Safety of UV‐treated oil from yellow mealworm (Tenebrio molitor larvae) 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 UV‐treated oil from yellow mealworm (Tenebrio molitor larvae) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from farmed T. molitor larvae and consists mainly of fat (~99%). It is obtained by mechanical separation and is subsequently exposed to UVB radiation to enhance vitamin D₃ content. UV‐treatment substantially increased vitamin D₃ levels. Under the proposed use levels, the NF represents a significant contributor to vitamin D intake from foods (including the background diet and fortified foods), accounting for up to half of the intake in older children, adolescents, and adults. Combined intakes from foods and the NF remained below the tolerable upper intake level (UL) for all age groups. Analytical data showed that contaminant levels were below regulatory limits established for other foods, and intake estimates indicated that consumption of the NF would not substantially increase overall dietary exposure to undesirable substances. The Panel further notes that there are no safety concerns regarding the stability of the NF. The NF is intended for use as an ingredient in a range of food products, including bakery products, sauces, dairy desserts, and fats. The target population is the general population. Toxicological studies, including newly submitted in vitro genotoxicity tests, did not raise safety concerns. Animal studies indicated that vitamin D₃ from the NF is bioavailable. The intake of the NF is not nutritionally disadvantageous. The Panel notes that allergic reactions may occur upon consumption, due to primary sensitisation or cross‐reactivity with other allergens. The Panel concludes that the NF is safe under the proposed uses and use levels.

1. INTRODUCTION

1.1. Background and Terms of Reference as provided by therequestor

On 24 December 2021, the applicant ‘Nutri'Earth’ submitted a request to the European Commission in accordance with Article 10 of Regulation (EU) 2015/2283 ¹ to authorise the placing on the Union market of “vitamin D3‐containing UV‐treated mealworm oil” as a novel food.

The applicant requests to authorise the use of vitamin D3‐containing UV‐treated mealworm oil as a novel food in a number of foods intended for the general population.

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

On 11 October 2023, in accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Commission asked EFSA to provide a scientific opinion on “vitamin D₃‐containing UV‐treated mealworm oil” as a novel food. The Commission also asked 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 vitamin D₃‐containing UV‐treated mealworm oil as a novel food regarding the proprietary data for which the applicant is requesting data protection.

1.2. Additional information

On 24 November 2020, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) adopted a scientific opinion on the safety of dried yellow mealworm (Tenebrio molitor larva) as NF pursuant to Regulation (EU) 2015/2283. The Panel concluded that the NF is safe for human consumption under the proposed uses and use levels (EFSA NDA Panel, 2021a). Following a favourable opinion of the Standing Committee on Plants, Animals, Food and Feed (Novel Food and Toxicological Safety Section) on 3 May 2021, the European Commission adopted on 1 June 2021 Commission Implementing Regulation (EU) 2021/882 ² authorising the placing on the market of dried yellow mealworm as an NF according to Regulation (EU) 2015/2283.

On 7 July 2021, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) adopted a scientific opinion on the safety of frozen and dried formulations from whole yellow mealworm (Tenebrio molitor larva) as an NF pursuant to Regulation (EU) 2015/2283. The Panel concluded that the NF is safe for human consumption under the proposed uses and use levels (EFSA NDA Panel, 2021b). Following a favourable opinion of the Standing Committee on Plants, Animals, Food and Feed (Novel Food and Toxicological Safety Section) on 30 November 2021, the European Commission adopted on 8 February 2022 Commission Implementing Regulation (EU) 2022/169 ³ authorising the placing on the market of frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) as an NF according to Regulation (EU) 2015/2283.

On 28 March 2023, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) adopted a scientific opinion on the safety of UV‐treated powder of whole yellow mealworm (Tenebrio molitor larva) as an NF pursuant to Regulation (EU) 2015/2283. The Panel concluded that the NF is safe under the proposed uses and use levels (EFSA NDA Panel, 2023a). Following a favourable opinion of the Standing Committee on Plants, Animals, Food and Feed (Novel Food and Toxicological Safety Section) on 20 November 2024, the European Commission adopted on 20 January 2025 Commission Implementing Regulation (EU) 2025/89 ⁴ authorising the placing on the market of UV‐treated powder of whole Tenebrio molitor larvae (yellow mealworm) as an NF according to Regulation (EU) 2015/2283.

2. DATA AND METHODOLOGIES

2.1. Data

The safety assessment of this NF is based on data supplied in the application and information submitted by the applicant following EFSA's requests for supplementary information. During the assessment, the Panel identified additional data which were not included in the application.

Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are listed in Commission Implementing Regulation (EU) 2017/2469 ⁵ .

A common and structured format of the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of an NF application (EFSA NDA Panel, 2021c). As indicated in this guidance, it is the duty of the applicant to provide all 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, 2021c) 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 Article 38 of the Regulation (EC) No 178/2002 ⁶ 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, ⁷ the non‐confidential version of the dossier has been published on Open.EFSA. ⁸

According to Article 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 on the non‐confidential version of the technical dossier from 4 June to 25 June 2024 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 the detailed description of the production process, compositional data, specifications, nutritional information, allergenicity, genotoxicity, and several annexes to the dossier (Appendix C).

2.2. Methodologies

The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel, 2021c) 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 it is not an assessment of the efficacy of the NF with regard to any claimed benefit.

3. ASSESSMENT

3.1. Introduction

The NF subject of the application is a UV‐treated oil derived from Tenebrio molitor larvae (yellow mealworm), an insect species belonging to the family of Tenebrionidae (darkling beetles). The NF falls under the category ‘food consisting of, isolated from, or produced from animals or their parts’, as described in Article 3(2)(v) of Regulation (EU) 2015/2283. The NF is obtained through controlled farming and processing of yellow mealworms and consists predominantly of fat. It is intended for use as an ingredient in a range of food products, including animal and vegetable fats, bakery products, pasta, dairy desserts, and cheese (see Section 3.7.2).l The target population for the NF is the general population.

3.2. Identity of the NF

The NF is a UV‐treated oil obtained from yellow mealworm. The term ‘mealworm’ refers to the larval stage of T. molitor, an insect species belonging to the family of Tenebrionidae (darkling beetles). Another identified scientific synonym is Tenebrio molitor Linnaeus, 1758. Common names for T. molitor larvae or derived products include ‘yellow mealworms’, ‘mealworms’, ‘vers de farine’, ‘Ténébrion meunier’, and ‘mealworm meal’.

The species T. molitor is thought to have originated in the Eastern Mediterranean region (Panagiotakopulu, 2000) but is now widely distributed across the globe due to human colonisation and trade (Panagiotakopulu, 2001). The applicant obtained the initial insect population from an external supplier and subsequently proceeded with the farming of the insects under controlled rearing conditions. The identity of both the initial insect population and those subsequently bred was confirmed by PCR testing.

3.3. Production process

According to the information provided, the NF is produced in line with Good Manufacturing Practice (GMP) and Hazard Analysis Critical Control Points (HACCP) principles. The production process can be divided into three main stages, i.e., farming, harvesting, and post‐harvest processing.

Farming includes mating of the adult insect population and rearing of the larvae. ■■■■■ After hatching, the light yellow‐brown larvae grow for a predefined period in dedicated ■■■■■ containers, compliant with the EU rules for food contact materials. The use of ■■■■■ minimises the risk of plastic ingestion by the larvae (EFSA NDA Panel, 2021a, 2021b). ■■■■■

Yellow mealworms are known to potentially bioaccumulate chemical contaminants such as metals and metalloids, pesticide residues, and other undesirable compounds (e.g., polychlorinated biphenyls (PCBs), dioxins) through feed intake (Bednarska & Swiaztek, 2016; Ghannem et al., 2018; Houbraken et al., 2016; Lindqvist & Block, 1995; Van der Fels‐Klerx et al., 2016; Vijver et al., 2003). The applicant reported that the feed provided to the insects complies with the requirements of Commission Regulation (EU) 2017/1017 on the Catalogue of feed materials. ⁹ ■■■■■

With respect to biological hazards, T. molitor may be susceptible to infections from bacteria, parasites, entomopathogenic fungi, or viruses, particularly under poor hygiene conditions (EFSA NDA Panel, 2021a, 2021b). However, the Panel concludes that the production process steps implemented, and the specification limits set (Section 3.5), mitigate the risk of these biological hazards.

During the rearing of the larvae, ■■■■■ faeces are monitored and removed. At harvest, mechanical sieving is applied to separate larvae from substrate, exuviae, and faeces. A ■■■■■ fasting step follows, allowing the larvae to discard their bowel content. ■■■■■

Post‐harvest begins with freezing of the larvae, followed by killing through boiling. Subsequently, the solid fraction is ■■■■■ separated from the aqueous and lipid fractions. The lipid fraction undergoes filtration to remove tissue residues and is subsequently heated under controlled conditions to reduce microbial load. To enhance the vitamin D₃ content, the heated oil is exposed to UVB radiation. The UV‐treated oil is further filtered and stored in opaque bottles at 10–25°C and 50% relative humidity.

The Panel considers that the current production process is sufficiently described and does not raise safety concerns. Nevertheless, the Panel notes that scale‐up to industrial production levels may introduce additional hazards, such as hydrocarbon contamination (e.g., mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH)), linked to the use of heavier machinery and more complex equipment.

