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6-Regulation: EC press release on GE food and feed regulation

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-------------------------------- GENET-news --------------------------------

TITLE:  Wallstroem and Byrne welcome EP acceptance of a trustworthy and
        safe approach to GMOs and GM food and feed
SOURCE: European Commission, Press Release
DATE:   Jul 2, 2003

------------------ archive: ------------------

Wallstroem and Byrne welcome EP acceptance of a trustworthy and safe
approach to GMOs and GM food and feed 

[please download document on questions and answers concerning GMOs at:]

DN: IP/03/935
Date: 02/07/2003



Brussels, 2 July 2003

Wallstroem and Byrne welcome EP acceptance of a trustworthy and safe
approach to GMOs and GM food and feed

Today the European Parliament adopted its second reading opinion on two
Commission proposals on genetically modified organisms (GMOs) which
establish a clear EU system to trace and label GMOs and to regulate the
placing on the market and labelling of food and feed products derived
from GMOs. The new legislation will consolidate a trustworthy and safe
approach to GMOs, GM food and GM feed. It will ensure full traceability
of GMOs throughout the chain from farm to table and will provide
consumers with comprehensive information by labelling all food and feed
consisting of, containing or produced from a GMO.

Environment Commissioner Margot Wallstroem said: "Today's vote is a very
important step forward towards full implementation of the EU legislation
on GMOs. It will reinforce our international credibility and will
certainly help in building public confidence in new technologies. I want
to thank the Parliament for its backing of our proposals, and look
forward to formal adoption by the Council. By ensuring that GMOs can be
traced at all stages in the production and marketing chain, we provide a
robust safeguard system and the foundation for a comprehensive labelling
system. In this way, we address the most critical concerns of the public
regarding the environmental and health effects of GMOs and enable
consumers to chose."

 Health and Consumer Protection Commissioner David Byrne said: "We will
now have the most rigorous pre-marketing assessment of GM food and feed
in the world. This should give consumers greater confidence that the
safety of GM products will be independently assessed by the European Food
Safety Authority: Consumers will also have a clear choice of products to
buy as GM food will now be clearly labelled. For the first time farmers
will see labels on GM-feed. Europe will now have a comprehensive and
transparent system of authorisation and labelling that can only enhance
business and consumer confidence."


 Traceability provides the means to track the movement of GM products
through the production and distribution chains. Traceability for certain
products has existed for many years. However, specific traceability
requirements for products that contain GMOs or are derived from GMOs do
not currently exist.

 Traceability will also facilitate monitoring of any effects on the
environment, accurate labelling and the control of labelling claims. It
additionally would enable products to be withdrawn from the market if any
unexpected adverse effects were to arise.

 The new Regulation on traceability and labelling will require business
operators when using or handling GM products to transmit and retain
information at each stage of the placing on the market. Information
concerning the presence of GMOs in products must be transmitted
throughout the commercial chain and must be retained for five years. The
industry will therefore have to ensure that systems are in place to
identify to whom and from whom GM products are made available.

* Transmission and storage of information will reduce the need for
sampling and testing of products. To facilitate a co-ordinated approach
for inspection and control by Member State, the Commission will develop
technical guidance on sampling and testing methods prior to the
application of this Regulation.


 The draft law will add to the current rules the labelling of:

 * All foods produced from GMOs irrespective of whether there is DNA or
protein of GM origin in the final product

* All genetically modified feed.


 Already today, retailers have to label food consisting of or containing
GMOs. This also includes food produced from GMOs if traces of DNA or
protein from the genetic modification is detectable in the final product
(such as flour produced from genetically modified maize.

 However, these labelling provisions do not cover some foods or food
ingredients, such as highly refined soya or maize oil produced from GM-
soya or GM-maize. The new law will extend the current labelling
requirements to also cover such food (soya or maize oil produced from GM-
soya or GM-maize) and food ingredients produced from GMOs (biscuits with
maize oil produced from GM-maize). and to allow consumers to exercise
their freedom of choice. The label has to indicate "This product contains
genetically modified organisms" or "... produced from genetically
modified (name of organism)".


