Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the commission related to Lutein for use in particular nutritional uses

Abstract

SUMMARYThe Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked to evaluate lutein, extracted from Tagetes erecta (marigold flowers) and from some species of edible plants, for use in the manufacture of foods for particular nutritional uses (FPNUs). Lutein, extracted from Tagetes erecta and from other species of edible plants, is already permitted for use as a food additive (E161b). The requested product has the same specifications as the approved food additive.Results from human intervention studies with foods high in lutein plus zeaxanthin, with lutein supplements using marigold as the lutein source or with enteral tube feeding containing lutein, indicate that lutein from these sources is bioavailable.The petitioner's proposed use of lutein is in foods for special medical purposes (FSMPs) at levels that would give rise to daily intakes of 0.5 to 2 mg lutein per day. This is within the range of a regular dietary intake.Lutein extracted from the natural strains of edible fruits and plants, grass, Lucerne (alfalfa) and Tagetes erecta (marigold flowers) is already permitted as a food additive (colour). Based on that, the Panel concluded that the use of lutein, obtained as an extract from Tagetes erecta and from the natural strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta in FSMPs, is not of safety concern under the proposed use levels which are in the range of the regular dietary intake of lutein, provided that it is in compliance with the existing EU specifications of the food additive.