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Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

Turck, Dominique, Bresson, Jean‐Louis, Burlingame, Barbara, Dean, Tara, Fairweather‐Tait, Susan, Heinonen, Marina, Hirsch‐Ernst, Karen Ildico, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Neuhäuser‐Berthold, Monika, Nowicka, Grażyna, Pentieva, Kristina, Sanz, Yolanda, Siani, Alfonso, Sjödin, Anders, Stern, Martin, Tomé, Daniel, Vinceti, Marco, Willatts, Peter, Engel, Karl–Heinz, Marchelli, Rosangela, Pöting, Annette, Poulsen, Morten, Schlatter, Josef, Gelbmann, Wolfgang and Van Loveren, Henk (2017) Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii). EFSA Journal, 15 (2). [Journal article]

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URL: http://dx.doi.org/10.2903/j.efsa.2017.4682

DOI: 10.2903/j.efsa.2017.4682

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for taxifolin-rich extract from Dahurian Larch as a food ingredient in the context of Regulation (EC) No 258/97. The novel food (NF) is a taxifolin-rich water–ethanol extract from the wood of the Dahurian Larch and contains a minimum of 90% taxifolin. The Panel considers that the taxifolin-rich extract is sufficiently characterised and that its compositional data and specifications do not raise safety concerns. The NF is intended to be added to non-alcoholic beverages, to yogurt and to chocolate confectionery. The Panel considers that the data on genotoxicity do not raise concern. In a subchronic rat study performed in accordance with OECD standards, the highest dose tested (i.e. 1,500 mg/kg bw) was considered to be the NOAEL. The margin of exposure (MOE) of the combined intake (158 mg) from the intended food uses (including 100 mg from food supplements) would result to about 660 for an adult weighing 70 kg. For adolescents, taking into account a default body weight of 45 kg, the MOE of the combined intake (146 mg) would be about 460. In the absence of a high percentile intake estimate for children between 9 and 14 years of age, the Panel considers the P97.5 intake estimate from the intended food uses (except from food supplements) for children between 10 and 17 years, i.e. 46 mg/day. Taking into account a default body weight of 29.4 kg (P5 body weight for children aged 10–14 years as suggested by EFSA Scientific Committee (2012)), the resulting MOE would be about 960.

Item Type:Journal article
Keywords:taxifolin-rich extract; novel food; safety evaluation
Faculties and Schools:Faculty of Life and Health Sciences > School of Biomedical Sciences
Faculty of Life and Health Sciences
Research Institutes and Groups:Biomedical Sciences Research Institute > Nutrition Innovation Centre for Food and Health (NICHE)
Biomedical Sciences Research Institute
ID Code:37117
Deposited By: Dr Kristina Pentieva
Deposited On:14 Mar 2017 18:27
Last Modified:28 Jul 2017 13:17

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