Safety of Acheta domesticus (house cricket) spray‐dried powder 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 the safety of a spray‐dried powder from house cricket (Acheta domesticus) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is intended as a whole food and for potential use as an ingredient in foods that can be consumed by the general population. The pilot‐scale production process has been described in adequate detail. The Panel notes that the production process, as reported by the applicant, involves steps and practices which may have contributed to cross‐contamination and batch‐to‐batch variability of certain microbiological parameters. The reported mineral oil aromatic hydrocarbons content in the NF raised safety concerns. Phthalates were also detected in the NF, and due to the limited information provided on materials in contact with the NF, the source of this contamination cannot be determined. The Panel identified major issues related to the microbiological quality of the NF. High variability of total aerobic mesophilic counts and, in some cases, elevated counts of presumptive Bacillus cereus, yeasts and moulds were observed across batches. The Panel cannot conclude on these aspects based on the available evidence. Regarding specifications, the Panel considers that the proposed limits do not adequately capture the variability of the NF and are insufficient to ensure product safety. The Panel considers that consumption of the NF may trigger primary sensitisation to A. domesticus proteins. Allergic reactions may also occur in subjects allergic to crustaceans, mites and molluscs (cross‐reactivity). Additionally, allergens from the feed may be present in the NF. The Panel concludes that the safety of the NF under the proposed uses and use levels cannot be established.

1. INTRODUCTION

1.1. Background and Terms of Reference as provided by the requestor

On 5 April 2023, the company Alia Insect Farm società agricola S.R.L. 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 Acheta domesticus (house cricket) spray‐dried powder as a novel food.

The applicant requests to authorise the use of Acheta domesticus (house cricket) spray‐dried powder as a novel food in a number of foods.

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

1.2. Additional information

On 7 July 2021, the NDA Panel adopted an opinion on the safety of frozen and dried formulations from whole house crickets (Acheta domesticus) as a novel food (NF) pursuant to Article 10 of 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, 2021b). Following a positive vote of the Standing Committee on Plants, Animals, Food and Feed, the European Commission adopted on 10 February 2022 Commission Implementing Regulation (EU) 2022/188 authorising the placing on the market of frozen, dried and powder forms of Acheta domesticus as NF pursuant to Regulation (EU) 2015/2283.

On 23 March 2022, the NDA Panel adopted an opinion on the safety of partially defatted house cricket (Acheta domesticus) powder as a novel food pursuant to Article 10 of 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, 2022). The Commission Implementing Regulation (EU) 2023/5 of 3 January 2023 authorised the placing on the market of partially defatted powder of A. domesticus (house cricket). On 26 June 2024, the NDA Panel adopted an opinion on the safety of Acheta domesticus powder as a novel food pursuant to Article 10 of 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, 2024).

2. DATA AND METHODOLOGIES

2.1. Data

The safety assessment of this NF is based on data supplied in the application, information submitted by the applicant following EFSA requests for supplementary information and additional data identified by the Panel.

Administrative and scientific requirements for NF applications referred in Article 10 of Regulation (EU) 2015/2283 are listed in Commission Implementing Regulation (EU) 2017/2469. ¹

A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of an NF application (EFSA NDA Panel, 2016). 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, 2021a, 2021b) 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 Regulation (EC) No 178/2002 ² 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, ³ the non‐confidential version of the dossier has been published on Open.EFSA. ⁴

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,² EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 10 July 2025 to 31 July 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 production process, compositional data, specifications, proposed uses, ADME, nutritional information, toxicological information and annexes.

2.2. Methodologies

The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel, 2021a, 2021b) 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 with regard to any claimed benefit.

In the context of this opinion, EFSA's definition of dietary fibre (i.e. non‐digestible carbohydrates plus lignin; EFSA NDA Panel, 2010) does not reflect the additional requirement of having a beneficial physiological effect demonstrated by generally accepted scientific evidence laid down in Annex I of Regulation (EC) 1169/2011 ⁵ for:

1. edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and

2. edible synthetic carbohydrate polymers.

It is out of the scope of this opinion to establish whether the fraction of non‐digestible carbohydrates present in the NF meets the legal definition of dietary fibre in the EU or not.

The assessment of small particles in the NF was conducted in line with the principles of the ‘Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles’ (EFSA Scientific Committee, 2021).

3. ASSESSMENT

3.1. Introduction

The NF, which is the subject of the application, is A. domesticus powder. The NF falls under the category of ‘food consisting of, isolated from or produced from animals or their parts’, as described in Article 3 (v) of Regulation (EU) 2015/2283. The NF is produced by farming and processing, including micronisation and spray‐drying, of A. domesticus and consists mainly of protein, fat and dietary fibre. The NF is proposed to be marketed in the form of powder. The applicant proposed to use the NF as an ingredient in various food products. The NF is intended for potential use in foods that can be consumed by the general population.

3.2. Identity of the NF

The NF consists of spray‐dried powder of house cricket. The term ‘house cricket’ refers to A. domesticus, an insect species that belongs to the family of Gryllidae, subfamily Gryllinae, genus Acheta. The species is present in various regions worldwide, including Australia, Asia, Africa, North America and Europe (GBIF Secretariat, 2023). The applicant provided a polymerase chain reaction (PCR) analysis confirming the identity of the NF's source, i.e. A. domesticus.

3.3. Production process

According to the applicant, the NF is produced following good manufacturing practice (GMP) and Hazard Analysis and Critical Control Point (HACCP) principles, as required by Regulation (EU) 2015/2283 and Regulation (EC) No 852/2004. The process is currently limited to pilot‐scale operations and can be divided into three main stages: rearing, harvesting and post‐harvest processing.

House crickets are reared under controlled conditions (temperature, humidity, light, ventilation). The farm structure allows vertical rearing in boxes made from materials reported by the applicant to be compliant with Regulation (EU) No 10/2011. ⁶ Cardboard or plastic layers are introduced into rearing boxes to promote movement and mating; cardboard layers are discarded after each cycle, while plastic ones are cleaned with hot water. Following a request from EFSA, the applicant could not provide information on the compliance with the respective EU standards of some materials coming into contact with the NF during the production process. No pesticides, antimicrobials, antiparasitic agents or solvents are used. Feed is of plant origin, compliant with Directive 2002/32/EC, and supplied by authorised farm animal feed producers. Eggs are laid in designated containers, and the newly hatched first‐instar cricket nymphs (commonly referred to as ‘pinheads’) are transferred to rearing boxes. The presence of dead insects is visually monitored, and boxes containing > 5% dead crickets are discarded to avoid increased microbial load and biogenic amine formation. Crickets are susceptible to certain viruses and parasites such as Cricket paralysis virus (CrPV), A. domesticus densovirus (AdDV), and the entomopathogenic nematode Heterorhabditis georgiana, but these are not pathogenic to humans. Prior to harvest, crickets undergo a fasting period of at least 24 h to clear bowel contents and reduce microbial load.

Harvested crickets are visually inspected, and dead individuals are removed. Killing is performed by freezing at approximately −20°C, followed by washing and an initial pasteurisation step (70°C, 5 min). Peracetic acid solutions (≤ 50 ppm) may be used during washing to enhance microbial control, decomposing into acetic acid, water and oxygen at high temperatures. Following pasteurisation, crickets are mechanically processed through shredding and micronisation (via mechanical grinding with steel equipment) to obtain a suspension.

