ANNEX ISupplementary provisions
ANNEX I SPECIFICATIONS OF TAXIFOLIN-RICH EXTRACT Definition: Chemical name [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin] Chemical formula C 15 H 12 O 7 Molecular mass 304,25 Da CAS No. 480-18-2 Description: Taxifolin-rich extract from the wood of Dahurian Larch ( Larix gmelinii (Rupr.) Rupr) is a white to pale-yellow powder that crystallizes from hot aqueous solutions. Specifications: Specification Parameter Limits Physical parameter Moisture ≤ 10 % Compound analysis Taxifolin (m/m) ≥ 90,0 % of the dry weight Heavy Metals, Pesticide Lead ≤ 0,5 mg/kg Arsenic ≤ 0,02 mg/kg Cadmium ≤ 0,5 mg/kg Mercury ≤ 0,1 mg/kg Dichlorodiphenyltrichloroethane (DDT) ≤ 0,05 mg/kg Residual solvents Ethanol < 5 000 mg/kg Microbial Parameters Total Plate Count (TPC) ≤ 10 4 CFU ( 1 ) /g Enterobacteria ≤ 100/g Yeast and Mould ≤ 100 CFU/g Escherichia coli Negative/1 g Salmonella spp. Negative/10 g Staphylococcus aureus Negative/1 g Pseudomonas spp. Negative/1 g Usual range of components of the Taxifolin-rich extract (as per dry substance) Extract component Content, usual observed range (%) Taxifolin 90 – 93 Aromadendrin 2,5 – 3,5 Eriodictyol 0,1 – 0,3 Quercetin 0,3 – 0,5 Naringenin 0,2 – 0,3 Kaempferol 0,01 – 0,1 Pinocembrin 0,05 – 0,12 Unidentified flavonoids 1 – 3 Water ( 2 ) 1,5 ( 1 ) CFU: Colony forming unit. ( 2 ) Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crystallisation in a quantity of 1,5 %.