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)
Date: 2011-08-19
Institutions: European Commission
Subjects: Israel, food industry, food supplement, market approval, soya bean




L_2011215EN.01002001.xml










20.8.2011   


EN


Official Journal of the European Union


L 215/20








            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)
(2011/513/EU)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:







(1)


On 28 September 2009 the company Cantox Health Science International on behalf of the company Enzymotec Ltd made a request to the competent authorities of Finland to place Phosphatidylserine from soya phospholipids on the market as novel food ingredient.












(2)


On 14 April 2010 the competent food assessment body of Finland issued its initial assessment report. In that report it came to the conclusion that the company Enzymotec has provided sufficient information to authorise the placing on the market of Phosphatidylserine from soya phospholipids as a novel food ingredient.












(3)


The Commission forwarded the initial assessment report to all Member States on 21 April 2010.












(4)


Within the 60 days-period laid down in Article 6(4) of Regulation (EC) No 258/97, one reasoned objection to the marketing of the product, which concerns the maximum daily intake, was raised in accordance with that provision. In accordance with the provisions of Article 6(4) a Commission implementing Decision is required that takes into account the reasoned objection raised.












(5)


Phosphatidylserine from soya phospholipids complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.












(6)


The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,





HAS ADOPTED THIS DECISION:



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.




Done at Brussels, 19 August 2011.


For the Commission

John DALLI
            

Member of the Commission






(1)  
            OJ L 43, 14.2.1997, p. 1.




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






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.