evaluation of certain food additives - libdoc.who.int - World Health ...

Chemical and technical considerations
Lycopene extract is obtained from ripe tomatoes with a high lycopene content
by first crushing the tomatoes and then extracting the pulp with ethyl acetate.
The solvent is removed, and the remaining extract is a dark red viscous liquid
containing 5–15% lycopene, of which at least 86% is all-trans-lycopene; the
balance of the extract is made up primarily of other naturally occurring fatty
acids (72%), waxes (6%) and flavour components. Minor amounts of cis isomers
of lycopene and other carotenoids and related substances, including -
carotene, phytofluene, phytoene and tocopherols, are also present. Because
lycopene is susceptible to chemical changes such as isomerization and degradation
when exposed to light, heat or oxygen, lycopene extract from tomato
is packed under nitrogen and stored at low temperatures.
Lycopene extract from tomato is intended for use as a food colour in dairy
products, non-alcoholic flavoured drinks, cereal and cereal products, bread
and baked goods, and spreads, providing colour shades from yellow to red.
Toxicological data
The existing toxicological database for lycopene is comprehensive and described
in section 3.1.8. The toxicity of lycopene extract from tomato was
assessed in 10-week and 13-week studies in rats and a 6-week study in human
volunteers. As the major non-lycopene constituents present in the extract
from tomato were naturally occurring fatty acids (72%), it was anticipated
that the toxicity profile of this lycopene extract would be similar to those of
synthetic lycopene and lycopene derived from Blakeslea trispora. Consistent
with the results of all toxicity studies on synthetic lycopene and lycopene
derived from B. trispora, no toxicologically relevant effects were observed
in the studies using lycopene extract from tomato.
Assessment of dietary exposure
Dietary exposure to lycopene naturally present in food is likely to be up to
10 mg/day in adults. Based on the proposed use levels, dietary exposure to
lycopene added as a food colour is estimated to be up to 5 times higher than
the upper end of the range of the background exposure, 10 mg/day.
Evaluation
The Committee evaluated the toxicity of lycopene extract from tomato together
with dietary exposure to lycopene naturally occurring in food and
lycopene from all sources that is used as a food colour and concluded that,
based on lycopene’s very low toxicity, there was no need to establish a
numerical ADI for lycopene. The Committee established a group ADI
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