The UK Government has confirmed today to the European Commission that it has assessed an application by Monsanto for the importation of a variety of genetically modified hybrid maize for processing, for example into animal feed, as complying with EU requirements.

This assessment reflects legal obligations under EC law and the advice from the Government's independent advisers, ACRE (the Advisory Committee on Releases to the Environment). The application and the UK's assessment will now be studied by other EU Member States before a collective decision is made. Consent, if granted, would not permit cultivation of the maize in the EU nor, without separate approval, could it be used in human food. Four other varieties of GM maize already have approval, dating back to 1997-98.

Under the EC Directive 2001/18, all applications to import or cultivate GM crops are initially assessed by the government to which they are originally submitted. Accordingly, the UK has assessed this application against the safety and other requirements of the Directive. It is now sending its assessment to the EU for the next stage scrutiny where all Member States have 60 days to comment.

Unanimous agreement is required for a decision or the application is referred on to the regulatory committee for the next stage of EU discussion. In forwarding the application the Government is insisting, if consent is subsequently given by the EU for import, that for the purpose of post market monitoring detailed arrangements for general surveillance are provided. Any consent would be subject to strict requirements on traceability and labelling set out in new EU Regulations.

The Government has been advised by ACRE that the maize:

"Does not pose a risk to human health or the environment. The marketing of this product for importation and processing in the UK will be no different from that of other maize imported for processing and animal feed purposes. In coming to this conclusion ACRE have taken account of the advice of the Advisory Committee on Animal Feedingstuffs (ACAF). ACRE also recommends that consent should be conditional on the notifier providing detailed arrangements for general surveillance of this product. Post Market Monitoring reports should be provided to the regulatory authorities on an annual basis."

Environment and Agri-Environment Minister Elliot Morley commented:

"In line with current EU legislation, we have completed assessment of this specific application on the basis of the scientific evidence.

The UK's independent Advisory Committee has no safety concerns with this application. Other Member States will now undertake similar assessments. If consent is then granted, we would insist, as advised by ACRE, on more stringent post-market monitoring reporting requirements.

Everyone will be able to make individual choices about GM food because products containing GM ingredients will be labelled."

See: ACRE advice on a notification for marketing of hybrid maize (NK603 X MON810) - Monsanto Europe S.A. - Ref C/GB/02/M3/3

BACKGROUND

1. The standards applying to the consideration of all applications to release Genetically Modified Organisms (GMOs) for research or for commercial (i.e., importation or cultivation) purposes are set out in EC Directive 2001/181, and this is the procedure being applied now to the application for importation of event NK603 X MON810. The Directive sets out a generic common framework to ensure that any GMO - such as food, feed, seeds, animals or bacteria - is adequately tested and evaluated at each stage in its development and, most importantly, before being placed on the European market. The requirements of all other EU legislation governing specific product sectors - including the new Regulation on GM Food and Feed - must be at least as stringent as Directive 2001/18. It is based on a transparent, case-by-case assessment across the EU of safety according to sound scientific evidence. Once a GMO has the suitable consent, it can be imported and, if the consent conditions permit, it can be cultivated anywhere in the EU, subject to other applicable legislation on seeds, pesticides and, where relevant novel food. For NK603 X MON810, the application is for import only, not for cultivation. The application and the UK's assessment will now be considered by all the other Member States before a collective
decision is taken. Any consent granted would be subject to the provisions of the Directive, as recently amended to cover stricter and more comprehensive requirements for the traceability and labelling of GMOs.

2. Additionally two new and interlinked EU Regulations2 on GMOs formally entered into force on 7 November 2003. One Regulation elaborates and extends existing rules on traceability and labelling of any GM product and the other Regulation sets up a more centralised and specific regime for the authorisation and labelling of GM food and animal feed, focused on the new European Food Safety Authority (EFSA). Importers, producers and suppliers will be required to keep and pass down the supply chain information about the GM content or derivation of a product to facilitate traceability and to underpin labelling information given to the final consumer.

3. Although both Regulations are now legally in force, their practical requirements will only apply to Member States and to individual stakeholders from 18th April 2004. At the end of last year Defra and the Food Standards Agency held face-to-face consultations with representative stakeholders on all practical aspects of their full implementation and are currently running a formal written consultation.
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1 Directive 2001/18/EC of the European Parliament and the Council of 12 March 2001 on the deliberate release of genetically modified organisms and repealing Council Directive 90/220/EEC

2 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September on genetically modified food and feed.