EFSA Unable to Establish Safety of Yellow/Orange Tomato Extract as a Novel Food Due to Lycopene Intake Concerns

The European Commission requested the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) to assess the safety of a yellow/orange tomato extract proposed as a novel food under Regulation (EU) 2015/2283. This extract is rich in carotenoids, primarily phytoene and phytofluene, along with smaller amounts of beta-carotene, zeta-carotene, and lycopene, and is produced using supercritical CO? extraction from tomato pulp. The applicant intends to use this extract in cereal bars, functional beverages, and food supplements for individuals over 15 years old, with the general population as the target for the first two categories. EFSA highlighted concerns based on their latest intake assessments for lycopene, which indicated that combining natural sources with its use as a food additive would already lead to intakes surpassing the established acceptable daily intake (ADI) of 0.5 mg/kg body weight per day for certain age groups. Introducing this novel food would further increase lycopene exposure beyond safe limits. Additionally, due to a lack of safety data for phytoene and phytofluene intake through this extract, EFSA could not determine if its consumption might be nutritionally disadvantageous. Consequently, the Panel concluded that the safety of this novel food has not been established under the proposed conditions of use.