Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out a supplementary safety assessment for taxifolin by considering also those population groups which were originally excluded at the request of the applicant (i.e. infants, young children and children up to 9 years) for the food categories set out in the application, and by taking into the extension of use of taxifolin from yogurt to a wider range of dairy products.
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 258/971 (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. The intended food categories for the extended proposed use of taxifolin were allocated to corresponding food categories of the EFSA Comprehensive Food Consumption Database (EFSA, 2011) which is based on data from EU Member States’ dietary surveys. Mean and high intakes (i.e. 95th percentile) were estimated for ‘all subjects’ for all age groups of the general population by using individual data of that data base and assuming that all foods of the intended food categories contain taxifolin at the maximum proposed use levels.
The highest mean and 95th percentile intakes per kg bw per day among all population groups are 0.94 and 1.54 mg, respectively, derived for toddlers. Noting that the NOAEL of the 90-day subchronic study was 1,500 mg/kg body weight (bw), the resulting margin of exposure (MOE) to the 95th percentile intake estimate for toddlers would be almost 1,000. For adults weighing 70 kg, the MOE to the combined intake from fortified foods and food supplements would be about 772. For adolescents, taking into account a default mean body weight of 61 kg, the MOE to the combined intake (including 100 mg from food supplements) would be about 627. The Panel considers that these MOEs are sufficient.
The Panel concludes that the NF food, taxifolin-rich extract from Dahurian Larch, is safe under the proposed conditions of use.