The micronised cricket suspension undergoes a second pasteurisation in a closed, continuous system to minimise contamination risks, followed immediately by spray‐drying. During spray‐drying, droplets are exposed to hot air (180°C–200°C) for less than 5 s. The resulting powder contains < 5% moisture and is packed in sealed, air‐tight containers. Overall, the Panel considers that the current processing conditions, in particular the heating steps (low temperatures and short duration), have not been demonstrated to be effective in controlling the microbiological hazards in the NF, as also supported by the analytical data provided (Section 3.4).

The Panel considers that the current pilot‐plant production process is sufficiently described. However, the Panel notes limitations related to the lack of documentation on the compliance of food contact materials and uncertainties regarding the adequacy of the processing steps, in particular the heating steps, to control microbiological hazards.

3.4. Compositional data

The applicant provided qualitative and quantitative data on chemical and microbiological parameters of multiple pilot‐scale‐produced NF batches. The Panel notes that the analyses initially provided were not performed on the same set of batches. For the majority of parameters, at least five independently produced batches were analysed. Certificates of accreditation for the laboratories that conducted the analyses were provided by the applicant. Analytical methods validated for other food matrices were used; for some in‐house methods, full methodological descriptions and validation data were provided.

The results of the proximate analysis of the NF are presented in Table 1, showing that the NF consists primarily of crude protein, carbohydrates and fat.

TABLE 1.

Batch‐to‐batch proximate analysis of the NF.

Parameter (unit)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Crude protein (g/100 g)	57.50	57.00	57.50	59.10	60.90	Kjeldahl (N × 6.25)
‘True’ protein (g/100 g)	46.53	45.15	45.41	48.54	49.79	Calculation based on anhydrous amino acid content
Total fat (g/100 g)	28.50	29.50	29.10	27.30	26.20	Gravimetric
Saturated FA (g/100 g)	11.28	11.72	11.47	10.86	10.43	GC‐FID, in‐house
MUFA (g/100 g)	6.16	6.49	6.38	6.00	5.74	GC‐FID, in‐house
PUFA (g/100 g)	9.79	9.99	9.96	9.24	8.88	GC‐FID, in‐house
trans FA (g/100 g)	0.13	0.13	0.14	0.13	0.14	GC‐FID, in‐house
Digestible carbohydrates (g/100 g)	3.40	1.70	1.60	2.50	2.90	By difference*
Dietary fibre (g/100 g)	2.30	3.20	4.20	3.70	3.80	AOAC gravimetric method/ S50 2018 Rev. 13 Gravimetric
Moisture (g/100 g)	4.50	4.70	4.10	4.00	3.00	Gravimetric
Ash (g/100 g)	3.77	3.88	3.46	3.37	3.25	Gravimetric
Energy (kcal/100 g)	505	507	507	500	499	By calculation

Abbreviations: AOAC, Association of Official Analytical Chemists; FA, Fatty Acids; GC‐FID, Gas Chromatography‐Flame Ionisation Detection; MUFA, Monounsaturated Fatty Acids; N, nitrogen; PUFA, Polyunsaturated Fatty Acids.

^*Digestible carbohydrates = 100 – (crude protein + total fat + dietary fibre + moisture + ash).

For chitin quantification, results obtained using three different analytical methods were submitted (Table 2). EFSA requested the applicant to comment on the suitability of the analytical methods employed. The Panel agrees with the applicant that the method described by Luparelli et al. (2023) is appropriate for this analyte.

TABLE 2.

Batch‐to‐batch proximate analysis of the NF.

Parameter (unit)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Chitin (g/100 g)	8.12	8.99	10.33	6.92	8.61	Gravimetric (Huang & Tsai, 2020)
	2.50	2.85	4.41	3.15	3.50	Acetyl group determination (Hahn et al., 2018)
	6.9	6.2	7.3	7.6	4.9	UPLC‐ESI‐MS (Luparelli et al., 2023)

Abbreviation: UPLC‐ESI‐MS, Ultra‐Performance Liquid Chromatography‐Electrospray Ionisation‐Mass Spectrometry.

The applicant also provided analytical data for vitamins and minerals (Table 3), and antinutrients (Table 4). Minerals were analysed by ICP‐MS and ICP‐OES, while vitamins were determined by LC‐MS/MS (in‐house method) and HPLC‐DAD/FLD in accordance with recognised ISO and AOCS standards. The Panel notes that results were consistent across batches, with limited variability.

TABLE 3.

Batch‐to‐batch analysis of micronutrients in the NF.

Parameter (unit)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Minerals
Cu (mg/100 g)	3.12	3.11	3.10	2.90	2.76	ICP‐MS, in‐house
Mn (mg/100 g)	4.64	4.14	4.22	4.16	4.16
Zn (mg/100 g)	21.3	21.5	21.4	20.5	22.3
Ca (mg/100 g)	188	184	156	127	156
Fe (mg/100 g)	6.85	6.84	6.74	6.20	6.41
P (mg/100 g)	762	746	746	697	654
Mg (mg/100 g)	84.0	75.6	73.1	70.8	69.2	ICP‐OES, in‐house
K (mg/100 g)	777	786	783	729	653
B (mg/100 g)	0.189	0.139	0.104	0.109	0.144
Mo (mg/kg)	0.060	0.060	0.062	0.068	0.079
Se (mg/kg)	0.052	0.050	0.053	0.051	0.043
Na (mg/100 g)	383	350	343	317	297
Iodine (μg/100 g)	NA	NA	71.6	NA	104.0
Vitamins
Riboflavin (mg/100 g)	2.63	3.98	2.94	4.11	2.45	LC–MS/MS, in‐house
Vitamin B6 (as pyridoxine base) (mg/100 g)	0.18	0.18	0.20	0.18	0.16
Cyanocobalamin (μg/100 g)	1.50	0.87	1.10	0.71	0.77	LC MS/MS, in‐house
Vitamin E (α‐tocopherol) (mg/100 g)	0.82	1.03	2.26	0.67	1.29	HPLC‐DAD/FLD based on ISO 9936:1997(E)
	2.63	2.45	2.94	NA	2.45	HPLC‐DAD/FL based on ISO 9936:2016 and AOCS Ce 8‐89 (2009).

Abbreviations: AOCS, American Oil Chemists' Society; HPLC‐DAD/FLD, High‐performance liquid chromatography with diode array and fluorescence detection; ICP‐MS, Inductively coupled plasma‐mass spectrometry; ICP‐OES, Inductively coupled plasma‐optical emission spectrometry; ISO, International Organization for Standardization; LC‐MS/MS, Liquid chromatography–tandem mass spectrometry.

TABLE 4.

Batch‐to‐batch analysis of antinutrients in the NF.

Parameter (unit)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Total polyphenols (as gallic acid) (mg/100 g)	NA	1091	1123	1129	1099	Folin–Ciocalteu (UV‐VIS, in‐house)
Total oxalates (soluble in 1M HCl and expressed as oxalic acid) (mg/kg)	496	522	517	549	562	LC‐MS/MS, in‐house
Hydrocyanic acid (mg/kg)	< 1.0	< 1.0	< 1.0	< 1.0	< 1.0	HPLC‐PAD, in‐house

Abbreviations: HPLC‐PAD, High‐Performance Liquid Chromatography‐Pulsed Amperometric Detection; LC‐MS/MS, Liquid Chromatography‐Tandem Mass Spectrometry; NA, Not Available; UV‐VIS: Ultraviolet‐Visible Spectrophotometry.

The applicant also provided analytical data on mycotoxins, including aflatoxins B1, B2, G1 and G2, ochratoxin A, deoxynivalenol, zearalenone, HT‐2 and T‐2 toxins and fumonisins B1 and B2 (Table 5). With the exception of the aflatoxin B1 and the fumonisins content detected in two batches, all reported values were below the limit of quantification (LOQ) of the applied analytical methods.

