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 taking into account the comments and objections of a scientific nature raised by the Member States. The assessment follows the methodology set in Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods (NFs) and NF ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council. The assessment is based on the data supplied in the original application, the initial assessment by the competent authority of France, the concerns and objections of the other Member States and the responses of the applicant.
The NF is a taxifolin-rich water–ethanol extract from the wood of the Dahurian Larch (Larix gmelinii (Rupr.) Rupr) and contains a minimum of 90% taxifolin ((2R,3R)-2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)-dihydroquercetin). 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 (at concentrations up to 0.02 g/L), to yogurt (up to 0.02 g/kg) and to chocolate confectionery (up to 0.07 g/kg). The target population for these foods added with taxifolin is the general population from 9 years onwards. In addition, the NF is also intended for food supplements (100 mg/day) for the general population with an age of 14 years and above.
The Panel considers that the data on genotoxicity do not raise concern. In a 90-day subchronic rat study performed in accordance with OECD standards, the highest dose tested (i.e. 1,500 mg/kg body weight (bw)) was considered to be the no observed adverse effect level (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 (P5 body weight for adolescents aged 14–18 years as suggested by EFSA SC (2012)), 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. The Panel concludes that the NF, taxifolin-rich extract from Dahurian Larch, is safe under the proposed conditions of use.
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