Keywords

1 Introduction

Innovation in the food sector is fostered by the growing consumer interest in dietary choices with a potentially more environmentally sustainable profile compared to the currently existing ones, and by the various challenges that the food system is facing. Among these challenges lies the constantly growing world population, predicted to reach 9.7 billion by 2050, as forecasted by the Food and Agriculture Organization (FAO) of the United Nations.Footnote 1 Since existing agricultural land is insufficient to satisfy the global demand for meat production,Footnote 2 alternative protein sources, novel or traditional ones, could represent an opportunity for more sustainable choices considering animal welfare aspects, while addressing consumer needs. Among these, algae, fungi, cultured meat, plants, and insects appear promising.

Entomophagy, i.e., the consumption of insects by humans, has gained increasing interest lately due to the nutrient composition of certain insect species, as well as due to their food technological potential. Several insects have been consumed by various population groups since prehistory. Moreover, insects have been reported as part of the habitual diet of over two billion people worldwide.Footnote 3,Footnote 4 Evidence of ancient entomophagy has been found in the United States of America (USA) and Mexico, through the analysis of fossilized fecal material.Footnote 5 Additionally, insect consumption by humans has been documented in the Middle East since ancient times (eighth century B.C.), while in Europe, there is proof that ancient Greeks and Romans consumed insects as ingredients of certain recipes.Footnote 6

Recent estimations of edible insects worldwide approximate that about 1600 insect species, are consumed in approximately 140 countries in Asia, Africa, Australia, North America and South America.Footnote 7 The most commonly consumed insect species belong taxonomically to the orders of Coleoptera (beetles) (31%), Lepidoptera (caterpillars) (18%), Hymenoptera (ants, bees and wasps) (14%), Orthoptera (grasshoppers, locusts and crickets) (13%), Hemiptera (cicadas, leafhoppers, planthoppers) (10%), Isoptera (termites) (3%), Odonata (dragonflies) (3%) and Diptera (flies) (2%)Footnote 8 (Fig. 1). In terms of production origin, 92% are wild harvested, 6% are semi-domesticated, and 2% are farmed.Footnote 9,Footnote 10

Fig. 1
A world map with some shaded states which are the United States and Mexico and parts of South America and Africa, Western Europe, the Middle East, South, and Southeast Asia, and Australia, followed by the illustration of insects and their scientific names.

Examples of insect species consumed as food around the world

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The use of insects and products thereof as food differs across the world when it comes to regulatory aspects. Existing legislative frameworks on insects as food and feed were recently compared by Lähteenmäki-Uutela (2021).Footnote 11 For instance, in the United States, edible insects and insect-derived foods fall under the ‘Food, Drug and Cosmetic Act’,Footnote 12 requiring approval from the Food and Drug Administration (FDA) before being marketed in the US market. An insect-derived protein is considered a food additive unless it has GRAS status (Generally Recognized as Safe). In Canada, the ‘Food and Drugs Act’ sets various requirements for foods sold in the Canadian market, setting pre-market notification requirements for infant formulas and for Novel Foods (Division 25 and Division 28). The safety and nutritional adequacy of Novel Foods in Canada must be evaluated before such products may enter the market.Footnote 13 In Australia and New Zealand insects intended for human consumption are regulated in general as ‘Novel Foods’.Footnote 14 Nevertheless, the food safety agency of Australia and New Zealand (Food Standards Australia New Zealand—FSANZ) categorized three insect species as non-novel: super mealworm (Zophobas morio); house cricket (Acheta domesticus); and yellow mealworm (Tenebrio molitor). In several Asian countries (e.g., China, Japan, Thailand), entomophagy has a long tradition. In China, there are no harmonized national laws for edible insects, however insects are traditionally consumed in both households and restaurants.Footnote 15 The Chinese Ministry of Health is responsible for authorizing new food raw materials based on local food safety standards, such as the one for edible frozen fresh silkworm pupae. To date, silkworm pupae and earthworm protein powder have been authorized as food ingredients.Footnote 16,Footnote 17 In Japan, various insect species such as the larvae and pupae of the wasp species Oxya yezoensis or Oxya japonica, and the pupae and female adults of the domestic silkmoth (Bombyx mori) are considered traditional foods. In 2016, the Korean Food and Drug Administration classified house crickets (A. domesticus) and yellow mealworms (T. molitor) as non-novel. The Thai Food and Drug Administration released the guidelines for cricket farmingFootnote 18 in 2017, with Thailand being the world’s biggest cricket producer.