TABLE 5.

Batch‐to‐batch mycotoxin analysis in the NF.

Parameter (μg/kg)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Aflatoxin B1	< 0.05	< 0.05	< 0.05	0.072	0.085	LC–MS/MS, in‐house
Aflatoxin B2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Aflatoxin G1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Aflatoxin G2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Sum aflatoxin B1, B2, G1, G2	< 0.05	< 0.05	< 0.05	0.072	0.085
Ochratoxin A	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2
Deoxynivalenol	< 50	< 50	< 50	< 50	< 50
Zearalenone	< 5	< 5	< 5	< 5	< 5
HT‐2 toxin + T‐2 toxin	< 20	< 20	< 20	< 20	< 20
Fumonisins (B1 + B2)	<50	<50	<50	66	60

Abbreviation: LC–MS/MS, Liquid Chromatography–Tandem Mass Spectrometry.

The Panel notes that the current EU legislation does not include maximum levels (MLs) for the presence of mycotoxins in insects and products thereof as food. The Panel notes, however, that the content of these substances reported for the NF does not exceed the MLs set by Regulation (EU) 2023/915 ⁷ for other foods.

Contaminants in the NF were also investigated. The applicant provided analytical data on chemical contaminants (Tables 6, 7, 8) and microbiological parameters (Table 9) and compared the values to the MLs set for foodstuffs considered as set in Regulation (EU) 2023/915. The Panel notes that the current EU legislation does not include MLs for the presence of regulated metals (and other elements), nor for dioxins and dioxin‐like PCBs, in insects and products thereof as food. The Panel notes, however, that the content of these substances reported for the NF does not exceed the MLs set by EU legislation for other foods.

TABLE 6.

Batch‐to‐batch contaminant analysis of the NF.

Parameter (unit)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Metals and other elements (mg/kg)
Arsenic	0.023	0.020	0.020	0.018	0.017	ICP‐MS, in‐house
Cadmium	0.067	0.066	0.064	0.063	0.058
Mercury	0.008	0.006	< 0.005	0.009	< 0.005
Lead	0.049	0.073	0.063	0.056	0.066
	#6	#7	#8	#9	#10
Dioxins and dioxin‐like PCBs (pg/g of NF)
Total WHO‐PCDD/F‐TEQ (UB)	0.122	0.123	0.064	0.054	0.058	EPA 1613 B 1994, WHOTEF 2005 ‐ HR‐GC‐MS
Total WHO‐PCDD/F‐PCB‐TEQ (UB)	0.171	0.167	0.11	0.083	0.094	EPA 1613 B 1994 + EPA 1668 C 2010, WHO‐TEF 2005, HR‐GC‐MS
Sum of PCBs 28,52,101,138, 153,180 (UB)	0.892	0.936	0.852	0.784	0.578	EPA 1668 C 2010, HR‐GC‐MS

Abbreviations: EPA, Environmental Protection Agency; HR‐GC‐MS, High‐Resolution Gas Chromatography‐Mass Spectrometry; ICP‐MS, Inductively Coupled Plasma‐Mass Spectrometry; PCB, Polychlorinated biphenyls; PCDD/F, Polychlorinated dibenzo‐p‐dioxins and furans; TEQ, Toxic Equivalents; UB, Upper Bound (non‐quantified compounds were assumed to be present at the limit of quantification when calculating Total or Sum); WHO, World Health Organization; WHO‐PCDD/F‐PCB‐TEQ, Toxic Equivalents of PCDDs, PCDFs, and dioxin‐like PCBs calculated using WHO 2005 Toxic Equivalency Factors; WHO‐PCDD/F‐TEQ, Toxic Equivalents of PCDDs and PCDFs calculated using WHO 2005 Toxic Equivalency Factors; and WHOTEF, World Health Organization Toxic Equivalency Factors.

TABLE 7.

Batch‐to‐batch analysis of phthalates in the NF.

Parameter (mg/kg)	Batches					Method of analysis
	#1	#8	#3	#9	#5
DIBP (CAS 84‐69‐5)	0.04	0.04	0.14	0.05	0.10	GC‐MS/MS, in‐house
DBP (CAS 84‐74‐2)	0.07	< 0.02	0.12	< 0.02	0.10
DEHP (CAS 117‐81‐7)	0.15	0.21	0.19	0.21	0.30
DINP (CAS 68515‐48‐0)	0.64	0.14	0.68	0.20	1.80
DIDP‐isomers (CAS 26761‐40‐0)	< 0.01	NA	< 0.01	NA	0.70

Abbreviations: CAS, Chemical Abstracts Service; DBP, Di‐n‐butyl Phthalate; DEHP, Di‐2‐ethylhexyl Phthalate; DIBP, Diisobutyl Phthalate; DIDP, Diisodecyl Phthalate; DINP, Diisononyl Phthalates; GC‐MS/MS, Gas Chromatography‐Tandem Mass Spectrometry; NA, Not Available.

TABLE 8.

Batch‐to‐batch analysis of other organic/processing contaminants in the NF.

Parameter (μg/kg)	Batches					Method of analysis
	#6	#7	#8	#9	#10
PFAS (sum of PFOS, PFOA, PFNA and PFHxS)	< 0.1	< 0.1	0.12	0.12	0.11	LC‐MS/MS, in‐house
PAHs
Benzo(a)anthracene	0.15	0.13	NA	0.25	0.24
Chrysene	0.28	0.29	NA	0.49	0.49
Benzo(b)fluoranthene	0.15	0.17	NA	0.36	0.36
Benzo(a)pyrene	< 0.10	< 0.10	NA	0.25	0.27
Sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene and chrysene (UB)	0.68	0.69	NA	1.35	1.36	GC‐MS/MS, in ‐house
Furans and alkylfurans
Furan	< 5	< 5	6.3	7	9.8	EPA 1613 B 1994, HR‐GC‐MS
2‐Methylfuran	< 5	< 5	< 5	< 5	< 5
3‐Methylfuran	< 5	< 5	< 5	< 5	< 5
2‐Ethylfuran	< 5	< 5	< 5	< 5	< 5
2,5‐Dimethylfuran	< 5	< 5	< 5	< 5	< 5
2‐Pentylfuran	16	9.6	13	15	19
Acrylamide	< 10	< 10	< 10	< 10	< 10	GC‐MS/MS, in‐house
MOSH—up to C50 mg/kg as CyCy*	< 250	< 250	< 250	< 250	< 250	HPLC‐GC/FID, in‐house
MOAH—up to C50 mg/kg as 1‐MN**	4.8	5	5.3	5.4	6.6

Abbreviations: GC‐MS/MS, Gas Chromatography‐Tandem Mass Spectrometry; HPLC‐GC/FID, High‐Performance Liquid Chromatography‐Gas Chromatography/Flame Ionisation Detection; HR‐GC‐MS, High‐Resolution Gas Chromatography‐Mass Spectrometry; LC‐MS/MS, Liquid Chromatography‐Tandem Mass Spectrometry; MOAH, Mineral Oil Aromatic Hydrocarbons; MOSH, Mineral Oil Saturated Hydrocarbons; PAHs, Polycyclic Aromatic Hydrocarbons; PFAS, Per‐ and Polyfluoroalkyl Substances; PFHxS, Perfluorohexanesulfonic Acid; PFNA, Perfluorononanoic Acid; PFOA, Perfluorooctanoic Acid; PFOS, Perfluorooctanesulfonic Acid.

