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.