Decision 2007/701 - 2007/701/EC: Commission Decision of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation 1829/2003 (notified under document number C(2007) 5140) - Main contents
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2007/701/EC: Commission Decision of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2007) 5140)| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2007/701 |
| Original proposal | COM(2007)403  |
| CELEX number i | 32007D0701 |
| Document | 24-10-2007 |
|---|---|
| Publication in Official Journal | 31-10-2007; OJ L 285 p. 37-41 |
| Effect | 24-10-2007; Entry into force Date notif. |
| End of validity | 31-12-9999; End of validity 10 Years See Art. 7 |
| Notification | 24-10-2007 |
31.10.2007 |
EN |
Official Journal of the European Union |
L 285/37 |
COMMISSION DECISION
of 24 October 2007
authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document number C(2007) 5140)
(Only the French and Dutch texts are authentic)
(Text with EEA relevance)
(2007/701/EC)
THE COMMISSION OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 7(3) and Article 19(3) thereof,
Whereas:
(1) |
On 1 June 2004, Monsanto Europe S.A., submitted to the competent authorities of The United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from NK603xMON810 maize (‘the application’). |
(2) |
The application also covers the placing on the market of other products containing or consisting of NK603xMON810 maize for the same uses as any other maize with the exception of cultivation. Therefore, in accordance with the provision of Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV 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 (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. |
(3) |
On 31 March 2006, the European Food Safety Authority (‘EFSA’) gave favourable opinions in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from NK603xMON810 maize as described in the application (‘the products’) will have adverse effects on human or animal health or the environment (3). In its opinion, EFSA concluded that it was acceptable to use the data for the single events in support of the safety of the products and considered all specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities provided for by Articles 6(4) and 18(4) of that Regulation. |
(4) |
In October 2006, upon request of the Commission, EFSA published detailed clarifications on how the comments of the competent authorities of the Member States had been taken into account in its opinion. It also published further information on the different elements considered by the Scientific Panel on Genetically Modified Organisms of EFSA and the reason why some specific additional studies such as a 90-day toxicology study in rats were not considered as necessary. |
(5) |
In its opinion, EFSA also concluded that the environmental monitoring plans, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products. |
(6) |
Taking into account those considerations, authorisation should be granted for the products. |
(7) |
A unique identifier should be assigned to each GMO as provided for in 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). |
(8) |
On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1)... |
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