18.9.2004   

EN

Official Journal of the European Union

L 295/35

(1)

Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of the Member State that received the notification for the placing on the market of that product in accordance with the procedure laid down in that Directive.

(2)

A notification concerning the placing on the market of a genetically modified maize product (Zea mays L. line NK603), to be used as any other maize but not for cultivation, was submitted by Monsanto SA to the competent authority of Spain which transmitted it to the Commission and to the competent authorities of other Member States with a positive opinion.

(3)

The competent authorities of other Member States raised objections to the placing on the market of the product.

(4)

The opinion adopted on 25 November 2003 by the European Food Safety Authority, as established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2), concluded that Zea mays L. line NK603 is as safe as conventional maize and that its placing on the market for food, feed or processing is therefore unlikely to have an adverse effect on human or animal health or, in that context, on the environment.

(5)

An examination of each of the objections in the light of Directive 2001/18/EC, of the information submitted in the notification and of the opinion of the European Food Safety Authority, discloses no reason to believe that the placing on the market of Zea mays L. line NK603 will adversely affect human or animal health or the environment.

(6)

A unique identifier should be assigned to the product for the purposes of Regulation (EC) No 1830/2003.

(7)

Adventitious or technically unavoidable traces of genetically modified organisms in products are exempted from labelling and traceability requirements in accordance with thresholds established under Directive 2001/18/EC and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (3).

(8)

Taking account of the opinion of the European Food Safety Authority, there is no reason to establish specific conditions with regard to the handling or packaging of the product and the protection of particular ecosystems/environments and/or geographical areas.

(9)

Prior to the placing on the market of the product, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate detection methodology, should be applicable.

(10)

The measures provided for in this Decision are not in accordance with the opinion of the Committee established under Article 30 of Directive 2001/18/EC and the Commission therefore submitted to the Council a proposal relating to these measures. Since on the expiry of the period laid down in Article 30(2) of Directive 2001/18/EC the Council had neither adopted the proposed measures nor indicated its opposition to them in accordance with Article 5(6) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4) the measures should be adopted by the Commission,

(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.

(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.

(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.