2011/761/EU: Commission Implementing Decision of 24 November 2011 authorising the placing on the market of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2011) 8362)

• CELEX: Regulation (EC) No 258/97
• Articles: 5

Article 1

Flavonoids from Glycyrrhiza glabra L. (hereinafter referred to as ‘Glavonoid’), as specified in Annex I, may be placed on the market in the Union as a novel food ingredient for the uses specified in Annex II.

Glavonoid shall not be sold to the final consumer as such.

Article 2

1.   The designation of flavonoids from Glycyrrhiza glabra L. authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘flavonoids from Glycyrrhiza glabra L.’.

2.   There shall be a statement on the labelling of the foods where the product was added as a novel food ingredient indicating that:

(a)

the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and

(b)

people taking prescription drugs should only consume the product under medical supervision;

(c)

a maximum of 120 mg of Glavonoid per day should be consumed.

3.   The amount of Glavonoid in the final food shall be indicated on the labelling of the food containing it.

4.   Beverages containing Glavonoid shall be presented to the final consumer as single portions.

Article 3

This Decision is addressed to Kaneka Pharma Europe NV, Triomflaan 173, 1160 Brussels, Belgium.

Schedules & Appendices

ANNEX I

ANNEX I

SPECIFICATIONS OF GLAVONOID

Description

Glavonoid is an extract derived from the roots or rootstock of Glycyrrhiza glabra L. by extraction with ethanol followed by further extraction of this ethanolic extract with medium-chain triglycerides. It is a dark-brown coloured liquid, containing 2,5 % to 3,5 % of glabridin.

Specifications

Parameter

Moisture

less than 0,5 %

Ash

less than 0,1 %

Peroxide value

less than 0,5 meq/kg

Glabridin

2,5 to 3,5 % of fat

Glycyrrhizinic acid

less than 0,005 %

Fat including polyphenol-type substances

not less than 99 %

Protein

less than 0,1 %

Carbohydrates

not detectable

ANNEX II

ANNEX II

Food category

Maximum content of Glavonoid

Beverages based on milk

Beverages based on yoghurt

Beverages based on fruits or vegetables

120 mg per daily portion

Food supplements

120 mg per portion of daily consumption