In the European Union (EU), the entry into force of the new Regulation 2283/2015Footnote 19 on Novel Foods and the implementation of Regulations 2468/2017Footnote 20 and 2469/2017Footnote 21 clarified and harmonized rules concerning insects and products thereof as food, specifying that Novel Foods cover whole insects, their parts and products thereof, since such products were not consumed to a significant degree within the EU before 15 May 1997.Footnote 22 From 1 January 2018, insects and insect-derived products must obtain an authorization as Novel Foods before being placed on the EU market.

Since the implementation of the new Novel Foods regulation,Footnote 23 an increasing trend can be observed regarding the number of applications of insects and products thereof as Novel Foods that aspire to enter the EU market. To date, the European Food Safety Authority (EFSA) has received several Novel Food applications for products derived from insect species of differing developmental stages. The concerned insect species comprise T. molitor larvae (yellow mealworm), Alphitobius diaperinus larvae (lesser mealworm), A. domesticus adults (house cricket), Locusta migratoria adults (migratory locust), Hermetia illucens larvae (black soldier fly larvae), male larvae of Apis melifera (honeybee drones), and Gryllodes sigillatus adults (banded cricket or Indian cricket). As of March 2022, the risk assessment process has been finalized for four of these applications.Footnote 24,Footnote 25,Footnote 26,Footnote 27 The authorization process by the European Commission (EC) has been completed, meaning that they can be legally marketed in the EU.Footnote 28,Footnote 29,Footnote 30,Footnote 31 Specifically, the authorized Novel Foods comprise products derived from the yellow mealworm, the migratory locust and the house cricket, following EFSA’s risk assessments which concluded that these products are safe for human consumption under the proposed conditions of use (Fig. 2).

Fig. 2
A donut chart with data, Tenebrio molitor, 4, Locusta migratoria, 2, Acheta domesticus, 3, Alphitobius diaperinus, 2, and Hermetia illucens, Apis melifera and Gryllodes sigillatus, 1.

Applications for insects and products thereof as Novel Foods received by EFSA from January 2018 until February 2022

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2 Overview of the Risk Assessment Process of Insects and Products Thereof As Novel Foods in the EU

2.1 Authorization Procedure for Novel Foods in the EU and Principles of the Risk Assessment Process

Before a Novel Food, including insects and products thereof, can be placed on the EU market, an authorization procedure based on a risk analysis is required. In this context, risk analysis encompasses three main areas: risk assessment, risk management and risk communication. The steps reflecting the authorization procedure of Novel Foods in the EU are presented in Fig. 3.

Fig. 3
A flowchart begins with the validation phase of the dossier followed by the risk assessment phase and ends with implementing the act in the risk management phase.

The Novel Foods applications workflow

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In practical terms, a Food Business Operator (FBO) who intends to place a Novel Food on the EU market, should submit an application to the European Commission that, together with the EU Member States, has risk management responsibilities. Within this framework, EFSA may be mandated by the European Commission to carry out the risk assessment of the technical dossiers submitted in the context of the application. Finally, the European Commission and EFSA share the responsibility to provide appropriate risk communication to inform any interested parties, mitigating any food safety-related issues.

Under the Regulation (EU) 2015/2283 on Novel Foods, FBOs are responsible for verifying with their national authorities whether the product that they intend to market falls within the Novel Food categories defined by the Regulation and therefore would require an application for authorization. Member States can be consulted to support this decision, following the procedure laid down in Commission Implementing Regulation (EU) 2018/456.Footnote 32 After issuing the validity of the application with respect to the requirements laid down in the Regulation (EU) 2015/2283 on Novel Foods, the European Commission makes the technical dossier available to the Member States and may mandate EFSA to carry out the risk assessment, in accordance with Article 10 of the respective Regulation.

