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Checkbiotech: EU's legal labyrinth of GMO legislation
Posted by: DR. RAUPP & madora (IP Logged)
Date: December 01, 2004 10:09AM ;

EU environment experts failed to approve a new type of genetically modified
maize (GMO) made by US agrochemicals giant Monsanto on Monday, again
revealing their deep divisions over biotech foods, November 2004.

The decision to authorise the maize MON 863, engineered to resist the corn
rootworm insect, now moves from experts to politicians: EU ministers and the
EU executive Commission.

European Union rules on genetically modified organisms (GMOs) are a legal

Several different procedures apply for authorising a biotech product,
depending on the uses that the manufacturer specifies in its request for EU

The most common requests are for cultivation, use in animal feed or
industrial processing.

Some of these laws have been updated and replaced since the bloc started an
effective moratorium on authorising new gene crops and products in 1998.

Following is a guide to the GMO legislation and authorisation process:


A company that intends to market a GMO must:

1. Apply to the competent national authority of the EU member state where
the product will first be placed on the market, and include a full risk

2. If the authority gives a favourable opinion, the member state informs
other member states via the European Commission.

3. If there are no objections by other member states, the notifying state or
its national food safety authority may authorise the product for marketing
throughout the EU.

4. If no objections are sustained, a decision is needed at EU level and the
following procedure is initiated:

- depending on the law used for the application, the Commission asks a
committee of member state scientists or the independent European Food Safety
Authority for an opinion.

- if the opinion is favourable, the Commission submits a draft decision to a
regulatory committee of either food safety or environment experts from the
member states. If they agree, the Commission adopts the decision and
authorises the new GMO.

- if the committee does not agree, the Commission sends its draft approval
to the Council of Ministers, likely to be either agriculture or environment
ministers, who have three months to reject or adopt it. If they do not act
within this time, the Commission may adopt its own decision and authorise
the new GMO.

- this was the procedure the Commission used to drop the unofficial ban, and
authorise imports of Bt-11 maize.


1.Deliberate Release Law (Directive 2001/18):

This is the EU's main GMO law, dating from October 2002 which updates an old
law. First approvals under this law are limited to a maximum of 10 years.

The law covers any environmental release of products that contain or consist
of GMOs. This includes live GMOs for planting, as well as those for use in
feed and processing.

The law also has a safeguard clause whereby a member state may provisionally
restrict or prohibit the use of a GMO on its territory if it has cause to
consider that an approved GMO product poses a risk to human health or the

This clause has been invoked nine times under the old legislation. In each
case, the Commission ruled that the restrictions must be withdrawn.

2. Novel Foods Law (Regulation 258/97):

This law dating from January 1997 covers food products and food ingredients
derived from GMOs -- such as flour, starch or oil from a GM maize, paste or
ketchup from a GM tomato. Only products deemed safe for human consumption
may be marketed.

The law has a special procedure for foods derived from GMOs but no longer
containing them. If a food is "substantially equivalent" to existing foods
or ingredients, the company may notify the Commission itself (with a
scientific justification).

A handful of applications have been submitted under this law, which has now
been replaced by the new GM Food and Feed Regulation. Only those products
with a final scientific assessment before the new regulation enters into
force may be processed under the Novel Foods law.

3. GM Food and Feed Law (Regulation 1829/2003) and GMO Traceability and
Labelling Law (Regulation 1830/2003):

These are the EU's most recent laws on GMO authorisations and came into full
effect across the bloc on April 18, 2004.

They set down criteria and standardised procedures for evaluating potential
risks, as well as rules on labelling feed that consists of GMOs, contains
GMOs or is produced from GMOs.

All GMO feed and all foods produced from GMOs, whether or not there is GMO
material in the final product, must be labelled.

This applies, for example, to biscuits made from biotech maize, refined
soyoil made from GMO soybeans, and corn gluten feed made from GMO maize. The
threshold for labelling is 0.9 percent.

For accidental GMO presence in food or feed, the threshold is 0.5 percent
but it must be proved this cannot be technically avoided. Above this, the
product may not be put on the market.

However, there is no requirement to label products such as meat, milk or
eggs that are obtained from animals fed with modified feed or treated with
modified medicinal products.

SEEDS (Directive 98/95)

EU rules on biotech seeds date from December 1998 and are due for an update.
However, member states disagree over the Commission's proposed thresholds
for GMO presence in organic and conventional seeds -- and the thresholds are
being redrafted.

The latest proposal in circulation suggests a 0.3 percent GMO limit for
maize and rapeseed, the only two biotech crops so far authorised. Batches of
conventional seed with GMO material below those levels would not have to be

The Commission authorised the first genetically modified (GMO) seeds for
commercial use across Europe in September 2004.

It entered 17 different strains of Monsanto's 810 maize into the Common
Catalogue, the EU's seed directory which allows the seed to be marketed
across the 25-nation bloc.

At present, national authorities that have agreed to the use of a seed on
their territory must notify the Commission, which examines the information

The seeds law also requires that biotech seeds must also be authorised under
the Deliberate Release law before they are included in the Catalogue and
marketed in the EU.

If the GM seed is intended for use in food, it must also be authorised under
the GM food and feed law.


In July 2003, the Commission issued guidelines on how farmers should
separate organic, conventional and biotech crops, to ensure that these crop
types can be safely grown alongside each other with a minimal risk of

But rather than pushing for EU-wide legislation, demanded by some countries,
it wants EU states to use national laws.

Germany and Denmark have already agreed strict coexistence laws. The
Commission assesses any national plan before it can become law.

The guidelines refer, for example, to isolation distances between crops,
buffer zones and pollen barriers such as hedgerows. They also advise on
cooperation among farmers on sowing plans and crop varieties with different
flowering times.

The issue is highly controversial as the main problem for countries will be
how to determine economic liability. When does a farmer growing biotech
crops have to pay if a neighbour complains of organic crops being


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