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Scientific Opinion on the re-evaluation of canthaxanthin (E 161 g) as a food additive

Metadata

Panel members at the time of adoption

F. Aguilar, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Gürtler, J. König, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D. Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen

Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of canthaxanthin (E 161g). Canthaxanthin is a carotenoid pigment, consisting predominantly of all-trans β-carotene-4,4’-dione together with minor amounts of other carotenoids, which is authorised in the EU as a food additive for colouring of saucisse de Strasbourg and as a colouring matter in feeding stuffs, and this use contributes to the exposure in humans. Canthaxanthin was previously evaluated by JECFA in 1974, 1987, and 1995, and the SCF in 1983, 1987 and 1997. Both committees have established an ADI of 0.03 mg/kg bw/day based on the formation of crystalline deposits in the retina, which was observed in monkeys and humans. A NOAEL of 0.25 mg/kg bw/day for scotopic b-wave changes (without impairment of vision) was reported in a human study and a BMDL05 of 12-20 mg/day, amounting to 0.20-0.33 mg/kg bw/day for a 60 kg person, were derived in a worst case BMD analysis of the data from a meta-analysis on the crystal incidence in human eyes with increasing daily doses of canthaxanthin. Based on these two studies, the Panel derived a point of departure of 0.30 mg/kg bw/day and allocated an ADI of 0.03 mg/kg bw/day using an uncertainty factor of 10. This ADI is in line with the ADI derived previously by JECFA and the SCF.The Panel concluded that for both adults and children, total anticipated combined exposure to canthaxanthin from application as food and feed additive is unlikely to exceed the ADI. The Panel noted that the specifications of canthaxanthin need to be updated with respect to the heavy metal levels. In addition, the Panel noted that canthaxanthin used as a food additive is manufactured synthetically and the EC specifications should be modified accordingly.