www.checkbiotech.org ; www.raupp.info ; www.czu.cz

Europe's food safety authority has issued draft guidance for the renewal of
authorisations of existing genetically modified products lawfully placed on
the market, November 2006.

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.
www.checkbiotech.org

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