The European Food Safety Authority’s (EFSA) Scientific Panel on Genetically Modified Organisms (GMO Panel) has published today two opinions on 1507 maize relating to (i) food use and (ii) import, feed and industrial processing and cultivation. GM 1507 maize has been developed for protection against specific lepidopteran pests such as the European corn borer. It also contains a gene providing tolerance to the herbicide glufosinate. This is the first application reviewed by the EFSA GMO Panel under the GM Food and Feed Regulation. It is also the first time that EFSA’s GMO Panel has published an opinion relating to GM plant cultivation. The Panel has concluded that 1507 maize will not have an adverse effect on human and animal health or the environment in the context of its proposed use. No data have emerged to indicate that 1507 maize is any less safe than its conventional counterpart.

The GM 1507 maize was assessed with reference to its intended use employing the appropriate principles as described in the “Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed” published by EFSA*. In addition to the examination of newly introduced DNA and proteins, comparative analyses of agronomic traits and composition were undertaken so that both nutritional quality and safety of the whole food and feed were evaluated. Furthermore a full environmental assessment was undertaken, including an assessment of the post-market monitoring plan.

In developing the opinion regarding food use**, EFSA held a more centralised role in the assessment process by liaising and consulting with Member States. This is in contrast to previous risk assessments whereby EFSA was consulted by the European Commission when issues of risk were raised by Member States. In considering all information and following consultations with Member States the Panel concluded that 1507 maize for food use does not raise safety concerns for human and animal health.

In its first environmental risk assessment with regard to cultivation of a GM crop***,the possible development of resistance in corn borers as a result of exposure to 1507 maize over several years, was identified. However, the case-specific monitoring plan to record the development of resistance, as provided by the applicant, was judged adequate to address this potential risk. The Panel also evaluated the applicant’s general surveillance plan and made recommendations to improve its scientific value, notably through more focused data collection. The Panel considers that 1507 maize will have similar impacts on the environment as other comparable non-GM maize cultivated plant varieties.

In conclusion, the Panel is of the opinion that there is no evidence to indicate that the placing of 1507 maize and derived products on the market is likely to cause adverse effects on human or animal health or the environment.

It should be noted that the evaluation of the complementary herbicide glufosinate is not part of the evaluation of 1507 maize as carried out by the GMO Panel addressed in these opinions. The pesticide evaluation is currently being evaluated by EFSA’sPRAPeR unit (Pesticide Risk Assessment Peer Review) as part of the review programme for existing substances under Community legislation concerning pesticides.

The full texts of the two opinions are available on the EFSA website at: http://www.efsa.eu.int/science/gmo/gmo_opinions/catindex_en.html

BACKGROUND

• On 24 September 2004, the GMO Panel issued an opinion relating to the import and processing of GM 1507 maize: Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference C/NL/00/10) for the placing on the market of insect-tolerant genetically modified maize 1507, for import and processing, under Part C of Directive 2001/18/EC from Pioneer Hi-Bred International/Mycogen Seeds, The EFSA Journal (2004) 124, 1-18.
  http://www.efsa.eu.int/science/gmo/gmo_opinions/663_en.html
   
• Within the framework of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, applications for the placing on the market of genetically modified organisms (GMOs) are transmitted to the European Food Safety Authority (EFSA) following a request for an opinion by the European Commission.
  http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_106/l_10620010417en00010038.pdf
   
• Regulation (EC) No 1829/2003 on genetically modified food and feed applies to applications for the placing on the market – in the territory of the European Union – of the following products: GMOs for food and feed use and food and feed containing GMOs, consisting of such organisms or produced from GMOs. Application are submitted to EFSA via a Member State.
  http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf
   
• Under the regulation on GM food and feed and in addition to the risk assessment carried out by the GMO Panel, EFSA is in charge of compiling all of the documentation required for GM applications under the regulation on GM food and feed. This includes detection methods validated by the Community Reference Laboratory and a labelling proposal submitted by the applicant.
   
• Community legislation concerning pesticides: Council Directive 91/414/EEC concerning the placing of plant protection products on the market and its amendments
  http://europa.eu.int/eur-lex/en/consleg/pdf/1991/en_1991L0414_do_001.pdf
  and Commission Regulation (EC) No 451/2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414./EEC and its amendments
  http://europa.eu.int/eur-lex/en/consleg/pdf/2000/en_2000R0451_do_001.pdf
   
• http://www.efsa.eu.int/science/gmo/gm_ff_applications

* http://www.efsa.eu.int/science/gmo/gmo_guidance/660/gmo_guidance_riskassess_en1.pdf

** Opinion of the Scientific Panel on an application from Pioneer Hi-Bred International / Mycogen Seeds for the placing on the market of insect-tolerant genetically modified 1507 maize for food use, under Regulation (EC) No 1829/2003 The EFSA Journal (2005) 182, 1-22.

*** Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission relating to the notification from Pioneer Hi-Bred International / Mycogen Seeds (Reference C/ES/01/01) for the placing on the market of insect-tolerant genetically modified 1507 maize, for import, feed and industrial processing and cultivation, under Part C of Directive 2001/18/EC

The EFSA Journal (2005) 181, 1-33.