks for human health related to the presence of grayanotoxins in certain honey
T2 - EFSA-Q-2020-00509
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, Jesús
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
AU - Petersen, Annette
AU - Sand, Salomon
AU - Schwerdtle, Tanja
AU - Vleminckx, Christiane
AU - Dusemund, Birgit
AU - Hart, Andrew
AU - Mulder, Patrick
AU - Viviani, Barbara
AU - Anastassiadou, Maria
AU - Cascio, Claudia
AU - Riolo, Francesca
AU - Wallace, Heather
N1 - Article number: 7866
PY - 2023
Y1 - 2023
N2 - The European Commission asked EFSA for a scientific opinion on the risks
for human health of the presence of grayanotoxins (GTXs) in ‘certain
honey’ from Ericaceae plants. The risk assessment included all
structurally related grayananes occurring with GTXs in ‘certain’ honey.
Oral exposure is associated with acute intoxication in humans. Acute
symptoms affect the muscles, nervous and cardiovascular systems. These
may lead to complete atrioventricular block, convulsions, mental
confusion, agitation, syncope and respiratory depression. For acute
effects, the CONTAM Panel derived a reference point (RP) of 15.3 μg/kg
body weight for the sum of GTX I and III based on a BMDL10
for reduced heart rate in rats. A similar relative potency was
considered for GTX I. Without chronic toxicity studies, an RP for
long-term effects could not be derived. There is evidence for
genotoxicity in mice exposed to GTX III or honey containing GTX I and
III, showing increased levels of chromosomal damage. The mechanism of
genotoxicity is unknown. Without representative occurrence data for the
sum of GTX I and III and consumption data from Ericaceae honey, acute
dietary exposure was estimated based on selected concentrations for GTX I
and III reflecting concentrations measured in ‘certain’ honeys.
Applying a margin of exposure (MOE) approach, the estimated MOEs raised
health concerns for acute toxicity. The Panel calculated the highest concentrations
for GTX I and III below which no acute effects would be expected
following ‘certain honey’ consumption. The Panel is 75% or more certain
that the calculated highest concentration of 0.05 mg for the sum
of GTX I and III per kg honey is protective for all age groups regarding
acute intoxications. This value does not consider other grayananes in
‘certain honey’ and does not cover the identified genotoxicity.
AB - The European Commission asked EFSA for a scientific opinion on the risks
for human health of the presence of grayanotoxins (GTXs) in ‘certain
honey’ from Ericaceae plants. The risk assessment included all
structurally related grayananes occurring with GTXs in ‘certain’ honey.
Oral exposure is associated with acute intoxication in humans. Acute
symptoms affect the muscles, nervous and cardiovascular systems. These
may lead to complete atrioventricular block, convulsions, mental
confusion, agitation, syncope and respiratory depression. For acute
effects, the CONTAM Panel derived a reference point (RP) of 15.3 μg/kg
body weight for the sum of GTX I and III based on a BMDL10
for reduced heart rate in rats. A similar relative potency was
considered for GTX I. Without chronic toxicity studies, an RP for
long-term effects could not be derived. There is evidence for
genotoxicity in mice exposed to GTX III or honey containing GTX I and
III, showing increased levels of chromosomal damage. The mechanism of
genotoxicity is unknown. Without representative occurrence data for the
sum of GTX I and III and consumption data from Ericaceae honey, acute
dietary exposure was estimated based on selected concentrations for GTX I
and III reflecting concentrations measured in ‘certain’ honeys.
Applying a margin of exposure (MOE) approach, the estimated MOEs raised
health concerns for acute toxicity. The Panel calculated the highest concentrations
for GTX I and III below which no acute effects would be expected
following ‘certain honey’ consumption. The Panel is 75% or more certain
that the calculated highest concentration of 0.05 mg for the sum
of GTX I and III per kg honey is protective for all age groups regarding
acute intoxications. This value does not consider other grayananes in
‘certain honey’ and does not cover the identified genotoxicity.
KW - Grayanotoxins
KW - Grayananes
KW - Rhododendron honey
KW - Ericaceae
U2 - 10.2903/j.efsa.2023.7866
DO - 10.2903/j.efsa.2023.7866
M3 - Report
C2 - 36875862
T3 - EFSA Journal
BT - Scientific Opinion on the risks for human health related to the presence of grayanotoxins in certain honey
PB - Wiley-VCH
ER -