Legal provisions of COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests - Main contents
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| dossier | COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to ... |
|---|---|
| document | COM(2013)758  |
| date | November 6, 2013 |
Contents
Article 1 - Consent
2. The consent shall, in accordance with Article 19(3) of Directive 2001/18/EC, explicitly specify the conditions to which the consent is subject, including any specific condition of use, handling and packaging of the GMO(s) as or in products, and conditions for the protection of particular ecosystems/environments and/or geographical areas, which are set out in Articles 3 (conditions for placing on the market) and 4 (monitoring).
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 south-western corn borer (Diatraea grandiosella), under the regulation of the ubiquitin promoter ubiZM1(2) derived from Zea mays and the ORF25PolyA terminator from Agrobacterium tumefaciens pTi15995;
(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 CaMV 35S promoter and terminator sequences.
2. The consent shall cover seeds from genetically modified progeny derived from crosses of Zea mays L., line 1507 with any traditionally bred maize as or in products.
Article 3 - Conditions for placing on the market
(a) In accordance with Article 15(4) of Directive 2001/18/EC, the period of validity of the consent shall be 10 years starting from the date at which the consent for Zea mays L., line 1507 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 make available positive and negative control samples of the product and its genetic materials to the competent authorities of Member States as well as to the National Reference Laboratories in charge of official controls on request; the consent holder shall announce where the reference material can be accessed;
(d) the detection method specific to Zea mays L., line 1507, as validated by the European Union reference laboratory as referred to in the Annex of Regulation (EC) No 1829/2003 shall be used for the purpose of inspection and control;
(e) 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 Union legislation sets a threshold below which such information is not required;
(f) it shall also be indicated on the label, or in an accompanying document for non-pre-packaged products, that the product protects itself against the European corn borer (Ostrinia nubilalis), pink borers (Sesamia spp.), fall armyworm (Spodoptera frugiperda), black cutworm (Agrotis ipsilon) and south-western corn borer (Diatraea grandiosella);
(g) the practices of the insect resistance management plan as contained in the notification shall be applied to minimise development of resistance in target pests and exposure of non-target insects to Bt-toxins and shall be modified to comply with the following provisions:
– the 20% refuge area shall be calculated in proportion to the total Lepidoptera-active Bt-maize area;
– the 20% refuge area shall also be applied in the case of a cluster of fields of Lepidoptera-active Bt-maize with an aggregate area greater than 5 ha, irrespective of individual field and farm size.
The practices of the insect resistance management plan shall include the recommendation to plant refuge maize in border rows along field margins where present.
(h) the consent holder shall provide instruction to farmers in order to ensure the implementation by them of required measures including, where appropriate, the planting of refuge maize in border rows, and monitoring, to minimise development of resistance in target pests and exposure of non-target insects to Bt-toxins, and to assist farmers in cultivating Zea mays L., line 1507;
(i) for the purpose of best possible handling and use of the product, the consent holder shall distribute with each bag of seeds to the operators a leaflet detailing information about the product and practices for its use, including the requirements indicated in paragraph (h). The content of this leaflet is listed in Annex II.
Article 4 - Monitoring by the consent holder
2. The consent holder shall directly inform the operators and users of the introduction of Zea mays L., line 1507 into the Union as well as of the safety and general characteristics of the product and of the conditions for monitoring.
3. The following obligations are laid down for the consent holder:
(a) The consent-holder shall undertake case-specific monitoring of the possible development of resistance in target species through exposure to the CRY1F protein in accordance with the insect resistance management plan contained in the monitoring plan, and taking account of Annex I in order to:
(i) Measure the baseline susceptibility of target pests to CRY1F protein;
(ii) Detect changes relative to baseline susceptibility that cause inadequate field protection against target pests.
(b) The consent holder shall undertake general surveillance and establish a general surveillance network through use of farmer questionnaires and taking account of the additional measures referred to in Annex I. The consent holder shall continue to develop the content and format of the questionnaire.
(c) In addition, the consent holder shall undertake a case-specific study on potential adverse effects on non-target organisms from cultivation of 1507 maize and report the outcome of this study to the rapporteur Competent Authority, the competent authorities of the other Member States and the European Commission.
(d) Without prejudice to Article 20 of Directive 2001/18/EC, the monitoring plan 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 in line with the results of the monitoring activities by the consent holder, and/or by the competent authority of the Member State which received the original notification. Revised monitoring plans shall be submitted by the competent authority to the Commission and the competent authorities of the other Member States.
4. 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 networks for monitoring of resistance and general surveillance will gather the information necessary for the monitoring and surveillance of the products; and
(b) on the time schedule for receipt of the above information by the consent holder and its transmission to the Commission and the competent authorities of the Member States.
5. The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of all monitoring activities, including general surveillance. The presentation of these reports shall be made in accordance with the Standard Reporting Format established by Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council.