Considerations on COM(2006)78 - Placing on the market, in accordance with Directive 2001/18/EC, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium - Main contents
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| dossier | COM(2006)78 - Placing on the market, in accordance with Directive 2001/18/EC, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 ... |
|---|---|
| document | COM(2006)78  |
| date | March 26, 2007 |
| (2) | A notification concerning the placing on the market of genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) was submitted by Bayer BioScience nv to the competent authority of Belgium. |
| (3) | The notification covered cultivation and import of the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) for all uses as for any other oilseed rape including use as or in feed, but with the exception of uses as or in food, in the Community. |
| (4) | In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of Belgium prepared an assessment report, which was submitted to the Commission and the competent authorities of other Member States; whereby the assessment report concluded that the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) should be placed on the market for import and processing and for use as any other oilseed rape but not for the requested use of cultivation. |
| (5) | The competent authorities of certain Member States raised objections to the placing on the market of the products. |
| (6) | In view of the objections raised by the competent authority of Belgium and other Member States concerning cultivation of the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3), the opinion of EFSA is restricted to import and processing, including use in feed. |
| (7) | The opinion adopted in September 2005 by the European Food Safety Authority, concluded that the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) are as safe as conventional oilseed rape for humans and animals, and in the context of the intended uses, for the environment. The European Food Safety Authority also concluded that the monitoring plan provided in the notification was acceptable in view of the intended uses. |
| (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 the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) will adversely affect human or animal health or the environment. |
| (9) | Processed oil from genetically modified oilseed rape derived from (a) the Ms8 oilseed rape line and all conventional crosses, (b) the Rf3 oilseed rape line and all conventional crosses and (c) the hybrid combination Ms8xRf3 has been placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (2). As a consequence, it is subject to the requirements provided for in Article 8 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (3) and may be placed on the market and used in accordance with the conditions mentioned in the Community register of genetically modified food and feed. |
| (10) | Unique identifiers should be assigned to the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) 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 (4) 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 (5). |
| (11) | 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. |
| (12) | In the 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 products and the protection of particular ecosystems, environments or geographical areas. |
| (13) | In the light of the opinion of the European Food Safety Authority, an appropriate management system should be in place to prevent grains of the genetically modified oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) entering cultivation. |
| (14) | Prior to the placing on the market of the products, 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. |
| (15) | 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, |