For the preparation of the technical dossier in support of their Novel Food application, applicants are recommended to follow the main scientific requirements outlined in EFSA’s ‘Guidance on the preparation and presentation of an application for authorization of a novel food in the context of Regulation (EU) 2015/2283’.Footnote 33 The guidance document was recently updated following the implementation of the Regulation (EU) 2019/1381,Footnote 34 which aims at increasing the transparency of the EU risk assessment in the food chain, and at strengthening the reliability, objectivity, and independence of the studies used by EFSA. Additionally, further information on the major challenges encountered during the risk assessment of Novel Food applications was also recently published.Footnote 35

EFSA’s mandate in the risk assessment of Novel Foods includes an assessment of the safety of the product for the general EU population or for specific segments of it, including an evaluation on whether the product could be nutritionally disadvantageous for the consumer. EFSA must adopt its scientific opinion within nine months of the date of receipt of a valid application from the European Commission. However, if additional information to support the assessment is requested from the applicant by EFSA, the assessment is suspended until the applicant replies.

Assessing the risk arising from the consumption of Novel Foods encompasses the four steps involved in a regular risk assessment process:

  1. 1.

    Hazard identification—the identification of biological, chemical, and physical agents capable of causing adverse health effects which may be present in a particular food or group of foods.

  2. 2.

    Hazard characterisation—the qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with the hazard.

  3. 3.

    Exposure assessment—a qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food, as well as exposures from other sources, if relevant.

  4. 4.

    Risk characterisation—a process of determining the qualitative and/or quantitative estimation, including attendant uncertainties of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterisation and exposure assessment.Footnote 36

EFSA’s risk assessment of Novel Foods ends with the adoption of the scientific opinion on the safety of the product in question by the external experts that constitute the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by a Working Group of external experts and by EFSA scientific officers. The scientific opinion is then published in the EFSA Journal.

Following the adoption of EFSA’s scientific opinion, the European Commission and the EU Member States act as risk managers of the process by evaluating the risk posed to consumers as assessed in EFSA’s opinion and by implementing appropriate measures or monitoring plans when needed. Within seven months of the date of publication of EFSA’s opinion, the European Commission submits a draft to the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) implementing an act authorizing the placing on the market within the Union of a Novel Food and updating the Union list of Novel FoodsFootnote 37 in line with Regulation (EU) 2017/2470.Footnote 38

According to Article 10, Regulation 2015/2283, the Novel Food applications workflow includes the following steps:

2.2 Main Challenges During the Safety Assessment of Insects

During the safety assessment process of insects and products thereof, several challenges may arise related to the production process, the compositional and nutritional analysis of the products, as well as aspects related to toxicological information and allergenicity potential.

2.2.1 Production Process

The production process can have a significant impact on the safety of insects and products thereof as Novel Foods and shall be described in detail. The conditions used in the manufacturing process of insects influence their compositional and nutritional analysis and a priori their safety. The NF’s source, i.e., the insect species, must be identified.

Thus, certificates from national repositories or documentation on genetic techniques evidencing the identity of the insect species could represent proofs on this aspect. Furthermore, eggs or larvae purchased from various suppliers that are intended to be used in the rearing and processing steps should be accompanied by quality and safety certificates from all the companies that provided the initial livestock.

Generally, the production process of insects consists of three main steps: farming, harvesting, and postharvest processing, each bearing potential hazards. As described in the published opinions, farming includes the mating of the adult insect population and rearing of the larvae. Eggs should be separated from the adult insects to avoid any contamination, for instance through faeces. It is therefore important that larvae are reared in disinfected, certified food-contact containers. Ingestion of soft-type plastic has been reported and may represent a potential physical hazard if it ends up in the final food product.Footnote 39,Footnote 40 Additionally, the feeding substrate could contain chemical and microbiological contaminants (e.g., heavy metals, pesticides residues, mycotoxins) that need to be monitored and must be compliant with European feed regulations (e.g., Directive 2002/32/EC).Footnote 41 It is recommended that substrates have not been in contact with other livestock animals (e.g., egg cartons).

