2011/513/EU: Commission Implementing Decision of 19 August 2011 authorising the placing on the market of Phosphatidylserine from soya phospholipids as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2011) 5897)

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

Article 1

Phosphatidylserine from soya phospholipids 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.

Article 2

The designation of Phosphatidylserine from soya phospholipids authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Soya phosphatidylserine’.

Article 3

This Decision is addressed to

Enzymotec Ltd, P.O. Box 6, Migdal HaEmeq, 23106 Israel.

Schedules & Appendices

ANNEX I

ANNEX I

Specifications of Phosphatidylserine from soya phospholipids

Description:

The novel food ingredient is an off-white to light yellow powder. It is also available in liquid form with a clear brown to orange colour. The liquid form contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to the fact that it includes significant amounts of oil (MCT).

Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soybean lecithin with the amino acid L-serine. Phosphatidylserine consists of a glycerophosphate skeleton conjugated with two fatty acids and L-serine via a phosphodiester linkage.

Structural Formula:

Text of image

R=Fatty Acids

Characteristics of Phosphatidylserine from soya phospholipids

Parameter

Powder Form

Liquid Form

Moisture

less than 2 %

less than 2 %

Phospholipids

not less than 85 %

not less than 25 %

Phosphatidylserine

not less than 61 %

not less than 20 %

Glycerides

less than 2 %

not applicable

free L-serine

less than 1 %

less than 1 %

Tocopherols

less than 0,3 %

less than 0,3 %

Phytosterols

less than 0,2 %

less than 0,2 %

ANNEX II

ANNEX II

Use-Level (mg) of Phosphatidylserine from soya phospholipids

Beverages based on yoghurt

50 mg/100 ml

Powders based on milk powder

3,5 g/100 g

(equivalent to 40 mg/100 ml ready to drink)

Foods based on yoghurt

80 mg/100 g

Cereal bars

350 mg/100 g

Chocolate based confectionary

200 mg/100 g

Phosphatidylserine from soya phospholipids may be used in food for special medical purposes only in compliance with Commission Directive 1999/21/EC  ( 1 ) .

( 1 )

OJ L 91, 7.4.1999, p. 29 .