RT info:eu-repo/semantics/article
T1 Safety of oil from Schizochytrium limacinum (strain TKD‐1) 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 Tecnologia de los Alimentos
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. (TKD-1) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain TKD-1, used by the applicant (ATK Biotech Co. Ltd.), belongs to the species Schizochytrium limacinum. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 53%–61% 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. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.
PB Wiley Open Access
SN 1831-4732
LK https://hdl.handle.net/10612/20075
UL https://hdl.handle.net/10612/20075
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 limacinum (strain TKD-1) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 21(12), Article e8414. https://doi.org/10.2903/J.EFSA.2023.8414
DS BULERIA. Repositorio Institucional de la Universidad de León
RD 19-may-2024