Decision 2008/280 - 2008/280/EC: Commission Decision of 28 March 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation 1829/2003 (notified under document number C(2008) 1112) - Main contents
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official title
2008/280/EC: Commission Decision of 28 March 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2008) 1112)| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2008/280 |
| Original proposal | COM(2008)47  |
| CELEX number i | 32008D0280 |
| Document | 28-03-2006 |
|---|---|
| Publication in Official Journal | 29-03-2008; OJ L 87 p. 19-22 |
| Effect | 28-03-2008; Entry into force Date notif. |
| End of validity | 27-03-2018; See Art. 7 |
| Notification | 28-03-2008 |
29.3.2008 |
EN |
Official Journal of the European Union |
L 87/19 |
COMMISSION DECISION
of 28 March 2008
authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document number C(2008) 1112)
(Only the French text is authentic)
(2008/280/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
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 29 July 2005, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, 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 GA21 maize. |
(2) |
That application also covers the placing on the market of other products containing or consisting of GA21 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 and repealing Council Directive 90/220/EEC (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 17 April 2007, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, submitted to the Commission an application, in accordance with Articles 8(4) and 20(4) of Regulation (EC) No 1829/2003, for the authorisation of existing products produced from GA21 maize (food additives, feed materials and feed additives produced from GA21 maize). |
(4) |
On 2 October 2007, the European Food Safety Authority (EFSA) gave a single comprehensive favourable opinion for both applications 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 GA21 maize as described in the applications (the products) will have adverse effects on human or animal health or the environment (3). In its opinion, EFSA 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. |
(5) |
In its opinion, EFSA also concluded that the environmental monitoring plan, 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) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for the foods, food ingredients, and feed containing, consisting of, or produced from GA21 maize. However, in order to ensure the use of the... |
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