RT info:eu-repo/semantics/article
T1 Safety of a change in specifications of the novel food oleores in from Haematococcus pluvialis containing astaxanthin 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 Marchelli, Rosangela
A1 Neuhäuser‐Berthold, Monika
A1 Poulsen, Morten
A1 Prieto Maradona, Miguel
A1 Schlatter, Josef Rudolf
A1 Siskos, Alexandros
A1 van Loveren, Henk
A1 Gelbmann, Wolfgang
A1 Knutsen, Helle Katrine
A2 Nutricion y Bromatologia
K1 Tecnología de los alimentos
K1 Astaxanthin
K1 9-cis astaxanthin
K1 Isomer
K1 Haematococcus pluvialis
K1 Micro algae
K1 Specification change
K1 Food supplements
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 a change of specifications of the novel food (NF) oleoresin from Haematococcus pluvialis containing astaxanthin (ATX) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient for the use in food supplements as defined in Directive 2002/46EC in accordance to Regulation (EU) 2017/2470. The NF concerns an oleoresin which contains ~ 10% ATX, obtained by supercritical CO2 extraction of the homogenised and dried biomass of cultivated H. pluvialis. This NF has been assessed by the Panel in 2014. With the present dossier, the applicant proposed to lower the minimum specification limits for protein and ATX monoesters for the NF, and to increase the maximum specification limit for the relative amount of ATX diesters in total ATX. An increase of the maximum specification limit for the 9-cis isomer is also applied for. Although the data are limited regarding bioavailability and distribution in humans of these three naturally occurring ATX isomers, the available in vitro and in vivo data suggest that the 13-cis rather than the 9-cis ATX is selectively absorbed, i.e. has a higher bioavailability and/or possibly emerges from isomerisation of all-trans ATX. The Panel notes that the toxicity of the individual ATX isomers has not been studied individually. However, the ADI of 0.2 mg/kg, which was established for synthetic ATX and ATX from H. pluvialis, applies also for ATX in the oleoresin from H. pluvialis with the proposed changes of specifications. The Panel concludes that the NF, oleoresin from H. pluvialis containing ATX, is safe with the proposed specification limits
PB Wiley
SN 1831-4732
LK https://hdl.handle.net/10612/20045
UL https://hdl.handle.net/10612/20045
NO Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Peláez, 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 a change in specifications of the novel food oleoresin from Haematococcus pluvialis containing astaxanthin pursuant to Regulation (EU) 2015/2283. EFSA Journal, 21(11). https://doi.org/10.2903/J.EFSA.2023.8338
DS BULERIA. Repositorio Institucional de la Universidad de León
RD 30-jun-2024