Safety of yellow tomato extract as a novel food pursuant to Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on yellow tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid‐rich extract from the yellow tomato containing predominantly phytoene plus phytofluene (PE/PF) at up to 10% of the NF, as well as a lesser amount of zeta‐carotene (≤ 5%), beta‐carotene (≤ 0.5%) and lycopene (≤ 0.4%). The NF is produced from the tomato pulp using supercritical CO₂ extraction. The applicant proposes to use the NF in food supplements (FS) for adults only at a maximum daily dose of 100 mg. The intake of lycopene from such FS would correspond to 0.4 mg/day which corresponds to 5.7 μg/kg body weight and day for an adult weighing 70 kg. This is approximately 1.1% of the acceptable daily intake (ADI) for lycopene established by EFSA (i.e. 0.5 mg/kg body weight), which does not raise safety concerns. According to the exposure assessment performed by EFSA, which included all population age groups, the highest mean and highest P95 intakes/kg bw estimates for PE/PF from the background diet of infants and toddlers are higher than the combined exposure of adults from the background diet and the NF under its proposed use and use levels in food supplements. Noting that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that PE/PF exposure from the background diet does not raise safety concern, the Panel considers that the NF is nutritionally not disadvantageous at the proposed intake of the NF of up to 100 mg/day used in FS in adults. The Panel concludes that the NF, yellow tomato extract, is safe under the proposed conditions of use.

INTRODUCTION

Background and Terms of Reference as provided by the requestor

On 30 April 2024, the company Lycored Ltd. submitted an application to the European Commission in accordance with Article 10 of Regulation (EU) 2015/2283 to authorise the placing on the Union market of yellow tomato extract as a novel food (NF).

The applicant requests to authorise the use of yellow tomato extract as a NF in food supplements (FS) as defined in Directive 2002/46/EC, for the adult population.

The applicant also requests data protection under Article 26 of Regulation (EU) 2015/2283.

In accordance with Article 29(l)(a) of Regulation (EC) No 178/2002, the European Commission asks the European Food Safety Authority to provide a scientific opinion by carrying out the assessment of yellow tomato extract as a NF, in accordance with Article 10(3) of Regulation (EU) 2015/2283.

The Commission also asks EFSA to evaluate and inform the Commission as to whether and if so, to what extent, the requirements of Article 26(2)(c) of Regulation (EU) 2015/2283 are fulfilled in elaborating its opinion on yellow tomato extract as a novel food, regarding the proprietary data for which the applicant is requesting data protection.

Additional information

In 2023, the Panel adopted an Opinion on the safety of the NF ‘yellow/orange tomato extract’, which was proposed as an ingredient for FS up to a maximum daily dose of 100 mg for individuals above 15 years of age. Additionally, the applicant aimed to add the NF at maximum use levels of 286 and 40 mg of the NF per 100 g, to cereal bars and functional drinks, respectively (EFSA NDA Panel, 2023). In that Opinion from 2023, the Panel noted that the information provided on the composition, production process and specifications were sufficient. The Panel however concluded that the safety of the NF has not been established under the proposed conditions of use due to concerns related to the intake of (or exposure to) lycopene and to phytoene and phytofluene (PE/PF) at the proposed use level. When considering the proposed maximum specification limit for lycopene of 5% in yellow/orange tomato extract, the highest P95 intake estimate for lycopene coming from cereal bars and functional drinks, corresponded to 12.6, 13.8 and 17.2% of its acceptable daily intake (ADI)¹ (i.e. 0.5 mg/kg bw per day) for other children (3 to < 10 years of age), adolescents (10 to < 18 years of age) and adults, respectively. The Panel also noted that according to the latest exposure assessment for lycopene by the ANS Panel (2017) when it is used as a food additive, the ADI is exceeded by both the highest estimated mean and the highest P95 intakes by children below 10 years of age. The estimated highest P95, but not the highest mean intakes, exceeded the ADI also in adolescents (10 and 17 years of age). In adults, the ADI was not exceeded by the highest estimated mean (i.e. 0.17 mg/kg bw per day) and P95 (i.e. 0.38 mg/kg bw per day) exposure to lycopene when used as food colour. This was also not the case, when estimated mean intake of lycopene from natural occurrence (about 5 mg per day or 0.07 mg/kg bw per day) was added to the exposure to lycopene used as a food colour. Only when combining the highest P95 estimate for lycopene exposure when used as a food colour, plus high exposure estimate for naturally occurring lycopene, the ADI would be reached or even exceeded also by adults.