^*MOSH with carbon chain lengths up to C50, quantified as cyclohexyl‐cyclohexyl (Cy‐Cy) equivalents.

^**MOAH with carbon chain lengths up to C50, quantified as 1‐methylnaphthalene (1‐MN) equivalents.

TABLE 9.

Batch‐to‐batch microbiological analysis of the NF.

Parameter (unit)	Batches										Method of analysis
	#1	#2	#3	#4	#5	#6	#7	#8	#9	#10
Total microbial count (CFU/g)	3200	40,000	< 40,000	< 40,000	48,000	530	24,000	3500	6200	7700	ISO 4833‐1‐2013/Amd 1:2022
Salmonella spp. (CFU in 25 g)	ND	ND	ND	ND	ND	ND	ND	ND	ND	ND	06 (S28) rev 12 2021, internal
L. monocytogenes (CFU in 25 g)	ND	ND	ND	ND	ND	ND	ND	ND	ND	ND	06 (S29) Rev 13 2021, internal
Campylobacter spp. (CFU in 25 g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	ISO 10272‐2‐2017
B. cereus presumed spores (CFU/g)	< 10	< 40	< 10	< 10	< 10	NA	NA	NA	NA	NA	Rev.12 2021 ‐enrichment, internal
B. cereus spores (CFU/g)	NA	NA	NA	NA	NA	< 10	1600	< 10	50	80	ISO 7932:2004/Amd 1:2020
Presumptive B. cereus (CFU/g)	170	13,000	7000	2300	160	600	1700	400	3500	3500	06 (S96) Rev. 82020, internal
Total Enterobacteriaceae (CFU/g)	50	< 10	< 10	< 10	420	< 10	< 10	< 10	< 10	< 10	ISO 21528‐2:2017
Coagulase positive staphylococci (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	06 (S27) rev 12 2021, internal
S. aureus (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	06 (S27) rev 12 2021, internal
Beta‐glucuronidase‐positive E. coli (CFU/g)	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	< 10	ISO 16649‐2:2001
Yeasts (CFU/g)	< 10	< 10	< 10	< 10	100	< 10	< 10	< 10	< 10	< 10	NF V08‐059: 2002
Moulds (CFU/g)	< 10	40	140	40	< 40	130	60	220	60	< 10	NF V08‐059: 2002

Abbreviations: CFU, Colony‐Forming Unit; ISO, International Organization for Standardization; NA, Not Available; ND, Not Detected; NF, novel food.

Analytical data on pesticide residues, produced using GC–MS or LC–MS/MS methods, were also provided. With the exception of one batch, no pesticide residues were detected in the NF.

Individual phthalates (DIBP, DBP, DEHP, DINP and DIDP) were analysed in five batches of the NF using an in‐house GC‐MS/MS method, and the values reported were all below 2 mg/kg (Table 7). The Panel notes that phthalates are not naturally present in insects and are likely introduced through contact with plastic materials used during rearing, processing or packaging, or from feed or environmental sources. The observed levels are consistent with background contamination typically associated with plastics from food contact materials (Cao, 2010). The Panel notes that, based on the provided evidence, the source of phthalates in the NF cannot be determined. Some phthalates, including DEHP, are restricted in food contact materials under Regulation (EU) No 10/2011 and may only be used in repeated‐use materials contacting non‐fatty foods.

Analyses of five production batches of the NF were carried out for per‐ and polyfluoroalkyl substances (PFASs), polycyclic aromatic hydrocarbons (PAHs), furans, and alkylfurans and acrylamide using in‐house validated analytical methods (Table 8). The concentration of the sum of PFOS, PFOA, PFNA and PFHxS was below or close to the limit of quantification (< 0.1–0.12 μg/kg). The sum of the four PAHs ranged from 0.68 to 1.36 μg/kg, and acrylamide was below the detection limit (< 10 μg/kg) in all batches. Furan and its alkyl derivatives were mostly not detected, except for 2‐pentylfuran, found at 9.6–19 μg/kg. The reported values of these compounds are within ranges commonly observed in other thermally processed foods. Nevertheless, the Panel notes that the reported content of mineral oil aromatic hydrocarbons (MOAH) in the NF exceeds the proposed limit of 1 mg/kg established by the European Commission, Health and Food Safety Directorate‐General (2022) and thus raises safety concerns.

Microbiological analyses of 10 batches showed no detection of Salmonella spp., Listeria monocytogenes, Campylobacter spp., Staphylococcus aureus or Escherichia coli. However, elevated counts of presumptive Bacillus cereus and substantial variability in total aerobic mesophilic counts were observed (Table 9). In response to EFSA's request for clarification, the applicant indicated that these results may be related to the pilot‐scale production process, which involves multiple manual handling steps as well as to the external spray‐drying facility where other products are also processed, possibly resulting in cross‐contamination. The applicant further stated that this issue is expected to be mitigated upon transition to a large‐scale production, and that no additional corrective actions can be implemented at the current stage. Based on the information provided, the Panel cannot draw conclusions regarding the occurrence of the elevated counts of certain microorganisms or the observed variability. Moreover, the Panel considers that the elevated counts of certain microorganisms and the observed variability represent a safety concern.

Additionally, the applicant provided analytical data for biogenic amines (Table 10). No MLs have been established for spermidine and spermine in foods. Higher concentrations than those found in the NF have been reported in legumes/soybean products (up to 207 mg/kg and up to 69 mg/kg, respectively) and cereals (up to 353 mg/kg and up to 146 mg/kg, respectively), while lower values have been reported in fresh meat (13 and 69 mg/kg, respectively) and cheese (38 and 3 mg/kg, respectively) (Muñoz‐Esparza et al., 2019). The histamine values were lower than the limit of 200 mg/kg for histamine in fishery products set in Regulation (EC) No 2073/2005. The Panel notes the concentration of putrescine reported in the NF and that no legal limit has been established for putrescine in any food, although it may accumulate to high concentrations in cheese (up to 1560 mg/kg), fermented sausages (up to 1550 mg/kg) and fish sauces (up to 1220 mg/kg) (EFSA BIOHAZ Panel, 2011). Tyramine concentration in the NF is lower than concentrations reported in other foods such as cheese (Andersen et al., 2019). Formation of biogenic amines can occur by endogenous biosynthesis, uptake from the feed source and by bacteria of the intestinal microbiota of insects. It can also occur during food processing and storage as a result of bacterial contamination (EFSA BIOHAZ Panel, 2011).

TABLE 10.

Batch‐to‐batch analysis of biogenic amines in the NF.

Parameter (mg/kg)	Batches					Method of analysis
	#1	#2	#3	#4	#5
Tryptamine	3.6	4.3	4.0	4.3	5.6	HPLC (in‐house)
Putrescine	7.8	11.7	12	11.1	9.8
Cadaverine	8.4	17.9	18	17.4	13.2
Histamine	3.4	9.5	10.4	11.4	6.3
Tyramine	1.8	3.3	4.1	3.5	2.9
Spermidine	35.5	38.1	38.1	33.1	35.7
Spermine	14.3	16.8	18.1	17.1	14.7

Abbreviation: HPLC, High‐Performance Liquid Chromatography.

Given the vegetable origin of the feed and the absence of prion or prion‐related encoding genes in insects, no risk of developing prion diseases is associated with the consumption of the NF (EFSA Scientific Committee, 2015).