During farming, insects can be infected by or become hosts for biological hazards such as bacteria, parasites, fungi and viruses (e.g., cricket paralysis virus and citrobacter for A. domesticus, tapeworms for T. molitor, virus Cricket iridovirus (CrIV) for L. migratoria). Their presence should be detected or documented by evidence in the literature. However, it has been reported that some of these pathogens (i.e., cricket paralysis virus and Cricket iridovirus) represent hazards for other insects, rather than for humans or other vertebrates due to phylogenetic differences, thus the risk of transmitting zoonotic infections is limited.Footnote 42,Footnote 43 Moreover, insects can also produce or accumulate from the environment substances such as antinutrients (phytic acid, quinones, cyanogenic glycosides), which inhibit the bioavailability of nutrients. In addition, as part of their defence mechanism, T. molitor adult insects can secrete chemical substances such as benzoquinones with potentially toxic effects.Footnote 44,Footnote 45 Such findings refer to T. molitor adult insects (beetles), but not to larvae. As a result, it should be noted that larvae should be reared separately from adult insects.

Furthermore, during harvesting insects are separated from frass, substrate, and dead insects to reduce the microbiological load and the presence of other hazards, as well as to avoid further deterioration. They usually undergo a one-day fasting step to discard their bowel content, which is a source of microbiological hazards. During post-harvest processing, thermal treatments are used to enhance the microbiological and chemical stability of the insect as Novel Foods (e.g., freezing/freeze drying, blanching, UV-treatment). For example, a blanching step could contribute to eliminating potentially present zoonotic agents such as parasites and viruses, but also inactivating or reducing the activity of enzymes (e.g., tyrosinase/phenoloxidase) that could cause enzymatic browning in larvae.Footnote 46 However, those methods are not fully effective to heat-resistant endospore-forming bacteria, which may produce toxins.Footnote 47 Drying steps are needed to reach a low water activity in the final product, since the presence of moisture is known to favour microbial growth.

In the case of insect fractions or extracts as Novel Foods, enzymes are often used to hydrolyse the macromolecules. If the safety of such enzymes has not yet been assessed by EFSA, analytical data demonstrating the absence of viable cells of the enzyme-producing microorganisms in the novel food or/and the enzyme preparations should be provided. If enzymes derive from genetically modified microorganisms, then analytical data demonstrating the absence of recombinant DNA are additionally needed. Considering the qualified presumption of safety (QPS) status of certain microorganisms (e.g., Bacillus licheniformis, Aspergillus niger), the absence of toxigenic potential (absence of food poisoning toxins, absence of surfactant activity, and absence of enterotoxic activity) in the corresponding enzyme preparations should be demonstrated according to EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) (2014).Footnote 48

Additionally, FBOs producing insects for human consumption should describe the measures implemented for ensuring the quality and safety of the novel foods and how their production control is assured (e.g., Good Manufacturing Practices (GMP), Hazard Analysis Critical Control Points (HACCP), and International Organization for Standardization (ISO) principles). Therefore, any potential risk could be mitigated via specific measures and actions that control the occurrence of possible contaminants such as solvents, pesticides, antimicrobial substances, or veterinary medicinal products.

2.2.2 Compositional Characterisation and Specifications of Insects and Products Thereof

In terms of compositional analysis, insects can be considered as whole foods, meaning that all their constituents cannot be fully characterised and/or identified. In this respect, insects as Novel Foods are characterised by a qualitative and quantitative assessment of the main constituents and proximate analysis parameters, of constituents of nutritional relevance and of compounds of possible concern for human health. The analytical data should be generated from experimental analysis and be further compared with data from the scientific literature, collected following the respective methodology developed by EFSA.Footnote 49

Nevertheless, providing definitive figures on the nutritional quality of insects is difficult due to the large taxonomic diversity of these organisms. Generally, the nutrient composition of insects spans a broad range of protein, fat, and dietary fibre. Insects are considered a source of protein with amino acid compositions that are generally balanced for humans. With regard to insects as Novel Foods assessed by EFSA, the larvae of dried T. molitor had an average of 57 g/100 g of crude protein. In L. migratoria the dried formulation ranged from 48.1 g/100 g to 48.9 g/100 g, and finally A. domesticus had an average of 60.3 g/100 g. Similarly, variability in fat, chitin, and digestible carbohydrates were observed in the different insect species assessed.

