Safety evaluation of certain food additives - ipcs inchem

ALKOXY-SUBSTITUTED ALLYLBENZENES 437
results in increased levels of 1-hydroxy metabolites. Additionally, the high
concentrations at which UDS has been demonstrated in these studies coincide with
those at which hepatocellular toxicity is observed. These high concentrations are
not achieved in the course of normal human exposure to these materials.
3. COMMENTS
3.1 Assessment of dietary exposure
Dietary exposure to these six substances in Europe, Asia and the USA
occurs mainly by consumption of foods, principally spices and herbs, in which they
occur and by consumption of essential oils that are isolated from these foods.
Exposures to myristicin and safrole occur mainly by consumption of nutmeg, mace,
parsley, parsley seed oil and star anise. Exposure to apiole is predominantly from
consumption of the herb parsley. Exposures to the three methoxy-substituted
allylbenzenes (estragole, methyl eugenol and elemicin) also occur principally from
consumption of spices and spice oils. Exposure to estragole occurs primarily from
consumption of foods containing sweet basil, fennel and anise or their essential oils;
exposure to methyl eugenol is from nutmeg, allspice, sweet basil and fennel; and
exposure to elemicin is from nutmeg, mace, tarragon and parsley seed oil.
The range of exposure to alkoxy-substituted allylbenzenes from spices and
spice oils is generally similar, with the mean exposures to safrole, myristicin,
estragole and methyl eugenol in the range of 63–166 μg/person per day. Based on
the highest reported levels of spice oil in the spice and the highest reported
concentration of the alkoxy-substituted allylbenzenes in the oil, the maximum
dietary exposure levels for the same four substances are in the range of 424–569
μg/person per day in the USA. Based primarily on EU import data for nutmeg and
mace, the predicted maximum dietary exposures to safrole and myristicin are 879
and 684 μg/person per day, respectively. The predicted maximum dietary
exposures to the remaining two alkoxy-substituted allylbenzenes (elemicin and
apiole) from all sources make a minor contribution to overall exposure. On the basis
of typical patterns of consumption, maximum daily exposure to each of these
substances from spices, foods and essential oils and as intentionally added flavour
ingredients does not exceed 1 mg/day (17 μg/kg bw per day). For the four alkoxysubstituted
allylbenzenes with the highest production volume, exposures from spice
sources normally exceed exposures from spice oil sources by at least a factor of 10.
Only estragole and methyl eugenol are used as flavouring agents, and use
is limited to the USA. Based on annual production volumes of 491 kg/year for
estragole and 77 kg/year for methyl eugenol, per capita intakes for the whole
population as flavouring agents for the USA are 5 and 0.8 μg/day, respectively.
These six alkoxy-substituted allylbenzenes have been and will continue to
be consumed as a normal part of a traditional diet. They occur in highest
concentrations in spices, which are generally consumed at low levels in food.
Recent data indicating that methyl eugenol is essentially ubiquitous in samples of
human serum establish the fact that humans are regularly exposed to this substance
in the diet.