Regarding the presence of small particles in the NF, the applicant referred to Ruggeri et al. (2023), who reported that the spray‐dried powder forms conglomerates of 22 μm of small particles, with scanning electron microscopy (SEM) analysis indicating no particles < 100 nm (200–500 nm range, ~250 nm average). In the light of the data submitted by the applicant, the Panel considered that the NF may contain a fraction of small particles < 250 nm, likely insoluble and composed of chitin and other indigestible polymers. While solubility and dissolution criteria would normally require a further assessment of this fraction, conventional studies for such complex material are challenging. Potential approaches, such as measuring total organic carbon before and after ultrafiltration or gravimetric assessment of ultrafiltration deposits, were not applied in accordance with the EFSA Scientific Committee Guidance (2021). The presence of small particles should have triggered further investigations based on the tiered approach outlined in the initial EFSA request. However, considering the limitations identified in other parts of the assessment of the NF, the Panel concluded that further investigation of the small particle fraction would not resolve remaining issues in other areas and therefore decided not to request additional studies. It is noted that, if these tests were performed, all safety studies would need to comply with Section 4 of EFSA Scientific Committee Guidance (2021), and toxicological studies without proper dispersion would not be valid unless the criteria in Section 4 were met.

The Panel considers that the information provided on the composition is not sufficient for characterising the NF and may raise safety concerns.

3.4.1. Stability

The applicant conducted stability tests on five independently produced batches of the NF. The tests were carried out at room temperature and at 60% RH in a dry place, but not in sealed sachets, i.e. the storage conditions under which the consumer is advised to store the NF, for a period of 2 years. The mycotoxin and microbiological profiles of the NF were monitored (Table 11). Following an EFSA request, the applicant investigated the oxidative stability of fats in the NF during storage. Lipid oxidation was evaluated in five additional batches using an accelerated stability test (40°C, 70% RH, 13.7 weeks) intended to simulate a 12‐month shelf‐life at ambient temperature (Table 12). The applicant justified the extrapolation of the study results to real‐time conditions using the Arrhenius equation.

TABLE 11.

Analysis of five batches after storage at room temperature for 2 years.

	#1	#2	#3	#4	#5
Mycotoxins (μg/kg)
Aflatoxin B1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Aflatoxin B2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Aflatoxin G1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Aflatoxin G2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Deoxynivalenol (DON)	< 50	< 50	< 50	< 50	< 50
Fumonisin B1	< 50	< 50	< 50	< 50	< 50
Fumonisin B2	< 50	< 50	< 50	< 50	< 50
HT‐2 toxin + T‐ 2 toxin sum	< 20	< 20	< 20	< 20	< 20
Ochratoxin A	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2
Sum B1, B2, G1, G2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Zearalenone	< 5	< 5	< 5	< 5	< 5
Microbiological parameters (unit)
Campylobacter (CFU/g)	< 10	< 10	< 10	< 10	< 10
B. cereus presumed spores (CFU/g)	50	50	60	< 10	< 40
Clostridium perfringens	< 10	< 10	< 10	< 10	< 10
Coagulase positive staphylococci (CFU/g)	< 10	< 10	< 10	< 10	< 10
E. coli (CFU/g)	< 10	< 10	< 10	< 10	< 10
L. monocytogenes (CFU in 25 g)	ND	ND	ND	ND	ND
Mesophilic aerobic spores	500	900	400	1500	800
Mesophilic anaerobic spores	< 10	< 10	< 10	< 10	< 10
Moulds CFU/g	< 10	< 10	< 10	< 10	270
Presumptive Bacillus cereus (CFU/g)	60	110	160	110	70
Pseudomonas aeruginosa (CFU/g)	< 10	< 10	< 10	< 10	< 10
S. aureus CFU/g	< 10	< 10	< 10	< 10	< 10
Salmonella in 25 g	ND	ND	ND	ND	ND
Thermophilic aerobic spores	< 10	< 10	< 10	< 10	< 10
Thermophilic anaerobic spores	< 10	< 10	< 10	< 10	< 10
Total Enterobacteriaceae (CFU/g)	< 10	100	60	< 10	< 10
Total microbial count (CFU/g)	2300	5000	6300	4500	11,000
Yeasts (CFU/g)	70	< 10	100	60	160

Abbreviations: CFU, colony‐forming unit; ND, not detected.

TABLE 12.

Results of accelerated stability testing of the NF.

Parameter (unit)	Batches										Analytical method
	#6	#7	#8	#9	#10	#6	#7	#8	#9	#10
Time point	0 months					12 months*
Water activity	0.150	0.210	0.236	0.241	0.229	0.231	0.534	0.553	0.566	0.558	Instrumental, in‐house
Free fatty acids (% of fat)	35.12	33.79	28.79	30.86	27.21	85.08	84.08	84.69	85.34	86.86	Titrimetric, NGD C10–1976.
Peroxide (meq O₂/kg fat)	2.2	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2	< 0.2	Titrimetric, ISO 3960:2017
p‐Anisidine	< 2	3.5	3.5	2.5	3.7	4.0	< 2	2.1	< 2	3.0	Spectrophotometry
Kreis test	neg.	neg.	neg.	neg.	neg.	neg.	neg.	neg.	neg.	neg.	Colorimetric, NGD C56–1979

Abbreviations: ISO, International Organization for Standardization; NGD, Norme italiane per il controllo dei Grassi e Derivati (Italian Standards for the Control of Fats and Derivatives).

^*Extrapolated from 13.7 weeks.

At baseline, the peroxide and p‐anisidine values indicated low primary and slight secondary oxidation, while free fatty acid (FFA) content was high (27%–35%), likely resulting from triglyceride hydrolysis during the freezing step used to kill the insects. FFA levels further increased during accelerated storage (84%–87%), indicating ongoing lipase activity (enzymes not inactivated by the production process). Despite this pronounced hydrolysis, primary and secondary oxidation markers remained low. Although FFAs are generally more prone to oxidative degradation than esterified lipids, the peroxide and p‐anisidine values indicated that lipid oxidation did not occur to a substantial extent under the conditions tested. Therefore, while the accumulation of FFAs may negatively affect the sensory quality of the NF, it does not raise safety concerns in relation to its oxidative stability.

The applicant indicated that the shelf‐life of the NF, stored in a fridge or at room temperature (max 25°C), in a dry place, is 12 months.

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

3.4.1.1. Stability in the intended‐for‐use matrices

The applicant examined microbiological data, water activity and hexanal content in pizza, pesto and dough containing the NF. Analytical values were compared to those from foods processed without the NF (control), except in the case of pesto. Overall, the NF inclusion did not seem to substantially affect the parameters tested. However, the Panel notes that the study is limited due to the sample size, with only a few replicates analysed, which may affect the representativeness of the results, and the absence of a control for the pesto sample prevents a direct comparison to assess the impact of NF addition.

3.5. Specifications

The specifications of the NF, proposed by the applicant, are indicated in Table 13.

TABLE 13.

Specifications of the NF.

