Legal provisions of COM(2004)193 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2004)193 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line NK603) genetically ...
document COM(2004)193 EN
date September 18, 2004

Contents

Article 1 - Consent

Without prejudice to other Community legislation, in particular Regulation (EC) No 258/97 of the European Parliament and of the Council (5) and Regulation (EC) No 1829/2003, written consent shall be granted by the competent authority of Spain 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/ES/00/01).

The written 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 increased tolerance to the herbicide glyphosate, derived from the maize line NK603 transformation event, which has been transformed using particle acceleration technology with a MluI restriction fragment isolated from plasmid PV-ZMGT32L and which contains the following DNA sequences in two intact cassettes:

(a)cassette 1:

a 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), which imparts tolerance to glyphosate, under the regulation of the rice actin 1 gene promoter, terminator sequences from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of Arabidopsis thaliana;

(b)cassette 2:

a 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), which imparts tolerance to glyphosate, under the regulation of an enhanced 35S promoter derived from cauliflower mosaic virus, terminator sequences from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of Arabidopsis thaliana.

The MluI restriction fragment, which contains the two cassettes specified in points (a) and (b) of the first subparagraph, does not contain the neomycin phosphotransferase type II gene conferring resistance to certain aminoglycoside antibiotics or the origin of replication from Escherichia coli, although both sequences are present in the original plasmid PV-ZMGT32L.

2. The unique identifier of the product is MON-00603-6.

3. The consent shall cover grains from progeny derived from crosses of maize line NK603 with any traditionally bred maize as or in products.

Article 3 - Conditions for placing on the market

The product may be used 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 written consent shall be for a period of 10 years;

(b)the unique identifier of the product shall be MON-00603-6 in accordance with Article 2(2);

(c)without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall make control samples available to the competent authorities on request;

(d)the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified maize’ shall appear either on a label or in a document accompanying the product, save 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 is responsible for ensuring that the general surveillance plan, as contained in the notification, for any adverse effects on human 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 general surveillance.

3. The consent holder shall, throughout the period of validity of the consent, without prejudice to Article 20 of Directive 2001/18/EC, submit to the Commission and to competent authorities of the Member States, annual reports on the results of the general surveillance and, in the light of the results, proposals for a revised monitoring plan.

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

(a)the surveillance networks, particularly those specified in table 1 of the monitoring plan contained in the notification, collect the information relevant for the general surveillance of the product; and

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

Article 5 - Applicability

This Decision shall not apply before the date of application of a Community Decision authorising the placing on the market of the products 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 those products.

Article 6

This Decision is addressed to the Kingdom of Spain.