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Scientific Opinion on the re-evaluation of paprika extract (E 160c) as a food additive

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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.