3.4. Compositional data

The applicant provided analytical data on chemical, microbiological and nutritional parameters for multiple batches of the NF produced on a pilot‐scale. The Panel noted that the analyses initially provided were not performed on a consistent set of batches. During the course of the assessment, the applicant reported implementing process improvements, particularly aimed at standardising vitamin D₃ content. In response to EFSA's request, analytical results from five newly produced batches were submitted. The Panel considered these five most recent batches in its assessment. In addition, the applicant provided data for five batches of the mealworm oil before UVB irradiation of proximate parameters, fatty acid profile, vitamin E, D₃, 7‐dehydrocholesterol (7‐DHC), lumisterol₃ and tachysterol₃. Certificates of accreditation for the laboratories that conducted the analyses were also provided. Analyses were performed using methods validated for other food matrices, and for in‐house methods, full descriptions and validation results were provided.

The results of the proximate analyses are presented in Table 1. The NF consists predominantly of fat (99%). The remainder of the NF is composed of carbohydrates and moisture. Analytical data were also provided for five independent batches of the mealworm oil before UV‐treatment; no substantial differences were observed.

TABLE 1.

Proximate analysis of the oil derived from whole yellow mealworm.

Parameter (g/100 g of NF)	Batch number										Analytical method
	Before UV‐treatment					After UV‐treatment (NF)
	#1*	#2*	#3*	#4*	#5*	#1	#2	#3	#4	#5
Crude protein	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	Kjeldahl (N × 6.25) COFRAC 1‐7085
Total fat	97.0	99.8	99.1	99.1	98.4	99.7	99.7	97.6	98.3	99.9	Gravimetry (COFRAC ESSAIS 1‐7219)
Carbohydrates	2.9	0.1	0.8	0.8	1.5	0.2	0.2	2.3	1.6	< 0.1	Calculation a
Moisture	0.08	0.07	0.07	0.08	0.08	0.08	0.08	0.09	0.09	0.09	Thermo‐gravimetry (COFRAC 1‐7085)
Ash	< 0.3	< 0.3	< 0.3	< 0.3	< 0.3	< 0.3	< 0.3	< 0.3	< 0.3	< 0.3	Gravimetry (COFRAC 1‐7219)

Abbreviations: COFRAC, Comité Français d'Accréditation; NF, novel food.

^*Not the novel food.

^a Total carbohydrates = 100 ‐ fat ‐ moisture content.

The fatty acid profile of the NF was analysed in five independent batches of the NF through gas chromatography with flame ionisation detection (GC‐FID) (Appendix A). On average, saturated (SFA), monounsaturated (MUFA), and polyunsaturated fatty acids (PUFA) comprise 24.1%, 47.8% and 26.5% of the NF, respectively. The average content of trans fatty acids (TFA) in the NF is 0.25%. The main fatty acids are oleic acid (C18:1), linoleic acid (C18:2), and palmitic acid (C16:0). Analytical data were also provided for five independent batches of the mealworm oil before UV‐treatment, with no substantial differences being observed.

The applicant provided analytical data on the levels of some vitamins (Table 2) and minerals (Table 3), and, after EFSA's request, added data on calcium, magnesium, manganese, phosphorus, potassium, selenium, and zinc. For vitamins D₃ and E, the applicant has also provided data on five batches of the mealworm oil before UV‐treatment. A substantial increase in the concentration of vitamin D₃ was noted post‐UV treatment. An increase in vitamin E (sum of tocopherols) was also reported. The effect of the UV treatment on vitamin D₃ is discussed in detail in Section 3.4.1.

TABLE 2.

Vitamin content of the NF.

Parameter (unit)	Batch number										Analytical method
	Before UV‐treatment					After UV‐treatment (NF)
	#1*	#2*	#3*	#4*	#5*	#1	#2	#3	#4	#5
Vitamin D3 (μg/100 g NF)	< 0.25	< 0.25	< 0.25	< 0.25	< 0.25	1770	1760	1780	1730	1720	LC‐DAD (EN 12821: 2009 mod.)
Vitamin D2 (μg/100 g NF)	NA	NA	NA	NA	NA	21.2	17.1	18.0	21.3	20.7	LC‐DAD (USP 41/ NF 36 method 1)
Sum of tocopherols (mg/100 g NF)	45.8	50.6	39.0	45.6	44.9	51.8	53.1	50.1	52.9	53.0	LC‐FLD (EN 12822:2014)
α‐Tocopherol (mg/100 g)	7.93	8.90	6.68	7.88	7.78	8.33	8.40	7.95	8.28	8.30
β‐Tocopherol (mg/100 g)	1.32	1.30	0.98	1.25	1.21	1.25	1.37	1.26	1.38	1.35
γ‐Tocopherol (mg/100 g)	27.7	30.4	23.5	27.5	27.1	31.5	32.3	30.6	32.3	32.5
δ‐Tocopherol (mg/100 g)	8.84	9.95	7.84	8.95	8.77	10.7	11.0	10.3	10.9	10.9

Abbreviations: EN, Europäische Norm (European Standard); LC‐DAD, liquid chromatography with diode‐array detection; LC‐FLD, liquid chromatography coupled with fluorescence detector; NA, not analysed; NF, novel food; USP, United States Pharmacopeia.

^*Not the novel food.

TABLE 3.

Mineral content of the NF.

Parameter (mg/100 g of the NF)	Batch number					Analytical method
	#1	#2	#3	#4	#5
Copper	< 0.03	< 0.03	< 0.03	< 0.03	< 0.03	ICP‐MS (COFRAC 1‐1488)
Calcium	< 0.50	< 0.50	< 0.50	< 0.50	< 0.50
Iron	< 0.10	< 0.10	< 0.10	< 0.10	< 0.10
Chromium	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01
Magnesium	< 0.10	< 0.10	< 0.10	0.23	< 0.10
Manganese	< 0.03	< 0.03	< 0.03	< 0.03	< 0.03
Phosphorus	< 0.30	< 0.30	< 0.30	< 0.30	< 0.30
Potassium	< 0.50	< 0.50	< 0.50	< 0.50	< 0.50
Selenium	< 0.02	< 0.02	< 0.02	< 0.02	< 0.02
Zinc	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05

Abbreviations: COFRAC, Comité Français d’ Accréditation; ICP‐MS, inductively coupled‐plasma mass spectrometry; NF, novel food.

Table 4 reports the content of heavy metals in the NF for five independently produced batches, analysed by inductively coupled‐plasma mass spectrometry (ICP‐MS). The Panel notes that the levels of these compounds reported for the NF do not exceed the maximum levels (MLs) established for other foods, as set in Commission Regulation (EU) 2023/915. ¹⁰ In the current EU legislation, no MLs of heavy metals are set for insects and products thereof as food. In addition, similar content levels were previously reported and assessed for other foods derived from whole insects (EFSA NDA Panel, 2021a, 2021b, 2021d, 2021e, 2023a).

TABLE 4.

Heavy metal content in the NF.

Parameter (mg/kg)	Batch number					Analytical method
	#1	#2	#3	#4	#5
Lead	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01	ICP‐MS (COFRAC 1‐1488)
Cadmium	< 0.005	< 0.005	< 0.005	< 0.005	< 0.005
Mercury	< 0.005	< 0.005	< 0.005	< 0.005	< 0.005
Arsenic	< 0.01	< 0.01	< 0.01	< 0.01	< 0.01

Abbreviations: COFRAC, Comité Français d’ Accréditation; ICP‐MS, inductively coupled‐plasma mass spectrometry; NF, novel food.

Additionally, the contents of polycyclic aromatic hydrocarbons (PAHs), dioxins and dioxin‐like polychlorinated biphenyls (PCBs) in the NF were also provided (Table 5). The values reported were lower than the MLs established for various foods in Commission Regulation (EU) 2023/915, and comparable to those previously reported and assessed for other foods derived from whole insects (EFSA NDA Panel, 2021a, 2021b, 2021c, 2021d, 2023a, 2023b). The Panel notes that in the current EU legislation, no MLs for PAHs or dioxins and dioxin‐like compounds are set for insects and products thereof as food.

TABLE 5.

Processing contaminants and halogenated persistent organic pollutants in the NF.

Parameter (unit)	Batch number					Analytical method
	#1	#2	#3	#4	#5
PAHs (μg/kg of NF)
Benzo(b)fluoranthene	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	GC–MS/MS (COFRAC 1‐0287)
Benz(a)anthracene	0.6	< 0.5	< 0.5	< 0.5	< 0.5
Benz(a)pyrene	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5
Chrysene	0.8	0.7	0.7	0.8	0.8
Sum of PAHs	1.3	0.7	0.7	0.8	0.8
Dioxins (ng/kg of NF)
WHO (2005) a PCDD/F + PCB TEQ (lower‐bound)	0.007	0.019	0.008	0.008	0.007	GC–MS/MS (Reg. EU 2017/644 (Food) & EU 2017/771 (Feed))
WHO (2005) PCDD/F + PCB TEQ (medium‐bound)	0.090	0.099	0.091	0.092	0.089
WHO (2005) PCDD/F + PCB TEQ (upper‐bound)	0.174	0.179	0.173	0.176	0.171
Chloropropanediol (μg/kg of NF)
3‐MCPD	< 10	10	< 10	< 10	< 10	GC–MS/MS (DIN EN ISO/IEC 17025:2018)
2‐MCPD	< 10	< 10	< 10	< 10	< 10

Abbreviations: COFRAC, Comité Français d'Accréditation; DIN, Deutsches Institut für Normung (German Institute for Standardisation); EN, Europäische Norm (European Standard); GC–MS/MS, gas chromatography tandem mass spectrometry; IEC, International Electrotechnical Commission; ISO, International Organization for Standardization; MCPD, monochloropropane‐1,2‐diol; NF, novel food; PAHs, polycyclic aromatic hydrocarbons; WHO (2005) PCDD/F + PCB TEQ, sum of polychlorinated dibenzo‐p‐dioxins‐polychlorinated dibenzofurans‐polychlorinated biphenyls expressed as World Health Organization toxic equivalent.

