Considerations on COM(2005)163 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line MON 863) genetically modified for resistance to corn rootworm

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dossier COM(2005)163 - Placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line MON 863) genetically ...
document COM(2005)163 EN
date August  8, 2005
 
table>(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 a Member State, in accordance with the procedure laid down in that Directive.
(2)A notification concerning the placing on the market of two genetically modified maize products (Zea mays L., line MON 863 and hybrid MON 863 × MON 810) was submitted by Monsanto SA to the competent authority of Germany.

(3)The notification covers importation and use as for any other maize grains including feed but not food use, with the exception of the cultivation in the Community of varieties derived from the MON 863 transformation event as well as with the exception of the cultivation in the Community of MON 863 × MON 810 hybrids.

(4)In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of Germany prepared an assessment report, which was submitted to the Commission and the competent authorities of the 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 MON 863 maize as well as MON 863 × MON 810 maize should be withheld, if specific conditions are fulfilled.

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

(6)The opinion adopted on 2 April 2004 by the European Food Safety Authority, in accordance with 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 Zea mays L. line MON 863 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed use. The European Food Safety Authority also found that the scope of the monitoring plan provided by the consent holder is in line with the intended uses of MON 863.

(7)Concerning the hybrid MON 863 × MON 810, the European Food Safety Authority considered that it is scientifically valid to use the data from the single lines MON 863 and MON 810 to support the safety assessment of the hybrid MON 863 × MON 810, but decided regarding the need for confirmatory data for the safety assessment of the hybrid itself, to request a 90-day sub-chronic rat study with the maize hybrid in order to complete its safety assessment. Thus, only the safety assessment of the maize line MON 863 has been finalised.

(8)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 MON 863 will adversely affect human or animal health or the environment.

(9)A unique identifier should be assigned to the MON 863 maize 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 (3) 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).

(10)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).

(11)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.

(12)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.

(13)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,