RT info:eu-repo/semantics/article
T1 Safety of oil from Schizochytrium sp. (strain CABIO‐A‐2) for use in infant and follow‐on formula 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 Aguilera Gómez, Margarita
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 Siskos, Alexandros
A1 van Loveren, Henk
A1 Turla, Emanuela
A1 Knutsen, Helle Katrine
A2 Nutricion y Bromatologia
K1 Tecnología de los alimentos
K1 Alga
K1 Docosahexaenoic acid (DHA)
K1 Fatty acid
K1 Infants and young children
K1 Novel foods
K1 Safety
K1 Schizochytrium
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 safety of Schizochytrium sp. (strain CABIO-A-2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. S. sp. is a single-cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%–44% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The evidence provided demonstrated that the strain S. sp. CABIO-A-2 is phylogenetically closely related to the strain S. sp. ATCC 20888. The assessment of some already authorised S. sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90-day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA-oils derived from strains belonging to the genus Schizochytrium, its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use
PB Wiley
SN 1831-4732
LK https://hdl.handle.net/10612/20077
UL https://hdl.handle.net/10612/20077
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., Aguilera-Gómez, M., Cubadda, F., Frenzel, T., Heinonen, M., et al. (2023). Safety of oil from Schizochytrium sp. (strain CABIO-A-2) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 21(12). https://doi.org/10.2903/J.EFSA.2023.8415
DS BULERIA. Repositorio Institucional de la Universidad de León
RD 15-jun-2024