2006/721/EC: Commission Decision of 23 October 2006 authorising the placing on the market of lycopene from Blakeslea trispora as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2006) 4973)
Date: 2006-10-23
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, market approval, sunflower seed oil

26.10.2006

EN

Official Journal of the European Union

L 296/13

COMMISSION DECISION

of 23 October 2006
authorising the placing on the market of lycopene from Blakeslea trispora as a novel food ingredient
under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2006) 4973)

(Only the Spanish text is authentic)

(2006/721/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

Having regard to the Treaty
Community,

establishing the Europeån

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,

(8)

Whereas:

(1)

(2)

On 30 October 2003 Vitatene Antibiotics SAU made a
request
the United
Kingdom to place lycopene from Blakeslea trispora on
the market as a novel food or novel food ingredient.

to the competent authorities of

On 6 April 2004 the competent food assessment body
the United Kingdom issued its initial assessment
of
In that report it came to the conclusion that
report.
the proposed uses for lycopene from Blakeslea trispora
are safe for human consumption.

(3)

The Commission forwarded the initial assessment report
to all Member States on 27 April 2004.

(4) Within the 60-day period laid down in Article 6(4) of
Regulation (EC) No 258/97 reasoned objections to the
marketing of the product were raised in accordance with
that provision.

The opinion came to the conclusion that the requested
levels of use of lycopene from Blakeslea trispora would
intake of up to about 2 mg/day.
lead to an additional
It also concluded that this additional intake was not of
concern from the safety point of view.

Food additives
falling within the scope of Council
Directive 89/107/EEC of 21 December 1988 on the
approximation of laws of the Member States concerning
food additives authorised for use in foodstuffs intended
for human consumption (2), are excluded from the scope
of Regulation (EC) No 258/97. This Decision does
therefore not constitute authorisation to use lycopene
from Blakeslea trispora as a food colour.

(9)

On the basis of the scientific assessment, it is established
that lycopene from Blakeslea trispora in an α-tocopherol
containing suspension complies with the criteria laid
down in Article 3(1) of Regulation (EC) No 258/97.

(10)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

(5)

(6)

Consequently,
(EFSA) was consulted on 22 November 2004.

the European Food Safety Authority

Lycopene from Blakeslea trispora as specified in Annex I, may be
placed on the market
food
ingredient for use in foods as specified in Annex II.

in the Community as a novel

On 21 April 2005 EFSA adopted the ‘Opinion of the
Scientific Panel on Dietetic Products, Nutrition and
Allergies on a request from the Commission related to
an application on the use of α-tocopherol-containing oil
suspension of lycopene from Blakeslea trispora as a novel
food ingredient’.

Article 2

The designation ‘lycopene’ shall be displayed in the list of ingre-
dients of foodstuffs containing it or, if there is no list of ingre-
dients, on the labelling of the product as such.

(1) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation

(EC) No 1882/2003.

L 296/14

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Official Journal of the European Union

26.10.2006

Vitatene Antibiotics SAU shall submit to the Commission, at the end of three years following the adoption
of this Decision, data as to the groups of foods with lycopene from Blakeslea trispora that have been placed
on the market in the EU and the corresponding use levels of this lycopene.

Article 3

This Decision is addressed to Vitatene Antibiotics SAU, Avd. de Antibioticos, 59-61, 24080 Leon, Spain.

Article 4

Done at Brussels, 23 October 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

26.10.2006

EN

Official Journal of the European Union

L 296/15

ANNEX I

SPECIFICATIONS OF LYCOPENE FROM BLAKESLEA TRISPORA

Definition

Obtained by extraction and crystallisation from a fungal fermentation of Blakeslea trispora, the product is supplied as a 5 %
or 20 % lycopene suspension in high oleic acid sunflower oil containing 1 % α-tocopherol of the lycopene level. The
lycopene from Blakeslea trispora consists of ≥ 90 % all-trans isomer and 1 % to 5 % of cis-isomeres.

Specifications

Chemical name

Lycopene

C.A.S. number

502-65-8 (all trans lycopene)

Chemical formula

C40H56

Structural formula

Formula weight

536,85

Not less than 95 %

Assay

Purity

Imidazole:
Sulfated ash:

Not more than 1 mg/kg
Not more than 1 %

Other Carotenoids:

Not more than 5 %

Mycotxins:

Aflatoxin B1:

Trichothecene (T2):
Ochratoxin:

Zearaleone:

Absent

Absent
Absent

Absent

Microbiology:

Moulds:

Yeasts:
Salmonella:
Escherichia coli:

Not more than 100/g

Not more than 100/g
Absent in 25 g

Absent in 5 g

L 296/16

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Official Journal of the European Union

26.10.2006

ANNEX II

USES OF LYCOPENE FROM BLAKESLEA TRISPORA

Use group

Maximum level of lycopene

Yellow fat spreads

Milk based and milk type products

Condiments, seasonings, relishes, pickles

Mustard

Savoury sauces and gravies

Soups and soup mixes

Sugar, preserves, confectionery

0,2-0,5 mg/100 g

0,3-0,6 mg/100 g

0,6 mg/100 g

0,5 mg/100 g

0,7 mg/100 g

0,6 mg/100 g

0,5 mg/100 g