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            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,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the 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:

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 (5) 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 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 restriction fragment isolated from plasmid PV-ZMGT32L and which contains the following DNA sequences in two intact cassettes:

The MluI restriction fragment, which contains the two cassettes specified in points (a) and (b) of the first subparagraph, does not contain the neomycin phosphotransferase type II gene 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.

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

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

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:

Article 4

Monitoring

1.   Throughout the period of validity of the consent, the consent holder is responsible for ensuring that the general 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 implemented.

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

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

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

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.

For the Commission

Margot WALLSTRÖM            

Member of the Commission

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(1)OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(2)OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(3)OJ L 268, 18.10.2003, p. 1.

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

(5)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).

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