Safety evaluation of certain food additives - ipcs inchem

SUBSTANCES STRUCTURALLY RELATED TO MENTHOL (addendum) 587
Table 2 (contd)
b Intake (μg/person per day) calculated as follows: [(annual volume, kg) × (1 × 10 9 μg/kg)]/
[population × survey correction factor × 365 days], where population (10%, “consumers only”)
= 32 × 10 6 for Europe, 28 × 10 6 for the USA and 13 × 10 6 for Japan; and where correction
factor = 0.8 for the surveys by the USA, Europe and Japan, representing the assumption that
only 80% of the annual flavour volume was reported in the poundage surveys (Japan Flavor
& Fragrance Materials Association, 2002; European Flavour and Fragrance Association,
2005; Gavin et al., 2007).
Intake (μg/kg bw per day) calculated as follows: (μg/person per day)/body weight, where
body weight = 60 kg. Slight variations may occur from rounding.
c Quantitative data for the USA reported by Stofberg & Grundschober (1987).
d The consumption ratio is calculated as follows: (annual consumption via food, kg)/(most
recent reported volume as a flavouring substance, kg).
Table 1 summarizes the evaluations of the 10 additional flavouring agents
structurally related to menthol (Nos 1852–1861) in this group.
1.5 Consideration of combined intakes from use as flavouring agents
The daily intakes of the 10 additional flavouring agents structurally related
to menthol considered in this group are all relatively low in comparison with
those of the previously considered flavouring agents in this group (Annex 1,
reference 137). In the unlikely event that the flavouring agents in structural class I
with the common metabolite menthol (No. 427) from this group (Nos 1852, 1854,
1855 and 1858) and the previously evaluated group (Nos 432, 433 and 447) were
to be consumed together with menthol (No. 427) on a daily basis, the estimated
combined intakes 1 would be 1527 μg/person per day in Europe and 3513 μg/person
per day in the USA. The estimated combined intake would therefore exceed the
human threshold of concern (i.e. 1800 μg/person per day for class I) in the USA.
However, the vast majority of the combined intake would be due to menthol per se,
which has an acceptable daily intake (ADI) of 0–4 mg/kg bw, established by the
Committee at its fifty-first meeting (Annex 1, reference 37). Also, all 10 flavouring
agents and the 14 flavouring agents considered previously are expected to be
metabolized efficiently and would not saturate available metabolic pathways. The
overall evaluation of the data indicated that combined intake would not raise safety
concerns.
1.6 Consideration of secondary components
No flavouring agents in this group have minimum assay values of less
than 95%.
1 Combined intake was calculated on a molar basis relative to the formation of a common
metabolite. In this case, the common metabolite is menthol, with a relative molecular mass
of 156.69.