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6-Regulation: EU legislative framework for GMOs is now in place

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                                  PART I
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TITLE:  European legislative framework for GMOs is now in place
SOURCE: European Commission, Press Release IP/03/1056
DATE:   Jul 22, 2003

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European legislative framework for GMOs is now in place

DN: IP/03/1056
Date: 22/07/2003


 Brussels, 22 July 2003

 European legislative framework for GMOs is now in place

 The Council of Ministers today formally adopted two European 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.
This 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 Wallström said: "I welcome today's final
adoption by Council of the new legislation on labelling and traceability
of GMOs, which completes the EU's legislation on GMOs. It will reinforce
our international credibility and will certainly help in building public
confidence in new technologies.. 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: "I am very
pleased that the European legislative framework for GMOs is now complete.
European consumers can now have confidence that any GM food or feed
marketed in Europe has been subject to the most rigorous pre-marketing
assessment in the world.: 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

The legislation will 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.

                                  PART II
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        EU Labeling Rule Not Supported by Science
SOURCE: Grocery Manufacturers of America, USA, Press Release
DATE:   Jul 22, 2003

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EU Labeling Rule Not Supported by Science

Washington, DC, July 22, 2003 - A decision by the European Council of
Ministers to approve plans for the traceability and labeling of biotech
food is not supported by science and will inhibit trade, the Grocery
Manufacturers of America said today.

"This decision flies in the face of sound science," said GMA Director of
Environment and Technologies Karil Kochenderfer. "Not only has the
European Commission found biotech foods on the market today to be as safe
as, if not safer than, conventional foods, so have numerous other
scientific bodies, including the Codex Alimentarius, the World Health
Organization and the French National Academy of Sciences."

The European regulations require labeling for all foods derived from
biotechnology regardless of whether any modified DNA or proteins are
detectable. In addition, the regulations require extensive documentation
by farmers, transporters, grain handlers, ingredients suppliers and food
processors regarding whether their products contain, may contain, or were
derived from biotechnology at each stage of the production cycle.
However, the regulations exempt two categories of products - cheeses and
wines - which use biotech enzymes, and that are major European products.

"GMA believes regulatory policies for biotech products around the world
must be based on scientific principles," Kochenderfer said. "By
dismissing the science showing the safety of biotech foods on the market,
the EU is sending mixed messages to European consumers by saying biotech
foods are safe, but still requiring distinct traceability and labeling
for these safe foods."

European officials have claimed that this traceability and labeling
scheme is required in order to end the de facto moratorium on approvals
of new varieties of biotech foods and crops.

"These regulations neither enhance consumer understanding nor facilitate
trade," Kochenderfer said. "They simply replace one trade barrier with a
worse trade barrier."


GMA is the world's largest association of food, beverage and consumer
product companies. With U.S. sales of more than $500 billion, GMA members
employ more than 2.5 million workers in all 50 states. The organization
applies legal, scientific and political expertise from its member
companies to vital food, nutrition and public policy issues affecting the
industry. Led by a board of 42 Chief Executive Officers, GMA speaks for
food and consumer product manufacturers and sales agencies at the state,
federal and international levels on legislative and regulatory issues.
The association also leads efforts to increase productivity, efficiency
and growth in the food, beverage and consumer products industry. 

Stephanie Childs (+1-202) 337-9400 or

                                  PART III
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TITLE:  NFPA Calls EU Adoption of Biotech Labeling and Traceability
Requirements "A New Brick Wall Blocking International Trade"
SOURCE: National Food Processors Association, USA, Press Release
DATE:   Jul 22, 2003

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NFPA Calls EU Adoption of Biotech Labeling and Traceability Requirements
"A New Brick Wall Blocking International Trade"

(Washington, D.C.) - In response to the formal adoption by the European
Union's Council of Ministers on July 22 of new requirements for labeling
and traceability of foods and feeds that contain genetically modified
ingredients, John R. Cady, President and CEO of the National Food
Processors Association (NFPA), made the following comments:

"These new required labels and traceability rules erect a new brick wall
blocking the free international trade in food and food products. The EU
has elected to turn away from food science and food safety to establish
yet another trade barrier that will keep many U.S. food products out of
the European market.

"Because there is no safety or nutrition issue associated with the
products of agricultural biotechnology on the market, there is no
scientific basis for requiring the labeling of biotech foods. Moreover,
such labels on food products will be seen as 'warning labels' by European
consumers. In essence, the requirements ensure that these products are
unlikely to enter the European market, thereby actually denying consumer
access to the products of agricultural biotechnology.

"NFPA opposes 'process-based' labeling, such as these new biotech
labeling requirements. Mandatory labeling should be based on the
composition, intended use, and health and safety characteristics of a
food product, not on the 'genetic process' from which it was derived.

"The traceability requirements are so complex and detailed that they
equate to the process for handling nuclear waste. What perception will
such a process, applied to food, bring about in the minds of European

"This new labeling scheme and traceability process sets the stage for
another World Trade Organization legal case that will take years to
resolve. This is a bad decision by the EU. NFPA urges the EU to
reconsider these new requirements, so that a new and unnecessary barrier
to trade is not established. And we will work with the U.S. Trade
Representative to make sure that the World Trade Organization understands
the problem these new requirements will pose, and request the WTO to take
appropriate action to resolve this issue."

NFPA is the voice of the $500 billion food processing industry on
scientific and public policy issues involving food safety, food security,
nutrition, technical and regulatory matters and consumer affairs.

For more information on this issue, contact Timothy Willard, NFPA's Vice
President of Communications, at (+1-202) 637-8060, or Libby Mikesell,
Senior Director of Communications, at (+1-202) 639-5919.


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)