^a Van den Berg et al. (2006).

Regarding processing contaminants, the applicant has provided data on the NF levels of 3‐monochloropropane‐1,2‐diol (3‐MCPD) and 2‐monochloropropane‐1,2‐diol (2‐MCPD), for five independently produced batches with all values below the limit of quantification (LOQ) (< 10 μg/kg) of the analytical method implemented, with the exception of batch #2 (3‐MCPD = 10 μg/kg) (Table 5). The Panel considers that the levels of the analysed processing contaminants do not raise safety concerns.

Table 6 reports the analytical data provided on the levels of total aflatoxins, ochratoxin, deoxynivalenol, fumonisins, and zearalenone in the NF. After EFSA's request, the applicant has also provided information on toxins T‐2 and HT‐2 in five NF batches. The values reported were below the LOQ of the analytical methods implemented and lower than the MLs set for other foods in Commission Regulation (EU) 2023/915. The Panel notes that in the current EU legislation, no MLs of mycotoxins are set for insects or products thereof.

TABLE 6.

Mycotoxins in the NF.

Parameter (μg/kg)	Batch number					Analytical method
	#1	#2	#3	#4	#5
Total aflatoxins a	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5	IAC‐LC‐FLD (COFRAC 1‐0287)
Ochratoxin A	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2
Deoxynivalenol	< 50	< 50	< 50	< 50	< 50	LC–MS/MS (COFRAC 1‐0287)
T‐2	< 20	< 20	< 20	< 20	< 20
HT‐2	< 20	< 20	< 20	< 20	< 20
Sum of T‐2 and HT‐2 a	< 40	< 40	< 40	< 40	< 40
Fumonisins B1	< 200	< 200	< 200	< 200	< 200	LC–MS/MS (DIN EN ISO/IEC 17025:2018)
Fumonisins B2	< 200	< 200	< 200	< 200	< 200
Sum of B1 + B2 a	< 400	< 400	< 400	< 400	< 400
Zearalenone	< 10	< 10	< 10	< 10	< 10

Abbreviations: COFRAC, Comité Français d'Accréditation; DIN, Deutsches Institut für Normung (German Institute for Standardisation); EN, Europäische Norm (European Standard); IAC‐LC‐FLD, immunoaffinity column extraction and liquid chromatography with fluorescence detection; IEC, International Electrotechnical Commission; ISO, International Organization for Standardization; LC–MS/MS, liquid chromatography–tandem mass spectrometry; LOQ, limit of quantification.

^a All individual analytes were < LOQ. Reported sum values represent the sum of the respective LOQs.

Analytical data on several pesticide residue levels were provided for five independently produced batches of the NF. The results showed that, for all residues analysed, the levels were below the respective LOQ of the analytical methods used.

In response to a request from EFSA, the applicant performed a literature review to identify additional relevant substances of potential concern in fresh or dried whole T. molitor larvae and in edible oils. The review covered heavy metals, mycotoxins, pesticides, PAHs, dioxins, PCBs and biogenic amines. No additional compounds of potential concern were identified. The available evidence indicates that the levels reported for certain contaminants were generally low and, where comparisons were possible, within the range or lower than those observed in commonly consumed vegetable oils.

The applicant provided microbiological data on five independently produced batches of the NF (Table 7).

TABLE 7.

Microbiological analysis of the NF.

Parameter (unit)	Batch number					Analytical method
	#1	#2	#3	#4	#5
Enterobacteriaceae (CFU/g)	< 10	< 10	< 10	< 10	< 10	NF V08‐054
Aerobic plate count (CFU/g)	< 4000	< 1000	< 4000	< 4000	< 1000	XP V08‐034
Yeasts and moulds (CFU/g)	< 10	< 10	< 10	< 10	< 10	NF V08‐036
Salmonella (in 25 g)	ND	ND	ND	ND	ND	BRD 07/11‐12/05
Staphylococci coag. positive (CFU/g)	< 100	< 100	< 100	< 100	< 100	NF EN ISO 6888‐1
β‐Glucuronidase‐positive E. coli (CFU/g)	< 10	< 10	< 10	< 10	< 10	NF ISO 16649‐2
Bacillus cereus (CFU/g)	< 100	< 100	< 100	< 100	< 100	Internal Method based on NF EN ISO 7932
Clostridium perfringens (CFU/g)	< 10	< 10	< 10	< 10	< 10	Internal Method based on NF EN ISO 7937:2005
Sulphite reducing anaerobes (CFU/g)	< 10	< 10	< 10	< 10	< 10	Internal Method based on NF V08‐061
Listeria monocytogenes (in 25 g)	ND	ND	ND	ND	ND	AES 10/03–09/00

Abbreviations: BRD, Bacteriology Reference Department; CFU, colony‐forming units; EN, Europäische Norm (European Standard); ISO, International Organization for Standardization; ND, not detected; NF, novel food; XP, Norme expérimentale (Experimental Standard, AFNOR).

3.4.1. The effect of UV treatment on vitamin D₃

The applicant provided data on the levels of vitamin D₃, 7‐dehydrocholesterol (7‐DHC), lumisterol₃ and tachysterol₃ for five NF batches, before and after the UV treatment (Table 8). Information on other sterols is provided in Table 9. For 7‐DHC, which is a precursor of vitamin D₃, the applicant compared its mean content before and after UV treatment and found no statistically significant difference (average reduction of ~4%), suggesting that UV irradiation has little effect on the content of 7‐DHC in the NF. Based on the analytical information provided, the Panel notes that the mean conversion rate of 7‐DHC to vitamin D₃ upon UV treatment is low (~2.4%), while the increase of vitamin D₃ was substantial (from < 0.25 to an average of 1752 μg/100 g). However, the reduction in 7‐DHC content cannot be fully explained by vitamin D₃ formation alone, as part of the 7‐DHC was also converted into vitamin D₃ photo‐isomers (Table 8). The analytical results indicated that tachysterol₃ was more abundant than lumisterol₃ after UV treatment.

TABLE 8.

Vitamin D₃, 7‐DHC, lumisterol₃ and tachysterol₃ levels in the mealworm oil before and after UV‐treatment.

Parameter (unit)	Batch number										Analytical methods
	Before UV‐treatment					After UV‐treatment
	#1*	#2*	#3*	#4*	#5*	#1	#2	#3	#4	#5
Vitamin D3 (μg/100 g)	< 0.25	< 0.25	< 0.25	< 0.25	< 0.25	1770	1760	1780	1730	1720	LC‐DAD (EN 12821: 2009)
7‐DHC (mg/kg)	698	752	746	725	702	664	725	724	696	670	GC (NF EN ISO 12228‐1)
Lumisterol3 (μg/100 g)	< 50	< 50	< 50	< 50	< 50	< 50	< 50	< 50	< 50	< 50	SPE/HPLC‐DAD (internal method)
Tachysterol3 (μg/100 g)	< 50	< 50	< 50	< 50	< 50	819.9	803.9	857.3	768.4	768.6

Abbreviations: DHC, dehydrocholesterol; EN, Europäische Norm (European Standard); GC, gas chromatography; HPLC‐DAD, high‐performance liquid chromatography with diode array detection; ISO, International Organization for Standardization; LC‐DAD, liquid chromatography with diode array detection; SPE, solid phase extraction.

^*Not the novel food.

TABLE 9.

Other sterols in the NF.

Parameter (g/100 g)	Batch number					Analytical method
	#6	#7	#8	#9	#10
Brassicasterol	0.03	0.03	0.03	0.03	0.03	GC‐FID (AOCS Ch 6–91:2017)
Campesterol	0.01	0.01	0.01	0.01	0.01
Campestanol	0.01	0.01	0.01	0.01	0.01
Sitostanol	0.01	0.01	0.01	0.01	0.01
Stigmasterol	0.00	0.00	0.00	0.00	0.00
β‐Sitosterol	0.03	0.03	0.03	0.03	0.03
Cholesterol	0.16	0.16	0.16	0.16	0.16
Total sterols	0.26	0.27	0.26	0.27	0.27

Abbreviations: AOAC, American Oil Chemists' Society; GC‐FID, gas chromatography coupled with flame ionisation detector.

The Panel notes a substantial increase in vitamin D₃ content in the NF following UV‐treatment, with an also marked rise in its photo‐isomer tachysterol₃, while lumisterol₃ formation remained negligible.

