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)

Regulation (EC) No 258/97 · 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

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.

Supplementary provisions

ANNEX ISupplementary provisions

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 IISupplementary provisions

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 .

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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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