2005/448/EC: Commission Decision of 3 March 2005 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2005) 580)
Date: 2005-03-03
Institutions: European Commission
Subjects: food safety, foodstuffs legislation, genetically modified organism, marketing

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 3 March 2005

authorising the placing on the market of foods and food ingredients derived from genetically
modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC)
No 258/97 of the European Parliament and of the Council

(notified under document number C(2005) 580)

(Only the French and Dutch texts are authentic)

(2005/448/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

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), (hereinafter referred
to as the Regulation), and in particular Article 7 thereof,

(4)

Whereas:

(1)

(2)

On 24 April 2001, Monsanto submitted to the
competent authorities of the Netherlands a request,
in
accordance with Article 4 of the Regulation, for placing
on the market foods and food ingredients derived from
genetically modified maize line NK 603 as novel foods or
as novel food ingredients.

(5)

In their initial assessment report of 5 November 2002,
the Netherlands’ competent food assessment body came
to the conclusion that foods and food ingredients derived
from maize NK 603 are as safe as foods and food ingre-
dients derived from conventional maize and may be used
in the same manner.

The Commission forwarded the initial assessment report
to all Member States on 6 January 2003. Within the 60
days period laid down in Article 6(4) of the Regulation,
reasoned objections to the marketing of the product were
raised in accordance with that provision.

the Commission requested an
On 27 August 2003,
opinion from the European Food Safety Authority
(EFSA), in accordance with Article 11 of the Regulation.
On 25 November 2003, EFSA delivered its opinion that
NK 603 maize is as safe as conventional maize and
therefore the placing on the market of NK 603 maize
for food or feed or processing is unlikely to have an
adverse effect on human and animal health and, in that
context, the environment (2). In delivering its opinion, the
EFSA considered all specific questions and concerns
raised by the Member States.

Article 46(1) of Regulation (EC) No 1829/2003 on
genetically modified food and feed (3) provides
that
requests submitted under Article 4 of Regulation (EC)
No 258/97 before the date of application of this Regu-
lation shall be processed under the provisions of Regu-
lation (EC) No 258/97, notwithstanding Article 38 of
Regulation (EC) No 1829/2003, in cases where the addi-
tional assessment report required in accordance with
Article 6(3) of Regulation (EC) No 258/97 has been
transmitted to the Commission before the date of appli-
cation of Regulation (EC) No 1829/2003.

(1) OJ L 43, 14. 2.1997, p. 1. Regulation as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(2) The EFSA Journal (2003) 9, 1-14.
(3) OJ L 268, 18.10.2003, p. 1.

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(6)

(7)

(8)

(9)

(10)

The Joint Research Centre of the European Commission
(JRC)
in collaboration with the European Network of
GMO Laboratories (ENGL), has validated a method for
detection of the NK 603 maize. The JRC has carried out
a full validation study (ring-trial) following internationally
accepted guidelines to test the performance of a quanti-
tative event-specific method to detect and quantify the
NK 603 transformation event in maize. The materials
needed in the study had been provided by Monsanto.
The JRC has considered that the method performance
was appropriate for
taken into
account
criteria proposed by the
ENGL for methods submitted for regulatory compliance
as well as the current scientific understanding about satis-
factory method performance. Both the method and the
results of
the validation have been made publicly
available.

its aimed purpose,

the performance

Reference material for maize from genetically modified
maize line NK 603 has been produced by the Joint
Research Centre (JRC) of the European Commission.

Food and food ingredients from genetically modified
maize line NK 603 should be labelled in accordance
with the provisions of Regulation (EC) No 1829/2003
and should be subject to the traceability requirements
laid down in Regulation (EC) No 1830/2003 concerning
the traceability and labelling of genetically modified
organisms
food and feed
products produced from genetically modified organisms
and amending Directive 2001/18/EC (1).

traceability of

and the

(11)

The Standing Committee on the Food Chain and Animal
Health has not given an opinion; the Commission has
therefore submitted a proposal
to the Council on
4 February 2004 pursuant to Article 13(b) of Regulation
(EC) No 258/97 and in accordance with Article 5(4) of
the Council Decision 1999/468/EC (3), the Council being-
required to act within three months.

(12) However, the Council has not acted within the required
time-limit; a Decision should now be adopted by the
Commission.

HAS ADOPTED THIS DECISION:

Article 1

Foods and food ingredients derived from genetically modified
maize line NK 603 (hereinafter referred to as the products), as
designated and specified in the Annex, may be placed on the
Community market as novel foods or novel food ingredients.

Article 2

The products shall be labelled as ‘genetically modified maize’ or
‘produced from genetically modified maize’ in accordance with
the labelling requirements laid down in Article 13 of Regulation
(EC) No 1829/2003.

Article 3

The products and the information included in the Annex shall
be entered in the Community register of genetically modified
food and feed.

Article 4

In accordance with Commission Regulation (EC) No
65/2004 (2), a unique identifier has been assigned to
the product
for the purposes of Regulation (EC) No
1830/2003.

This Decision is addressed to Monsanto Europe SA, Avenue de
Tervuren 270-272, B-1150 Brussels, Belgium, representing the
Monsanto Company, United States of America. It shall be valid
for a period of 10 years.

Information, contained in the Annex, on the identifi-
foods and food ingredients derived from
cation of
genetically modified maize line NK 603,
including the
validated detection method and the reference material,
should be retrievable from the Register referred to in
Article 28 of Regulation (EC) No 1829/2003.

Done at Brussels, 3 March 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 24.
(2) OJ L 10, 16.1.2004, p. 5.

(3) OJ L 184, 17.7.1999, p. 23.

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ANNEX

INFORMATION TO BE ENTERED IN THE COMMUNITY REGISTER OF GENETICALLY MODIFIED FOOD
AND FEED

(a) Authorisation holder:

Name: Monsanto Europe SA

Address: Avenue de Tervuren 270-272, B-1150 Brussels, Belgium

On behalf of Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, United States of America.

(b) Designation and specification of the products:

Foods and food ingredients derived from genetically modified maize (Zea maize L.) line NK 603 with increased
tolerance to the herbicide glyphosate and from all
its crosses with traditionally bred maize lines. Maize line NK
603 contains the following DNA sequences in two intact cassettes:

— A 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium spec. strain CP (CP4
EPSPS), which imparts tolerance to glyphosate, under the regulation of the rice actin 1 gene promoter, terminator
sequence from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of
Arabidopsis thaliana,

— A 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium spec. strain CP (CP4
EPSPS), which imparts tolerance to glyphosate, under the regulation of an enhanced 35S promoter derived
from cauliflower mosaic virus, terminator sequence from Agrobacterium tumefaciens and the chloroplast transit
peptide sequence from the epsps gene of Arabidopsis thaliana.

(c) Labelling: ‘Genetically modified maize’ or ‘produced from genetically modified maize’

(d) Method for detection:

— Event specific real-time quantitative PCR based method for genetically modified NK 603 maize.

— Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European

Network of GMO Laboratories (ENGL), to be published at http://gmo-crl.jrc.it/statusofdoss.htm.

— Reference Material: IRMM-415 produced by the Joint Research Centre (JRC) of the European Commission.

(e) Unique identifier: MON-00603-6

(f) Information required under Annex II to the Cartagena Protocol: Not applicable

(g) Conditions or restrictions on the placing on the market of the product: Not applicable

(h) Post market monitoring requirements: Not appropriate.