Safety of β‐hydroxybutyrate salts 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 β‐hydroxybutyrate (BHB) salts as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of sodium, magnesium and calcium BHB salts, and is proposed to be used by adults as a food ingredient in a number of food categories and as food supplement. The data provided by the applicant about the identity, the production process and the compositional data of the NF over the course of the risk assessment period were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the test item used in the subchronic toxicity study and human studies provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.

Allergic Reaction to a Commercially Available Insect Snack Caused by House Cricket (Acheta domesticus) Tropomyosin

“…[ 5 ] Subsequently, frozen, dried, and powdered forms of migratory locust ( Locusta migratoria ) (http://data.europa.eu/eli/reg_impl/2021/1975/oj), yellow mealworm ( T. molitor larva) (http://data.europa.eu/eli/reg_impl/2022/169/oj), and house cricket ( Acheta domesticus ) (http://data.europa.eu/eli/reg_impl/2022/188/oj) were granted by the European Commission as save novel foods following positive opinions by the EFSA. [ 6,7 ] Most recently, in January 2023 frozen, paste, dried, and powder forms of the lesser mealworm ( Alphitobius diaperinus larvae; http://data.europa.eu/eli/reg_impl/2023/58/oj) [ 8 ] and partially defatted powder from the house cricket [ 9 ] were authorized mostly for the use as supplement for example in bread and rolls, crackers, cereal bars, biscuits, and pasta‐based products (http://data.europa.eu/eli/reg_impl/2023/5/oj).…”

“…[ 1,10,11 ] For the Arthropod family, to which the house cricket belongs, several proteins, like tropomyosin, arginine kinase, glutathione‐S‐transferase, and chitinase, are described as allergens. [ 7 ] As these allergens show conserved IgE‐binding epitopes, there is a high risk that patients allergic to any of these allergens will show adverse reactions after ingesting cricket food preparations. [ 1 ] Even if the processing includes thermal or enzymatic treatment, the risk of allergic reactions is not minimized, as some of these allergens, like tropomyosin, are highly stable to food processing methods.…”

“…[ 12 ] Furthermore, the EFSA Panel clearly stated that it cannot be excluded that the exposure, e.g., by handling crickets for breeding, or consumption of A. domesticus itself can trigger a primary sensitization to cricket proteins. [ 9,7 ] Additionally there is a statement of the EFSA Panel, that allergens which are present in the substrate fed to the insects can as well reach the consumer and research to determine the allergenicity and potential IgE cross‐reactivity to other allergens is highly recommended. [ 9,7 ] Therefore, the European Commission requests a special labeling of foodstuff containing A. domesticus , “that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs, and products thereof, and to dust mites” (http://data.europa.eu/eli/reg_impl/2023/5/oj).…”