Lycopene oleoresin from tomatoes, submitted as a novel food ingredient, consists of a mixture of a lipid 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 and derived an Acceptable Daily Intake (ADI) 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. However considering the various sources of lycopene (natural occurrence, fortified foods, supplements, food colour) some users of lycopene products may exceed the ADI.