RT info:eu-repo/semantics/article T1 Safety of Wolffia globosa powder as a Novel food pursuant to Regulation (EU) 2015/2283 A1 Turck, Dominique A1 Bohn, Torsten A1 Castenmiller, Jacqueline A1 De Henauw, Stefaan A1 Hirsch‐Ernst, Karen Ildico A1 Maciuk, Alexandre A1 Mangelsdorf, Inge A1 McArdle, Harry J A1 Naska, Androniki A1 Peláez, Carmen A1 Pentieva, Kristina A1 Siani, Alfonso A1 Thies, Frank A1 Tsabouri, Sophia A1 Vinceti, Marco A1 Cubadda, Francesco A1 Frenzel, Thomas A1 Heinonen, Marina A1 Prieto Maradona, Miguel A1 Marchelli, Rosangela A1 Neuhäuser‐Berthold, Monika A1 Poulsen, Morten A1 Schlatter, Josef Rudolf A1 van Loveren, Henk A1 Kouloura, Eirini A1 Knutsen, Helle Katrine A2 Nutricion y Bromatologia K1 Tecnología de los alimentos K1 Novel food K1 Food supplement K1 Isolated from plants K1 Water lentil K1 Duckweed K1 Wolffia globosa K1 3309 Tecnología de Los Alimentos AB [EN]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 Wolffia globosa powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Wolffia globosa is an aquatic plant, one out of the 38 species of the water lentil family which is composed by five genera (i.e. Spirodela, Landoltia, Lemna, Wolffiella and Wolffia). The NF is produced by cultivation of Wolffia globosa plants under controlled conditions, washing with hot water and drying. The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is intended to be used as food ingredient in a variety of food categories and as food supplement. The target population is the general population except for food supplements which are intended to be consumed exclusively by adults. The Panel considers that with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The subchronic toxicity study provided with the NF revealed a number of significant findings and the Panel considers the middle dose (6.5 g/kg body weight (bw) per day) as the no observed adverse effect level (NOAEL). Based on the protein concentration, the Panel considers that the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be established. PB Wiley Open Access SN 1831-4732 LK https://hdl.handle.net/10612/21467 UL https://hdl.handle.net/10612/21467 NO 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., Maradona, M. P., ... Knutsen, H. K. (2021). Safety of Wolffia globosa powder as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 19(12), Article e06938. https://doi.org/10.2903/J.EFSA.2021.6938 DS BULERIA. Repositorio Institucional de la Universidad de León RD 29-jun-2024