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

3.4.2. Stability

The NF has a proposed shelf life of 6 months. It is intended to be stored at room temperature (18–22°C) in an environment with humidity below 65%. To prevent oxidation from exposure to air and light, the NF is kept in hermetically sealed packaging. The applicant investigated the NF stability in five batches. The tests were carried out at normal storage conditions during a period of 6 months. The batches were analysed for lipid oxidation (peroxide value, acid value, and free fatty acids levels) and microbiological parameters. Following EFSA's request, the applicant also provided analytical data on additional lipid oxidation parameters (p‐anisidine and totox values). The results of the stability testing are presented in Table 10 and in Table 11.

TABLE 10.

Oxidative status of fats in the NF during the proposed shelf life.

Parameter (unit)	Batch number										Analytical method
	#1		#2		#3		#4		#5
Time (months)	T0	T6	T0	T6	T0	T6	T0	T6	T0	T6
p‐Anisidine value	< 1	< 1	< 1	< 1	< 1	< 1	< 1	< 1	< 1	< 1	Spectrophotometry (ISO 6885:2016)
Peroxide value (meq O2/kg fat)	3.5	3.9	3.6	4.0	3.7	3.9	3.7	3.9	3.7	3.9	Titrimetry (NF EN ISO 660)
TOTOX value	8.0	8.8	8.2	9.0	8.4	8.8	8.4	8.8	8.4	8.8	Calculation a
Acid value (mg KOH/g)	0.47	0.49	0.47	0.49	0.47	0.49	0.47	0.49	0.47	0.49	Titrimetry COFRAC 1–7085
Free FA as oleic acid (%)	0.23	0.25	0.24	0.25	0.23	0.25	0.23	0.25	0.24	0.25
Free FA as lauric acid (%)	0.17	0.17	0.17	0.17	0.17	0.17	0.17	0.18	0.17	0.17

Abbreviations: COFRAC, Comité Français d'Accréditation; EN, Europäische Norm (European Standard); FA, fatty acid; ISO, International Organization for Standardization; NF, novel food.

^a TOTOX value = 2 × peroxide value + p‐anisidine value.

TABLE 11.

Microbiological status of the NF during the proposed shelf life.

Parameter (unit)	Batch number										Analytical method
	#1		#2		#3		#4		#5
Time (months)	T0	T6	T0	T6	T0	T6	T0	T6	T0	T6
Enterobacteriaceae (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	NF V08‐054
Aerobic plate count (CFU/g)	< 4000	< 1000	< 1000	< 1000	< 4000	< 1000	< 4000	< 1000	< 1000	< 1000	XP V08‐034
Yeasts and moulds (CFU/g)	< 10	< 40	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	NF V08‐036
Salmonella (in 25 g)	ND	ND	ND	ND	ND	ND	ND	ND	ND	ND	BRD 07/11–12/05
Staphylococci coag. positive (CFU/g)	< 100	< 100	< 100	< 100	< 100	< 100	< 100	< 100	< 100	< 100	NF EN ISO 6888‐1
β‐Glucuronidase‐positive E. coli (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	NF ISO 16649‐2
Listeria monocytogenes (in 25 g)	ND	ND	ND	ND	ND	ND	ND	ND	ND	ND	AES 10/03–09/00
Clostridium perfringens (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	NF EN ISO7937:2005
Bacillus cereus (CFU/g)	< 100	< 100	< 100	< 100	< 100	< 100	< 100	< 100	< 100	< 100	NF EN ISO 7932
Sulphite‐reducing anaerobes (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	NF V08‐061 plates

Abbreviations: BRD, Bacteriology Reference Department; CFU, colony‐forming units; EN, Europäische Norm (European Standard); ISO, International Organization for Standardization; ND, not detected.

Over a 6‐month period, the p‐anisidine values remained consistently low (< 1) across all batches, indicating minimal secondary oxidation. Peroxide values showed a slight increase over time (from approximately 3.5–3.7 meq O₂/kg fat at T0 to 3.9–4.0 meq O₂/kg fat at T6), suggesting minor primary oxidation. Acid values and free FA levels remained stable, with only negligible changes, indicating minimal hydrolytic degradation. Overall, the data suggested good oxidative and hydrolytic stability of the NF. Data were also provided for the mealworm oil at T0 prior to UV treatment, showing lower peroxide values (ranging from 2.1 to 2.5), which might potentially indicate an increase, albeit modest, in fat oxidation resulting from the exposure to UVB light. Other oxidative parameters were comparable to those observed in NF following UV‐treatment.

The Panel notes that the peroxide and p‐anisidine values were found to remain within the specifications (≤ 4 meq O₂/kg fat and < 1, respectively) when samples were stored under the proposed conditions.

The microbiological stability testing of the NF showed consistent stability over a period of 6 months. All tested parameters remained within the specification limits.

The Panel notes that the microbiological values did not exceed the given specification limits after 6 months of storage under the proposed storage conditions.

3.4.2.1. Stability in different matrices for intended use

The NF is intended for use as an ingredient in several food categories. To assess its behaviour during additional processing, the applicant provided data on the formation of acrylamide and chloropropanols (3‐MCPD and 2‐MCPD) under different baking conditions. A cake containing 1% NF was baked at 160°C for 55 minutes and at 180°C for 45 minutes. Results were compared to a control cake prepared without the NF (180°C for 45 min). Acrylamide levels in cakes containing the NF were not higher than those in the control. Concentrations of 2‐ and 3‐MCPD were below the LOQ (10 μg/kg) in all preparations.

Microbiological analyses were conducted on a fruit puree containing 0.5% of the NF to evaluate the stability of the NF in a wet matrix over its six‐month shelf life. The preparation involved heating the fruit in water at 100°C for 35 minutes, blending it with 0.5 g of NF per 100 g of puree, and placing the mixture in aluminium trays. These trays were sterilised at 110–120°C and stored at room temperature for 6 months. Five trays, each containing a different batch of the NF, were tested. The Panel notes that the resulting microbiological values did not raise any safety concerns.

The Panel further notes that the food items containing the NF have to comply with currently established legislative limits, such as microbiological levels set in Regulation (EC) No 2073/2005 ¹¹ and the benchmark levels of acrylamide in bakery products established by Regulation (EU) 2017/2158. ¹² The stability data on microbial contamination in the fruit puree tested did not raise safety concerns at the end of the shelf life. Provided that the NF specifications are met at the end of the shelf life, and that products containing the NF as an ingredient are compliant with respective legislative limits on processing contaminants, the stability data do not raise safety concerns.

The Panel considers that the data provided sufficient information with respect to the stability of the NF.

3.5. Specifications

The specifications of the NF are indicated in Table 12.

TABLE 12.

Specifications of the NF.

Description: UV‐treated yellow mealworm oil
Source: yellow mealworm (Tenebrio molitor larvae)
Parameter	Unit	Specification
Appearance	–	Yellow liquid oil
Peroxide value	meq O2/kg fat	≤ 4
ρ‐Anisidine value	–	≤ 1
Moisture	g/100 g	0.08–0.09
Ashes	g/100 g	< 0.3
Crude protein (N × 6.25)	g/100 g	< 0.5
Total fat	g/100 g	97.6–99.9
Vitamin E	mg/100 g	50.1–53.1
Vitamin D3	μg/100 g	1720–1780
Lead	mg/kg	≤ 0.01
Cadmium	mg/kg	≤ 0.005
Mercury	mg/kg	≤ 0.005
Arsenic	mg/kg	≤ 0.05
Dioxin + dioxin‐like PCB (WHO 2005 TEQ with LQ)	pg/g fat	0.18–2.3
Microbiological
Enterobacteriaceae	CFU/g	≤ 10
TAMC	CFU/g	≤ 4000
TYMC	CFU/g	≤ 10
Salmonella spp.	in 25 g	Not detected
Coagulase‐positive staphylococci	CFU/g	≤ 100
β‐Glucuronidase‐positive Escherichia coli	CFU/g	≤ 10
Bacillus cereus	CFU/g	≤ 100
Sulphite‐reducing anaerobes	CFU/g	< 10
Clostridium perfringens	CFU/g	< 10
Listeria monocytogenes	in 25 g	Not detected
Mycotoxins
Aflatoxins B1 + B2, G1 + G2	μg/kg	≤ 0.5
Ochratoxin A	μg/kg	≤ 0.2
Deoxynivalenol	μg/kg	≤ 50
Zearalenone	μg/kg	≤ 10
T2	μg/kg	≤ 20
HT‐2	μg/kg	≤ 20
Fumonisin B1 + B2	μg/kg	≤ 400

Abbreviations: CFU, colony‐forming units; PCB, polychlorinated biphenyls; TAMC, total aerobic mesophilic count; WHO 2005 TEQ with LQ, toxic equivalents expressed as World Health Organization toxic equivalent; TYMC, total yeast and mould count.

The Panel considers that the information provided on the specifications of the NF is sufficient and does not raise safety concerns.

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

There is no documented history of use of the NF. The source of the NF is the yellow mealworm, consumed as part of the traditional diet or for medicinal purposes in some non‐EU countries such as Thailand, China, and Mexico (Feng et al., 2018; Hanboonsong et al., 2013; Ramos‐Elorduy, 1997; Ramos‐Elorduy, 2009; Ramos‐Elorduy & Moreno, 2004).

