EFSA evaluates new proposed uses of the red food colour lycopene
EFSA’s NDA Panel carried out evaluations of new proposed uses of the red food colour lycopene in food supplements and as a food ingredient Any substance deliberately added to a foodstuff which will remain in the finished product, even in an altered form. The NDA Panel adopted two opinions on lycopene oleoresin from tomatoes and synthetic lycopene as novel foods under the Novel Foods Regulation.
Lycopene oleoresin from tomatoes, submitted as a novel food ingredient, consists of a mixture of a lipid Fat and fat-like substance fraction, rich of the carotenoid “lycopene” and a resin obtained by extraction from the pulp of ripe non-GM tomatoes.
For the synthetic ingredient the applicant proposed the use of synthetic lycopene to be marketed in three different formulations (lycopene 10%, lycopene 10 cold water dispersion (CWD), and lycopene dispersion 20%. The proposal is for the novel food to be used both in food supplements and as a food ingredient (i.e. in beverages and diary products, breakfast cereals, cereal bars).
The NDA Panel concluded that lycopene oleoresin from tomatoes and two of the formulations of synthetic lycopene proposed by the applicants are as safe as lycopene from other accepted sources. However, due to the absence of data, the Panel could not conclude on the safety of the synthetic lycopene 20% formulation.
The recent Opinion of the AFC Panel on the safety of the lycopene from all food sources, considered both lycopene contained naturally in fruit and vegetables and the use of lycopene as a food additive A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food and derived an Acceptable Daily Intake The amount of a substance (e.g. nutrient or chemical) that is ingested by a person or animal via the diet ( ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs) of 0 – 0.5 mf/kg body weight per day.
The NDA Panel considered that for the average user consumption of lycopene oleoresin from tomatoes and of synthetic lycopene will be below the ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. However considering the various sources of lycopene (natural occurrence The fact or frequency of something (e.g. a disease or deficiency in a population) happening, fortified foods, supplements, food colour) some users of lycopene products may exceed the ADI The acceptable daily intake (ADI) is an estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.