2005/635/EC: Commission Decision of 31 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate (notified under document number C(2005) 3110)
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 the Netherlands to the placing on the market, in accordance with this Decision, of the product identified in Article 2, as notified by Monsanto Europe S.A. (Reference C/NL/98/11).
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 oilseed rape ( Brassica napus L.), with tolerance to the herbicide glyphosate, derived from the oilseed rape GT73 line, which has been transformed with Agrobacterium tumefaciens , using the vector PV-BNGT04. The product contains the following DNA in two cassettes:
(a)
Cassette 1
A 5-enolpyruvylshikimate-3-phospate synthase ( epsps ) gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers glyphosate tolerance, under the regulation of the modified figwort mosaic virus promoter ( P-CMoVb ), terminator sequences from the pea rbcS E9 gene encoding the small subunit of ribulose bisphosphate carboxylase/oxygenase and the N-terminal chloroplast transit peptide CTP2 sequence from the epsps gene of Arabidopsis thaliana .
(b)
Cassette 2
The variant 247 of the original glyphosate oxidoreductase gene ( goxv247 ) derived from Ochrobactrum anthropi strain LBAA, which confers glyphosate tolerance, under the regulation of the modified figwort mosaic virus promoter ( P-CMoVb ), terminator sequences from Agrobacterium tumefaciens and the N-terminal chloroplast transit peptide sequence CTP1 from the ribulose bisphosphate carboxylase/oxygenase ( Arab-ssu1a ) gene of Arabidopsis thaliana .
The product does not contain the adenyltransferase gene ( aad ) encoding resistance to streptomycin and spectinomycin, as present in the transformation vector used.
2. The unique identifier of the product is MON-00073-7.
3. The consent shall cover grains from progeny derived from crosses of oilseed rape line GT73 with any traditionally bred oilseed rape as or in products.
Conditions for placing on the market
The product may be put to the same uses as any other oilseed rape, 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 for a period of 10 years starting from the date on which the consent is issued;
(b)
the unique identifier of the product shall be MON-00073-7;
(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;
(d)
the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified GT73 oilseed rape’ 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; and
(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, 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 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 existing monitoring networks, as specified in the monitoring plan contained in the notification, gathers the information relevant for the monitoring of the product; and
(b)
that these existing monitoring networks have agreed to make available that information to the consent holder before the date of 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 detection method specific to the GT73 oilseed rape is validated by the Community reference laboratory as referred to in the Annex of Regulation (EC) No 1829/2003, and as specified in Commission Regulation (EC) No 641/2004 ( 7 ) on detailed rules for the implementation of Regulation (EC) No 1829/2003.
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.
