Scientific Opinion on the re‐evaluation of paprika extract (E 160c) as a food additive
2015; Wiley; Volume: 13; Issue: 12 Linguagem: Inglês
10.2903/j.efsa.2015.4320
ISSN1831-4732
Tópico(s)Consumer Attitudes and Food Labeling
ResumoEFSA JournalVolume 13, Issue 12 4320 OpinionOpen Access Scientific Opinion on the re-evaluation of paprika extract (E 160c) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this author EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this author First published: 10 December 2015 https://doi.org/10.2903/j.efsa.2015.4320Citations: 5 Panel members: 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. Correspondence: [email protected] Acknowledgement: The Panel wishes to thank the members of the former Working Group 'B' Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on the re-evaluation of food colours: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Maria Jose Frutos, Pierre Galtier, David Gott, Claude Lambré, Jean-Charles Leblanc, Agneta Oskarsson, Jeanne Stadler, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen, for the preparatory work on this scientific opinion and EFSA staff members Ana Maria Rincon, Alexandra Tard and Stavroula Tasiopoulou for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, bodies and other organisations that provided data for this scientific output. Adoption date: 19 November 2015 Published date: 10 December 2015 Updated: 5 June 2017 Question number: EFSA-Q-2011-00353 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL 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. References Documentation provided to EFSA Confederation of the Food and Drink Industries of the EU (CIAA), 2009. Exercise on occurrence data – EFSA re-evaluation of some food colours (December 2009). 14.12.2009. Mc Garry S, 2014. 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