Decision 2010/419 - 2010/419/: Commission Decision of 28 July 2010 renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation 1829/2003 repealing Decision 2004/657/EC (notified under document C(2010) 5129) - Main contents

EN

Official Journal of the European Union

L 197/11

On 17 April 2007, Syngenta Seeds SAS on behalf of Syngenta Crop Protection AG, submitted to the Commission an application, in accordance with Articles 5, 11, 17 and 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for continued marketing of existing foods and food ingredients produced from Bt11 maize (including food additives), and renewal of the authorisation for continued marketing of existing feed containing, consisting of or produced from Bt11 maize (including feed additives and feed materials) and products other than food and feed containing and consisting of Bt11 maize with the exception of cultivation (the application) which were previously notified in accordance with Article 8(1)(a)(b) and Article 20(1)(a)(b) of that Regulation. The application also covers the renewal of the authorisation for the placing on the market of foods and food ingredients which are authorised under Commission Decision 2004/657/EC of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (2). Within its application, Syngenta Seeds SAS also requested the authorisation of foods and food ingredients containing or consisting of Bt11 field maize which were never authorised in the Union.

On 17 February 2009, the European Food Safety Authority (EFSA) gave a favourable opinion (3) in accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003 and concluded that the new information provided in the application and the review of the literature that has been published since the previous scientific opinion on Bt11 maize (4) by EFSA does not require changes and confirmed the previous conclusion that Bt11 maize is as safe as its non-genetically modified counterpart and that it is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses which also applies to the products which are subject of the application.

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 Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

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.

Taking into account these considerations, the fact that the company Syngenta Crop Protection AG Switzerland which absorbed Syngenta Seeds AG, addressee of Decision 2004/657/EC is the same legal entity, on behalf of which the applicant asked for the renewal of authorisation, that it confirmed that the scope of its application also covers the request for authorisation of foods...