Decision 2005/465 - 2005/465/EC: Commission Decision of 22 June 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC, of an oilseed rape product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide glyphosate (notified under document number C(2005) 1838) - Main contents

EN

Official Journal of the European Union

L 164/57

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 concerned, in accordance with the procedure laid down in that Directive.

A notification concerning the placing on the market of a genetically modified oilseed rape product (Brassica napus L., GT73 line) was submitted by Monsanto SA to the competent authority of the Netherlands.

The notification covers the same uses as for any other oilseed rape, with the exception of the uses as or in food and the cultivation in the Community of varieties derived from the genetically modified product (GT73 transformation event). The notification covers the importation and storage of the GT73 oilseed rape, and its use as feed as well as in the processing for feed, and its industrial uses as or in products.

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which is submitted to the Commission and the competent authorities of other Member States. That assessment report concludes that no reasons have emerged on the basis of which consent for the placing on the market of GT73 oilseed rape should be withheld.

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

The opinion adopted on 11 February 2004 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, from all evidence provided, that Brassica napus L. line GT73 is as safe as conventional oilseed rape for humans and animals, and in the context of the proposed uses, for the environment. The European Food Safety Authority also found that the monitoring plan provided by the consent holder was appropriate for the intended uses of the GT73 oilseed rape.

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 Brassica napus L. line GT73 will adversely affect human or animal health or the environment.

Refined oil from GT73 oilseed rape has been commercially released for food purposes in the Community in accordance with the procedure referred to in Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (3).

A unique identifier should be assigned to the GT73 oilseed rape for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC and Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4).

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 (5).

In light of the opinion of the European Food Safety Authority, it is not necessary to establish specific conditions for the intended uses with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.

In the light of the opinion of the European Food Safety Authority, an appropriate management system should be in place to prevent grains of GT73 oilseed rape entering cultivation.

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 validated detection methodology, should be applicable.

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 (6) the measures should be adopted by the Commission,

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.

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 period of validity of the consent shall be for a period of 10 years starting from the date on which the consent is issued;

the unique identifier of the product shall be MON-00073-7;

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;

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

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.

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

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.

The consent holder shall inform operators in the Community, namely traders and processors of bulk mixtures of imported oilseed rape grains, which may contain GT73 oilseed rape, that:

The consent holder will provide operators with a national contact person for the reporting of any unanticipated adverse effects.

The consent holder shall inform operators that the possibility of and consequences arising from accidental spillage of GT73 oilseed rape have been evaluated by the European Food Safety Authority (EFSA) in the context of its intended uses. The consent holder will maintain regular contact with operators to ensure that they are informed of any changes to current practice which may change the conclusions of the environmental risk assessment.

The consent holder shall ensure that operators are alert to the possibility that accidental spillage of imported oilseed rape grain in ports and crushing facilities may result in the germination and establishment of volunteer plants, which could include GT73 oilseed rape.

In the event that volunteer oilseed rape plants could include GT73 oilseed rape, the consent holder shall:

Member States may, taking account of Article 4(5) of Directive 2001/18/EC and section C.1.6 of Council Decision 2002/811/EC (1), carry out checks and/or additional monitoring with respect to accidental spillage of GT73 oilseed rape grains and identification of potential unanticipated adverse effects arising from such spillage.