Legal provisions of COM(2005)163 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line MON 863) genetically modified for resistance to corn rootworm

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dossier COM(2005)163 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line MON 863) genetically ...
document COM(2005)163 EN
date August  8, 2005

Contents

Article 1 - Consent

Without prejudice to other Community legislation, in particular Regulation (EC) No 258/97 and Regulation (EC) No 1829/2003, written consent shall be granted by the competent authority of Germany 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/DE/02/9).

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 corn rootworm (Diabrotica spp.), derived from the Zea mays cell culture line AT824 (initiated from immature embryos of an inbred maize line AT), which has been transformed using particle acceleration technology with a MluI DNA restriction fragment isolated from plasmid PV-ZMIR13.

The product contains the following DNA in two cassettes:

(a)Cassette 1:

A modified cry3Bb1 gene derived from Bacillus thuringiensis subsp. kumamotoensis, which confers resistance to the corn rootworm Diabrotica spp., under the regulation of the 4AS1 promoter derived from Cauliflower Mosaic Virus, the wtCAB translation enhancer from wheat (Triticum aestivum), the transcription enhancer ract1 intron from the actin 1 gene of rice (Oryza sativa) and terminator sequences tahsp 17 3’ from wheat.

(b)Cassette 2:

The nptII gene from E. coli, which confers resistance to aminoglycosides comprising kanamycin and neomycin, under the regulation of the 35S Cauliflower Mosaic Virus promoter, and the NOS 3’ terminator sequences from Agrobacterium tumefaciens as well as the non-functional, truncated ble gene from E. coli.

2. The consent shall cover grains from progeny derived from crosses of maize line MON 863 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:

(a)the period of validity of the consent shall be 10 years starting from the date on which the consent is issued;

(b)the unique identifier of the product shall be MON-ØØ863-5;

(c)without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall, whenever requested to do so, make positive and negative control samples of the product, or its genetic material, or reference materials available to the competent authorities and inspection services of Member States as well as to the Community control laboratories;

(d)without prejudice to specific labelling requirements provided by Regulation (EC) No 1829/2003 the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified MON 863 maize’ shall appear either on a label or in a document accompanying the product, except 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

1. Throughout the period of validity of the consent, the consent holder shall ensure that the monitoring plan, contained in the notification, 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 and users concerning the safety and general characteristics of the product and of the conditions as to monitoring, including the appropriate management measures to be taken in case of accidental grain spillage.

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.

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

(a)that the monitoring networks as specified in the monitoring plan contained in the notification collect the information relevant for the monitoring of the product and

(b)that the members of these networks have agreed to make available that information to the consent holder before the date of the submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.

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 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 Federal Republic of Germany.