COMMISSION IMPLEMENTING DECISION (EU) 2017/2079
of 10 November 2017
authorising the placing on the market of taxifolin-rich extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2017) 7418)
(Only the English text is authentic)
Article 1
Article 2
Article 3
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 |
C15H12O7 |
Molecular mass |
304,25 Da |
CAS No. |
480-18-2 |
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) |
≤ 104 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 |
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 |