Description: Whole spray‐dried powder form of the house cricket.
Source: Acheta domesticus
Parameter	Unit	Value
Proximate parameters
Ash	% w/w	3–4
Crude protein (N × 6.25)	% w/w	57–61
Dietary fibre	% w/w	2–5
Digestible carbohydrates	% w/w	0.5–2.5
Total fat	% w/w	26–30
Of which saturated	% w/w	10–12
Moisture	% w/w	≤ 5
Peroxide value	mEqO2/kg of fat	≤ 2.5
Chitin *	% w/w	4–8
Metals and other elements
Lead	mg/kg	≤ 0.075
Cadmium	mg/kg	≤ 0.075
Mycotoxins
Aflatoxins (sum of B1, B2, G1, G2)	μg/kg	< 0.1
Deoxynivalenol	μg/kg	< 50
Sum of fumonisin B1 + fumonisin B2	μg/kg	< 70
Ochratoxin A	μg/kg	< 0.2
Zearalenone	μg/kg	< 5
Dioxins and dioxin‐like PCBs
Total WHO‐PCDD/F‐PCB TEQ on fat (UB)	pg/g fat	< 1
Microbiological parameters
Campylobacter	CFU in 25 g	< 10
Coagulase‐positive staphylococci	CFU/g	< 10
Enterobacteriaceae	CFU/g	< 500
Escherichia coli	CFU/g	< 10
Listeria monocytogenes	CFU in 25 g	Not detected
Bacillus cereus (presumptive)	CFU/g	< 105
Salmonella spp.	CFU in 25 g	Not detected
TAMC	CFU/g	≤ 105
TYMC	CFU/g	< 100

Abbreviations: CFU, colony‐forming unit; N, nitrogen; PCB, Polychlorinated biphenyls; PCDD/F, Polychlorinated dibenzo‐p‐dioxins and furans; TAMC, total aerobic microbial count; Toxic Equivalents; w/w, weight per weight; TYMC, total yeast and mould count; UB, Upper Bound (non‐quantified compounds were assumed to be present at the limit of quantification (LOQ) when calculating Total); WHO, World Health Organisation; WHO‐PCDD/F‐PCB‐TEQ, Toxic Equivalents of PCDDs, PCDFs, and dioxin‐like PCBs calculated using WHO 2005 Toxic Equivalency Factors.

^*Determined according to Luparelli et al. (2023).

The applicant proposed specification limits of 0.5–2.5 g/100 g for digestible carbohydrates and 2–5 g/100 g for dietary fibre. The Panel notes that analytical data for five batches show digestible carbohydrate values of 1.6–3.4 g/100 g, with two batches (3.40 and 2.90 g/100 g) exceeding the proposed upper limit. The Panel considers that the proposed range does not reflect the natural variability of the production process. Chitin content was analysed using three different methods, yielding values between approximately 2.5 and 10.3 g/100 g for the same batches. The applicant proposed a specification of 4%–8% chitin and indicated that compliance would be based on results obtained using the method of Luparelli et al. (2023). The Panel notes that results from this method fall within the proposed range, whereas other analytical methods (e.g. gravimetric) yield non‐compliant values. The Panel considers that the selected method should be clearly stated in the specifications. With regard to lead and cadmium, the Panel notes that the proposed specification limits are slightly higher than those proposed for other products derived from dried insects.

The Panel notes that the applicant did not propose specification limits for certain safety‐relevant elements, such as manganese (Mn), although analytical data were provided.

Regarding microbiological parameters, the applicant proposed limits of ≤ 10⁵ CFU/g for TAMC and < 10⁵ CFU/g for presumptive B. cereus. The Panel notes that, while values were within these limits, some batches were close to the upper specification, indicating limited process margin. The presence of B. cereus in several batches (up to 1.3 x 10⁴ CFU/g) suggests spore survival after processing. Considering the nature of the NF and the batch data provided, the Panel considers that a stricter limit (e.g. < 10² CFU/g) must be proposed to provide greater assurance of microbiological safety, in line with previous assessment of relevant products (EFSA NDA Panel, 2021a, 2021b, 2022, 2024). For Enterobacteriaceae, the applicant proposed a limit of < 500 CFU/g. While most results were < 10 CFU/g, one batch showed 420 CFU/g, indicating variable hygiene. Previous EFSA opinions on comparable NFs (EFSA NDA Panel, 2021a, 2021b, 2022, 2024) have applied a stricter limit of < 100 CFU/g. The Panel therefore considers that a limit of < 100 CFU/g should be applied. The applicant proposed a limit of < 100 CFU/g for yeasts and moulds. However, the Panel notes that not all batches were compliant. Occasional exceedances may reflect humidity or storage issues that should be addressed to ensure consistent compliance with the proposed specification.

The Panel considers that the information provided by the applicant on the specifications of the NF is not sufficient and raises safety concerns.

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

As per the information provided by the applicant, the NF has not been made available for consumption in European countries, or in countries outside of Europe.

A. domesticus, either collected from the wild or reared in farms, is consumed as part of the customary diet in some non‐EU countries. Its consumption by humans has been reported mainly in Thailand (Hanboonsong et al., 2013; Yen, 2015), the Lao People's Democratic Republic (LPDR) (Codex Alimentarius Commission, 2010; Durst & Hanboonsong, 2015), Cambodia (FAO, 2013), Ghana (Anankware et al., 2016), Mexico (Ramos‐Elorduy, 2009), the Democratic Republic of Congo and Kenya (Halloran et al., 2018).

Hanboonsong et al. (2013) reported that around 20,000 A. domesticus small‐ and medium‐sized farms are registered in Thailand. Products are distributed to wholesalers and local markets. Commercial chicken feed and vegetables are used as substrate, and 7500 tonnes of crickets (including A. domesticus) are produced per year. In 2017, the Thai Agricultural Standards Committee established good agricultural farming practices for cricket farming, including A. domesticus (ACFS, 2017).

A. domesticus is also farmed in Lao PDR (Hanboonsong & Durst, 2014), as well as to a lesser extent in Cambodia, the Democratic Republic of Congo and Kenya (Halloran et al., 2018).

Additionally, in Australia and New Zealand, it is considered a non‐traditional, but not novel food, and no safety concerns were identified with the exception of a potential risk of allergenicity in crustacean‐allergic or other sensitive individuals when consuming crickets or foods derived from crickets (FSANZ, 2023). Since 1 May 2017, A. domesticus in the adult phase is among the insect species that can be legally introduced in the Swiss market as food (whole, chopped or ground). In Canada, it is considered non‐novel for use as a food or food ingredient (Health Canada, 2021). A. domesticus is marketed for human consumption in the EU, Australia and the USA as a whole insect or as a food ingredient in several food products (e.g. nutritional bars, lollipops, flour, chocolate).

3.7. Proposed uses and use levels and anticipated intake

3.7.1. Target population

The target population initially proposed by the applicant was the general population, excluding children under 3 years of age. However, as the NF is intended to be used as an ingredient in standard food categories, it cannot be excluded that the NF would also be consumed by other groups of the population. Therefore, the safety data and the exposure assessment shall cover all population groups (Commission Implementing Regulation (EU) 2017/2469, Article 5(6)). The applicant amended the target population accordingly.

3.7.2. Proposed uses and use levels

The NF is proposed to be used as an ingredient in several food products, including bakery products, snacks, pasta, confectionery, desserts and sauces, with maximum use levels ranging from 1 to 40 g NF/100 g. The food products were defined using the FoodEx2 ⁸ hierarchy. Additionally, the applicant proposed the use of the NF as a whole food.

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

The applicant did not provide ADME studies with the NF or its components.

3.9. Nutritional information

The applicant provided nutritional analyses of the NF, which consists mainly of protein (58.4 ± 1.6% w/w), fat (28.1 ± 1.4% w/w) and dietary fibre (3.4 ± 0.7% w/w). The energy value of the NF is on average 504 ± 4 kcal/100 g (Table 1). Analytical data were provided for macronutrients (Table 1) and micronutrients (Table 3), as well as for the amino acid profile (Appendix A), fatty acid profile (Appendix B) and antinutrient content (Table 4).

