Decision 2005/608 - 2005/608/EC: Commission Decision of 8 August 2005 concerning the 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 (notified under document number C(2005) 2950) - Main contents
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official title
2005/608/EC: Commission Decision of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm (notified under document number C(2005) 2950)| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2005/608 |
| Original proposal | COM(2005)163  |
| CELEX number i | 32005D0608 |
| Document | 08-08-2005 |
|---|---|
| Publication in Official Journal | 12-12-2006; OJ L 207, 10.8.2005,OJ L 349M , 12.12.2006, p. 17–19 |
| Effect | 08-08-2005; Entry into force Date notif. |
| End of validity | 31-12-9999 |
| Notification | 08-08-2005 |
10.8.2005 |
EN |
Official Journal of the European Union |
L 207/17 |
COMMISSION DECISION
of 8 August 2005
concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to corn rootworm
(notified under document number C(2005) 2950)
(Only the German text is authentic)
(Text with EEA relevance)
(2005/608/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (1), and in particular the first subparagraph of Article 18(1) thereof,
After consulting the European Food Safety Authority,
Whereas:
(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... |
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