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6-Regulation: Overview of the new EU GMO legislation



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TITLE:  Decision time ahead
        A new regulatory framework ahead on authorisation, labelling and
        traceability
SOURCE: Consumer Voice, Health and Consumer Protection DG, Belgium
        http://europa.eu.int/comm/dgs/health_consumer/newsletter/
        200305/0.htm
DATE:   May 2003

------------------ archive: http://www.gene.ch/genet.html ------------------


Decision time ahead
(Editorial by David Byrne, Commissioner)

For nearly two years now, I have had intensive discussions with
Parliamentarians and Ministers, consumers and industry about genetically
modified foodstuffs and feed. Although the debate has at times been
heated, I was impressed by how determined everyone was to seek a solution.

All arguments are now on the table. On 17 March 2003, the Council agreed
two Common Positions on draft Regulations designed to improve the current
legislation governing GMOs and GM food and feed. These new rules would
provide for clearer and more stringent mandatory labelling of GM food and
feed as well as traceability .

The Commission supports the Council's approach, as it is balanced and
rational. An approach that meets the needs of consumers and industry
alike. I now call on the European Parliament to play its part and move
the proposals towards final adoption.

The European Union already has a stringent regime on GMOs. I am confident
that the adoption of both Regulations will re-assure consumers that only
the most rigorously assessed GMOs are marketed in the EU, and that we can
trace them all the way through the food chain and label them accordingly.

*****


A new regulatory framework ahead on authorisation, labelling and traceability
(Article)

The overhaul of the current EU legislative system on authorisation,
labelling and traceability of GMOs in food and feed is entering its final
stages. Commissioner David Byrne told Consumer Voice that adoption of two
new regulations would give clear rules to industry and protect consumer
choice.

"We propose to set up a streamlined system to authorise GMOs in food and
feed, with clear decision-making responsibilities at EU level given to
the European Food Safety Authority (EFSA), for risk assessment, and to
the European Commission for risk management. The other regulation
proposes to trace GMOs all the way through the production and
distribution chains, and to reinforce the current labelling rules."

The Commissioner explained: "I firmly believe that our regulatory
framework - which is the most stringent in the world - will gain
consumers' confidence. They will ultimately make the choice whether to
purchase GM food or not."

European Parliament second reading The two ground-breaking regulations,
adopted by the Council in March 2003 in the form of "Common Positions",
have been transmitted to the European Parliament for second reading.

This constitutes the last stage of the co-decision process.

The Council Common Positions reflect the essential elements of the
Commission's original proposals, the opinion of the European Parliament
in the first reading, and specific concerns of the Member States.


** The new system will provide for a single approval process for GMOs **

Under the new system, it will be possible to file a single application
for obtaining both an authorisation for the deliberate release of a GMO
into the environment; and an authorisation for the use of this GMO and
all products derived from it in food and feed.

This authorisation, valid throughout the EU, will be granted subject to:
- a single risk assessment (covering both the environmental and health
risks), by the European Food Safety Authority (EFSA)
- a single risk management process, involving the European Commission and
the Member States through a regulatory committee procedure

Following a full risk assessment and validation of the detection method
provided by the applicant, the opinion of EFSA will be made available to
the public who can make comments to the Commission within 30 days.

The Commission, acting as risk manager, will propose to the regulatory
committee a decision on whether or not to authorise the GMO in question.
The Commission can propose a decision that differs from the opinion of
EFSA, though only if it has an appropriate justification for doing so.

The initial authorisation, published as a Commission decision, will be
granted for a period of 10 years. Its eventual renewal will only be
granted after another application.


** The new system will provide for traceability across production and
distribution chains **

Traceability is defined as the ability to trace GMOs, and products
produced from them, at all stages of their placing on the market
throughout the production and distribution chains, facilitating control
and also holding the potential to withdraw products if necessary.

The obligation of traceability is designed to facilitate accurate
labelling of the final product and to provide the means for inspection
and control of labelling claims. It is a direct response to the voices of
consumers who have made it clear that they want - and have a right - to
make informed choices.

This proposal places an obligation on all parts of the distribution chain
to provide that information. It also builds on the current EU food-
labelling scheme but adds additional provisions to allow for inspection
and control of compliance with the current rules and reduces reliance on
analytical methods to detect the presence of GMOs.

There are a number of key objectives for traceability, including limiting
the potential for loss of product specific information through the food
and feed chains and making it easy to withdraw products if an unforeseen
risk to human health or the environment is established. Traceability also
facilitates the monitoring of the potential effects that the GMOs could
have on the environment.


** The new system will provide for extensive mandatory labelling of GMOs
in food and feed **

Already today, retailers have to label food consisting of or containing
GMOs. This includes food produced from GMOs if traces of DNA or proteins
from the genetic modification is detectable in the final product (such as
flour produced from GM maize). However, the current labelling provisions
do not cover some food or food ingredients where these traces are not
detectable (such as highly refined soya or maize oil produced from GM-
soya or GM-maize). Neither do they cover certain derived products, such
as biscuits produced using GM-maize oil.

With the new regulations, all products containing an authorised GMO will
have to be labelled accordingly. They will have to bear a label
mentioning: "This product contains genetically modified organisms" or "...
produced from genetically modified (name of organism)".

In order to avoid over-labelling, European Ministers agreed that these
requirements should only apply if the presence of the GMO in the final
product is more than 0.9%, if it is adventitious and technically
unavoidable. This threshold is 1% in the current system.

For the first time, the new regulations will also cover all kinds of
animal feed made of or containing a GMO, such as GM soy meal or corn
gluten feed produced from GM maize.

All GM foods, including those approved under the Novel Foods Regulation,
will have to be labelled in accordance with the GM Food and Feed
Regulation, when it comes into force.


** The new system will provide for a labelling threshold for traces of
unauthorised GM material **

The adventitious or unintended presence of minute traces of GMOs in
products placed on the market in the EU is largely unavoidable and can
occur during cultivation, handling, storage and transport. This situation
already exists and affects products originating both in the EU and in
third countries.

It is not a problem unique to GMOs. In the production of food and feed,
it is practically impossible to achieve products that are 100% pure.

The Common Positions acknowledge this fact and define a threshold of 0.5%
under which a technically unavoidable presence of GMOs, not yet formally
authorised, could be permitted. This GMO, however, should have received a
favourable scientific risk assessment before the date of application of
the Regulation and the operator should be in a position to demonstrate
that its presence was technically unavoidable. This exemption applies for
a limited time period of three years. It aims to solve the problem faced
by operators who have tried to avoid GMOs, but find that their products
still contain a very low percentage of GM material.




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GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6
D - 38116 Braunschweig
Germany

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