It is worth mentioning that the compositional value of insects is not only species specific but may largely depend on other factors such as rearing conditions. Determining factors include the feed used, the developmental stage of the insects at the time of harvesting, and the ambient conditions.Footnote 50 As an example, the quantitative and qualitative lipid profile in T. molitor can vary when larvae are reared at different temperatures, while a change in feed protein concentration can result in different protein content in the final product.Footnote 51 In additional studies, the fatty acid profile of A. domesticus was found to have a specific polyunsaturated fatty acids profile as a result of the feed used,Footnote 52 with the quantity of fat in A. domesticus adults being correlated with the one present in the feed.Footnote 53

Changes in the micronutrient composition of the feed have also been shown to affect the final composition of insects. For example, the addition of carrots to the diet of T. molitor has been shown to affect the total carotenoid content of the harvested insect,Footnote 54 and can change the content of calcium (Ca), potassium (K), magnesium (Mg), and sodium (Na) in adults of L. migratoria.Footnote 55

The protein conversion factor is a largely debated point in protein quantification in whole insects and certain products thereof. In foods, protein content is generally estimated by multiplying the nitrogen content measured by the Kjeldahl method with a nitrogen-to-protein conversion factor of 6.25, resulting in the so-called crude protein contentFootnote 56 (Regulation (EU) No 1169/2011 (2011) on the provision of food information to consumers). However, in whole insects, as well as in insect-derived products containing chitin, this factor leads to an overestimation of the protein content due to the presence of non-protein nitrogen derived mainly from chitin. More accurate conversion factors were reported for insects and other food products.Footnote 57 For instance, Janssen et al. 2017 proposed an alternative conversion factor of 4.76 based on amino acid data on the larvae of yellow mealworms, lesser mealworms and black soldier flies.Footnote 58 Other studies from 20 insect samples including 13 species and different developmental stages, resulted in an average protein conversion factor of 5.81; ranging from 4.56 to 6.45, confirming an overestimation of true protein content.Footnote 59

In addition to the nutritional characterisation of insects, a qualitative and quantitative characterisation of other substances such as heavy metals, undesirable substances, or processing contaminants is an essential part of risk assessment. This is performed by means of literature review and chemical analyses. For instance, since the bioaccumulation of heavy metals (e.g., arsenic, lead, cadmium) can occur if the larvae of T. molitor are fed with contaminated substrates,Footnote 60 their content is reported and discussed during the risk assessment and reported in the specifications.

Finally, the stability of insects and products thereof is assessed both after production and during their shelf life. Two main aspects are investigated: microbiological stability and oxidative stability of fats. It is in fact important that the microbiological count and lipid oxidation in insects is within specific ranges throughout their shelf life, to ensure safe consumption. Assessment of the stability and behaviour of the Novel Foods in food matrices is required when the novel food is intended to be used as a food ingredient. For example, the levels of acrylamide in biscuits containing yellow mealworm powder were investigated and found to be below the levels set by EU legislation for other products. However, it could not be concluded whether the Novel Foods contributes to the formation of the acrylamide or not, due to absence of appropriate control samples.Footnote 61

2.2.3 Proposed Uses, Use Levels

Depending on their phylogenetic order, insects are consumed at different developmental stages, as eggs, pupae, larvae, or adults. As Novel Foods, insects are typically consumed as a whole food or else are incorporated in other foodstuffs as a food ingredient, for example in the form of a powder. They can also be consumed as a food supplement. In some cases, the hard parts of insects, such as spines, wings, or rostrums, which can be considered physical hazards, are removed to limit the risk of intestinal constipation caused by ingestion.Footnote 62 An example is the removal of the legs and wings of the insect L. migratoria.

In the case of the application for dried and/or frozen yellow mealworm, the applicants proposed to use the Novel Food in the form of whole, dried and/or frozen insect, and as a food ingredient (powdered) in a number of food products (e.g., snacks such as chips, biscuits, legumes-based dishes, pasta, cereal bars, pasta, meat imitates and bakery products). In the case of the frozen and dried formulations from migratory locust, the applicant proposed to use the Novel Food in the form of frozen, dried and ground insect, as snack, and as a food ingredient in various food categories (e.g., soups, frozen yogurt, and beverages). Finally, in the case of the frozen and dried formulations from house crickets, the applicant proposed to use the Novel Food as a snack, and as a food ingredient in 40 different food categories (among others, meat imitations, whey powder, tortilla chips, snacks other than chips, chocolate, and mixed alcoholic drinks).

