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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001note, and in particular Article 12(1) thereof,Whereas:
(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470note has established a Union list of novel foods.
(3)On 30 April 2024, the company Lycored Ltd (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place yellow tomato extract on the Union market as a novel food. The applicant requested for the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Councilnote for adult population.
(4)On 30 April 2024, the applicant also made a request to the Commission for the protection of the following proprietary data: Reverse Mutation Assay Ames Testnote and Micronucleus Test in Human Lymphocytes in vitronote.
(5)On 13 August 2024, the Commission requested the European Food Safety Authority (‘the Authority’) to provide a scientific opinion on yellow tomato extract as a novel food.
(6)On 24 March 2025, the Authority adopted its scientific opinion on the ‘Safety of yellow tomato extract as a novel food pursuant to Regulation (EU) 2015/2283’note in accordance with Article 11 of Regulation (EU) 2015/2283.
(7)In its scientific opinion, the Authority concluded that yellow tomato extract is safe under the proposed conditions of use.
(8)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data: Reverse Mutation Assay Ames Test and Micronucleus Test in Human Lymphocytes in vitro, without which it could not have assessed the novel food and reached its conclusion.
(9)The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283.
(10)The applicant declared that they held proprietary and exclusive rights of reference to Reverse Mutation Assay Ames Test and Micronucleus Test in Human Lymphocytes in vitro, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.
(11)The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on Reverse Mutation Assay Ames Test and Micronucleus Test in Human Lymphocytes in vitro, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place yellow tomato extract on the market within the Union during a period of five years from the entry into force of this Regulation.
(12)However, such restriction of the authorisation and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.
(13)It is appropriate that the inclusion of yellow tomato extract a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In line with the conditions of use of food supplements containing yellow tomato extract as proposed by the applicant, it is necessary to inform the consumers in that regard by appropriate labelling about the uses of food supplements containing yellow tomato extract.
(14)Yellow tomato extract should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(15)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
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.
Article 2#
Only the company Lycored Ltdnote 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.
Article 3#
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.
Article 4#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(1)in Table 1 (Authorised novel foods) the following entry is inserted:Authorised novel foodConditions under which the novel food may be usedAdditional specific labelling requirementsOther requirementsData protection‘Yellow tomato extractSpecified food categoryMaximum 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 population100 mg/day
(2)in Table 2 (Specifications), the following entry is inserted:Authorised Novel Food | SpecificationsYellow 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 CO2 extractionCharacteristics/composition:Appearance: Viscous, dark brown liquidMoisture: < 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 meqO2/kg(**)Carotenoids:Total carotenoids: 10-13 g/100 gPhytoene + phytofluene (including cis- and all-trans isomers): 7-10 g/100 gbeta-Carotene: 0,1-0,5 g/100 gzeta-Carotene: 2-4 g/100 gLycopene: 0,1-0,4 g/100 gHeavy metalsLead: ≤ 1 mg/kgCadmium: ≤ 1 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 1 mg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 1000 CFU/gE. coli: Not detected in 10 gSalmonella: Not detected in 25 gStaphylococcus aureus: Not detected in 10 gYeasts/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.htmAbbreviation: CFU, colony forming units
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
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