The European Commission has authorised the placing on the market of the genetically modified maize 1507. The authorisation covers the import and processing of this GMO, including its use in animal feed. The maize has been modified to make it resistant to certain pests (1) and for tolerance to the herbicide glufosinate-ammonium. This decision is valid for 10 years and results from an application submitted by the company Pioneer/Mycogen Seeds. An authorisation for use as food is still under examination.

Ensuring the safety of human health, animal health and the environment remains the fundamental objective when agreeing to new approvals of GMOs. For each product, we seek the opinions of the Member States and any diverging scientific views among Member States are submitted for an opinion of the European Food Safety Authority which acts as an independent arbiter. Thus a GM product is placed on the market only if the scientific studies indicate that the product is safe for human and animal health and the environment.

With today’s approval of 1507 maize, the Commission is applying the regulatory framework governing the release of GMOs, one of the strictest in the world. The 1507 maize has been subject to a rigorous pre-market risk assessment and has been deemed as safe as any conventional maize by the European Food Safety Authority. Robust post-marketing rules will ensure that the product can be traced and monitored when put on the market.

1507 maize is the fourth product (2) to be assessed and approved after the entry into force of Directive 2001/18/EC (3). Today’s authorisation covers the import and the use of this GMO as animal feed. It does not authorise it for cultivation or food uses. The product will be covered by the new strict labelling and traceability rules which came into force in April 2004 (4). When put on the market, it will need to be clearly labelled as containing genetically modified maize. Its post-market monitoring will be assured through a unique identifier assigned to the maize to enable its traceability.

During the past four years the EU has put in place a clear, transparent and stringent system to regulate genetically modified food, feed and crops. The authorisation procedure under this new system ensures that only GMOs which are safe for human and animal consumption and for release into the environment can be placed on the European market. Clear labelling rules allow farmers, other users and consumers to choose whether or not to purchase such products. Individual authorisations are granted following scientific and technical appraisal on a case by case.

Background

A notification concerning the placing on the market of a genetically modified maize product (line 1507) was submitted by Pioneer/Mycogen Seeds to the competent authority of the Netherlands. The requested uses of the product included import, processing and feed use - but not food use or cultivation. The Dutch forwarded their assessment report to the Commission and Member states with a positive recommendation that the maize is as safe as any conventional maize.

This was subsequently confirmed by European Food Safety Authority (EFSA) on 24 September 2004. EFSA concluded that the 1507 maize was as safe as conventional maize and that its placing on the market for feed or processing was therefore unlikely to have an adverse effect on human or animal health or, in that context, on the environment.

Consequently, a draft Commission Decision to place the product on the market was presented to the Regulatory Committee set up under the Directive 2001/18. The Committee, acting by qualified majority, did not deliver an opinion on 17 May 2005. The Commission therefore submitted the proposal to the Council. The European Parliament was informed on 24 May 2005. The Agriculture Council of 20 September 2005, acting by qualified majority, neither adopted the proposal nor indicated its opposition. Therefore, in accordance with comitology rules, the final decision has to be adopted by the Commission, which was done today.

This Decision will apply from the date on which a Community Decision, authorising the placing on the market of the product for use in food and including a validated detection method for the product, will be taken.

Further information on the regulation on GMOs in the European Union can be found at: MEMO/05/104.

(1) Lepidopteran pests – the lepidopteran group of insects include the butterfly, moth and about 300 such insects.

(2) First product was NK 603 maize, see IP/04/957 of 19 July 2004. Second product was maize MON 863, see IP/05/1046 of 8 August 2005. Third product was oilseed rape GT73, see IP/05/1077 of 31 August 2005.

(3) Directive 2001/18/EC on the deliberate use of genetically modified organisms into the environment.

(4) Regulation (EC) N° 1829/2003 on GM food and feed ; Regulation (EC) N° 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and deed products produced from genetically modified organisms