GENET archive


6-Regulation: EU environmental ministers call EFSA and comitology into question

                                 PART I
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SOURCE: AGRA FACTS No. 21-06, Belgium, 
DATE:   10 Mar 2006

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Changes to the way the European Food Safety Authority carries out risk
assessments on GMOs may be beneficial and could make the whole process of
authorising GM products more comprehensive & transparent, according to
Environment Commissioner Stavros Dimas at yesterday's Environment
Council, with Commission officials confirming afterwards that changes to
EFSA are now inevitable. Speaking after a public debate on the GMO
authorisation procedure, the Commissioner said he was optimistic that
changes to EFSA would lessen Member State concerns over the decision-
making procedure, notably comitology. Both EFSA's safety assessments and
the comitology procedure came under attack from most Environment
Ministers during the one & a half hour debate (relayed in full to the
Council press room) at which every Member State except Fin & Svk spoke.
There was almost unanimity among Ministers on the need for EFSA to be
more transparent, with even the UK, which voiced strong support for the
current system, calling for better communication by the Parma-based body.
More specifically, a large number of delegations (Esp, D, It, Sln, Lith,
Hun, Mal, Pol, Lux, Lat, Aus & Cz) complained that it consistently failed
to take Member State concerns into account when carrying out risk
assessments. Suggestions on how to improve the assessment process
included changes to the composition of the panel which carries out the
assessments (Lat, Gre, Hun) & obligatory public declarations by EFSA
explaining its opinions when they differ from those of Member States'
(Aus, Esp, Swe). Several delegations questioned the scientific basis for
EFSA's decisions, with Danish Minister for the Environment Connie
Hedegaard saying that research on the safety of GMOs should not be left
to private companies such as Monsanto, and other Ministers saying that
studies on the environmental impact of a particular GMO must also be
taken into account during safety assessments. It is not clear yet what
changes might be made to EFSA, but officials confirmed today that
proposals could be made before the end of the year, with the Commission
able to implement them without any further legislative action. On the
issue of comitology - the other big issue of the day - the Commission was
more hesitant about changes. It, Hun, Gre, Lux, At & Dk had all said that
the Commission should not approve a GMO if there is a simple majority
[i.e. 13 Member States] against the proposal, rather than the qualified
majority required to block approval under current rules. However,
Commissioner Dimas said that Member States had voted for the comitology
procedure and that any changes would apply to other policy areas, as the
procedure is used on a wide variety of issues. The comitology procedure
is being examined at the moment, he said, and Member States can make
changes, but he reiterated once more his belief that the real problem in
the GMO authorisation process was the lack of confidence in the risk
assessments by EFSA.

                                 PART II
------------------------------- GENET-news -------------------------------

TITLE:  Commission gives go-ahead for GM maize
SOURCE: The Irish Times, by Judith Crosbie
        posted by Checkbiotech, Switzerland
DATE:   14 Mar 2006

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Commission gives go-ahead for GM maize

Despite advances in the application of genetically modified organisms the
issue remains a divisive one within Europe.

This month the European Commission approved a genetically modified maize
for use in the EU.

lt was the ninth authorisation for a genetically modified organism (GMO)
to be passed by the EU in two years since a moratorium was lifted on GMOs
entering the union. Despite the lifting of the moratorium, Europe remains
a highly restrictive place for GMOs. Legislation requires strict approval
methods, and rules on labelling and traceability often result in
reluctance among retailers and food processors to deal in the organisms.

Now the way the organisms are approved is under fire from some EU states
and environmental activists, who fear the Commission is ignoring the
health risks to prevent a trade war with GMO producers, particularly the US.

The decision to approve the latest type of maize was taken by the
Commission after members states failed to reach agreement on it last
December. Some EU countries consistently vote against GMOs, like Austria,
Greece or Luxembourg. Some tend to vote for them or abstain from voting,
like Ireland, the Netherlands or Britain.

But because national votes are weighted according to the size of a member
state, half the EU countries can vote against a product without being
able to block it, in a voting process known as Qualified Majority Voting.
When this happens the ultimate decision then passes on to the Commission.
Various issues apart from GMOs are dealt with in this way if approval is
not reached.

Opponents of GMOs feel this is not the best way to handle this sensitive
topic. They point to the fact that the Commission is advised by the
European Food Safety Authority (EFSA) which has never given a negative
opinion on a GMO and which, they say, relies on information supplied to
it by the companies who make the organism. That information, together
with tests carried out on animals to assess the potential health risks,
is generally not made public to protect commercial sensitivity, though
each member state is given a copy of the report.

