Decision 2009/184 - 2009/184/EC: Commission Decision of 10 March 2009 authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation 1829/2003 (notified under document number C(2009) 1541) - Main contents
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official title
2009/184/EC: Commission Decision of 10 March 2009 authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2009) 1541)| Legal instrument | Decision |
|---|---|
| Number legal act | Decision 2009/184 |
| CELEX number i | 32009D0184 |
| Document | 10-03-2009 |
|---|---|
| Publication in Official Journal | 13-03-2009; OJ L 68 p. 28-32 |
| Effect | 11-03-2009; Takes effect Date notif. |
| End of validity | 31-12-9999; See Art. 8 |
| Notification | 11-03-2009 |
13.3.2009 |
EN |
Official Journal of the European Union |
L 68/28 |
COMMISSION DECISION
of 10 March 2009
authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document number C(2009) 1541)
(Only the German text is authentic)
(Text with EEA relevance)
(2009/184/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 Articles 7(3) and 19(3) thereof,
Whereas:
(1) |
On 28 October 2005, Bayer CropScience AG submitted to the competent authority 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 or produced from T45 oilseed rape. |
(2) |
The application also covers the placing on the market of other products containing T45 oilseed rape for the same uses as any other oilseed rape with the exception of cultivation. Therefore, in accordance with 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, Bayer CropScience 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 T45 oilseed rape (food additives and feed materials produced from T45 oilseed rape). |
(4) |
The applicant indicated in its applications and in communications to the Commission that the commercialisation of T45 oilseed rape seeds was stopped after the 2005 planting season. |
(5) |
Therefore, the only purpose of these applications is to cover the presence of T45 oilseed rape resulting from its past cultivation in third countries. |
(6) |
On 5 March 2008, 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 or produced from T45 oilseed rape as described in the applications (‘the products’) will have any adverse effects on human or animal health or the environment in the context of their intended uses (3). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation. |
(7) |
In particular, EFSA concluded that as no indication of biologically relevant compositional and agronomical changes was identified for seeds from T45 oilseed rape except the presence of the PAT protein, no further animal safety studies with the whole food/feed (e.g. a 90-day toxicity study in rats) are needed. |
(8) |
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. However... |
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