
Article 1 
Without prejudice to Directive 2002/46/EC, taxifolin-rich extract as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient to be used in food supplements for the general population, excluding infants, young children, children and adolescents younger than 14 years at the maximum levels established in Annex II to this Decision.
Article 2 
The designation of taxifolin-rich extract authorised by this Decision for the labelling of the foodstuffs shall be ‘taxifolin-rich extract’.
Article 3 
This Decision is addressed to Ametis JSC, 68, Naberezhnaya St., Blagoveshchensk, Amur District, Russia 675000.
Done at Brussels, 10 November 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX I

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 C15H12O7
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.


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) ≤ 104 CFU/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



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 1,5


ANNEX II

Food category Maximum levels
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants, young children, children and adolescents younger than 14 years 100 mg/day