Regarding PE/PF, the Panel considered in 2023 that at the proposed combined maximum specification limit for PE/PF (i.e. 22 g/100 g NF), the consumption of 100 mg of the NF with FS by adults would amount to an intake of 22 mg PE/PF per day, which was about 10 times higher than their estimated exposure from natural occurrence. Such intake would correspond to the intake of these compounds coming from more than 1 kg red tomatoes. The Panel also noted that no health-based guidance value (HBGV) has been established for phytoene and phytofluene.

The same applicant submitted a new application for ‘yellow tomato extract’, subject of this Opinion, aiming to address the concerns expressed by the Panel by (1) using only yellow tomatoes instead of yellow and orange tomatoes for the production of the NF. This will reduce the maximum concentration specification limits for lycopene by a factor of 12.5 (from 5% to 0.4%) and for PE/PF by a factor of 2.2 (from 22% to 10%), respectively, and by (2) limiting the intended uses to only FS for adults.

DATA AND METHODOLOGIES

Data

The safety assessment of this NF is based on data supplied in the application and on an exposure assessment for PE/PF from the background diet performed by EFSA.

Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are listed in the Commission Implementing Regulation (EU) 2017/2469.²

A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of a NF application (EFSA NDA Panel, 2021). As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific data, (including both data in favour and not in favour) that are pertinent to the safety of the NF.

The applicant has submitted a confidential and a non-confidential version of a dossier following the ‘EFSA guidelines on the preparation and presentation of a NF application’ (EFSA NDA Panel, 2021) and the ‘Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283’ (EFSA, 2021).

In accordance with Art. 38 of the Regulation (EC) No 178/2002³ and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality,⁴ the non-confidential version of the dossier has been published on Open.EFSA.⁵

According to Art. 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre-submission phase and public consultations, EFSA carried out a public consultation (PC-1335) on the non-confidential version of the technical dossier from 25/2/2025 to 18/3/2025 for which no comments were received.

This NF application includes a request for protection of proprietary data in accordance with Article 26 of Regulation (EU) 2015/2283. The data requested by the applicant to be protected comprise two genotoxicity tests, i.e. a bacterial reverse mutation test (GLP, OECD TG 471) and an in vitro micronucleus (GLP, OECD TG 487) which have been already assessed and described by the EFSA NDA Panel (2023) in their opinion on yellow-orange tomato extract.

Methodologies

The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel, 2021) and the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. The legal provisions for the assessment are laid down in Article 11 of Regulation (EU) 2015/2283 and in Article 7 of Commission Implementing Regulation (EU) 2017/2469.

This assessment concerns only the risks that might be associated with consumption of the NF under the proposed conditions of use and is not an assessment of the efficacy of the NF regarding any claimed benefit.

ASSESSMENT

Introduction

The only difference as compared to the NF ‘yellow/orange tomato extract’ assessed by the EFSA NDA Panel in 2023 is that the production of the NF subject of this safety assessment does not include orange tomatoes as a source, but only yellow tomatoes.

The NF, which is the subject of the application, is an extract obtained from yellow tomatoes. The NF is produced by separation of the tomato pulp, its drying and subsequent extraction using supercritical CO₂. The NF is an oil fraction of the tomato fruit and consists of mainly fat (triglycerides) and carotenoids. The NF is proposed by the applicant to be used only in FS in adults.

The applicant indicates that, as defined by Regulation (EU) 2015/2283, Article 3, paragraph 2(iv), the NF falls under the category: ‘food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:

• –traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
• –non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances.

Identity of the NF

The NF is a carotenoid-rich extract from the pulp of the fruits of yellow tomatoes, a cultivar of the common tomato (Lat. Lycopersicon esculentum) grown in outdoor open fields in Israel.

The identity of the species has been verified through the Plant List and Plants of the world online as Lycopersicon esculentum Mill with the following synonyms: Solanum lycopersicum L; Lycopersicon lycopersicum (L.) H. Karst and Lycopersicon pyriforme Dunal.

Scientific classification

Kingdom: Plantae

Order: Solanales

Family: Solanaceae

Production process

According to the information provided, the only difference to the production process as described in the Opinion of the EFSA NDA Panel (2023), is that only yellow tomatoes are used to produce the NF.

Compositional data

The NF mainly consists of lipids including carotenoids, with lesser constituents being phytosterols.

To confirm that the manufacturing process is reproducible and adequate to produce on a commercial scale a product with the required characteristics, the applicant provided analytical information for five independent batches of the NF (Tables 1–4).

The physical and proximate characteristics of the yellow tomato extract are described in Table 1. Batch Nos 1, 2 and 3 were among the five batches already assessed by the EFSA NDA Panel (2023). In addition to these three batches, the applicant analysed two more batches produced from yellow tomatoes. The extract is a viscous, dark brown liquid with a characteristic odour and a moisture content of 0.2% or less. Ash content of five batches was found to be < 0.1%.