 The Regulation also introduces for the first time comprehensive
labelling requirements of GM-feed based on the same principle as for GM
food. Currently there are no labelling requirements in place for feed
produced from GMOs. The Regulation will require labelling of, for
example, GM-soy meal and any compound feed that includes in its
composition the GM-soya meal. It will also require labelling of corn
gluten feed produced from GM maize.

 Threshold for labelling

 Minute traces of GMOs in conventional food and feed could arise during
cultivation, harvest, transport and processing. Whether we like it or not
this has become a reality. This is something that is not particular to
GMOs. In the production of food, feed and seed, it is practically
impossible to achieve products that are 100% pure.

 With this background, the EU's objective is to ensure legal certainty
and establish certain thresholds above which conventional food and feed
have to be labelled as consisting of or containing or being produced from
a GMO.

 Under current legislation the presence of GM material in conventional
food does not have to be labelled if it is below 1% and if it can be
shown to be adventitious and technically unavoidable. The Parliament
confirmed today a threshold of no higher than 0,9%.

 GMOs scientifically assessed in the EU to be safe

 Under current legislation, there is no tolerance threshold for the
adventitious presence of GM material in food or feed which has not yet
been authorised but which has received a favourable EU scientific risk
assessment. The Parliament has endorsed today a 0,5% threshold for the
adventitious or technically unavoidable presence of such GM material,
provided that the operator can demonstrate that its presence was
technically unavoidable. Above this threshold the product will not be
allowed on the market. This provision will expire after 3 years.

 Authorisation procedure

 Clear rules are set out in the EU for the assessment and authorisation
of GMOs and GM-food but responsibilities are shared between Member States
and the Community. The Regulation establishes a "one door one key"
procedure for the scientific assessment and authorisation of GMOs and GM
food and feed resulting in a centralised, clear and transparent EU
procedure where an operator is able to file a single application. The
Regulation provides that GMOs that could be used as food or feed must be
authorised for both uses or not at all.

 The scientific risk assessment will be carried out by the European Food
Safety Authority. Its opinion will be made available to the public and
the public will have the possibility to make comments. On the basis of
this opinion, the Commission will draft a proposal for granting or
refusing authorisation. The proposal will as it is currently the case be
approved through qualified majority by the Member States within a
Regulatory Committee. Products authorised shall be entered into a public
register of GM-food and feed. The authorisation should be granted for a
period of 10 years, subject where appropriate to a post-market monitoring
plan. Authorisations are renewable for 10-year periods.

 The simplified procedure for putting on the market GM-foods which are
considered to be substantially equivalent to existing foods will be abandoned.

 Current GM-products will remain eligible for marketing. Operators will
however be obliged to provide detection methods to the Commission within
six months of entry into force of the new law. The Regulation also
establishes the Joint Research Centre (JRC) of the Commission as new
Community Reference Laboratory which will have the main task of
validating detection methods. The JRC will continue to work with the
"European Network of GMO laboratories".

 Existing GM-products shall also be entered into the public register and
the time limit of 10 years from the day when the concerned product was
first placed on the market equally applies to them.


 Measures to ensure that the production of organic and conventional crops
can co-exist with GM-crops were introduced into the draft Regulation on
GM Food and Feed during the second reading of the Parliament. In this
context, Member States will be allowed to take appropriate measure to
avoid the unintended presence of GMOs in other products. The Commission
will bring forward a Recommendation to Member States providing a
framework to put this into practice.

 Next steps

Council will have to confirm the results of the second reading before the
Regulations can enter into force 20 days after publication in the
Official Journal of the European Union. Operators have to comply with the
new previsions on labelling within 6 months after the date of publication.



European NGO Network on Genetic Engineering

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

phone:  +49-531-5168746
fax:    +49-531-5168747
mobile: +49-162-1054755
email:  genetnl(at)