2005/772/EC: 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)
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.
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:
(a)
cassette 1:
a synthetic version of the truncated cry 1F 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 ubi ZM1(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.
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 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.
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:
(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.
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.
Addressee
This Decision is addressed to the Kingdom of the Netherlands.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
