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

Dominique Turck, Jean‐Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather‐Tait, Marina Heinonen, Karen Ildico Hirsch‐Ernst, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Monika Neuhäuser‐Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Marco Vinceti, Peter Willatts & 7 others Karl–Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Josef Schlatter, Wolfgang Gelbmann, Henk Van Loveren

Research output: Contribution to journalArticle

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.
LanguageEnglish
JournalEFSA Journal
Volume15
Issue number2
DOIs
Publication statusPublished - 14 Feb 2017

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Larix
Food
Body Weight
Dietary Supplements
No-Observed-Adverse-Effect Level
Yogurt
Dietetics
Beverages
Hypersensitivity
Ethanol
taxifolin
Safety
Water

Keywords

  • taxifolin-rich extract
  • novel food
  • safety evaluation

Cite this

Turck, D., Bresson, JL., Burlingame, B., Dean, T., Fairweather‐Tait, S., Heinonen, M., ... Van Loveren, H. (2017). Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii). EFSA Journal, 15(2). https://doi.org/10.2903/j.efsa.2017.4682
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 ; Van Loveren, Henk. / Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii). In: EFSA Journal. 2017 ; Vol. 15, No. 2.
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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.",
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Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather‐Tait, S, Heinonen, M, Hirsch‐Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Neuhäuser‐Berthold, M, Nowicka, G, Pentieva, K, Sanz, Y, Siani, A, Sjödin, A, Stern, M, Tomé, D, Vinceti, M, Willatts, P, Engel, KH, Marchelli, R, Pöting, A, Poulsen, M, Schlatter, J, Gelbmann, W & Van Loveren, H 2017, 'Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)', EFSA Journal, vol. 15, no. 2. https://doi.org/10.2903/j.efsa.2017.4682

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; Van Loveren, Henk.

In: EFSA Journal, Vol. 15, No. 2, 14.02.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

AU - Turck, Dominique

AU - Bresson, Jean‐Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather‐Tait, Susan

AU - Heinonen, Marina

AU - Hirsch‐Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Neuhäuser‐Berthold, Monika

AU - Nowicka, Grażyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Siani, Alfonso

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Vinceti, Marco

AU - Willatts, Peter

AU - Engel, Karl–Heinz

AU - Marchelli, Rosangela

AU - Pöting, Annette

AU - Poulsen, Morten

AU - Schlatter, Josef

AU - Gelbmann, Wolfgang

AU - Van Loveren, Henk

PY - 2017/2/14

Y1 - 2017/2/14

N2 - 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.

AB - 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.

KW - taxifolin-rich extract

KW - novel food

KW - safety evaluation

U2 - 10.2903/j.efsa.2017.4682

DO - 10.2903/j.efsa.2017.4682

M3 - Article

VL - 15

JO - EFSA Journal

T2 - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

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Turck D, Bresson JL, Burlingame B, Dean T, Fairweather‐Tait S, Heinonen M et al. Scientific Opinion on taxifolin‐rich extract from Dahurian Larch (Larix gmelinii). EFSA Journal. 2017 Feb 14;15(2). https://doi.org/10.2903/j.efsa.2017.4682