Legal provisions of COM(2005)284 - Placing on the market, in accordance with Directive 2001/18/EC, 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 - Main contents
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| dossier | COM(2005)284 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L., line 1507) genetically ... |
|---|---|
| document | COM(2005)284  |
| date | November 3, 2005 |
Contents
Article 1 - Consent
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
| (a) | cassette 1: a synthetic version of the truncated cry1F gene derived from Bacillus thuringiensis subsp. aizawai, which confers resistance to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests such as the pink borer (Sesamia spp.), fall armyworm (Spodoptera frugiperda), black cutworm (Agrotis ipsilon) and southwestern corn borer (Diatraea grandiosella), under the regulation of the ubiquitin promoter ubiZM1(2) derived from Zea mays and the ORF25PolyA terminator from Agrobacterium tumefaciens pTi15955; |
| (b) | cassette 2: a synthetic version of the pat gene derived from Streptomyces viridochromogenes strain Tü494, which confers tolerance to the herbicide glufosinate-ammonium, under the regulation of the 35S Cauliflower Mosaic Virus promoter and terminator sequences. |
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
| (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 DAS-Ø15Ø7-1; |
| (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 1507 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
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:
| (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. |