HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 215/20
EN
Official Journal of the European Union
20.8.2011
DECISIONS
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,
(5) Phosphatidylserine
from
soya
phospholipids
complies
with the criteria laid down in Article 3(1) of Regulation
Having regard to the Treaty on the Functioning of the European
(EC) No 258/97.
Union,
Having regard to Regulation (EC) No 258/97 of the European
(6) The
measures
provided
for
in
this
Decision
are
in
Parliament and of the Council of 27 January 1997 concerning
accordance with the opinion of the Standing
novel foods and novel food ingredients (
Committee on the Food Chain and Animal Health,

1 ), and in particular
Article 7 thereof,
HAS ADOPTED THIS DECISION:
Whereas:
Article 1
(1) On
28
September
2009
the
company
Cantox
Health
Science International on behalf of the company
Phosphatidylserine from soya phospholipids as specified in
Enzymotec Ltd made a request to the competent
Annex I may be placed on the market in the Union as a
authorities of Finland to place Phosphatidylserine from
novel food ingredient for the uses specified in Annex II.
soya phospholipids on the market as novel food
ingredient.
Article 2
(2) On
14
April
2010
the
competent
food
assessment
body The designation of Phosphatidylserine from soya phospholipids
of Finland issued its initial assessment report. In that
authorised by this Decision on the labelling of the foodstuff
report it came to the conclusion that the company
containing it shall be ‘Soya phosphatidylserine’.
Enzymotec has provided sufficient information to
authorise the placing on the market of Phosphatidylserine
from soya phospholipids as a novel food ingredient.
Article 3
This Decision is addressed to Enzymotec Ltd, P.O. Box 6,
(3) The
Commission
forwarded
the
initial
assessment
report Migdal HaEmeq, 23106 Israel.
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
Done at Brussels, 19 August 2011.
the marketing of the product, which concerns the
maximum daily intake, was raised in accordance with
that provision. In accordance with the provisions of
For the Commission
Article 6(4) a Commission implementing Decision is
required that takes into account the reasoned objection
John DALLI
raised.
Member of the Commission
( 1 ) OJ L 43, 14.2.1997, p. 1.

---

EN
20.8.2011 Official
Journal
of
the
European
Union L
215/21
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-phosphatidyl
choline 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:
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
%

---

L 215/22
EN
Official Journal of the European Union
20.8.2011
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.

---