"Decisions are being taken behind closed doors. We are discussing food
which we eat, there shouldn't be any doubt at all," says Hiltrud Breyer,
a German Green MEP. Proponents of GMOs say the authority is made up of
independent scientists who are just looking at the facts.

"lt is absolutely important that this issue of approval is not
politicised . . . the EFSA must stick to science when making their
decisions," says Simon Barber of EuropaBio, a Brussels-based group which
represents European bio-industries.

A public debate among EU environmental ministers last Thursday showed
that there were concerns about the GMO approval mechanism.

"lt doesn't do much for democratic legitimacy if the European Commission
approves specific GMOs even in the face of objections from a majority of
member states," said Danish Environment Minister Connie Hedegaard.

"This procedure does not seem to be able to make the wishes of a majority
of member states possible. There is a big majority against GMOs in public
opinion," added Stavros Kaloyannis, Greece's state environment secretary.

Ireland's Minister for the Environment Dick Roche did not oppose the
mechanism saying it was the ministers themselves who approved the system.

The authority also came in for criticism: "We need credibility, trust
from the public for our authorisation procedure," said Humberto Rosa,
state environment secretary for Portugal.

Mr Roche said while concerns were raised by member states, "no one
questions the expertise of the EFSRA."

The matter will be raised again at the ministers' next meeting in May,
but in the meantime fears have been raised that the EU will come under
further pressure to approve GMO5. The US and other countries which grow
genetically modified crops are putting pressure on the EU to accept their

Their case has been buoyed up by a leaked judgment from the World Trade
Organisation last month said that the 1998-2004 GMO ban by the EU was
illegal. At the back of the debate lies the issue of public health and
whether the organ isms pose a risk. "There's not a single long-term study
which proves there are no risks," says Breyer.

Greenpeace addressed environment ministers last week in Brussels citing
the halting of studies in Australia on peas producing an insecticide
protein after allergic reactions and lung inflammation were noticed in
mice fed the product.

On the other side, industry proponents say millions of people around the
world have been eating GM products for years with no adverse reaction.
"Last year there were 80 million hectares of GM crops grown and not one
reported incident of health side effects anywhere to animals or human,"
says Barber.

Even in the area of medical research the debate is not clear-cut.
Research is being co-ordinated by Trinity College Dublin into ways of
tackling obesity by taking genes from marine algae to produce a seed oil
which would help reduce the level of saturated fat in the blood.

Other research by Lipgene includes changing the bacterial productions in
cows' stomachs to alter the fat types produced in dairy products. Prof
Michael Gibney who works on the project believes people will change their
minds and see the benefits of GM technology: "When trains came out first,
people were afraid to travel in the opposite direction to the earth." But
others disagree. "lt is completely unnecessary. We should not be fooled
by pie-in-the-sky ideas," says Eric Gall of Greenpeace's European unit.
"We da not need GMOs or the reality of what they deliver."

                                 PART III
------------------------------- GENET-news -------------------------------

TITLE:  GMO Panel's future in doubt after barrage of criticism
SOURCE: GM Free Cymru, UK, Press Release
DATE:   15 Mar 2006

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GMO Panel's future in doubt after barrage of criticism

The European Food Safety Agency (EFSA) has come under sustained and
unprecedented attack from a variety of different quarters during recent
months, largely because of the actions of its widely-despised GMO Panel.
The future of that expert panel must now be in doubt, even if there are
wholesale changes in its personnel and in its working methods.

NGOs and consumer groups all over Europe have long been dissatisfied with
the work of the GMO Panel, accusing it of obsessive secrecy, a strong
bias towards the GM industry, and a reluctance to take seriously the
"precautionary" instincts of European consumers and many European
governments. Since its formation, it has always given "positive opinions"
of the GM varieties in the applications process, and it has always
dismissed out of hand the attempts of various Governments (for example
Italy, Austria, Hungary and Greece) to invoke the "safeguard clause" and
to ban various GM crops from their territories. It has been seen --
rightly or wrongly -- as working hand in glove with the Commission to
force through GM approvals for political reasons, against the wishes of
European consumers.

