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)

• CELEX: Implementing Decision (EU) 2017/2079
• Articles: 5

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.

Schedules & Appendices

ANNEX I

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 II

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