Safety evaluation of certain food additives - ipcs inchem

PAPRIKA EXTRACT 97
The potential dietary exposure to total carotenoids from use of paprika
extract as a colour from national survey data for France and the United Kingdom
were in the same order of magnitude as the per capita mean dietary exposures to
total carotenoids predicted from FAO food balance sheet data from consumption of
fresh and dried peppers and chillies: i.e. France, 1–4 mg/day; and United Kingdom,
2–5 mg/day (assuming a concentration of 5000–13 000 mg total carotenoids/kg dry
weight and a conversion factor of 20 for fresh peppers and 2 for dried peppers to
dry weight). However, for countries with a much higher use of peppers and chillies
in the diet, the per capita mean dietary exposure to total carotenoids predicted from
FAO food balance sheet data from consumption of fresh and dried peppers and
chillies was up to 60 mg/day (at concentrations of 5000 mg/kg dry weight) or
160 mg/day (at concentrations of 13 000 mg/kg dry weight).
Limited data were available on the potential dietary exposure to capsaicin
from the use of paprika extract as a food colour. Dietary exposure to capsaicin could
be predicted from estimates of dietary exposures to total carotenoids by applying a
ratio of capsaicin content to total carotenoid content.
5. EVALUATION
The concentration of capsaicin in paprika extracts is to be controlled by the
specifications. Concern has been expressed in the past that capsaicin may be
carcinogenic; however, older long-term studies with capsaicin do not appear to
provide evidence for carcinogenicity, and recent studies show that pure capsaicin
is not genotoxic. The epidemiological studies reporting a relationship between
consumption of chilli pepper and increased risk of gastric cancer have considerable
limitations, which preclude the drawing of any definitive conclusion. Moreover,
the Committee expressed the view that these studies were not relevant to the
assessment of paprika extract used as a food colour.
In a well conducted 90-day study in rats given diets containing a commercial
sample of paprika extract, no adverse effects were reported at a dietary
concentration of 5%, equivalent to 3000 mg/kg bw. Similarly, in a long-term study
of combined toxicity/carcinogenicity in rats given the same material, no evidence of
toxicity or carcinogenicity was noted at dietary concentrations of up to 5%.
The Committee expressed concern as to whether the material tested in the
90-day and long-term studies was representative of all commercial production of
paprika extract. The fact that the material tested contained less than 0.01%
capsaicin and the fact that the Committee did not receive adequate data to establish
a limit for capsaicin in the specifications for paprika extract added to this concern.
The Committee requested data pertaining to the composition and capsaicin content
of various commercial samples and information as to whether the material used in
the toxicological tests was representative of all the products in commerce.
New specifications were prepared and made tentative pending the receipt
of additional information on paprika extract, including concentrations of capsaicin
and additional information about the composition of batches of extract produced by
a variety of manufacturers. Therefore, the Committee did not allocate an ADI.