The European Commission authorised today the placing on the market of the genetically modified maize MON 863 for import and processing as animal feed. The decision does not cover uses as human food or cultivation. The maize has been modified by Monsanto to make it resistant to the corn rootworm. This authorisation has been granted to Monsanto for 10 years.

With today’s approval of MON863, the Commission is applying the regulatory framework governing the release of GMOs, one of the strictest in the world. The MON863 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.

MON863 is the second product(1) to be assessed and approved after the entry into force of Directive 2001/18/EC(2). Today’s authorisation covers the import and the use as animal feed, but not cultivation or food uses. The product will be covered by the new strict labelling and traceability rules which came into force in April 2004(3). When put on the market, it will need to be clearly labelled as containing genetically modified maize. Its post-marketing 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. Under this new system, only GMOs which are safe for human and animal consumption and for release into the environment can be placed onto 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 appraisal of the GMOs in question on a case by case basis. Requests for authorisations which do not fulfil all criteria have been and will continue to be rejected.

Background on MON 863

A request to market a genetically modified maize product (line MON863), with resistance to corn rootworm, was submitted by Monsanto to the competent authority of Germany for assessment. The requested uses of the product included import, processing and feed use but not use in food or for cultivation.

The German competent authority concluded that there was no scientific evidence that indicated any risk for human health or the environment for the requested uses. However, other Member States raised and maintained objections in terms of molecular characterisation, allergenicity, toxicity, an inadequate monitoring plan, accidental spillage, presence of an antibiotic resistance marker gene and detectability. The European Food Safety Authority (EFSA) was consulted and delivered its opinion on 16 April 2004 concluding that the MON863 maize was as safe as conventional maize and unlikely to produce adverse effects.

Consequently, a draft Commission Decision to place the product on the market was presented to the Regulatory Committee for vote on 20 September 2004. However, on 17 September 2004, the German competent authority submitted to the Commission and to the Member States, a re-evaluation of a rat-feeding study included in the original application.

Many Member States expressed concerns in terms of reaching a formal position in the Regulatory Committee meeting, pending an examination of this re-evaluation and consequently, no formal vote took place at this time. Following the meeting, EFSA was requested to evaluate the impact of the conclusions of the re-evaluated rat study on the original risk assessment concluded that it did not put into question its initial opinion on this product.

The Regulatory Committee was re-convened on 29 November 2004. The Committee, acting by qualified majority, did not deliver an opinion. The Commission consequently submitted a draft Proposal to the Council. On 24 June, the Environment Council failed to reach a position on the proposal. As foreseen under EU legislation, the Commission is therefore required to adopt a final decision.

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

(1) First product was NK603 maize, see IP/04/957 of 19 July 2004

(2) Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment

(3) Regulation (EC) No 1829/2003 on GM food and feed

Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms