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            COMMISSION DECISION         

of 3 November 2005         

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 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium

(notified under document number C(2005) 4192)

(Only the Dutch text is authentic)

(2005/772/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 (6) and Regulation (EC) No 1829/2003, written consent shall be granted by the competent authority of the Netherlands to the placing on the market, in accordance with this Decision, of the product identified in Article 2, as notified by Pioneer Hi-Bred International, Inc. and Mycogen Seeds (Reference C/NL/00/10).

The 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 resistance to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests and with tolerance to the herbicide glufosinate-ammonium, derived from Zea mays line 1507, which has been transformed using particle acceleration technology with the linear DNA fragment PHI8999A containing the following DNA in two cassettes:

2.   The consent shall cover grains from progeny derived from crosses of maize line 1507 with any traditionally bred maize as or in products.

Article 3

Conditions for placing on the market

The product may be put to the same uses 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 shall ensure that the monitoring plan contained in the notification, and consisting of a general surveillance plan, to check for any adverse effects on human and animal 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, users, national agencies for animal nutrition and feed research as well as veterinary services of the introduction of 1507 maize into the Community as well as on the safety and general characteristics of the product and of the conditions as to monitoring.

3.   The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of the monitoring activities.

4.   Without prejudice to Article 20 of Directive 2001/18/EC the monitoring plan as notified shall, where appropriate and subject to the agreement of the Commission and the competent authority of the Member State which received the original notification, be revised by the consent holder, and/or by the competent authority of the Member State which received the original notification, in the light of the results of the monitoring activities. Proposals for a revised monitoring plan shall be submitted to the competent authorities of the Member States.

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

Article 5

Applicability

This Decision shall apply from the date on which a Community Decision authorising the placing on the market of the product referred to in Article 1 for uses as or in food within the meaning of Regulation (EC) No 178/2002 of the European Parliament and of the Council (7) and including a method, validated by the Community reference laboratory, for detection of the product is applicable.

Article 6

Addressee

This Decision is addressed to the Kingdom of the Netherlands.

Done at Brussels, 3 November 2005.

For the Commission

Stavros DIMAS            

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 268, 18.10.2003, p. 24.

(3)OJ L 10, 16.1.2004, p. 5.

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

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

(6)OJ L 43, 14.2.1997, p. 1.

(7)OJ L 31, 1.2.2002, p. 1.

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