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

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.

Statement on the safety of taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

“…On 13 December 2016, the EFSA NDA Panel adopted the Scientific Opinion on the safety of taxifolin-rich extract from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to Regulation (EC) No 258/97 1 (EFSA NDA Panel et al, 2016). In order to address the present mandate, an intake assessment was carried out by taking into account all population groups (including now also children below 9 years of age) and by considering the food intended categories for which the applicant provided maximum use levels of taxifolin.…”

“…On 13 December 2016, the EFSA NDA Panel adopted the Scientific Opinion on the safety of taxifolinrich extract from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to Regulation (EC) No 258/97 1 (EFSA NDA Panel, 2016). The maximum use levels proposed by the applicant were 0.02 g/L for non-alcoholic beverages, 0.02 g/kg for yogurts and 0.07 g/kg for chocolate confectionery.…”

“…On 13 December 2016, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) adopted the Scientific Opinion on the safety of taxifolin-rich extract from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to Regulation (EC) No 258/97 1 (EFSA NDA Panel, 2016).…”

“…The Panel concluded that the margins of exposure (MOEs) of this NOAEL and the estimated intake of taxifolin from the intended food uses (including 100 mg taxifolin/ day from supplements) were 660 for adults consuming 158 mg/day and 460 for adolescents consuming 146 mg/day, respectively. The Panel concluded that the NF, taxifolin-rich extract from Dahurian Larch, is safe under the proposed conditions of use (EFSA NDA Panel, 2016).…”

COMPARATIVE ASSESSMENT OF NATURAL FEED ADDITIVES FOR FUNCTIONAL EFFECTS ON THE DIGESTIVE PROCESSES IN THE RUMEN OF SHEEP (Ovis aries)

“…Дигидрокверцитин (ДКВ), который получают из лиственницы даурской (Larix dahurica Turez), участвует в регуляции метаболических процессов, положительно влияет на функциональное состояние внутренних органов, создает механизмы защиты здоровых клеток организма от патологий. ДКВ широко применяется в медицине, пищевой промышленности и других отраслях народного хозяйства (11). По запросу Европейской комиссии (European Commission, EC) группой ученых по диетическим продуктам и питанию была проведена оценка и показана безопасность использования экстракта из лиственницы даурской, богатого дигидрокверцетином (таксифолином), как пищевого ингредиента согласно Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.…”