Abstract
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on UV-treated oil from yellow mealworm (Tenebrio molitor larvae) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from farmed T. molitor larvae and consists mainly of fat (~99%). It is obtained by mechanical separation and is subsequently exposed to UVB radiation to enhance vitamin D(3) content. UV-treatment substantially increased vitamin D(3) levels. Under the proposed use levels, the NF represents a significant contributor to vitamin D intake from foods (including the background diet and fortified foods), accounting for up to half of the intake in older children, adolescents, and adults. Combined intakes from foods and the NF remained below the tolerable upper intake level (UL) for all age groups. Analytical data showed that contaminant levels were below regulatory limits established for other foods, and intake estimates indicated that consumption of the NF would not substantially increase overall dietary exposure to undesirable substances. The Panel further notes that there are no safety concerns regarding the stability of the NF. The NF is intended for use as an ingredient in a range of food products, including bakery products, sauces, dairy desserts, and fats. The target population is the general population. Toxicological studies, including newly submitted in vitro genotoxicity tests, did not raise safety concerns. Animal studies indicated that vitamin D(3) from the NF is bioavailable. The intake of the NF is not nutritionally disadvantageous. The Panel notes that allergic reactions may occur upon consumption, due to primary sensitisation or cross-reactivity with other allergens. The Panel concludes that the NF is safe under the proposed uses and use levels.