2004/643/EC: Commission Decision of 19 July 2004 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance (notified under document number C(2004) 2761)(Text with EEA relevance)
Date: 2004-07-19
Institutions: European Commission
Subjects: consumer information, environmental protection, genetically modified organism, health policy, labelling, maize, marketing standard

18.9.2004

EN

Official Journal of the European Union

L 295/35

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 19 July 2004

concerning the placing on the market, in accordance with Directive 2001/18/EC of the European
Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for
glyphosate tolerance

(notified under document number C(2004) 2761)

(Only the Spanish text is authentic)

(Text with EEA relevance)

(2004/643/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

the Commission and to the competent authorities of
other Member States with a positive opinion.

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/18/EC of
the Council of 12 March 2001 on the
Parliament and of
deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC (1), and
in particular the first subparagraph of Article 18(1) thereof,

After consulting the European Food Safety Authority,

Whereas:

(1)

(2)

Pursuant to Directive 2001/18/EC, the placing on the
market of a product containing or consisting of a
genetically modified organism or a combination of
to written
genetically modified organisms
consent being granted by the competent authority of
the Member State that received the notification for the
placing on the market of that product in accordance with
the procedure laid down in that Directive.

subject

is

A notification concerning the placing on the market of a
genetically modified maize product
line
NK603), to be used as any other maize but not for
cultivation, was
submitted by Monsanto SA to the
competent authority of Spain which transmitted it to

(Zea mays L.

(3)

(4)

(5)

The competent authorities of other Member States raised
objections to the placing on the market of the product.

The opinion adopted on 25 November 2003 by the
European Food Safety Authority, as established by Regu-
lation (EC) No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down the
general principles and requirements of food law, estab-
lishing the European Food Safety Authority and laying
down procedures in matters of food safety (2), concluded
that Zea mays L. line NK603 is as safe as conventional
maize and that its placing on the market for food, feed
or processing is therefore unlikely to have an adverse
effect on human or animal health or,
in that context,
on the environment.

An examination of each of the objections in the light of
Directive 2001/18/EC, of the information submitted in
the notification and of the opinion of the European Food
Safety Authority, discloses no reason to believe that the
placing on the market of Zea mays L. line NK603 will
adversely affect human or animal health or the envir-
onment.

(6)

A unique identifier should be assigned to the product for
the purposes of Regulation (EC) No 1830/2003.

(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(2) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

L 295/36

EN

Official Journal of the European Union

18.9.2004

(7)

(8)

(9)

(10)

traces

organisms

technically

accordance with

unavoidable
in

of
Adventitious or
genetically modified
are
exempted from labelling and traceability requirements
under
in
(EC) No
Directive
1829/2003 of
the
Council of 22 September 2003 on genetically modified
food and feed (1).

the European Parliament and of

2001/18/EC

established

Regulation

thresholds

products

and

Taking account of the opinion of the European Food
Safety Authority, there is no reason to establish specific
conditions with regard to the handling or packaging of
the product and the protection of particular ecosystem-
s/environments and/or geographical areas.

The written consent shall, in accordance with Article 19(3) of
Directive 2001/18/EC, explicitly specify the conditions to which
the consent is subject, which are set out in Articles 3 and 4.

Article 2

Product

1.
The genetically modified organisms to be placed on the
market as or in products, hereinafter ‘the product’, are grains of
maize (Zea mays L.), with increased tolerance to the herbicide
glyphosate, derived from the maize line NK603 transformation
event, which has been transformed using particle acceleration
technology with a MluI
isolated from
plasmid PV-ZMGT32L and which contains the following DNA
sequences in two intact cassettes:

restriction fragment

Prior to the placing on the market of the product, the
necessary measures to ensure its labelling and traceability
at all stages of its placing on the market, including veri-
fication by appropriate detection methodology, should be
applicable.

(a) cassette 1:

The measures provided for in this Decision are not in
accordance with the opinion of the Committee estab-
lished under Article 30 of Directive 2001/18/EC and
the Commission therefore submitted to the Council a
relating to these measures. Since on the
proposal
expiry of
the period laid down in Article 30(2) of
Directive 2001/18/EC the Council had neither adopted
the proposed measures nor indicated its opposition to
them in accordance with Article 5(6) of Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (2) the measures should be
adopted by the Commission,

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

(b) cassette 2:

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

terminator

sequences

HAS ADOPTED THIS DECISION:

Article 1

Consent

Without prejudice to other Community legislation, in particular
Regulation (EC) No 258/97 of the European Parliament and of
the Council (3) and Regulation (EC) No 1829/2003, written
consent shall be granted by the competent authority of Spain
to the placing on the market, in accordance with this Decision,
of the product identified in Article 2, as notified by Monsanto
Europe SA (reference C/ES/00/01).

The MluI restriction fragment, which contains the two cassettes
specified in points (a) and (b) of the first subparagraph, does not
gene
contain the neomycin phosphotransferase
conferring resistance to certain aminoglycoside antibiotics or
the origin of replication from Escherichia coli, although both
sequences are present in the original plasmid PV-ZMGT32L.

type

II

2.

The unique identifier of the product is MON-00603-6.

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.
(3) 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).

3.
The consent shall cover grains from progeny derived from
crosses of maize line NK603 with any traditionally bred maize
as or in products.

18.9.2004

EN

Official Journal of the European Union

L 295/37

Article 3

Conditions for placing on the market

The product may be used as any other maize, with the
exception of cultivation and uses as or in food, and may be
placed on the market subject to the following conditions:

(a)

the period of validity of the written consent shall be for a
period of 10 years;

(b) the unique identifier of the product shall be MON-00603-6

in accordance with Article 2(2);

(c) without prejudice to Article 25 of Directive 2001/18/EC,
the consent holder shall make control samples available to
the competent authorities on request;

(d) the words

‘This product contains genetically modified
organisms’ or ‘This product contains genetically modified
maize’ shall appear either on a label or in a document
accompanying the product, save where other Community
legislation sets a threshold below which such information
is not required;

(e) as long as the product has not been authorised for the
placing on the market for the purpose of cultivation, the
words ‘not for cultivation’ shall appear either on a label or
in a document accompanying the product.

Article 4

Monitoring

Throughout

the period of validity of

the
1.
the general
consent holder is responsible for ensuring that
surveillance plan, as contained in the notification,
for any
adverse effects on human health or the environment arising
from handling or use of the product is put in place and imple-
mented.

the consent,

The consent holder shall, throughout the period of validity
3.
of the consent, without prejudice to Article 20 of Directive
to the Commission and to competent
2001/18/EC, submit
reports on the
authorities of
the
results of
results, proposals for a revised monitoring plan.

the general surveillance and,

the Member States, annual

in the light of

4.
The consent holder shall be in the position to give
evidence to the Commission and the competent authorities of
the Member States that:

(a)

the surveillance networks, particularly those specified in
table 1 of the monitoring plan contained in the notification,
collect the information relevant for the general surveillance
of the product; and

(b) that

these surveillance networks have agreed to make
available this information to the consent holder before the
to the
date of
Commission and competent authorities of
the Member
States in accordance with paragraph 3.

the monitoring report

submission of

Article 5

Applicability

This Decision shall not apply before the date of application of a
Community Decision authorising the placing on the market of
the products referred to in Article 1 for uses as or in food
within the meaning of Regulation (EC) No 178/2002 and
including a method, validated by the Community reference
laboratory, for detection of those products.

Article 6

This Decision is addressed to the Kingdom of Spain.

Done at Brussels, 19 July 2004.

The consent holder shall directly inform the operators and
2.
users concerning the safety and general characteristics of the
product and of the conditions as to general surveillance.

For the Commission

Margot WALLSTRÖM
Member of the Commission