Total lipid content including carotenoids, across five samples of the yellow tomato extract ranged from 96.6% to 99.3%, and the protein content ranged from 0.2% to 0.5% (Table 1). In one batch, glucose was detected (0.1 g/100 g), while the other four batches did not contain carbohydrates above the limit of quantification.

TABLE 1 Proximates' batch-to-batch analysis of the NF.

Parameter (unit)	Batches	Method of analysis
#1	#2	#3	#4*	#5*
Moisture (%)	0.1	< 0.1	NA	0.2	0.2	Karl Fisher titration
Ash (%)	< 0.1	< 0.1	NA	< 0.09	< 0.09	Gravimetry
Total lipids (g/100 g)	98.0	96.6	99.3	98.1	97.2	Hydrolysis-gravimetry
Protein (g/100 g)	0.5	0.3	0.4	0.3	0.2	In-house method based on AOAC 976.05, 950.36, 991.20 and 986.25
Sugars (g/100 g)	< 2.0	< 2.0	< 2.0	< 0.1	0.1	HPLC-RI
Glucose (g/100 g)	< 0.4	< 0.4	< 0.4	< 0.1	0.1
Fructose (g/100 g)	< 0.4	< 0.4	< 0.4	< 0.1	< 0.1
Dietary fibre	–	–	–	< 0.3	< 0.3	Gravimetry

The free fatty acid content of five samples of the NF indicated a low acid value ranging from 3.1 to 4.8 mg KOH/g. The range for the peroxide value was 6.1–11.3 meq O₂/kg.

The applicant performed a carotenoid profile analysis for five samples of the NF (Table 2). Total carotenoids ranged from 10.1% to 12.1%. The predominant carotenoids in the NF were phytoene and phytofluene, which ranged from 7.4% to 8.9%, followed by zeta-carotene from 2.0% to 2.7%, lycopene from 0.1% to 0.2% and beta-carotene from 0.1% to 0.3%.

TABLE 2 Carotenoid profile batch-to-batch analysis of the NF.

Parameter (g/100 g)	Batches	Method of analysis
#1	#2	#3	#4	#5
Total carotenoids	10.1	12.1	10.8	11.5	11.1	Calculation
Lycopene	0.2	0.2	0.1	0.2	0.2	HPLC-DAD
Phytoene and Phytofluene	7.4	8.9	8.6	8.5	8.1
zeta-Carotene	2.2	2.7	2.0	2.5	2.5
beta-Carotene	0.3	0.2	0.1	0.3	0.2

The applicant provided data on the phytosterols present in the five batches of the NF (results not shown). The NF contains around 1% phytosterols, composed mainly of stigmasterol, beta-sitosterol and campesterol. The unsaponifiable matter for three batches ranged between 12 and 17 g/100 g NF.

Regarding the presence of inherent toxins in the NF, the applicant provided analytical data on the content of glycoalkaloids and alkaloids in five representative samples of the NF, presented in Table 3.

TABLE 3 Batch-to-batch analysis of glycoalkaloids and alkaloids in the NF.

Parameter (unit)	Batches	Method of analysis
#1	#2	#3	#4	#5
Tomatidin (mg/kg)	0.075	0.089	0.050	0.116	0.128	LC–MS/MS
Tomatin (mg/kg)	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01
alpha-Solanin (mg/kg)	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01
alpha-Chaconin (mg/kg)	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01
Solanidin (mg/kg)	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01

The Panel notes that the concentrations of glycoalkaloids in the NF are lower than the average concentrations in tomatoes (EFSA CONTAM Panel, 2020) and do not raise safety concerns.

The applicant also presented analytical data of certain contaminants which are summarised in Table 4.

A multi-residue screening analysis of pesticides in five of the samples of the NF was also performed (results not shown). Each of the samples tested was found to comply with the MRL for tomatoes set in Regulation (EC) No 396/2005⁷ with the LOQ being 0.01 mg/kg. The applicant also provided results for microbiological analyses of total plate count, Escherichia coli, Salmonella spp., Staphylococcus aureus and yeasts/moulds performed in five samples of the NF which comply with Regulation (EC) No 2073/2005.⁸

Additionally, the applicant performed analyses for dioxins, dioxin-like polychlorinated biphenyls (PCBs) and polycyclic aromatic hydrocarbons (PAHs).

TABLE 4 Batch-to-batch analysis of contaminants in the NF.

Parameter (unit)	Batches	Method of analysis
#1	#2	#3	#4	#5
Heavy metals
Mercury (Hg) (mg/kg)	< 0.005	< 0.005	< 0.005	< 0.001	< 0.005	ICP-MS (in house procedure) for batch #4 and ICP-MS (based on AOAC 2011.19 and 993.14) for the rest
Cadmium (Cd) (mg/kg)	< 0.005	< 0.005	< 0.005	< 0.001	< 0.01
Lead (Pb) (mg/kg)	< 0.005	< 0.005	< 0.005	0.013	< 0.01
Arsenic (As) (mg/kg)	< 0.010	< 0.010	< 0.010	0.002	< 0.010
Dioxins and dioxin-like PCBs – calculations per wet weight (upper bound results) a
WHO-PCDD/PCDF-TEQb (ng/kg)	0.192	0.184	0.205	NA	NA	GC/HRMS
WHO-PCB-TEQ (ng/kg)	0.133	0.134	NA	NA	NA
WHO-PCDD/F-PCB-TEQ (ng/kg)	0.326	0.318	NA	NA	NA
Polycyclic aromatic hydrocarbons (PAHs)
Benz(a)anthracene (μg/kg)	1.7	1.4	1.5	1.2	< 1.00	HPLC - FD
Benzo(a)pyrene (μg/kg)	1.0	0.7	1.4	< 1.00	< 1.00
Benzo(b)fluoranthene (μg/kg)	1.7	1.2	2.4	< 1.00	< 1.00
Chrysene (μg/kg)	3.2	2.4	2.7	2.2	1.00
Microbiological analysis
Total plate count (CFU/g)	< 10/g	< 10/g	< 10/g	< 10/g	< 10/g	ISO 4833
Yeasts/Moulds (CFU/g)	< 10/g	< 10/g	< 10/g	< 10/g	< 10/g	ISO 21527
Escherichia coli in 10 g	ND	ND	ND	ND	ND	USP <2022>
Salmonella spp. in 25 g	ND	ND	ND	ND	ND	ISO 6579
Staphylococcus aureus in 10 g	ND	ND	ND	ND	ND	USP <2022>

Information was provided on the accreditation of the laboratories that conducted the analyses presented in the application.

The Panel considers that the information provided on the composition is sufficient for characterising the NF.

Stability

At least three of the four batches assessed in the Opinion on yellow/orange tomato extract (EFSA NDA Panel, 2023) concerned extracts from yellow tomatoes. The Panel considers that the data provided and assessed in that Opinion contain sufficient information with respect to the stability of the present NF.

Specifications

The specifications of the NF are indicated in Table 5.

TABLE 5 Specifications of the NF.

Description: Carotenoid-rich extract from yellow tomatoes (Lycopersicon esculentum Mill.)
Parameter	Specification proposed for the NF (yellow tomato extract)
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 meqO2/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
Total plate count	≤ 1000 CFU/g
Escherichia coli	Not detected in 10 g
Salmonella spp.	Not detected in 25 g
Staphylococcus aureus	Not detected in 10 g
Yeasts/moulds	≤ 100 CFU/g

The Panel considers that the information provided on the specifications of the NF is sufficient.

History of use of the NF and/or of its source

There is no history of use of the NF.

The source of the NF is yellow tomato (Solanum lycopersicum L., syn. Lycopersicon esculentum Mill.), an annual or perennial plant from the Solanaceae family. Being a common crop since the 18th century, the specific tomato type used in the production of the NF, i.e. the ‘yellow/orange tomato’, has been consumed in Europe, and has been cultivated using traditional breeding techniques.

Proposed uses and use levels and anticipated intake

The applicant intends to market the NF as ingredient added to FS at a maximum daily dose of 100 mg for adults only.

Absorption, distribution, metabolism and excretion (ADME)

The applicant refers to two references already assessed by the Panel in 2023 (EFSA NDA, 2023). One of these two studies was performed with the NF and concerned a pharmacokinetic clinical study (Unpublished report, 2019) performed in 24 healthy volunteers that consumed the NF in capsule form once a day for 28 days. Considering the contents of lycopene (0.09 mg), phytoene (7.33 mg) and phytofluene (2.06 mg) per capsule, the Panel considers that this study was performed with a batch produced from yellow tomatoes.

No additional data related to ADME were provided for this application.

Nutritional information

The applicant provided a nutritional analysis of the NF (Table 1, Compositional data section). The NF is mainly composed of lipids (96.6–99.3 g/100 g) of which up to 13 g are carotenoids and contains a minor amount of proteins (0.2–0.5 g/100 g). The NF does not contain relevant amounts of carbohydrates, sugars or dietary fibre.

When considering the consumption of the NF at the proposed maximum use level of 100 mg/day from FS for adults and the proposed maximum specification limits for the carotenoids present in the NF, daily intakes for each component in mg/day can be calculated and are presented in Table 6.

TABLE 6 Maximum daily intakes (mg/day) of carotenoids from the NF when consumed in FS at 100 mg/day considering maximum specifications limits.

NF carotenoids' profile	Maximum specification limit (g/100 g)	Maximum daily intake (mg/day)
Total carotenoids	13	13
beta-Carotene	0.5	0.5
zeta-Carotene	4	4
Lycopene	0.4	0.4
Phytoene + phytofluene	10	10

Lycopene

As compared to the maximum specification limit (5 g/100 g) which had been proposed for the extract produced from yellow/orange tomato (EFSA NDA Panel, 2023), the proposed maximum specification limit for the present NF, i.e. yellow tomato extract, is 0.4 g/100 g. This corresponds to a reduction and lower exposure to lycopene from FS by a factor of 12. Considering the established ADI for lycopene of 0.5 mg/kg bw per day (EFSA AFC Panel, 2008) which corresponds to a daily intake of 35 mg for an adult weighting 70 kg, 0.4 mg lycopene from 100 mg yellow tomato extract would represent about 1.1% of the ADI. As noted by EFSA NDA Panel (2023), P95 intake estimates of lycopene from its use as a food additive plus mean exposure estimates from natural occurrence do not exceed the ADI in adults. Only if the P97.5 exposure estimate for lycopene from natural occurrence is added to the P95 intake estimate from its use as a food additive, the ADI in adults would be exceeded. The Panel considers such scenario to be highly conservative. The Panel has no safety concerns regarding a maximum daily intake of 0.4 mg lycopene from the NF used in FS intended for adults.

Phytoene and phytofluene

Based on the maximum specification limit for PE/PF of the NF (10 g/100 g), the maximum daily intake of these carotenoids will be 10 mg/day, which is about four times the mean intake estimates in adults of 2.7 and 2.4 mg PE/PF as reported in two consumption surveys performed in Luxembourg (Biehler et al., 2012) and Spain (Olmedilla-Alonso et al., 2021), respectively. These studies identified tomatoes and carrots as the main foods contributing to the PE/PF intake, but significant contribution came also from citrus and stone fruits, especially apricots, fruit and vegetable juices and bell peppers. Up to now, no HBGV for PE/PF have been established and literature is scarce on the occurrence of PE/PF in food and intake estimates for these carotenoids. Intake estimates in younger populations were not retrieved.

The Panel considers that PE/PF exposure from the background diet on a per kg bw basis, may be considerably higher in younger population groups as compared to adults due to their higher food consumption per kg bw (EFSA Scientific Committee, 2012). In order to support this assumption, EFSA performed an exposure assessment by using the occurrence data of the food items presented by Biehler et al. (2012) and Olmedilla-Alonso et al. (2021) and combined them with the individual food consumption data of the EFSA Comprehensive Food Consumption Database by using the Dietary Exposure Tool DietEx⁹ (Table 7).

TABLE 7 Occurrence data for PE/PF in food derived from Biehler et al. (2012) and Olmedilla-Alonso et al. (2021), corresponding FoodEx2 items and levels.

	Biehler et al. (2012)	Olmedilla-Alonso et al. (2021)	EFSA DietEx food category and level	Value used by EFSA
mg PE/PF per 100 g edible food
Apricot	9.57	3.43	Apricots (L5)	6.50
Carrot (raw, boiled, canned)	1.97	8.96	Carrots and similar (L3): –Carrots –Baby carrots, –Coloured carrots varieties (L4)	5.46
Grapefruit	0.83	0.16	Grapefruit (L5)	0.50
Grapefruit juice	0.29	n.t.	Grapefruit juice (L4)	0.29
Mandarin	0.30	0.11	Mandarins and similar (L4)	0.20
Melon orange	0.25	n.t.	Melons (L6)	0.25
Orange	0.74	1.01a	Oranges (L5)	0.65
Orange juice	0.00	0.16	Orange juice (L4)	0.16
Peach	0.23	0.06b	Common peaches (L5)	0.15
Pear	0.00	0.03	Pears (L5)	0.02
Peppersc	1.39	n.t	Peppers and similar (L4): –Sweet peppers (L5) –Chilli peppers (L5)	1.39
Quince	n.t.	0.16	Quinces (L5)	0.16
Tomato	1.79	2.03	Tomato (L5)	1.91
Tomato canned	1.79	2.88	Preserved tomato (whole or pieces) L5	2.34
Tomato sauce	1.79	1.17d	Tomato sauces (L4)	1.48
Tomato juice	2.08	2.88	Tomato juice (L4)	2.48
Tomato ketchup	4.52	0.49	Tomato ketchup (L4)	2.51
Watermelon	1.61	0.20	Watermelons (L6)	0.91

Tables 8 and 9 present summary statistics for the whole population (comprising ‘consumers’ and ‘non-consumers’) obtained with the EFSA DietEx Tool, on a per person and per kg bw basis, respectively, using occurrence data reported by Biehler et al. (2012) and Olmedilla-Alonso et al. (2021). Annex A (supporting documents) provides detailed results for all population groups and individual European countries.

TABLE 8 Summary statistics for PE/PF intake estimates in mg/day and using EFSA DietEx.

Population group	Age (years)	No. of studies	Mean intake (mg/day)	P95 intake (mg/day)
Lowesta	Highesta	Lowestb	Highestb
Infants	< 1	12	0.20	1.80	0.98	4.10
Toddlers	1 to < 3	15	0.65	2.23	2.14	4.44
Other children	3 to < 10	19	0.58	2.57	2.06	6.75
Adolescents	10 to < 18	21	0.83	2.62	2.71	6.88
Adults	≥ 18 to 64	22	0.87	3.09	2.76	8.41

TABLE 9 Summary statistics for PE/PF intake estimates in mg/kg bw and using EFSA DietEx.

Population group	Age (years)	No. of studies	Mean intake (mg/kg bw per day)	P95 intake (mg/kg bw per day)
Lowesta	Highesta	Lowestb	Highestb
Infants	< 1	12	0.021	0.215	0.103	0.500
Toddlers	1 to < 3	15	0.053	0.195	0.164	0.418
Other children	3 to < 10	19	0.025	0.119	0.090	0.320
Adolescents	10 to < 18	21	0.015	0.054	0.049	0.149
Adultsc	≥ 18 to 64	22	0.012	0.043	0.041	0.121

The Panel notes that the highest P95 intake estimates of all population groups younger than 18 years of age, are higher than 0.14 mg PE/PF per kg bw, which would be the exposure of adults to PE/PF resulting from the intake of the NF in FS by considering the proposed maximum specification limit of PE/PF. Furthermore, the highest mean intakes estimated for infants (0.215 mg/kg bw) and toddlers (0.195 mg/kg bw) are also higher than the combined exposure of adults coming from the diet (0.043 mg/kg bw) and the NF (0.14 mg/kg bw).

Foods of the two categories ‘ready to eat meal for infants and young children’ and ‘other food for infants and children’ often containing carrots, tomatoes or fruits such as apricots, contributed significantly to the beta-carotene intakes in infants and toddlers (Annex D, 2024; EFSA NDA Panel, 2024). Since these two food categories were not considered in the exposure assessment for PE/PF, the results may underestimate of the PE/PF intake for these youngest population groups for some countries covered in this estimate.

In that Opinion, the Panel noted that for all age groups, main contributors to background beta-carotene intakes are vegetables and vegetable products (mainly carrots, tomatoes, spinach), fruit/vegetable juices and nectars. Since apart from spinach, which does not contain detectable concentrations of PE/PF, all these food items are also main sources for PE/PF, not considering the food categories ‘ready to eat meal for infants and young children’ and ‘other food for infants and children’ may result to an underestimate of the PE/PF intake in the youngest age groups.

The Panel notes that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that there is no evidence that PE/PF exposure from the diet does raise safety concern and therefore considers that the NF at the proposed conditions of use is nutritionally not disadvantageous at the intended use in FS in adults.

Toxicological information

EFSA NDA Panel (2023) on ‘yellow/orange tomato extract’ summarised two genotoxicity studies on the NF, which were conducted in compliance with OECD principles of good laboratory practice (GLP) (OECD, 1997) and in accordance with the test guidelines (TG) No 471 and 487 from the Organisation for Economic Co-operation and Development (OECD) (OECD, 1997, 2014). Both studies were performed with a batch produced from only yellow tomatoes (with batch No 2 presented in Tables 1–5 of the present Opinion) as indicated in the certificates of analyses presented in the study reports. These two genotoxicity studies, together with the nature, source and information on the production process, led the Panel to the conclusion that the test substance was not genotoxic.

The applicant did not provide a 90-day toxicity study. Instead, the applicant referred to a 90-day toxicity study for a previously adopted NF (tomato oleoresin) (EFSA NDA, 2008). The Panel notes that the concentration for the sum of PE and PF in tomato oleoresin assessed in 2008 was lower than in the present NF. The Panel considers that the test material is not representative of the NF and that therefore no conclusions can be drawn from this study on the safety of the NF. Noting the source (i.e. yellow tomato), the production process which does not raise safety concerns, the extensive characterisation of the NF, its intended use and the exposure assessment of PE/PF from the background diet provided and discussed in the ‘nutritional section’, the Panel considers that a subchronic toxicity study with the NF is not necessary to establish its safety.

Allergenicity

According to the specifications, the NF may contain 0.2%–0.6% (w/w) proteins from yellow tomatoes.

Tomato allergy is common and known. The Panel considers that the NF has no greater potential than tomato to trigger allergic reactions under the proposed conditions of use.

DISCUSSION

The NF which is the subject of the application is a carotenoid-rich extract from yellow tomatoes. The extract is produced from the tomato pulp using supercritical CO₂ extraction. In 2023, the Panel concluded that the safety of a yellow-orange tomato extract had not been established under the proposed conditions of use due to concerns related to the intake of lycopene and PE/PF resulting from their concentration in the NF and its proposed uses and use levels (EFSA NDA, 2023). Consequently, the same applicant decided to source only yellow tomatoes and abandoned the use of orange tomatoes. No change other than this limitation of the source, is applied for the production of the NF that is the subject of this assessment, i.e. yellow tomato extract.

As a result, the applicant reduced the maximum specification limits for lycopene from 5 to 0.4 mg/100 g, and for PE/PF from 22 to 10 mg/100 mg of the NF. Furthermore, the applicant limited the intended use of the NF yellow tomato extract to only FS for adults at a maximum daily intake of 100 mg of the NF. The resulting maximum daily exposure to PE/PF and lycopene under such proposed conditions of use of the NF would be 10 mg (or 0.14 mg/kg bw) and 0.4 mg (or 0.0057 mg/kg), respectively, for an adult weighing 70 kg. Regarding lycopene, such exposure is about 1.1% of its ADI established by EFSA (i.e. 0.5 mg/kg bw) (EFSA AFC Panel, 2008). The Panel considers that lycopene exposure from FS at this level does not raise safety concern.

With regards to the PE/PF, the applicant provided two references, which estimated combined daily mean intakes for adults at 2.7 mg and 2.4 mg for Luxemburg (Biehler et al., 2012) and Spain (Olmedilla-Alonso et al., 2021), respectively. An intake of 10 mg PE/PF from 100 mg of the NF would therefore correspond to approximately four times these estimates. EFSA performed an exposure assessment which made use of the occurrence data provided by these two references and the EFSA DietEx tool which uses the individual consumption data of the EFSA comprehensive food consumption database. According to this exercise which included all population age groups, the highest mean and highest P95 intakes per kg bw estimates for PE/PF from the background diet of infants and toddlers are higher than the combined exposure of adults from the background diet and the NF under its proposed use and use levels in food supplements. Noting that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that there is no evidence that PE/PF exposure from background diet is of concern, the Panel considers that the NF is nutritionally not disadvantageous at the intended use in FS in adults.

CONCLUSIONS

The Panel concludes that the NF, yellow tomato extract, is safe under the proposed conditions of use.

Protection of Proprietary data in accordance with Article 26 of Regulation (EU) 2015/2283

The Panel could not have reached the conclusion on the safety of the NF under the proposed conditions of use without the data claimed as proprietary by the applicant, i.e. a bacterial reverse mutation test following GLP and OECD TG 471) and an in vitro micronucleus following GLP and OECD TG 487.

ABBREVIATIONS

• ADI
• acceptable daily intake
• ADME
• absorption, distribution, metabolism and excretion
• AFC
• EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food
• ANS
• EFSA Panel on Food Additives and Nutrient Sources added to Food
• AOAC
• Association of Official Analytical Chemists
• bw
• body weight
• cfu
• colony forming units
• CONTAM
• EFSA Panel on Contaminants
• DietEx
• EFSA Dietetic Exposure tool
• FS
• food supplement
• GC/HRMS
• gas chromatography/high-resolution mass spectroscopy
• GLP
• Good Laboratory Practice
• HACCP
• Hazard Analysis Critical Control Points
• HBGV
• health-based guidance value
• HPLC-DAD
• high-performance liquid chromatography-diode array detector
• HPLC-FD
• high-performance liquid chromatography with fluorescence detection
• HPLC-RI
• high-performance liquid chromatography refractive index detection
• ICP-MS
• inductively coupled plasma mass spectrometry
• ISO
• International Organization for Standardization
• LC–MS/MS
• liquid chromatography–tandem mass spectrometry
• LOQ
• limit of quantification
• NA
• not analysed
• ND
• not detected
• NDA
• EFSA Panel on Nutrition, Novel Foods and Food Allergens
• NOAEL
• no observed adverse effect level
• NF
• novel food
• n.t.
• not tested
• OECD
• Organisation for Economic Co-operation and Development
• P95
• 95th percentile
• PAHs
• polycyclic aromatic hydrocarbons
• PCBs
• polychlorinated biphenyls
• PCDDs
• polychlorinated dibenzo-p-dioxins
• PCDFs
• polychlorinated dibenzo-p-dioxins
• PE/PF
• phytoene and phytofluene
• TG
• Test Guideline
• USP
• United States Pharmacopeia
• WHO-TEFs
• World Health Organization (WHO) toxic equivalent factors
• w/w
• weight per weight

REQUESTOR

European Commission

QUESTION NUMBER

EFSA-Q-2024-00284

COPYRIGHT FOR NON-EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani and Frank Thies.

Appendix

ANNEX A - Estimates of dietary exposure to phytoene and phytofluene for each population group covered by EU dietary surveys

Information provided in this Annex is shown in an Excel file (downloadable at https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.9373#support-information-section).

References

Annex D. (2024). Annex D – EFSA's intake assessment for β‐carotene. Excel 2007 spreadsheet. https://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2024.8814&file=efs28814‐sup‐0004‐Annex‐D.xlsx

Biehler, E., Alkerwi, A., Hoffmann, L., Krause, E., Guillaume, M., Lair, M. L., & Bohn, T. (2012). Contribution of violaxanthin, neoxanthin, phytoene and phytofluene to total carotenoid intake: Assessment in Luxembourg. Journal of Food Composition and Analysis, 25(1), 56–65. https://doi.org/10.1016/j.jfca.2011.07.005

EFSA (European Food Safety Authority). (2021). Administrative guidance for the preparation of applications on novel foods pursuant to article 10 of regulation (EU) 2015/2283. EFSA Supporting Publications, EN‐6488. https://doi.org/10.2903/sp.efsa.2021.EN‐6488

EFSA AFC Panel (EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food). (2008). Scientific Opinion of the panel on food additives, flavourings, processing aids and materials in contact with food on a request from the commission on the safety of use of lycopene as a food colour. EFSA Journal, 2008, 674. https://doi.org/10.2903/j.efsa.2008.674

EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food). (2017). Scientific Opinion on the extension of use of lycopene (E 160d) to certain meat preparations, meat products and fruit and vegetable preparations. EFSA Journal, 15(12), 5064. https://doi.org/10.2903/j.efsa.2017.5064

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain). (2020). Scientific Opinion – Risk assessment of glycoalkaloids in feed and food, in particular in potatoes and potato‐derived products. EFSA Journal, 18(8), 6222, 190 pp. https://doi.org/10.2903/j.efsa.2020.6222

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). (2008). Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on a request from the European Commission on the safety of ‘lycopene oleoresin from tomatoes’. The EFSA Journal, 675, 1–22.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies). (2021). Guidance on the preparation and submission of an application for authorisation of a novel food in the context of regulation (EU) 2015/2283 (revision 1). EFSA Journal, 19(3), 6555. https://doi.org/10.2903/j.efsa.2021.6555

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch‐Ernst, K. I., Maciuk, A., Mangelsdorf, I., HJ, M. A., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Aguilera‐Gómez, M., Cubadda, F., Frenzel, T., … Knutsen, H. K. (2023). Scientific Opinion on the safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 21(5), 7994. https://doi.org/10.2903/j.efsa.2023.7994

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens). (2024). Scientific opinion on the tolerable upper intake level for preformed vitamin A and β‐carotene. EFSA Journal, 22(6). https://doi.org/10.2903/j.efsa.2024.8814

EFSA Scientific Committee. (2012). Guidance on selected default values to be used by the EFSA Scientific Committee, scientific panels and units in the absence of actual measured data. EFSA Journal, 10(3), 2579. https://doi.org/10.2903/j.efsa.2012.2579

OECD (Organisation for Economic Co‐operation and Development). (1997). Test No. 471: Bacterial reverse mutation test. In: OECD guidelines for the testing of chemicals, Section 4: Healtheffects, 11 pp.

OECD (Organisation for Economic Co‐operation and Development). (2014). Test No. 475: Mammalian bone marrow chromosomal aberration test. In: OECD guidelines for the testing of chemicals, Section 4: Health effects, 16 pp.

Olmedilla‐Alonso, B., Benitez‐Gonzalez, A. M., Estevez‐Santiago, R., Mapelli‐Brahm, P., Stinco, C. M., & Melendez‐Martınez, A. J. (2021). Assessment of food sources and the intake of the colourless carotenoids phytoene and phytofluene in Spain. Nutrients, 13, 4436. https://doi.org/10.3390/nu13124436

Unpublished report. (2019). Analysis of effect of multiple oral administration of Lumenato (Golden Tomato) capsules to healthy volunteers on the plasma levels of phytoene, phytofluene, lycopene and zeta‐carotene phytonutrients. Department of Clinical Biochemistry and Pharmacology Faculty of Health Sciences Ben‐Gurion University of the Negev Beer‐Sheva, Israel. Unpublished document.