3.7. Proposed uses and use levels, and anticipated intake

3.7.1. Target population

As the NF is intended to be used as an ingredient in several food categories, the NF can be consumed by any groups of the population. Therefore, the target population is the general population, and the safety data and the exposure assessment shall cover all population groups (Commission Implementing Regulation (EU) 2017/2469, article 5(6)).

3.7.2. Proposed uses and use levels

The NF is proposed to be used as an ingredient in several food products. The food categories defined using the FoodEx2 hierarchy (EFSA, 2015) and the maximum use levels are reported in Table 13.

TABLE 13.

Food categories and maximum use levels intended by the applicant.

FoodEx2 level	FoodEx2 code	Food category	Max use level (g NF/100 g)
2	A0F3D	Animal and vegetable fats/oils	0.1
2	A004V	Bread and similar products	0.1
2	A00CV	Breakfast cereals	0.1
2	A02QE	Cheese	0.1
2	A04QN	Condiments (including table‐top formats)	0.1
2	A02PT	Dairy dessert and similar	0.05
2	A03VB	Dishes, incl. ready to eat meals (excluding soups and salads)	0.05
2	A039B	Fat emulsions and blended fats	0.1
2	A009T	Fine bakery wares	0.1
2	A026J	Meat specialties	0.1
2	A04QT	Pasta, doughs and similar products	0.1
2	A01ML	Processed fruit products	0.1
2	A00ZA	Processed or preserved vegetables and similar	0.05
2	A0EQE	Savoury extracts and sauce ingredients	0.1
2	A00ZS	Starchy roots and tubers	0.05

3.7.3. Anticipated intake of the NF

EFSA performed an intake assessment of the anticipated daily intake of the NF based on the applicant's proposed uses and maximum proposed use levels (Table 13), using the EFSA Dietary Exposure (DietEx) Tool, ¹³ which is based on individual data from the EFSA Comprehensive European Food Consumption Database (EFSA, 2011). The lowest and highest means and 95th percentiles of the anticipated daily intake of the NF (on a mg/kg body weight (bw) basis and as mg per day), among the EU dietary surveys, are presented in Tables 14 and 15.

TABLE 14.

Intake estimate of the NF resulting from its use as an ingredient in the intended food categories at the maximum proposed use levels in mg/kg bw per day.

Population group	Age (years)	Mean intake (mg/kg bw per day)		P95 intake (mg/kg bw per day)
		Lowest a	Highest a	Lowest b	Highest b
Infants	< 1	2.7	13.5	10.8	40.7
Young children c	1 to < 3	8.7	20.0	15.2	38.0
Other children	3 to < 10	6.9	16.4	11.2	28.9
Adolescents	10 to < 18	3.0	8.8	5.0	15.6
Adults d	≥ 18	2.7	6.3	5.2	12.1

Abbreviations: bw, body weight; NF, novel food; P95, 95th percentile.

^a Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest averages observed among all EU surveys are reported in these columns.

^b Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest P95^h observed among all EU surveys are reported in these columns (P95 based on less than 60 individuals are not considered).

^c Referred to as ‘toddlers’ in the EFSA food consumption comprehensive database (EFSA, 2011).

^d Includes elderly, very elderly, pregnant and lactating women.

TABLE 15.

Intake estimate of the NF resulting from its use as an ingredient in the intended food categories at the maximum proposed use levels in mg per day.

Population group	Age (years)	Mean intake (mg/day)		P95 intake (mg/day)
		Lowest a	Highest a	Lowest b	Highest b
Infants	< 1	24.1	95.9	85.9	288.9
Young children c	1 to < 3	86.7	238.2	150.4	410.0
Other children	3 to < 10	127.1	363.9	200.0	581.1
Adolescents	10 to < 18	160.5	411.5	254.3	753.1
Adults d	≥ 18	198.2	444.5	365.0	841.8

Abbreviations: bw, body weight; NF, novel food; P95, 95th percentile.

^a Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest averages observed among all EU surveys are reported in these columns.

^b Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest P95 observed among all EU surveys are reported in these columns (P95 based on less than 60 individuals are not considered).

^c Referred to as ‘toddlers’ in the EFSA food consumption comprehensive database (EFSA, 2011).

^d Includes elderly, very elderly, pregnant, and lactating women.

The estimated daily intake of the NF for each population group from each EU dietary survey is available in the excel file annexed to this scientific opinion (under supporting information).

3.7.4. Estimate of exposure to undesirable substances

Based on the highest P95 intake estimates (Table 14), EFSA calculated the exposure to undesirable substances (e.g. heavy metals, mycotoxins) from the NF across all population groups. The specification limits (Table 12) were used as maximum values for the substances considered. Where no specification limits were proposed for a substance of potential concern, the highest values reported in the analysed batches were used.

The Panel considers that consumption of the NF under the proposed uses and use levels does not substantially contribute to the overall dietary intake of undesirable substances.

3.8. Absorption, distribution, metabolism, and excretion (ADME)

The applicant has conducted two studies related to the bioavailability of vitamin D₃ in mealworm oil. The first study assessed the intestinal lymphatic absorption of vitamin D₃ derived from a ‘Tenebrio molitor mealworm oil rich in vitamin D₃’ in rats. The Panel notes that the vitamin D₃ concentration in this mealworm oil (25 μg/mL) is different from that of the NF. Rats received by gavage doses of the mealworm oil standardised to deliver either 0, 25 or 50 μg of vitamin D₃ per rat. Lymph was collected over 6 h post‐administration, and vitamin D₃ levels were quantified using high‐performance liquid chromatography (HPLC). The intestinal absorption efficiency of vitamin D₃ from the mealworm oil, expressed as a percentage relative to a lipid tracer assumed to have an absorption rate of 100% was around 22%. ■■■■■

The Panel considers that these studies in rats indicate intestinal absorption and systemic bioavailability of vitamin D₃ from the NF.

3.9. Nutritional information

Analytical data on the nutrient composition of the NF, including the fatty acid profile (Appendix A), sterols, minerals, and vitamins, have been provided for several batches of the NF (Section 3.4). The NF is composed almost entirely of lipids (~99%), mainly in the form of MUFAs (47.8%), followed by PUFAs (26.5%) and SFAs (24.1%). The average level of TFA in the NF is 0.3%. The FA profile of the NF indicates that oleic acid is the predominant compound (Appendix A). The Panel notes that, under the proposed conditions of use, the NF's contribution to overall fat intake is small (< 1 g/day).

The estimated average content of vitamin D₃ in the NF is 1752 μg/100 g (Section 3.4). The information on its bioavailability is presented in Section 3.8.

3.9.1. Anticipated intake of vitamin D₃ from the NF used as a food ingredient, and combined vitamin D intake from other dietary sources

EFSA performed an intake assessment of the anticipated daily intake of vitamin D₃ from the NF based on the applicant's proposed uses and maximum proposed use levels of the NF (Table 13), using individual data from the EFSA Comprehensive European Food Consumption Database (EFSA, 2011). The higher bound of the specification limit for vitamin D₃ (Table 12) was used as the vitamin D₃ content present in the NF. The lowest and highest mean and 95th percentile anticipated daily intakes of vitamin D₃ from the NF (in μg/day), among the EU dietary surveys, are presented in Table 16. The estimated highest mean intake of vitamin D₃ resulting from the consumption of the NF ranged from 1.71 μg/day in infants to 7.91 μg/day in adults, including the elderly, very elderly, and pregnant and lactating women.

TABLE 16.

Intake estimates of vitamin D₃ resulting from the use of the NF as an ingredient in the intended food categories at the maximum proposed use levels (μg/day).

Population group	Age (years)	Mean intake		P95 intake
		Lowest a	Highest a	Lowest b	Highest b
Infants	< 1	0.43	1.71	1.53	5.14
Young children c	1 to < 3	1.54	4.24	2.68	7.30
Other children	3 to < 10	2.26	6.48	3.56	10.34
Adolescents	10 to < 18	2.86	7.32	4.53	13.41
Adults d	≥ 18	3.53	7.91	6.50	14.98

Abbreviations: NF, novel food; P95, 95th percentile.

^a Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest averages observed among all EU surveys are reported in these columns.

^b Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest P95 observed among all EU surveys are reported in these columns (P95 based on less than 60 individuals are not considered).

^c Referred as ‘toddlers’ in the EFSA food consumption comprehensive database (EFSA, 2011).

^d Includes elderly, very elderly, pregnant, and lactating women.

The combined intake of vitamin D from the NF (vitamin D₃) and other dietary sources is presented in Table 17. These intake estimates were calculated by adding the NF contribution (as estimated by EFSA in Table 16) to the highest intake levels from other food sources, as reported in the EFSA NDA Panel update of the tolerable upper intake level for vitamin D for infants (EFSA NDA Panel, 2018) and the scientific opinion on the tolerable upper intake level for vitamin D (EFSA NDA Panel, 2023b).

TABLE 17.

Estimated vitamin D intake from the background diet, fortified foods, and the NF and tolerable upper intake levels by population group (μg/day).