Estimations of the anticipated daily intake of the Novel Food, as well as exposure of consumers to nutrients and substances of concern after consumption of an insect as novel food are both considered in the risk assessment. Exposure refers to the concentration or amount of a particular agent that reaches a target organism, system, or (sub)population in a specific frequency for a defined duration.Footnote 63 To estimate the chronic intake (average and high percentiles) and acute intake when acute effects may be of concern, the following tools and databases are made available to the public by EFSA: the Food Additives Intake Model (FAIM), the Dietary-Exposure tool (DietEx), FoodEx2 and the EFSA Comprehensive European Food Consumption Database.

Based on the applicant’s choice of the intended uses and maximum use levels, it is possible to calculate the respective intake of the Novel Food in the different target population groups in the EU. One important point to be taken into consideration is that if a Novel Food is intended to be used as food ingredient, a safe level of consumption should be proven for the general healthy population,Footnote 64 whereas in the case of food supplements it is possible to establish a specific target population (e.g., adults).

As such, based on the highest percentile (P95th intake estimate), the estimate of exposure to undesirable substances (e.g., heavy meals, mycotoxins) is calculated for all population groups considering the specified limits for the concentrations of the respective substances of possible concern. However, it was noted in the published outputs on the safety of insects and products thereof as Novel Foods that the consumption of the Novel Food under the proposed uses and use levels did not contribute significantly to the overall exposure to the analysed undesirable substances through diet.

2.2.4 Nutritional Information

When assessing the nutritional aspects of an insect-based product as Novel Food, two important elements must be considered to investigate whether the consumption of the product is not nutritionally disadvantageous under the proposed conditions of use: its role in the diet in terms of dietary supply of nutrients and its possible interaction with nutrient absorption. Specifically, an insect-based product as Novel Food could be nutritionally disadvantageous if its consumption may significantly impact the nutrient supply of consumers or if the tolerable upper intake levels (ULs)Footnote 65 for nutrients are exceeded under the proposed use levels. This is of particular concern in the case of Novel Foods intending to substitute products that are already part of the European diet, as may be the case for new protein sources intending to replace meat, for example. The nutrient composition and the bioavailability of nutrients can be impacted by the farming aspects (e.g., feed substrate, developmental stage of the insect, environmental factors), stability, as well as processing, as previously stated in this chapter.

Protein quality is an important factor to be investigated in safety assessment. To conclude on protein quality, the amino acid profile as well as the digestibility of the protein are primarily considered. The amino acid profile must be defined qualitatively and quantitatively, using methods in accordance with ISO 13903:2005 and/or Commission Regulation (EC) 152/2009 (2009).Footnote 66 Digestibility studies should be performed according to the report by FAO (2013).Footnote 67 In its report FAO recommends the use of a new method to evaluate protein, namely, the digestible indispensable amino acid score (DIAAS)Footnote 68 instead of the protein digestibility-corrected amino acid score (PDCAAS),Footnote 69 since it has been shown to better reflect the amounts of amino acids absorbed from proteins.

In the case of yellow mealworms (freeze-dried), the study by Jensen et al. (2019)Footnote 70 reported a protein digestibility-corrected amino acid score (PDCAAS) of 76% that was comparable to the PDCAAS value of 73% reported on average for vegetablesFootnote 71 but lower than those for beef at 92% and soy at 91%.Footnote 72 In another study by Oibiokpa et al. (2018),Footnote 73 crickets (Gryllus assimilis), were shown to have a higher protein quality and digestibility (measured as protein digestibility-corrected amino acid score or PDCAAS) as compared to the protein quality of other insects analyzed (grasshopper—Melanoplus foedus, termite—Macrotermes nigeriensis and moth caterpillar—Cirina forda).

The literature reports that some insect species contain micronutrients like minerals (iron, zinc, magnesium, manganese, phosphorus and selenium) and vitamins (riboflavin, pantothenic acid, biotin). Rumpold and Schlüter (2013a, b) compiled the nutrient composition of 236 edible insect species and noted that in general, 100 g of edible insects did not meet the daily requirements for Ca and K for instance, but could provide specific levels of other micronutrients such as copper, iron, magnesium, manganese, phosphorous, selenium, and zinc. As already mentioned, the intakes of micronutrients from the background diet are considered in the safety assessment of insects as Novel Foods for establishing the mean and high daily intake scenarios. The resulting estimates are further discussed in the context of available dietary reference values including the ULs.

