EFSA issues draft guidance on GM approvals

The guidance, from the European Food Safety Authority (EFSA), aims to assist applicants in the preparation and presentation of applications for renewal of authorisation of existing products according to articles 11 and 23 of regulation (EC) 1829/2003 on genetically modified food and feed.

An application for renewal of authorisation for an existing product can only be submitted for the 26 products listed in the community register of existing products.

EFSA said that applications for renewal should be submitted, at the earliest, one year before the expiry of the authorisation, which will first take place in year 2015.

The issue of GM approval within the EU is one of the most contentious in agriculture. The recent announcement that US authorities had traced amounts of unapproved genetically modified (GM) food in samples of rice prompted the EU to clamp down on all imports from the US.

The immediacy of this action illustrated the stringent controls the EU has in place to guard against unauthorised products entering the food chain, and also reflected consumer fears over the technology.

However, many biotech firms believe that the European market has a potentially lucrative future. The WTO ruled earlier this year that the EU and six member states had broken trade rules by barring entry to GM crops and foods.

The World Trade Organisation agreed with the United States, Argentina and Canada that an effective moratorium on GMO imports between June 1999 and August 2003 had been put in place.

The EFSA assessment of an application for renewal of the authorisation for an existing product is an adaptation of the procedure used to assess new GM applications and takes into account any new information, experience and data that have been collected during the authorisation period.

An application should be submitted by the authorisation-holder to the European Commission. The European Commission then sends the application to EFSA, which in turn makes the full application available to Member States and the summary of the application available to the public.

An application for an existing product falling under Articles 8(1)(a) and/or 20(1)(a) must be submitted within nine years from the date on which the products were first placed on the market, but in no case earlier than 18 April 2007. However, for products where the foreseen nine-year period ends earlier than 18 April 2007, the application for renewal has to be submitted on that date.