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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)

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)

Implementing Decision (EU) 2017/2079 · Decision · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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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

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The designation of taxifolin-rich extract authorised by this Decision for the labelling of the foodstuffs shall be ‘taxifolin-rich extract’.

Article 3

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This Decision is addressed to Ametis JSC, 68, Naberezhnaya St., Blagoveshchensk, Amur District, Russia 675000.

Supplementary provisions

ANNEX ISupplementary provisions

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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

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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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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