Safety evaluation of certain food additives - ipcs inchem

292 ALIPHATIC BRANCHED-CHAIN SATURATED AND UNSATURATED ALCOHOLS
Flavouring Agents (see Figure 1, Introduction) (Annex 1, reference 131). None of
these flavouring agents has previously been evaluated by the Committee.
The Committee previously evaluated 32 other members of this group of
flavouring agents at its sixty-first meeting (Annex 1, reference 166). All 32 flavouring
agents in that group were concluded to be of no safety concern at the current estimated
levels of intake, and the Committee maintained the previously established
group acceptable daily intake (ADI) of 0–0.5 mg/kg body weight (bw), expressed
as citral, for citral (No. 1225), citronellol (No. 1219), geranyl acetate (No. 58), linalool
(No. 356) and linalyl acetate (No. 359). Citral and citronellol had already been evaluated
by the Committee at its eleventh meeting (Annex 1, reference 14), at which
conditional ADIs 1 of 0–0.25 mg/kg bw and 0–1 mg/kg bw, respectively, were allocated.
At the twenty-third meeting of the Committee (Annex 1, reference 50), citronellol
and citral were re-evaluated as part of a group of terpenoid flavouring agents,
including geranyl acetate, linalool and linalyl acetate. A group ADI of 0–0.5 mg/kg
bw, expressed as citral, was established for citral, geranyl acetate, citronellol,
linalool and linalyl acetate on the basis of their clearly defined metabolism, rapid
excretion and low toxicity in short-term studies. The Committee maintained,
however, that a long-term study was required for at least one member of this group.
At its forty-ninth meeting (Annex 1, reference 131), the Committee evaluated
a group of 26 geranyl, neryl, citronellyl and rhodinyl esters derived from branchedchain
terpenoid alcohols and aliphatic acyclic carboxylic acids by the Procedure.
Two-year studies of carcinogenicity had been conducted for a mixture of two of
these esters, geranyl acetate and citronellyl acetate. The Committee concluded that
there were no safety concerns for any of the 26 substances at the low levels of intake
arising from their use as flavouring agents and maintained the group ADI for citral,
geranyl acetate, citronellol, linalool and linalyl acetate. Likewise, at its fifty-fifth
meeting (Annex 1, reference 137), when the Committee re-evaluated linalool and
linalyl acetate as part of a group of 23 aliphatic acyclic and alicyclic terpenoid tertiary
alcohols and structurally related substances by the Procedure, the group ADI was
maintained. The findings from all previous evaluations were considered in the
present evaluation.
Twelve of the 20 flavouring agents in this group have been reported to occur
naturally in foods (Nos 1815, 1818, 1820, 1822, 1824–1827, 1830–1832 and 1834).
They have been detected in bread, animal fat, a variety of fruits, cinnamon, citrus
peel oils, peppermint oil, cheddar cheese, black tea, coffee, white wine, carrot,
honey and kelp, for example (Nijssen et al., 2007).
1.2 Assessment of dietary exposure
The total annual volume of production of the 20 flavouring agents in this
group is approximately 270 kg in Europe (European Flavour and Fragrance
Association, 2005), 2200 kg in the USA (Gavin et al., 2007) and 40 kg in Japan
(Japan Flavor & Fragrance Materials Association, 2002). In Europe, the USA as
well as Japan, prenyl acetate (No. 1827) makes the biggest contribution to the
total annual production volume (67%, 59% and 58%, respectively). The estimated
1 “Conditional ADI”, which signifies an ADI with special considerations, is a term no longer
used by the Joint FAO/WHO Expert Committee on Food Additives.