Commission Implementing Regulation (EU) 2025/2242 of 7 November 2025 authorising the placing on the market of yellow tomato extract as a novel food and amending Implementing Regulation (EU) 2017/2470
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Yellow tomato extract is authorised to be placed on the market within the Union. Yellow tomato extract shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. 2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Only the company Lycored Ltd ( 7 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 30 November 2025, unless a subsequent applicant obtains an authorisation for the novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company Lycored Ltd.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the company Lycored Ltd.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods) the following entry is inserted: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection ‘ Yellow tomato extract Specified food category Maximum levels 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be “yellow tomato extract”. 2. The labelling of food supplements containing yellow tomato extract shall bear a statement that the food supplements should be consumed by adults only. Authorised on 30 November 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Lycored Ltd, P.O Box 320, Beer Sheva 8410202, Israel. During the period of data protection, the novel food yellow tomato extract is authorised for placing on the market within the Union only by Lycored Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Lycored Ltd. End date of the date protection: 30 November 2030’. Food supplements as defined in Directive 2002/46/EC for the adult population 100 mg/day (2) in Table 2 (Specifications), the following entry is inserted: Authorised Novel Food Specifications ‘ Yellow tomato extract Description/Definition: The novel food is a carotenoid-rich extract derived from the pulp of ripe yellow tomatoes ( Lycopersicon esculentum Mill.) using supercritical CO 2 extraction Characteristics/composition: Appearance: Viscous, dark brown liquid Moisture: < 0,5 % Proteins: 0,2 %–0,6 % Total lipids: > 95 % Saturated fat: 12 %–25 % Monounsaturated fat: 17 %–30 % Polyunsaturated fat: 50 %–65 % Trans fatty acids: ≤ 2 % Unsaponifiable matter: < 20 % Acid value: < 5 mg KOH/g(*) Peroxide value: ≤ 15 meqO 2 /kg(**) Carotenoids: Total carotenoids: 10-13 g/100 g Phytoene + phytofluene (including cis- and all-trans isomers): 7-10 g/100 g beta-Carotene: 0,1-0,5 g/100 g zeta-Carotene: 2-4 g/100 g Lycopene: 0,1-0,4 g/100 g Heavy metals Lead: ≤ 1 mg/kg Cadmium: ≤ 1 mg/kg Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 1 mg/kg Microbiological criteria: Total aerobic microbial count: ≤ 1 000 CFU/g E. coli: Not detected in 10 g Salmonella: Not detected in 25 g Staphylococcus aureus : Not detected in 10 g Yeasts/moulds: ≤ 100 CFU/g (*) Acid value based all fatty acids. (**) Based on Codex Alimentarius guidelines for peroxid value in concentrated oil https://www.fao.org/3/y2774e/y2774e04.htm Abbreviation: CFU, colony forming units’
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