Population group	Highest P95 vitamin D intake from the background diet a	Highest P95 vitamin D intake from the background diet + FF b	Highest P95 vitamin D3 intake from the NF c	Total vitamin D intake (background diet + NF)	Total vitamin D intake (background diet + FF + NF)	UL (EFSA NDA Panel, 2018, 2023b) d
Infants (< 12 months) e	16.9	22.2	5.14	22.0	27.3	35
Young children (1 to < 3 years) f	9.1	11.7	7.3	16.4	19.0	50
Other children g (3 to < 10 years)	10.1	11.7	10.3	20.4	22.0	50
Adolescents h (10 to < 18 years)	11.9	13.1	13.4	25.3	26.5	100
Adults i (≥18 years)	16.1	19.5	15.0	31.1	34.5	100

Abbreviations: FF, fortified foods; NF, novel food; P95, 95th percentile; UL, tolerable upper intake level.

^a Excluding food fortification and food supplements. Data was retrieved from EFSA NDA Panel (2018) for infants and EFSA NDA Panel (2023b) for other population groups.

^b Combined intakes of vitamin D from the background diet and fortified foods. The highest P95 reported for toddlers is used for children 3–10 years, as intake estimates for this specific age category were not available. Data was retrieved from EFSA NDA Panel (2018) for infants and EFSA NDA Panel (2023b) for other population groups.

^c Intakes are assessed for all EU dietary surveys available in the food comprehensive database on 5/2/2024. The lowest and the highest P95 observed among all EU surveys are reported in these columns (P95 based on less than 60 individuals are not considered).

^d Upper tolerable intake levels for vitamin D are expressed as μg vitamin D equivalents (VDE)/day as described by the EFSA NDA Panel (2023b).

^e Intakes are assessed separately for formula consumers and non‐formula consumers; the maximum intake among these subpopulations is reported in the Table. P95 values were derived only for infants 4–12 months old.

^f Referred as ‘toddlers’ in the EFSA food consumption comprehensive database (EFSA, 2011).

^g Intakes are assessed separately for young (3 to < 7 years) and older children (7 to < 10 years); the maximum intake among these subpopulations is reported in the table.

^h Intakes are assessed separately for young (10–14 years and old adolescent [14–18 years]); the maximum intake among these subpopulations is reported in the table.

ⁱ Intakes are assessed separately for adults [18–65 years], elderly [65–75 years] and very elderly [≥ 75 years], pregnant and lactating women; the maximum intake among these subpopulations is reported in the table.

For infants, data on vitamin D intake for high consumers were available only for 4‐12‐month‐olds and were estimated by EFSA using composition data from the EFSA nutrient composition database and individual consumption data from national surveys from six European countries (EFSA NDA Panel, 2018). In addition to the vitamin D provided by infant formula or follow‐on formula, the intake from complementary foods was considered, including foods naturally containing vitamin D and fortified foods. Among this age group, the combined intake of vitamin D from the NF and the background diet, including fortified foods, was 27.3 μg/day. The Panel notes that this value remains below the tolerable upper intake level (UL) of 35 μg/day for infants aged 6 to < 12 months, as established by EFSA (EFSA NDA Panel, 2018). However, since a daily oral vitamin D supplementation of 10 μg is generally recommended for all infants during the first year of life (ESPGHAN Committee on Nutrition, Braegger et al., 2013, cited in EFSA NDA Panel, 2016a), there is a potential risk of exceeding the UL if such supplementation is used in addition to the intake from the diet, including fortified foods, and the NF. Estimated vitamin D intakes in young children and other children were 19.0 and 22.0 μg/day, respectively, both remaining within the UL of 50 μg/day (EFSA NDA Panel, 2023b). Among adolescents and adults, intakes reached 26.5 and 34.5 μg/day, respectively, also below the UL of 100 μg vitamin D equivalents (VDE) per day for these groups (EFSA NDA Panel, 2023b).

Regarding other vitamins and minerals, considering the higher bound of the specification limits (Table 12), or, where no limits are defined, the highest levels reported in Tables 2 and 3 (Section 3.4), and the estimated 95th percentile of daily intake of the NF (Table 15), the Panel concludes that none of the existing ULs or safe levels of intake for the analysed micronutrients are expected to be exceeded from the NF intake alone, for any population group.

Taking into account the composition of the NF and the proposed conditions of use, the Panel considers that the consumption of the NF is not nutritionally disadvantageous.

3.10. Toxicological information

The toxicological profile of T. molitor larvae has been previously assessed by the Panel (EFSA NDA Panel, 2021a, 2021b, 2025). The Panel noted that T. molitor larvae should be reared separately from the adults since it has been reported that T. molitor adults may excrete potentially toxic substances as part of their defence mechanisms (Attygalle et al., 1991; Brown et al., 1992; Ladisch et al., 1967). The Panel also assessed toxicological studies available in the literature (in vitro and in vivo genotoxicity, acute, subacute and subchronic toxicity) with freeze‐dried T. molitor larvae as the testing material (Han et al., 2014; Han et al., 2016).

The applicant referenced an acute and a subacute toxicity study (28‐day) from the literature (Alves et al., 2019). In the acute study, administration of 5000 mg/kg bw of T. molitor (TM) oil did not result in mortality or any substantial changes in safety‐related parameters. In the subacute study, no statistically significant dose‐related adverse effects were observed by the authors in either of the test groups (125 and 250 mg/kg bw), compared to the control group. The Panel considers the study of limited relevance for this risk assessment, as the test material in Alves et al. (2019) was a lipid fraction obtained by solvent extraction and is therefore not representative of the NF, which is a UV‐treated TM oil obtained by mechanical means.

Moreover, the applicant referred to several patents (from South Korea) and certain feed efficacy studies. The Panel notes the limited relevance of this evidence for the risk assessment, both in terms of the test materials used and the design and scope of the studies (e.g., not designed to assess safety or lacking safety‐relevant endpoints).

Regarding the use of UVB radiation in the production process, the UV‐treatment leads to a substantial increase in the content of vitamin D₃‐photoisomer, tachysterol₃, as reported in Section 3.4.1. Recent research has shown that tachysterol₃ undergoes enzymatic hydroxylation by CYP11A1 and CYP27A1, producing 20S‐hydroxytachysterol₃ [20S(OH)T₃] and 25(OH)T₃ (Slominski et al., 2022). The Panel notes that current evidence is insufficient to conclude whether these metabolites have a biological role.

Taking into account the production process and the composition of the NF, the Panel noted that the NF contains approximately three times the fat contained in the previously assessed UV‐treated whole yellow mealworm powder (EFSA NDA Panel, 2023a). The Panel considers that subchronic toxicity studies are not required. However, the applicant was requested to conduct the standard in vitro genotoxicity test battery using the NF as the test material.

3.10.1. Genotoxicity

No genotoxicity studies using the NF, or any relevant test material, were initially provided by the applicant or identified in the literature. For fully characterised mixtures, a component‐based approach is recommended, in which each component is individually assessed for its genotoxic potential (EFSA Scientific Committee, 2019). The NF is a complex mixture that cannot be fully characterised. Based on the currently available evidence, no specific components of the NF have been identified as raising genotoxicity‐related concerns. Following the EFSA request for additional genotoxicity testing of the NF, the applicant submitted the studies described below.

A preliminary solubility test showed that the NF was insoluble in dimethyl sulfoxide (DMSO) and ethanol, but soluble in acetone at 1002.5 mg/mL.

To evaluate the potential of the NF to induce gene mutations, a Bacterial Reverse Mutation assay (Ames test) was carried out following OECD TG 471 (1997, corrected in 2020), in a study claimed to be compliant with good laboratory practice (GLP). Two independent experiments were conducted in the presence and absence of metabolic activation, applying the plate incorporation and pre‐incubation methods, with five Salmonella Typhimurium strains (TA98, TA100, TA1535, TA1537, TA102) (GenEvolutioN, 2024a). The test item was formulated in acetone and tested using at least seven concentrations ranging from 5 to 5000 μg/plate. Precipitation, in the form of droplets not interfering with the analysis, was observed at 500 μg/plate and above. Exceptions were strains TA1535 and TA1537, showing precipitate starting from 300 μg/plate in the absence of metabolic activation. No toxicity, indicated by a reduction in the background bacterial lawn, was observed in any tester strains and experimental conditions. No biologically relevant changes in the number of revertant colonies were induced by the test item compared to the vehicle control under any experimental condition, and their number remained within historical control ranges. The Panel therefore concludes that the NF did not induce gene mutations in bacteria under the experimental conditions employed in this study.

To evaluate the potential of the NF to induce chromosomal damage, an in vitro mammalian cell micronucleus (MN) test was performed with human peripheral blood lymphocytes following OECD TG 487 (2016, corrected 2023), in a study claimed to be GLP‐compliant (GenEvolutioN, 2024b). The maximum concentration used (2 μg/mL) was limited by precipitation, visible as ‘droplets on the side of the treatment tube’. Three concentrations of the test item (corresponding to 500, 1000, 2000 μg/mL) were used applying a short treatment (3 + 21 h of recovery) in the presence and absence of metabolic activation and a continuous treatment (24 + 0 h of recovery) without metabolic activation. Cytotoxicity up to 32% was observed under short treatment in the presence of metabolic activation. The frequency of micronucleated binucleated (MNBN) cells in treated cultures was comparable with vehicle control cultures across all the experimental conditions and fell within historical control ranges. No dose–response trend was observed. The Panel notes that the test item was not diluted in a vehicle (solvent), but was directly pipetted into the culture medium. In response to EFSA's request for clarification, the applicant explained that this approach was necessary due to the limited solubility of the NF in commonly used and compatible vehicles. To attempt even distribution of the test item among cells, mixing procedures (i.e., vortexing) were applied. Additionally, the use of a suspension cell system (cultured human peripheral blood lymphocytes) was employed to facilitate a uniform exposure. The Panel notes the limitations of the MN assay, in particular uncertainties regarding even distribution and the partitioning of the NF in the culture medium, linked to the absence of a vehicle. In view of these uncertainties due to methodological limitations, the Panel considers the MN test conducted to provide supportive rather than definitive evidence.