Regarding the content of these micronutrients in the insects assessed by EFSA up to date, considering the mean and the estimated P95th percentile of exposure to the Novel Food, it was stated that none of the existing ULs for the analyzed micronutrients in the respective insect species (e.g. calcium, copper, iron, magnesium, zinc, iodine, selenium, molybdenum, folate, riboflavin) was expected to be exceeded, for any population group.Footnote 74 However, at present there is insufficient information as to the bioavailability of these micronutrients from insects.

Insects may contain antinutritional factors (ANFs) such as tannins, oxalates, phytate, and hydrogencyanide,Footnote 75 thiaminases,Footnote 76 and protein inhibitors.Footnote 77 These substances can be produced by insects or be accumulated from the environment.Footnote 78 Some of them can negatively impact the bioavailability of nutrients from insects, for example by interfering with the absorption of minerals. From a nutritional perspective, consumption of such substances may have adverse health effects for people who consume insufficient amounts of nutrients. For instance, the levels of oxalic acid were below 0.04 g/100 g in the dried yellow mealworm larvae and below 0.01 g/100 g in the dried and ground formulations of the migratory locust and house crickets assessed. The phytic acid content had ranges between 1.0 and 2.5 g/kg in the dried forms of the insect species assessed, while the total polyphenol content (mg/kg gallic acid) ranged from 0.44 mg/kg gallic acid in the dried, frozen, and ground migratory locust to 1.04 mg/kg gallic acid in the frozen and dried yellow mealworm larvae. However, the levels of these substances in the insect species assessed by EFSA are relatively low, being comparable to the occurrence levels of these compounds in other foodstuffs.Footnote 79

2.2.5 Toxicological Information

To date, the nutrient and microbiological profiles for a variety of insect species and products thereof intended for human consumption, as well as the occurrence level of contaminants, have been broadly investigated. Nonetheless, the existing evidence on genotoxicity, subchronic toxicity, and toxicokinetics is currently limited.

Such toxicological information contributes to the safety assessment of Novel Foods by EFSA. The strategy for the generation of toxicological data to support the safety of insects and products thereof as Novel Foods should be carefully considered, taking into account various aspects such as the compositional profile of the food under-assessment, and the history of use of the food/food ingredient per se and of its source.

EFSA proposes a tiered toxicity testing approach, which can also be applicable to insect-derived products.Footnote 80 It should be taken into consideration that insects and insect-derived ingredients are complex matrices that cannot be readily tested using the classic toxicity approaches. The scientific limitations and hurdles to be carefully considered and overcome are linked to the sensitivity and the selectivity of toxicological methods, as well as to practical issues such as the difficulty to administer toxicologically meaningful amounts of insects to test animals. For example, regarding genotoxicity, since insects are whole foods, it should be considered that the classic genotoxicity approaches are usually not easily applicable, and instead, genotoxicity testing on their fractions could be performed.

In the case of dried, frozen and powder forms of T. molitor larvae, toxicological data retrieved from the literature contributed to the risk assessment. The studies retrieved from the literature investigated subchronic toxicity,Footnote 81 in vitro and in vivo genotoxicity, and subacute toxicityFootnote 82 of lyophilised (freeze-dried) powder of the T. molitor larvae. The EFSA NDA Panel concluded that the testing material used in those studies could not be considered representative of novel foods from a processing point of view (differences in rearing, processing); nevertheless, the test item was considered representative of novel foods as far as the occurrence of endogenously produced compounds was concerned.

It has been reportedFootnote 83 that T. molitor adults secrete benzoquinones, compounds with demonstrated toxic effects, as part of their defence mechanism.Footnote 84 Nevertheless, the secretion of these compounds has been reported only in T. molitor adults, and not in T. molitor larvae, i.e., the source of the novel foods assessed by EFSA. In T. molitor larvae, the excretion of β-carboline, as well as its precursor, the essential amino acid tryptophan, have been reported as part of their defence mechanisms.Footnote 85 The presence of β-carbolines has been reported in fruits, juices, and breakfast cereals. Considering the results of the toxicological studies, the described production process (i.e., that the larvae are reared separately from the adults), alongside the history of use, no safety concerns were raised from a toxicological point of view for these novel foods.

