PAPRIKA extract
Overview
Chemical Names
Capsanthin: (3R, 3’S, 5’R)-3,3’-dihydroxy-beta,k-carotene-6-one
Capsorubin: (3S, 3’S, 5R, 5’R)-3,3’-dihydroxy-beta,k-carotene-6,6’-dione
Synonyms
Capsanthin, Capsorubin, Paprika oleoresin
INS
160c(ii)
Functional Class
Food Additives
COLOUR
COLOUR
INS matches
160c(ii)
Evaluations
Evaluation year: 2014
ADI:0–1.5 mg/kg bw
ADI:
0–1.5 mg/kg bw
Comments:
Expressed as total carotenoids
Intake:
The assessment of dietary exposure to paprika extract used as a colour was based on exposure to total carotenoids in paprika extract. Based on survey data, the highest exposure at the 95th percentile was estimated to be 6.3–13.2 mg/day (equivalent to 0.1–0.2 mg/kg bw per day, based on a body weight of 60 kg), which is below the ADI. The Committee concluded that dietary exposure to paprika extract used as a food colour does not present a health concern.
Meeting:
79
Specs Code:
M
Report:
Specification:
Toxicological study
Pivotal Study:
The results of a 90-day dietary toxicity study and a combined 52-week toxicity and 104-week carcinogenicity study in rats, both conducted with a paprika extract representative of the various extracts used in commerce as a food colour, did not provide evidence of any adverse effects.
Animal Specie:
Rat
Effect:
The NOAEL for paprika extract in both studies was 5% in the diet, the highest concentration tested.
NOAEL:
NOAEL of 2052 mg/kg bw per day is equivalent to 153 mg/kg bw per day for paprika extracts when expressed as total carotenoids
Evaluation year: 2008
ADI:
NO ADI ALLOCATED
Comments:
Concern was expressed as to whether the material tested in the 90-day and long-term studies was representative of all commercial
production of paprika extract used as food colour. The fact
that the material tested contained less than 0.01% capsaicin
and the fact that no adequate data were receive to establish a limit for capsaicin in the specifications for paprika extract
added to this concern.
Report:
Tox Monograph:
Specification: