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 frozen and dried formulations from whole lesser mealworm (Alphitobius diaperinus larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term lesser mealworm refers to the larval form of the insect species Alphitobius diaperinus. The NF comprises the frozen and freeze-dried formulations of the lesser mealworm as whole or in the form of a paste or powder. Apart from water in the frozen formulations (whole, paste), the main components of the NF are crude protein and fat, besides smaller amounts of digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the concentration of such substances in the insect feed. The Panel notes furthermore that the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF formulations added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. Additionally, the applicant proposed to use the NF as a food supplement in adults. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted subchronic 90-day toxicity study with the NF as testing material did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to lesser mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. Allergenicity aside, the Panel concludes that the NF is safe under the proposed uses and use levels.

Safety of frozen and freeze-dried formulations of the lesser mealworm (Alphitobius diaperinus larva) as a Novel food pursuant to Regulation (EU) 2015/2283 / Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; Mcardle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; van Loveren, H.; Ververis, E.; Knutsen, H. K.. - In: EFSA JOURNAL. - ISSN 1831-4732. - 20:7(2022), pp. e07325-e07361. [10.2903/j.efsa.2022.7325]

Safety of frozen and freeze-dried formulations of the lesser mealworm (Alphitobius diaperinus larva) as a Novel food pursuant to Regulation (EU) 2015/2283

Vinceti M.;
2022-01-01

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 frozen and dried formulations from whole lesser mealworm (Alphitobius diaperinus larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term lesser mealworm refers to the larval form of the insect species Alphitobius diaperinus. The NF comprises the frozen and freeze-dried formulations of the lesser mealworm as whole or in the form of a paste or powder. Apart from water in the frozen formulations (whole, paste), the main components of the NF are crude protein and fat, besides smaller amounts of digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the concentration of such substances in the insect feed. The Panel notes furthermore that the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF formulations added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. Additionally, the applicant proposed to use the NF as a food supplement in adults. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted subchronic 90-day toxicity study with the NF as testing material did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to lesser mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. Allergenicity aside, the Panel concludes that the NF is safe under the proposed uses and use levels.
2022
20
7
e07325
e07361
Safety of frozen and freeze-dried formulations of the lesser mealworm (Alphitobius diaperinus larva) as a Novel food pursuant to Regulation (EU) 2015/2283 / Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; Mcardle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; van Loveren, H.; Ververis, E.; Knutsen, H. K.. - In: EFSA JOURNAL. - ISSN 1831-4732. - 20:7(2022), pp. e07325-e07361. [10.2903/j.efsa.2022.7325]
Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; Mcardle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; van Loveren, H.; Ververis, E.; Knutsen, H. K.
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