However, taking into account the results of the Ames test, the fact that no substances raising genotoxicity‐related concerns were identified in the NF or from the literature, as well as the safety of products derived from the NF source (T. molitor larvae) as illustrated in previous assessments and published studies, the Panel concludes that there are no concerns regarding the genotoxicity of the NF.

3.11. Human data

The applicant did not provide any human studies conducted with the NF or its source. No human studies were retrieved from the literature search.

3.12. Allergenicity

The Panel has previously considered that the consumption of the NF source (yellow mealworm) may trigger primary sensitisation to yellow mealworm proteins. The Panel has also considered that allergic reactions may occur in subjects allergic to crustaceans, molluscs, and dust mites due to cross‐reactivity. Furthermore, the Panel has noted that additional allergens may end up in the NF, if these allergens are present in the substrate fed to the insects (e.g., gluten). This may include allergens listed in Annex II of Regulation (EU) No 1169/2011 (EFSA NDA Panel, 2021a, 2021b).

The Panel considers that the allergenicity risk is not expected to be greater compared to that associated with the consumption of non‐UV‐treated dried yellow mealworm and UV‐treated yellow mealworm powder. The additional UV treatment is not expected to alter the allergenicity risk.

4. DISCUSSION

The NF subject of the application is a UV‐treated oil from yellow mealworm. The production process is sufficiently described. The concentrations of contaminants depend mainly on the occurrence of these substances in the insect feed. The Panel notes that the chemical and microbiological values of the analysed batches do not exceed the specification limits upon production and during the proposed shelf‐life of 6 months. The applicant intends to market the NF as an ingredient in several food products, with the target population being the general population. The highest intake estimates of the NF result for infants, ranging from 10.8 to 40.7 mg NF/kg bw per day at the 95th percentile. The Panel notes that consumption of the NF under the proposed uses and use levels does not contribute substantially to the total dietary exposure of the population to the analysed undesirable substances (e.g., heavy metals, mycotoxins). Regarding vitamin D₃, the Panel notes that the evidence provided demonstrates bioavailability of vitamin D₃ from the NF. None of the existing ULs for the analysed micronutrients, including vitamin D, are exceeded at the proposed uses and use levels.

The Panel notes limitations in the assessment of potential combined exposure to vitamin D from the NF and other dietary sources. The assessment does not account for potential contributions from other authorised NFs with enhanced vitamin D content, such as UV‐treated bread (EFSA NDA Panel, 2015), UV‐treated milk (EFSA NDA Panel, 2016b), UV‐treated mushroom powder (EFSA NDA Panel, 2020, 2021f, 2024), UV‐treated baker's yeast (EFSA NDA Panel, 2014, 2021g), UV‐treated powder of whole yellow mealworm (EFSA NDA Panel, 2023), and vitamin D₂ mushroom powder (EFSA NDA Panel, 2024). However, the Panel considers the approach applied to estimate potential vitamin D exposure from the NF to be highly conservative, given the broad range of food categories proposed by the applicant and used in the intake estimates. Additional sources of uncertainty related to vitamin D intake from the background diet and fortified foods are addressed in the scientific opinion on the UL for vitamin D, which concluded that exceeding the UL is unlikely in European populations, except for regular users of food supplements containing high doses of vitamin D (EFSA NDA Panel, 2023).

Taking into account the composition of the NF and the proposed conditions of use, the Panel concludes that the consumption of the NF is not nutritionally disadvantageous.

As no adverse effects were reported in the toxicological studies available in the literature on dried yellow mealworms or oil derived from yellow mealworms, nor identified from the history of use of the NF's source, and given the production process, the compositional profiling of the NF which did not reveal substances raising genotoxicity‐related concerns, the genotoxicity studies provided by the applicant, as well as the evidence from toxicological studies on other yellow mealworm‐derived products of which the lipid fraction is an integral component, the Panel concludes that there are no safety concerns, provided the larvae are reared separately from the adults.

The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergies to crustaceans, molluscs, and dust mites due to cross‐reactivity. Additionally, the Panel notes that allergens from the feed (e.g., gluten) may end up in the NF.

5. CONCLUSIONS

The Panel concludes that the NF is safe under the proposed uses and use levels. The Panel notes that allergic reactions may occur upon its consumption.

5.1. 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 following data claimed as proprietary by the applicant: the detailed description of the production process, compositional analyses, and the genotoxicity studies, alongside certain associated Annexes to these sections (Appendix C).

ABBREVIATIONS

2‐MCPD

2‐monochloropropane‐1,2‐diol

3‐MCPD

3‐monochloropropane‐1,2‐diol

7‐DHC

7‐dehydrocholesterol

ADME

absorption, distribution, metabolism, and excretion

AFNOR

Association Française de Normalisation (French Standardization Association)

AOCS

American Oil Chemists' Society

BRD

Bacteriology Reference Department/Reference Determination

bw

body weight

CFU

colony forming units

COFRAC

Comité Français d'Accréditation

CYP

cytochrome P450

DietEx

dietary exposure (tool)

DIN

Deutsches Institut für Normung (German Institute for Standardisation)

DMSO

dimethyl sulfoxide

EN

Europäische Norm (European Standard)

ESPGHAN

European Society for Paediatric Gastroenterology, Hepatology and Nutrition

FA

fatty acids

FF

fortified foods

GC‐FID

gas chromatography with flame ionisation detection

GC–MS/MS

gas chromatography–tandem mass spectrometry

GLP

Good Laboratory Practice

GMP

Good Manufacturing Practice

HACCP

Hazard Analysis and Critical Control Points

HDPP

high‐density polypropylene

HPLC

high‐performance liquid chromatography

HPLC‐DAD

high‐performance liquid chromatography with diode array detection

HT‐2

a type A trichothecene mycotoxin

IAC‐LC‐FLD

immunoaffinity column extraction and liquid chromatography with fluorescence detection

ICP‐MS

inductively coupled plasma–mass spectrometry

IEC

International Electrotechnical Commission

ISO

International Organization for Standardization

KOH

potassium hydroxide

LC‐DAD

liquid chromatography with diode array detection

LC‐FLD

liquid chromatography with fluorescence detection

LOD

limit of detection

LOQ

limit of quantification

MLs

maximum levels

MN

micronucleus

MNBN

micronucleated binucleated cells

MOAH

mineral oil aromatic hydrocarbons

MOSH

mineral oil saturated hydrocarbons

MUFA

monounsaturated fatty acids

NA

not analysed

NDA

Nutrition, Novel Foods and Food Allergens (EFSA Panel)

NF

Novel Food

OECD

Organisation for Economic Co‐operation and Development

P95

95th percentile

PAHs

polycyclic aromatic hydrocarbons

PCBs

polychlorinated biphenyls

PCDD

polychlorinated dibenzodioxins

PCR

polymerase chain reaction

PUFA

polyunsaturated fatty acids

SFA

saturated fatty acids

SPE

solid phase extraction

T‐2

a type A trichothecene mycotoxin

TAMC

total aerobic mesophilic count

TEQ

toxic equivalents

TFA

trans fatty acids

TG

Test Guideline

TOTOX

total oxidation value

TYMC

total yeast and mould count

UL

tolerable upper intake level

USP

United States Pharmacopeia

UV

ultraviolet

UVB

ultraviolet B

VDE

vitamin D equivalents

WHO

World Health Organization

XP

Norme expérimentale (Experimental Standard, AFNOR)

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2022‐00534

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, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, and Frank Thies.

LEGAL NOTICE

Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by EFSA. The full output has been shared with the European Commission, EU Member States, and the applicant. The blackening may be subject to review once the decision on the confidentiality requests is adopted by EFSA, and in case it rejects some of the confidentiality requests.

