L 300/48 Official Journal of the European Union 25.9.2004 COMMISSION COMMISSION DECISION 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 (notified under document number C(2004) 1865) (only the Dutch text is authentic) (2004/657EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients ('), (hereinafter referred to as the Regulation), and in particular Article 7 thereof, Whereas: (1)  Consent has been granted on 22 April 1998 for the placing on the market of grains of genetically modified maize line Btll to be used for feed, processing and importing (), in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (3). () Food and food ingredients derived from the original transformant Btll and any inbred and hybrid lines derived from it and containing the introduced genes may be placed on the market in the Community following a notification (4) pursuant to Article 5 of Regu- lation (EC) No 258/97. (3)  On 11 February 1999, Novartis (in the meantime: Syngenta), submitted a request to the competent autho- rities of the Netherlands for placing sweet maize from genetically modified maize line Bt11 on the market as a novel food or as a novel food ingredient. (') OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (O] L 284, 31.10.2003, p. 1). () Commission Decision 98/292/EC (O] L 131, 5.5.1998, p. 28). () O] L 117, 8.5.1990, p. 15. Directive amended by Commission Directive 97/35/EC (O L 169, 27.6.1997, p. 72). () O] C 181, 26.6.1999, p. 22. () In their initial assessment report of 12 May 2000, the Netherlands’ competent food assessment body came to the conclusion that Btll sweet maize is as safe as conventional sweet maize. (5)  The Commission forwarded the initial assessment report to all Member States on 15 June 2000. Within the 60 days period laid down in Article 6(4) of the Regulation, reasoned objections to the marketing of the product were raised in accordance with that provision. (6)  On 13 December 2000, the Commission requested an opinion from the Scientific Committee on Food, in accordance with Article 11 of the Regulation. On 17 April 2002, the Scientific Committee on Food delivered its opinion that Btl1 sweet maize is as safe for human food use as its conventional counterparts. This opinion focused, as requested by the Commission, on the issues raised in the comments made by Member States’ autho- rities, including molecular characterisation and toxicity studies. The concerns raised in the opinion of the ‘Agence francaise de sécurité sanitaire des aliments’ (AFSSA) of 26 November 2003 do not bring any new scientific elements in addition to the initial assessment of sweet maize Btll. (7)  The data provided by the applicant and the safety assessment of the product carried out followed the criteria and requirements laid down in the Commission Recommendation 618/97/EC (°) concerning the scientific aspects and the presentation of applications under the Novel Food Regulation. The methodology used for the safety assessment of Bt11 was also in line with the recent guidelines prepared by the Scientific Steering Committee concerning the assessment of GMOs, GM food and GM feed and with the Codex Principles and Guidelines on Foods Derived from Biotechnology. () O] L 253, 16.9.1997, p. 1.