In the assessment of dried, frozen, and powder forms of L. migratoria adults, EFSA identified two studies providing additional toxicological information. Kwak et al. (2020)Footnote 86 performed a 28-day repeated-dose oral toxicity study with the powder of lyophilised L. migratoria as testing material whereas Ochiai et al. (2020)Footnote 87 conducted acute, subacute and subchronic oral toxicity studies using again powder of L. migratoria. The EFSA NDA Panel identified certain limitations in the two studies and used them only as supportive evidence towards the assessment of the toxic potential of the Novel Food. In the case of dried, frozen, and powder forms of A. domesticus adults, it was considered that the production of endogenously produced compounds as part of the defence mechanism of A. domesticus was not reported.

For the risk assessment of both the A. domesticus and L. migratoria forms, no further additional toxicological studies with the novel food as testing material were requested. This was due to the fact that no safety concerns arose from the compositional data of the Novel Foods and from the history of use of their source, i.e., L. migratoria adults and A. domesticus adults, as food in other parts of the world.

The absence of any history of safe use of the Novel Food per se and/or its source, and the nature and levels of compounds of possible toxicological concern, particularly in fractionated products such as insect-derived oils or insect protein preparations (e.g., hydrolysates, isolates, and concentrates), may trigger the need for additional toxicological studies. The effect of the production process on the chemical composition of the final products must be considered, alongside the insect species (physiology and developmental stage), the feed used, and the farming and processing methods. Regarding insects and products thereof as whole foods, if the need to perform an in vivo subchronic toxicity study cannot be ruled out based on the available body of evidence, further guidance is provided by EFSA on how to conduct such a study with a whole food as testing material.Footnote 88

2.2.6 Allergenicity

Insects belong to the Hexapoda (Insecta) class, a subphylum of Arthropoda. Tropomyosin, arginine kinase, and glutathione S-tranferase are among the allergens reported within arthropods. Additionally, the enzymes that degrade chitin, i.e., chitinases, also have allergenic potential.Footnote 89 In its safety assessments of insects and products thereof as Novel Foods, the EFSA NDA Panel concluded that the consumption of such products may cause allergic reactions to individuals through sensitisation to insect proteins, as well as via cross-reactivity of insect protein in individuals allergic to crustaceans, molluscs, and dust mites. Moreover, allergens from the feed (e.g., soy, gluten) can end up in these Novel Foods, since insects are consumed alongside their intestinal tract. Additionally, it was noted that allergic reactions can occur in individuals via skin contact and/or inhalation (occupational exposure). The allergenicity potential of insects, including cross-reactivity to other allergens, should be further investigated, noting also that the current epidemiological evidence regarding allergic reactions induced due to insect consumption is limited.

3 Conclusions and Future Prospects

There is growing interest in insects as alternative food sources in Europe and other parts of the world, driven by factors including, among others, the sustainability of food production, interest in alternative protein sources, and new consumer trends.Footnote 90,Footnote 91,Footnote 92 Since 2018, when the new Novel Food regulation came into force, an increasing number of applications regarding insects and products thereof has been noted through the centralization of the safety assessment process executed by EFSA. A multifaceted risk assessment of these products is needed to investigate their safe consumption before such products are put on the market. Recent EFSA outputs have not raised safety concerns regarding the consumption of insect-derived products under the proposed conditions of use.

When assessing the safety of insects and products thereof, several aspects need to be addressed related to farming, harvesting, and processing practices. The work carried out by EFSA on the risk assessment of insect-derived products as Novel Foods provides scientific input to the decision by risk managers (European Commission, Member States) on the market authorization of such products. Furthermore, EFSA’s outputs can provide advice and raise awareness regarding the safety aspects to be considered during the production of similar foodstuffs for FBOs willing to market products. Moreover, aspects discussed in EFSA’s outputs in the remit of edible insects can help consumers to make more informed dietary choices.