Supporting information

APPENDIX B: Dietary exposure estimates to the Novel Food for each population group from each EU dietary survey

APPENDIX A. Detailed fatty acid profile of the oil derived from whole yellow mealworm before and after UV‐treatment^*

Parameter (g/100 g of NF)	Batch number
	Before UV‐treatment					After UV‐treatment (NF)
	#1**	#2**	#3**	#4**	#5**	#1	#2	#3	#4	#5
C8:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C10:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C12:0	0.38	0.39	0.39	0.39	0.38	0.38	0.39	0.38	0.38	0.38
C13:0	0.07	0.07	0.07	0.07	0.07	0.07	0.07	0.07	0.07	0.07
C14:0	3.45	3.57	3.52	3.55	3.52	3.51	3.57	3.46	3.52	3.54
C15:0	0.17	0.17	0.17	0.17	0.17	0.18	0.17	0.17	0.17	0.17
C16:0	17.24	17.73	17.62	17.63	17.54	17.55	17.71	17.35	17.49	17.65
C16:1	2.10	2.17	2.14	2.15	2.14	2.13	2.16	2.11	2.13	2.15
C17:0	0.44	0.45	< 0.05	0.45	< 0.05	0.44	0.45	0.49	0.44	0.05
C18:0	2.11	2.18	2.17	2.16	2.15	2.15	2.17	2.14	2.14	2.17
C18:1	45.03	44.90	44.94	44.90	44.98	45.03	45.45	44.77	44.81	45.38
C18:2	24.62	25.34	25.30	25.15	25.10	25.06	25.31	25.00	25.00	25.25
C18:3	1.29	1.34	1.33	1.33	1.32	1.31	1.33	1.31	1.32	1.33
C19:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C20:0	0.08	0.09	0.09	0.09	0.09	0.08	0.09	0.09	0.09	0.09
C20:1	0.12	0.12	0.12	0.12	0.11	0.12	0.12	0.12	0.12	0.11
C20:2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C20:5	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Total SFA	24.00	24.67	24.02	24.50	24.00	24.36	24.38	23.92	24.39	24.00
Total MUFA	46.78	48.11	48.01	47.78	47.68	47.59	47.57	48.27	47.57	47.82
Total PUFA	25.92	26.72	26.70	26.53	26.48	26.37	26.43	26.56	26.42	26.55
Total n‐3	1.28	1.32	1.31	1.31	1.30	1.31	1.34	1.31	1.32	1.33
Total n‐6	24.30	25.00	25.00	24.82	24.77	25.06	25.31	24.91	25.00	25.25
Ratio n‐6 to n‐3	19.09	19.08	18.05	18.93	19.05	19.12	19.03	19.16	19.03	19.12
Total TFA	0.24	0.26	0.25	0.25	0.26	0.25	0.26	0.24	0.25	0.26
Other FA	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05

Abbreviations: COFRAC, Comité Français d'Accréditation; FA, fatty acids; MUFA, monounsaturated fatty acid; NF, novel food; PUFA, polyunsaturated fatty acid; SFA, saturated fatty acid; TFA, trans fatty acid.

^*Measured by gas chromatography with flame ionisation detection (GC‐FID), COFRAC 1‐7085.

^**Not the novel food.

APPENDIX B. Dietary exposure estimates to the Novel Food for each population group from each EU dietary survey

Information provided in this Annex is shown in an Excel file (downloadable at https://efsa.onlinelibrary.wiley.com/doi/j.efsa.9710#support‐information‐section).

APPENDIX C. List of elements of the dossier for which data protection was requested

Dossier section	Elements of the application dossier for which the applicant has requested data protection	Considered pertinent for the NDA Panel (Yes/No)
Production Process	Production process_UPDATED 18102024.pdf	Yes
Compositional Data	Compositional data_UPDATED 18102024.pdf	Yes
Specifications	Specification_UPDATED 18102024.pdf	No
Nutritional Information	Nutritional data_UPDATED 18102024.pdf	No
	TM‐oil digestibility_REFERENCE.pdf	No
Genotoxicity	Genotoxicity_UPDATED 18102024.pdf	Yes
Allergenicity	Allergenicity_UPDATED 18102024.pdf	No
Annexes	NF Bacterial reverse mutation assay OTM_ANNEX	Yes
	4‐HAP cake‐oil 180 analyses_ANNEX.pdf	No
	7‐DHC NF analyses_ANNEX.pdf	Yes
	7‐DHC NF OTM_ANNEX	Yes
	Acid value NF Analyses_ANNEX.pdf	Yes
	Acrylamide cake‐oil 160 analyses_ANNEX.pdf	No
	Acrylamide cake‐oil 180 analyses_ANNEX.pdf	No
	Acrylamide Ctrl cake 180 analyses_ANNEX.pdf	No
	Aflatoxins NF Analyses_ANNEX.pdf	Yes
	Allergens NF OTM_ANNEX	No
	Analytical results NF OTM_ANNEX	Yes
	Anisidine NF Analyses_ANNEX.pdf	Yes
	Arsenic NF Analyses_ANNEX.pdf	Yes
	Ashes NF Analyses_ANNEX.pdf	Yes
	Bioavailability NF OTM_ANNEX	No
	Cadmium NF Analyses_ANNEX.pdf	Yes
	Carbohydrates NF Analyses_ANNEX.pdf	Yes
	Chloropropanol Ctrl cake 180 analyses_ANNEX.pdf	Yes
	Chromium NF Analyses_ANNEX.pdf	Yes
	Copper NF Analyses_ANNEX.pdf	Yes
	Deoxynivalenol NF Analyses_ANNEX.pdf	Yes
	Dioxine & PCB NF Analyses_ANNEX.pdf	Yes
	Dioxins NF OTM_ANNEX	Yes
	Fatty acids NF Analyses_ANNEX.pdf	Yes
	Fibers NF Analyses_ANNEX.pdf	Yes
	Fumonisins NF Analyses_ANNEX.pdf	Yes
	HAP NF Analyses_ANNEX.pdf	Yes
	Heavy metals NF OTM_ANNEX	Yes
	Iron NF Analyses_ANNEX.pdf	Yes
	Iterg Biodispo Study_ANNEX	No
	Letter Interference D3 T6_ANNEX	Yes
	Lumi‐Tachy NF OTM_ANNEX	Yes
	MCPD cake‐oil 160 analyses_ANNEX.pdf	No
	MCPD cake‐oil 180 analyses_ANNEX.pdf	No
	MCPD NF Analyses_ANNEX.pdf	Yes
	MCPD NF OTM_ANNEX	Yes
	Mercury NF Analyses_ANNEX.pdf	Yes
	Microbiology Fruit puree with NF‐oil_ANNEX.pdf	No
	Microbiology NF OTM_ANNEX	Yes
	Minerals NF OTM_ANNEX	Yes
	Moisture NF Analyses_ANNEX.pdf	Yes
	Mycotoxins NF OTM_ANNEX	Yes
	NF Micronucleus assay OTM_ANNEX	Yes
	NF T‐2 HT‐2 OTM_ANNEX	Yes
	No UV 7‐DHC MO_ANNEX	Yes
	No UV Lumi‐Tachy MO_ANNEX	Yes
	No UV Nutritional compo MO_ANNEX	Yes
	No UV Oxidation MO_ANNEX	Yes
	No UV Vitamin D3 Analyses_ANNEX	Yes
	No UV Vitamin D3 MO_ANNEX	Yes
	No UV Vitamin E MO_ANNEX	Yes
	Nutritional compo NF OTM_ANNEX	Yes
	Ochratoxin NF Analyses_ANNEX.pdf	Yes
	Oxidation NF OTM_ANNEX	Yes
	PAH NF OTM_ANNEX	Yes
	Particules NF_ANNEX.pdf	Yes
	Peroxide NF Value_ANNEX.pdf	Yes
	Pesticides NF Analyses_ANNEX.pdf	Yes
	Pesticides NF OTM_ANNEX	Yes
	Proteins & Fat NF Analyses_ANNEX.pdf	Yes
	Stats NF OTM_ANNEX	Yes
	Sterols NF Analyses_ANNEX.pdf	Yes
	T0 microbiology 1 NF Analyses_ANNEX.pdf	Yes
	T0 microbiology 2 NF Analyses_ANNEX.pdf	Yes
	T6 Acid value NF Analyses_ANNEX.pdf	Yes
	T6 Microbiology 1 NF Analyses_ANNEX.pdf	Yes
	T6 Microbiology 2 NF Analyses_ANNEX.pdf	Yes
	T6 Peroxide value NF Analyses_ANNEX.pdf	Yes
	T6M Microbiology NF OTM_ANNEX	Yes
	T6M Oxidation NF OTM_ANNEX	Yes
	T6M Vitamin D3 NF OTM_ANNEX	Yes
	TM identity Methodology_ANNEX	Yes
	TM identity Results_ANNEX	Yes
	Unsaponifiable matter NF Analyses_ANNEX.pdf	Yes
	Validation method Lumi‐Tachy oil_ANNEX	Yes
	Vitamin D2 NF OTM_ANNEX	Yes
	Vitamin D3 NF analyses_ANNEX.pdf	Yes
	Vitamin D3 NF analyses_ANNEX.pdf	Yes
	Vitamin D3 NF OTM_ANNEX	Yes
	Vitamin E D3MO_ANNEX	Yes
	Vitamin E NF Analyses_ANNEX.pdf	Yes
	Vitamin E NF OTM_ANNEX	Yes

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens) , Turck, D. , Bohn, T. , Cámara, M. , Castenmiller, J. , De Henauw, S. , Jos, Á. , Maciuk, A. , Mangelsdorf, I. , McNulty, B. , Naska, A. , Pentieva, K. , Siani, A. , Thies, F. , Aguilera‐Gómez, M. , Cubadda, F. , Frenzel, T. , Heinonen, M. , Marcon, F. , … Hirsch‐Ernst, K. I. (2025). Safety of UV‐treated oil from yellow mealworm (Tenebrio molitor larvae) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 23(11), e9710. 10.2903/j.efsa.2025.9710