Brussels, 03 Feb 2004
Proposal for a
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) N° 258/97 of the European Parliament and of the Council
On 11 February 1999, Novartis (in the meantime Syngenta) submitted a request under Article 4 of the Novel Food Regulation (EC) N° 258/97 to the competent authorities 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.
Following the transmission of the Dutch initial assessment report, which concluded that Bt11 sweet maize is as safe as conventional sweet maize, to all Member States, reasoned objections to the marketing of the product were raised.
Therefore, a Community Decision was required under Article 7, paragraph 1 of Regulation (EC) No 258/97 and the Commission requested an opinion of the Scientific Committee on Food as there might be an effect on public health. On 17 April 2002, the Scientific Committee on Food delivered its opinion that Bt11 sweet maize is as safe for human food use as its conventional counterparts.
In order to grant a Community authorisation, a draft Commission Decision was submitted to the Standing Committee on Food Chain and Animal Health on 8 December 2003. This Committee did not deliver its opinion on the draft submitted by the Commission, since no qualified majority was reached.
The results of the vote were:
In favour: 33 (Spain, Ireland, The Netherlands, Finland, Sweden, United Kingdom)
Against: 29 (Denmark, Greece, France, Luxembourg, Austria, Portugal)
Abstention: 25 (Belgium, Germany, Italy)
Some Member States, in particular France, claimed that scientific questions had not been addressed adequately in the assessment. However, the data provided by the applicant and the safety assessment of the product followed the criteria and requirements laid down in the Commission Recommendation 618/97/EC 1. 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 feed2 and with the Codex Principles and Guidelines on Foods Derived from Biotechnology3.
The concerns raised in the opinion of the "Agence française 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 Bt11 carried out by the competent authorities of the Netherlands. In fact these concerns were also expressed in two AFSSA opinions of 21 July 2000 and 20 March 2001 and were duly considered by the Scientific Committee on Food (SCF) in its opinion of 17 April 2002, which confirmed the findings of the initial assessment that Bt11 sweet maize is as safe for human food use as conventional maize.
Pursuant to Article 13, paragraph 4 b) of Regulation (EC) No 258/97 and in accordance with the Regulatory Committee procedure of Article 5, and in particular paragraph 4, of the Council Decision 1999/468/EC , the Commission must now submit a proposal to the Council.
In accordance with Article 46 of Regulation (EC) No 1829/2003 on genetically modified food and feed, the authorisation in case must be granted under the provisions of Regulation (EC) No 258/97 . However, in order take into account the new legislative framework for the authorisation of genetically modified food and feed and as requested by the Member States at the meeting of the Standing Committee on Food Chain and Animal Health of 10 November 2003, the Commission proposal includes also the particulars required by Article 6, paragraph 5 and Article 7, paragraph 2 of Regulation (EC) No 1829/2003 .
The proposed authorisation is to take effect from 18 April 2004, date of application of Regulation (EC) No 1829/2003 , and to be valid for a period of 10 years.