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.
The designation of taxifolin-rich extract authorised by this Decision for the labelling of the foodstuffs shall be ‘taxifolin-rich extract’.
This Decision is addressed to Ametis JSC, 68, Naberezhnaya St., Blagoveshchensk, Amur District, Russia 675000.
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 %.
ANNEX IISupplementary provisions
ANNEX II
AUTHORISED USES OF TAXIFOLIN-RICH EXTRACT
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