HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 21/32
EN
Official Journal of the European Union
24.1.2013
COMMISSION IMPLEMENTING DECISION
of 22 January 2013
authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under
Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2013) 110)
(Only the Dutch text is authentic)
(2013/49/EU)
THE EUROPEAN COMMISSION,
(8) On
25
January
2012
the
applicant
provided
additional
information and proposed an intake of synthetic zeax
anthin as an ingredient in food supplements of up to
Having regard to the Treaty on the Functioning of the European
2 mg per person per day.
Union,

Having regard to Regulation (EC) No 258/97 of the European
(9) Following
a
request
from
the
Commission,
EFSA
was
Parliament and of the Council of 27 January 1997 concerning
asked to update its opinion on the safety of synthetic
novel foods and novel food ingredients ( 1 ), and in particular
zeaxanthin as a novel food ingredient in food
Article 7 thereof,
supplements in the light of the additional information.
On 13 September 2012, EFSA adopted a ‘Statement on
Whereas:
the safety of synthetic zeaxanthin as an ingredient in
food supplements’ ( 3 ) concluding that the use level
proposed by the applicant does not raise safety concerns.
(1) On
1
June
2004,
the
company
DSM
Nutritional
Products
VML made a request to the competent authorities of the
Netherlands to place synthetic zeaxanthin on the market
as a novel food ingredient.
(10) On the basis of the scientific assessment, it is established

that synthetic zeaxanthin complies with the criteria laid
down in Article 3(1) of Regulation (EC) No 258/97.
(2) On
16
June
2005
the
competent
food
assessment
body
of the Netherlands issued its initial assessment report. In
that report it came to the conclusion that synthetic zeax
(11) The
intentional
addition
of
synthetic
zeaxanthin
to
food
anthin with a maximum intake for not more than 20 mg
for colouring purposes falls within the scope of Regu
per person per day, would not present a significant risk
lation (EC) No 1333/2008 of the European Parliament
for human health. However, it concluded that the data
and of the Council of 16 December 2008 on food
presented were not sufficient to complete the safety
additives ( 4 ) and should be authorised in accordance
assessment.
with that Regulation.
(3) Therefore
an
additional
assessment
was
required.
(12) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
(4) The
Commission
forwarded
the
initial
assessment
report
Committee on the Food Chain and Animal Health,
to all Member States on 1 August 2005 for additional

comments.
HAS ADOPTED THIS DECISION:
(5) On
2
February
2007
the
applicant
informed
the
Commission that the use of zeaxanthin should be
limited to be used only as an ingredient in food supple
ments.
Article 1
Synthetic zeaxanthin as specified in the Annex may be placed
(6) The
Commission
consulted
the
European
Food
Safety on the market in the Union as a novel food ingredient in food
Authority (EFSA) on 20 March 2007.
supplements at the maximum intake recommended by the
manufacturer of up to 2 mg per day.
(7) On
24
April
2008
the
EFSA
adopted
a
Scientific
Opinion
on the safety of ‘synthetic zeaxanthin as an ingredient in
Article 2
food supplements’ ( 2 ) concluding that based on the
existing data, the safety of synthetic zeaxanthin as an
The designation of synthetic zeaxanthin authorised by this
ingredient in food supplements at the proposed level of
Decision on the labelling of the foodstuffs containing it shall
20 mg per person per day has not been established.
be ‘synthetic zeaxanthin’.
( 1 ) OJ L 43, 14.2.1997, p. 1.
( 3 ) EFSA Journal 2012: 10(10):2891.
( 2 ) EFSA Journal (2008) 728, 1-27.
( 4 ) OJ L 354, 31.12.2008, p. 16.

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EN
24.1.2013 Official
Journal
of
the
European
Union L
21/33
Article 3
This Decision is addressed to DSM Nutritional Products, Alexander Fleminglaan 1, 2613 AX Delft, The
Netherlands.
Done at Brussels, 22 January 2013.
For the Commission
Tonio BORG
Member of the Commission
ANNEX
SPECIFICATIONS OF SYNTHETIC ZEAXANTHIN
Definition
Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid. Synthetic zeaxanthin is produced
by a multi-step chemical synthesis from smaller molecules.
Synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added
α-tocopherol and ascorbyl palmitate or as a corn oil suspension with added α-tocopherol
Description: Orange-red crystalline powder with little or no odour
Chemical formula: C 40 H 56 O 2
Structural formula:
CAS No: 144-68-3
Molecular weight: 568,9 daltons
Physical-chemical properties of synthetic zeaxanthin
Loss on drying less
than
0,2
%
All-trans zeaxanthin more
than
96
%
Cis-zeaxanthin less
than
2
%
Other carotenoids less
than
1,5
%
Triphenylphosphine oxid
less than 50 mg/kg
(CAS No 791-28-6)

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Document Outline

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