Safety evaluation of certain food additives - ipcs inchem

96 PAPRIKA EXTRACT
long-term studies demonstrated no evidence that compounds extracted from
Capsicum species are carcinogenic in experimental animals.
The historical literature on the mutagenicity and genotoxicity of extracts of
chilli peppers and of various samples of capsaicin itself shows varied and often
contradictory results. Nonetheless, the more recent studies using short-term tests
considered in the present assessment clearly showed that pure capsaicin is not
genotoxic.
While reports of epidemiological studies conducted in India and Mexico
indicated an increased risk of gastric cancer in individuals who consumed large
quantities of chilli peppers, these studies had limitations, including potential
misclassification of subjects by exposure, large statistical imprecision of some of
the analyses, lack of control of confounding factors and possible recall bias.
Moreover, the relevance of these studies on consumption of chilli pepper to the use
of paprika extract as a food colour is uncertain.
The Committee noted that there were no studies of reproductive toxicity with
paprika extract.
4.2 Assessment of dietary exposure
Paprika extract is used in a wide range of foods as a colour. There were
limited data on potential dietary exposures to total carotenoids from use of paprika
extract as a food colour. Some data were available on dietary exposure to total
carotenoids from consumption of fresh, dried peppers and chilli peppers. These data
were used to put potential dietary exposure to total carotenoids from use of paprika
extract as a food colour into the context of the whole diet.
Production data for Europe on the amount of paprika oleoresin sold for use
as a food colour and as a spice were made available to the Committee at its present
meeting by AFEXPO. Of the 1210 tonnes of paprika oleoresin sold annually, 16%
was reported to be used as a food colour. Assuming that 7% of the paprika extract
was total carotenoids and assuming a European population of 730 million, this
resulted in a potential per capita mean dietary exposure to total carotenoids from
use of paprika extract as a food colour of 0.05 mg of total carotenoids per day.
Estimates of dietary exposure to total carotenoids from use of paprika extract
as a food colour were available for French and United Kingdom consumers. These
were based on data on food consumption from the French Household Economic
Survey, the United Kingdom NDNS and the 2007 NATCOL survey of use levels.
Assuming that 7% of the paprika extract was total carotenoids, the estimated mean
population dietary exposures to total carotenoids were 2–7 mg/day. For high
consumers in France, estimated population dietary exposure to total carotenoids
was 7 mg/day, assuming high consumption of foods containing paprika extract for
two food categories at the 97.5th percentile of exposure and at a mean level for all
other food groups. Estimated dietary exposures to total carotenoids for high
consumers in the United Kingdom at the 95th percentile of exposure ranged from 6
to 13 mg/day.