3.9.1. Protein content and protein quality

The NF contains on average 58.4 ± 1.6 g protein per 100 g, calculated as the total nitrogen measured by the Kjeldahl method multiplied by a nitrogen‐to‐protein conversion factor of 6.25 (crude protein), in accordance with Regulation (EU) No 1169/2011. Amino acid analysis confirmed the presence of all indispensable amino acids (Appendix A). Based on the sum of anhydrous amino acids, the applicant calculated the true protein content of the NF at 47.1 ± 2.0 g/100 g. The Panel notes that the use of the conventional factor overestimates the true protein content in the NF due to the presence of non‐protein nitrogen derived mainly from chitin (Janssen et al., 2017).

Regarding protein digestibility, the applicant referred to the published study by Ruggeri et al. (2023), which analysed the NF. In this study, the protein digestibility was assessed through an in vitro protein digestibility‐corrected amino acid score (PDCAAS) enzymatic digestion method. The results showed an in vitro digestibility of 1.08 ± 0.02 and an amino acid score of 1.04 ± 0.01, with L‐tryptophan identified as the first limiting amino acid, leading to a PDCAAS value of 1.0. The authors attributed the high digestibility to the fine particle size of the spray‐dried material, which may enhance protein bioaccessibility.

However, the Panel noted that the PDCAAS approach applied in Ruggeri et al. (2023) is an in vitro model simulating rat digestion and does not consider intestinal absorption, microbiota interactions or antinutritional factors. Therefore, the results should be interpreted as indicative rather than conclusive evidence under physiological conditions.

3.9.2. Fatty acids, vitamins and minerals

The major fatty acids in the NF are linoleic acid, palmitic acid and oleic acid (Appendix B), accounting on average for 80% of all fatty acids in the NF. On average, saturated fatty acids, monounsaturated fatty acids and polyunsaturated fatty acids constitute 40%, 23% and 36% of the total fatty acids, respectively. The average trans fatty acid content is 0.13 ± 0.01% of total fatty acids. Analytical data for certain minerals and vitamins were provided (Table 2).

3.9.3. Antinutrients

The applicant determined the content of total polyphenols, oxalates and hydrocyanic acid in the NF (Table 4). The reported values for the NF are comparable to the content of these compounds in other foodstuffs (EFSA CONTAM Panel, 2019; Gupta, 1987; Holmes & Kennedy, 2000; Rao & Prabhavathi, 1982; Schlemmer et al., 2009) and to other published EFSA NF opinions (EFSA NDA Panel, 2021a, 2021b, 2022).

The Panel considers that the nutrient composition of the NF does not raise safety concerns.

3.10. Toxicological information

The toxicological profile of A. domesticus has been previously assessed by the Panel (EFSA NDA Panel, 2021a, 2021b, 2022, 2024). The Panel concluded that no safety concerns arose from the history of use and compositional data of A. domesticus. The Panel notes that the NF under assessment can be considered representative of the previously assessed A. domesticus (EFSA NDA Panel, 2021a, 2021b, 2022, 2024) only with regard to the profile of endogenously produced compounds of possible concerns, but not for compositional data and for any compound that can be present due to rearing conditions (e.g. feed) or processing.

The applicant referred to a recently published toxicological study available in the literature (in vitro and in vivo genotoxicity, 14‐ and 90‐day subchronic toxicity studies) with processed (dried and sterilised) A. domesticus powder as the testing material (Yasuki et al., 2022). All tests were reported to follow relevant OECD guidelines. The Panel considers that, since these studies were not performed with the NF, the outcomes can only be considered as supporting evidence for the safety of the NF (EFSA NDA Panel, 2024).

The applicant provided a cytotoxicity study report, which has also been published (Ruggeri et al., 2023). The Panel considers that this study is not relevant for the assessment of the safety of the NF. The applicant also referred to studies in the scientific literature (Dobermann & Scheers, 2021; Kinyuru et al., 2021) and to registered clinical trials. However, the Panel considers their relevance for the safety assessment of the NF to be limited.

The Panel notes that the NF may contain a fraction of small particles < 250 nm, likely insoluble and composed of chitin and other indigestible polymers. Therefore, further toxicological investigations may be required to address this aspect, particularly in view of the applicant's assumption of increased bioavailability related to physicochemical properties. Given the unresolved issues identified in other parts of the assessment (e.g. microbiological aspects), no additional investigations were requested.

3.11. Allergenicity

The Panel has previously considered that the consumption of house cricket‐derived food ingredients might induce primary sensitisation to A. domesticus proteins. The Panel also considered that allergic reactions may occur in subjects allergic to crustaceans, mites and molluscs (cross‐reactivity) (EFSA NDA Panel, 2021a, 2021b, 2022, 2024). Based on the literature, 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. This may include allergens listed in Annex II of Regulation (EU) No 1169/2011.

4. DISCUSSION

The NF subject of the application is a spray‐dried powder from house cricket (A. domesticus), intended as a whole food and for potential use in foods that can be consumed by the general population. The pilot‐scale production process has been adequately described. The Panel notes that the production process, as reported by the applicant, involves steps and practices which might have contributed to cross‐contamination and batch‐to‐batch variability of certain microbiological parameters. The reported MOAH values raise safety concerns. Phthalates were also detected in the NF, and due to the limited information provided on the materials in contact with the NF, uncertainty and safety concerns remain.

The Panel identified major issues related to the microbiological quality of the NF. High variability of total aerobic mesophilic counts and, in some cases, elevated counts of presumptive B. cereus, yeasts and moulds were observed across batches. The Panel acknowledges the applicant's explanation for those findings, but cannot conclude on these aspects based on the available evidence. The observed variability can be associated with pilot‐scale production conditions, but the currently submitted evidence prevents any definitive safety conclusion in this regard. Thus, safety concerns regarding the microbiological profile of the NF remain. Moreover, uncertainties remain regarding the presence and characterisation of the small‐particle fraction in the NF and its assessment.

Regarding specifications, the Panel considers that the specifications proposed by the applicant do not adequately capture the variability of the NF for certain parameters and that some of the proposed ranges or limits are insufficient to ensure the safety of the NF.

The Panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins. The Panel also considers that allergic reactions may occur in subjects allergic to crustaceans, mites and molluscs (cross‐reactivity). Additionally, the Panel notes that allergens from the feed (e.g. gluten) may be present in the NF.

Overall, safety concerns relate to microbiological variability and high microbial counts, MOAH exceedances, phthalate presence and compositional inconsistencies linked to the current production process. Given the unresolved issues in the aforementioned areas, the Panel did not consider it pertinent to request further data in the areas of e.g. small particles or toxicological testing, as such additional investigations would not address the current fundamental limitations.

5. CONCLUSIONS

Based on the available data, the Panel concludes that the safety of the NF, spray‐dried powder from house cricket (A. domesticus), cannot be established.

