Vitamin D2 mushroom powder (Luxidum) authorised as a novel food: 245–460 µg D2/g after UV irradiation, up to 15 µg/day in food supplements; EFSA — vitamin D2 by LC-MS/MS, photoisomers by GC-MS (vitamin D4 5.5 µg/g, tachysterol 21.2 µg/g), 31 % less D2 after 37 months
Commission Implementing Regulation (EU) 2025/691, published on 10 April 2025, adds to the Union list of novel foods vitamin D2 mushroom powder (Agaricus bisporus), produced by controlled UV irradiation that converts ergosterol into vitamin D2; Luxidum GmbH (Germany) holds exclusivity until 30 April 2030. It is authorised in more than a dozen food categories, in foods for special medical purposes (excluding infants) and in food supplements (excluding infants and young children). In its opinion of 30 April 2024 EFSA found it safe: the combined vitamin D intake stays below the upper levels of 50 and 100 µg/day.
- Specification (annex): vitamin D2 245–460 µg/g, moisture ≤ 10 %, ash ≤ 12 %, water activity < 0.5, fat ≤ 4.5 %, carbohydrates ≤ 45 %, protein ≤ 36 %; lead and cadmium ≤ 0.5, mercury ≤ 0.1, arsenic ≤ 0.3 mg/kg; aflatoxin B1 ≤ 2 and sum of aflatoxins < 4 µg/kg. Aerobic microorganisms ≤ 5000 CFU/g, yeasts and moulds < 100 CFU/g, coliforms ≤ 10 CFU/g; Salmonella and Listeria monocytogenes not detected in 25 g, Staphylococcus aureus and E. coli — in 10 g. UV irradiation at wavelengths similar to other authorised UV-treated products.
- Analyses (EFSA, five batches): vitamin D2 278–337 µg/g (LC-MS/MS), and as a check 299–311 µg/g (GC-MS); ergosterol 2000–2500 µg/g; photoisomers by GC-MS — vitamin D4 on average 5.5 µg/g, tachysterol 21.2 µg/g, lumisterol below the LOD of 4.6 µg/g (less than in previous opinions on UV-treated products). Elements by ICP-MS to DIN EN 15763 (mod.): lead 0.04–0.05, cadmium 0.04–0.05, arsenic 0.13–0.14, mercury 0.011–0.031 mg/kg; protein by Kjeldahl, fat by Weibull–Stoldt, water activity by dew point (ISO 18787).
- Stability (EFSA): at 21 ± 2 °C and 62 ± 10 % humidity the vitamin D2 content fell by 31 % after 37 months (from 451 to 312 µg/g); EFSA accepted a shelf life of 24 months. Production: the powder passes through an LED UV unit (LED2D®) with a combination of wavelengths. Vitamin D2 from irradiated mushrooms is bioavailable — serum 25(OH)D2 rises.
- Maximum vitamin D2 levels (annex): 2.4 µg/100 g in among others breakfast cereals, yeast-leavened bread, pasta, cheese, soups and meat analogues; 1.2 µg in fruit and yoghurt drinks; 8.4 µg in concentrated fruit drinks; 21.6 in powdered soups; 24 in milk and whey powder; 98.4 in cream powder; in food supplements 15 µg/day. On the label: “UV-treated mushroom powder containing vitamin D2”, and on supplements a warning for infants and young children.