RT info:eu-repo/semantics/article T1 Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283 A1 Turck, Dominique A1 Castenmiller, Jacqueline A1 De Henauw, Stefaan A1 Hirsch‐Ernst, Karen Ildico A1 Kearney, John 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 Marchelli, Rosangela A1 Neuhäuser‐Berthold, Monika A1 Poulsen, Morten A1 Prieto Maradona, Miguel A1 Schlatter, Josef Rudolf A1 van Loveren, Henk A1 Colombo, Paolo A1 Knutsen, Helle Katrine A2 Nutricion y Bromatologia K1 Tecnología de los alimentos K1 Galacto-oligosaccharides K1 GOS K1 Ddietary fibre K1 Novel foods K1 Food supplement 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 the change in the conditions of use of galacto-oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of GOS, consisting of different galactosyl residues (two to nine) linked to a terminal glucose by a β-glycosidic bond but also contains lactose and its monomers (galactose and glucose). The NF is a syrup containing ≥ 55% GOS (w/w dry matter) and is produced enzymatically by two β-galactosidases. GOS produced by β-galactosidases according to the same production process is already authorised and included in the EU Union list of novel foods. This application is limited to an assessment of the proposed increase of the use level as food supplement. The proposed change in the conditions of use increases the maximum level in food supplements from 0.333 kg GOS/kg food supplement (33.3%) to 0.450 kg GOS/kg food supplement (45.0%). Since it is recommended that individuals consume no more than 3 servings of 12 g/day, the maximum recommended daily intake would be no more than 16.2 g GOS. No new food uses or other increases to the already approved use levels are being proposed. The information provided on the proposed use levels and anticipated intake do not raise safety concerns. The Panel concludes that the proposed increase in the maximum level of galacto-oligosaccharides as a NF in food supplements is safe under the proposed changes in conditions of use. PB Wiley Open Access SN 1831-4732 LK https://hdl.handle.net/10612/21474 UL https://hdl.handle.net/10612/21474 NO Turck, D., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Kearney, J., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Peláez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., ... Knutsen, H. K. (2021). Safety of a change in the conditions of use of galacto-oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283. EFSA Journal, 19(1), Article e06384. https://doi.org/10.2903/J.EFSA.2021.6384 DS BULERIA. Repositorio Institucional de la Universidad de León RD 29-jun-2024