Re-evaluation of paprika extract (E 160c) as a food additive

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Article
Paprika extract, E 160c, CAS Registry Number 465-42-9, CAS Registry Number 470-38-2, capsanthin, capsorubin, food colour
First published in the EFSA Journal
10 December 2015
Adopted
19 November 2015
Last Updated
5 June 2017. This version replaces the previous one/s.
Type
Scientific Opinion
Abstract
The EFSA Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of paprika extract (E 160c). Paprika extract (E 160c) is a natural dye allowed as a food additive in the EU. The bioavailability of capsanthin and capsorubin from paprika extract is very low. Toxicological data were limited to a 13-week oral toxicity and one chronic toxicity and carcinogenicity study on a specified paprika extract (DN-933), representative of commercially produced paprika extracts used as food colour. Based on the new studies on the specified paprika extract (DN-933), compliant with good laboratory practice (GLP), which fulfil the requirements for genotoxicity assessment according to the EFSA guidelines on food additives, the Panel concluded that paprika extracts used as food colours do not raise a genotoxic concern. No reproductive and developmental toxicity studies are available, but evaluated by read-across. The Panel concluded in the chronic toxicity and carcinogenicity study that for the dose levels tested, paprika extract (E 160c) was not carcinogenic. Based on the lack of genotoxic potential, the Panel considered that the no‑observed-adverse-effect level (NOAEL) for histopathological changes from this study could be used for establishing an acceptable daily intake (ADI). On this basis, the Panel established an ADI of 24 mg/kg bw/day for paprika extract (E 160c). Based on the analytical data on paprika extract N1, which is reported to be comparable to the specified paprika extract used in these studies (DN-933), the total carotenoid content was 7.1%. Using this value, the Panel established an ADI of 1.7 mg carotenoids/kg bw/day for paprika extract (E 160c). Exposures to paprika extract (E 160c) for the refined exposure assessment scenarios were below the ADI established by the Panel.
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Younes Maged.
Panel on Food Additives and Nutrient Sources Added to Food
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2015.4320
EFSA Journal 2015;13(12):4320 [51 pp.].
Question Number
On request from
European Commission
Print on demand
Number of Pages
51