ABBREVIATIONS

1‐MN

1‐methylnaphthalene

ACFS

Agricultural Commodity and Food Standards

AdDV

Acheta domesticus densovirus

ADME

Absorption, Distribution, Metabolism, and Excretion

AOAC

Association of Official Analytical Chemists

AOCS

American Oil Chemists' Society

BIOHAZ

EFSA Panel on Biological Hazards

bw

body weight

CAS

Chemical Abstracts Service

CFU

Colony‐Forming Unit

CONTAM

EFSA Panel on Contaminants in the Food Chain

CrPV

Cricket paralysis virus

Cy‐Cy

Cyclohexyl‐cyclohexyl

DBP

Dibutyl phthalate

DEHP

Di(2‐ethylhexyl) phthalate

DIBP

Diisobutyl phthalate

DIDP

Diisodecyl phthalate

DIN

Deutsches Institut für Normung (German Institute for Standardisation)

DINP

Diisononyl phthalate

DON

Deoxynivalenol

EPA

Environmental Protection Agency

FA

Fatty Acids

FAO

Food and Agriculture Organisation [of the United Nations]

FFA

Free Fatty Acids

GBIF

Global Biodiversity Information Facility

GC‐FID

Gas Chromatography with Flame Ionisation Detection

GC‐MS/MS

Gas Chromatography‐Tandem Mass Spectrometry

GMP

Good Manufacturing Practice

HACCP

Hazard Analysis and Critical Control Points

HPLC

High‐Performance Liquid Chromatography

HPLC‐DAD/FLD

High‐Performance Liquid Chromatography with Diode Array and Fluorescence Detection

HPLC‐PAD

High‐Performance Liquid Chromatography‐Pulsed Amperometric Detection

HR‐GC‐MS

High‐Resolution Gas Chromatography–Mass Spectrometry

HT‐2

a Type A trichothecene mycotoxin

ICP‐MS

Inductively Coupled Plasma ‐ Mass Spectrometry

ICP‐OES

Inductively Coupled Plasma Optical Emission Spectrometry

ISO

International Organization for Standardization

LC‐DAD

Liquid Chromatography with Diode Array Detection

LC‐MS/MS

Liquid Chromatography‐Tandem Mass Spectrometry

LOQ

Limit of Quantification

LPDR

Lao People's Democratic Republic

MLs

Maximum Levels

MOAH

Mineral Oil Aromatic Hydrocarbons

MOSH

Mineral Oil Saturated Hydrocarbons

MUFA

Monounsaturated Fatty Acids

NA

Not Available

NDA

Nutrition, Novel Foods and Food Allergens (EFSA Panel)

NF

Novel Food

NGD

Norme italiane per il controllo dei Grassi e Derivati (Italian Standards for the Control of Fats and Derivatives)

OECD

Organisation for Economic Co‐operation and Development

PAFF

Standing Committee on Plants, Animals, Food and Feed

PAHs

Polycyclic Aromatic Hydrocarbons

PCBs

Polychlorinated Biphenyls

PCDD

Polychlorinated Dibenzodioxins

PCR

Polymerase Chain Reaction

PDCAAS

Protein Digestibility‐Corrected Amino Acid Score

PFAS

Per‐ and Polyfluoroalkyl Substances

PFHxS

Perfluorohexane sulfonic acid

PFNA

Perfluorononanoic Acid

PFOA

Perfluorooctanoic Acid

PFOS

Perfluorooctane Sulfonate

PUFA

Polyunsaturated Fatty Acids

RH

Relative Humidity

SEM

Scanning Electron Microscopy

T‐2

a Type A trichothecene mycotoxin

TAMC

Total Aerobic Mesophilic Count

TEQ

Toxic Equivalents

TYMC

Total Yeast and Mould Count

UB

Upper Bound

UPLC‐ESI‐MS

Ultra Performance Liquid Chromatography‐Electrospray Ionization‐Mass Spectrometry

UV‐VIS

Ultraviolet‐Visible Spectroscopy

w/w

weight per weight

WHO

World Health Organization

WHO‐PCDD/F‐PCB‐TEQ

Toxic Equivalents of PCDDs, PCDFs, and dioxin‐like PCBs calculated using WHO 2005 Toxic Equivalency Factors.

WHO‐PCDD/F‐TEQ

Toxic Equivalents of PCDDs and PCDFs calculated using WHO 2005 Toxic Equivalency Factors

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00374

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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 A. Batch‐to‐batch amino acid profile of the NF

Parameter (g/100 g)	Batch 1	Batch 2	Batch 3	Batch 4	Batch 5
Aspartic acid, including asparagine	5.32	5.18	5.10	5.02	5.05
Total glutamic acid, including glutamine	7.47	7.34	7.27	7.09	7.09
Alanine	3.91	4.29	4.39	4.97	5.56
Arginine	4.02	3.98	3.99	4.00	3.97
Phenylalanine	2.23	2.22	2.22	2.23	2.17
Glycine	2.79	2.90	2.97	3.16	3.29
Hydroxyproline	< 0.1	< 0.1	< 0.1	< 0.1	< 0.1
Isoleucine	2.28	2.32	2.30	2.28	2.28
Histidine	1.27	1.30	1.30	1.35	1.39
Leucine	4.48	4.46	4.46	4.50	4.58
Lysine	4.09	3.87	3.84	3.67	3.66
Proline	2.95	3.15	3.20	3.52	3.74
Serine	2.44	2.44	2.46	2.57	2.64
Tyrosine	3.02	3.20	3.37	3.80	4.07
Threonine	2.43	2.40	2.42	2.46	2.49
Valine	3.01	3.19	3.19	3.35	3.47
Tryptophan	0.682	0.679	0.671	0.644	0.662
Total cysteine and cystine (as cysteine)	0.611	0.579	0.579	0.553	0.546
Methionine	1.15	1.08	1.08	1.05	0.999

APPENDIX B. Batch‐to‐batch fatty acid profile of the NF (GC‐FID)

Parameter (% of total fatty acids)	#1	#2	#3	#4	#5
C4:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C6:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C7:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C8:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C10:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C10:1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C12:0	< 0.05	0.08	< 0.05	< 0.05	< 0.05
C12:1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C13:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C14:0	0.56	0.58	0.56	0.56	0.56
C14:1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C15:0 (12‐methyl, anteiso)	0.08	0.09	0.08	0.08	0.09
C15:0 (pentadecanoic)	0.13	0.13	0.13	0.13	0.13
C15:1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C16:0 (14‐methyl, iso)	< 0.05	< 0.05	< 0.05	0.05	< 0.05
C16:0	27.00	27.19	27.00	27.21	27.28
C16:1	0.81	0.80	0.79	0.80	0.81
C17:0 (15‐methyl, iso)	0.06	0.09	0.07	0.07	0.07
C17:0 (14‐methyl, iso)	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C17:0	0.23	0.15	0.23	0.24	0.14
C17:1	0.05	0.05	0.05	0.06	0.05
C18:0	12.53	12.37	12.33	12.42	12.48
C18:1	21.63	22.02	22.00	21.96	21.93
C18:2	31.28	31.09	31.38	31.07	31.14
C18:3	4.24	4.24	4.34	4.21	4.19
C18:4	0.05	< 0.05	< 0.05	< 0.05	< 0.05
C20:0	0.57	0.55	0.55	0.55	0.56
C20:1	0.05	0.06	0.05	0.06	0.06
C20:2	< 0.05	0.07	0.06	0.05	0.05
C20:3	0.37	< 0.05	< 0.05	< 0.05	< 0.05
C20:3	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C20:4	< 0.05	< 0.05	< 0.05	< 0.05	0.06
C20:5	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C21:0	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C22:0	0.16	0.25	0.17	0.16	0.17
C22:1	0.06	0.06	< 0.05	0.08	< 0.05
C22:2	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C22:4	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C22:5	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C22:6	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
C24:0	< 0.05	< 0.05	< 0.05	0.06	0.06
C24:1	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05
Other	< 0.05	< 0.05	< 0.05	< 0.05	< 0.05

Abbreviation: GC‐FID, gas chromatography with flame ionisation detection.

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. , Frenzel, T. , McArdle, H. J. , Moldeus, P. , Neuhäuser‐Berthold, M. , … Hirsch‐Ernst, K. I. (2026). Safety of Acheta domesticus (house cricket) spray‐dried powder as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 24(9), e9946. 10.2903/j.efsa.2026.9946