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The PSG was formed in 2006 incorporating the three (3) major production capabilities for Paprika Oleoresin; Europe (co-ordinated by AFEXPO), India (co-ordinated by Spices Board of India), North / South Americas (co-ordinated by KALSEC) and laterally (2014) China (Chenguang BioTech) in response to the JECFA call for data for Paprika Oleoresin as a food colour. The dossier (funded by the 3 production areas) was submitted via NATCOL in 15 December 2007 for evaluation at the 69th JECFA June 2008.
The Committee did not allocate an ADI but did allocate the name Paprika Extract for use as a food colour to differentiate it from Paprika Oleoresin for use as a spice. New tentative specifications were prepared pending receipt of additional information on Paprika Extract as a food colour; including concentrations of capsaicin and additional information about the composition of commercial batches produced by a variety of manufacturers.
NATCOL subsequently submitted the additional data for Paprika Extract (INS 160c) in reply to the Call for Data for the JECFA 77th Meeting and at the 79th JECFA, The Committee established an ADI for paprika extract used as a food colour of 0–1.51 mg/kg bw, expressed as total carotenoids, with the application of an uncertainty factor of 100 to the NOAEL of 153 mg/kg bw per day from a 2-year toxicity and carcinogenicity study in rats. Furthermore, The Committee concluded that dietary exposure to paprika extract used as a food colour does not present a health concern. Paprika Extract has been assigned INS 160c(ii), while Paprika Oleoresin is assigned INS 160c(i).
Meanwhile, EFSA have re-evaluated Paprika Extract E 160c as part of the colours re-evaluation (initial Call for data Dec 2006) and subsequently reverted with a series of additional information requests (by way of public calls for data 31 March 2011 & 23 March 2014) on Technical/Manufacturing Issues; Characterisation/Chemistry Issues; Toxicological Issues and Intake/Exposure Issues, necessitating a further genotoxicity study and characterisation studies to be funded by the PSG. NATCOL submitted data to the EFSA ANS Panel on the Technical/Manufacturing Issues; Characterisation/Chemistry Issues and Intake/Exposure Issues in October 2012 and submitted the additional genotoxicity study to the EFSA FIP Panel in September 2014. We await feedback from the ANS Panel Standing WG on Colours.
Secretary – Dr Mary O’Callaghan
Intake Consultant – David Tennant
Dossier Consultant – Manfred Luetzow