In 2004 FoE Europe produced a damning report called "Throwing Caution to
the Wind" on the workings of EFSA (1), and accused the Agency of repeated
bias in favor of the biotech industry. It also claimed that EFSA's GMO
panel had ignored views of scientists working for EU governments and had
issued a string of hasty and ill-considered positive assessments on GMO
safety. In May of last year the Italian Government was openly critical of
the workings of EFSA (2), and further criticism came from voluntary
groups who discovered that the EC case being presented to the WTO during
the "GM moratorium" dispute with the US highlighted many concerns and
uncertainties about GM crops which were directly contradicted by
statements coming from EFSA (3). That caused considerable behind-the-
scenes anger within the EU.

Also in 2005, EFSA attracted widespread condemnation for the manner in
which it connived with Monsanto to keep the results of its MON863
"secret" 90-day rat feeding study away from public scrutiny or peer
review, and then issued a positive opinion of the variety in the face of
serious doubts about its safety being raised within the scientific
community (4). With its reputation already dangerously damaged, EFSA
arranged a "Stakeholder Platform" as part of a charm offensive, but found
itself confronted by ten challenges from a determined and united front of
NGOs and consumer groups (5). At the same time, Greenpeace attacked EFSA
with a new report (6) which claimed that in its assessment of Bt11 maize
it had failed to fulfill its legal responsibilities and had in effect
been negligent.

With criticism directed at EFSA from an increasingly disenchanted
European Parliament and from various European governments, pressure
increased with the accession of the Austrians to the presidency of the
EU. The Austrians immediately flagged up their intention to subject the
GM approvals process to close scrutiny, and Agriculture and Environment
Minister Josef Proell openly attacked EFSA in print in February (7).
There were signs that the Commission's DG-SANCO was also becoming
critical of the quality of some of EFSA's scientific opinions, and in
spite of assurances on the record of its full confidence in the
"excellent science" conducted by the GMO Panel, it instituted a full
independent evaluation of the work of EFSA which contained many damning
indictments of its working methods (8).

In another attempt to mount a charm offensive, EFSA met with eight
representatives of NGOs in Parma on 22nd February, ostensibly to talk
over "GM science." But at the meeting the EFSA Acting Chairman Herman
Koeter and his GMO Panel members were left in no doubt that the NGOs had
little confidence in their impartiality or in their ability to conduct
objective science, and they were bombarded with many very specific
criticisms (9). They made no commitments either to revisit unsound "GM
opinions" or to alter their working methods, and things finally came to a
head with the Environment Council Meeting on 9th March at which the NGO
concerns were echoed over and again by European Ministers (10). Press
reports referred to the "intense criticism" directed at EFSA by one
speaker after another, and also reported that Commissioner Stavros Dimas
(previously a staunch supporter of the Agency) now accepted that
fundamental changes would have to be made to the GMO Panel's working methods.

Ironically, one of the very few voices heard in support of EFSA at the
Environment Council meeting was that of the UK Environment Minister
Eliott Morley, who argued that GM assessment procedures were basically
sound. This was no great surprise, since the UK (with Ireland and
Holland) has always voted for GM approvals and has consistently dismissed
public concerns about GM. The Westminster government has also shown
itself to be incapable of recognizing the abundant evidence of harm
appearing in the GM scientific literature (11).

Commenting on the EU's dramatic loss of confidence in EFSA, GM Free Cymru
spokesman Dr Brian John said: "I cannot see how the GMO Panel can
continue to operate under present circumstances. It is now so heavily
compromised, and so heavily criticised for its industry bias and
connivance in fraudulent science, that it cannot possibly regain the
confidence of either the EU or European consumers. We believe that all of
the discredited GMO Panel members and its Acting Executive Director must
now resign. A new Panel must be put in its place with a much more
balanced representation, and its terms of reference must be rewritten.
And while this goes on, the GMO approvals process must be frozen; it
would be grossly irresponsible in the present circumstances for either
EFSA or the Commission to do any further work regarding GM crops or foods."


Dr Brian John
GM Free Cymru
Tel +44-1239-820470


(1) In November 2004 Friends of the Earth published "Throwing caution to
the wind, a detailed critique of the EFSA and its work on GM foods". The
report and recommendations can be downloaded here:

(2) Italy calls for independent EU research on GMOs REUTERS, Mon May 30,
2005 By Jeremy Smith

(3) See this:


(5) Re the Stakeholder Platform (6th October 2005) and the "Ten Demands" see:
The demands were supported by the European Public Health Alliance,
Eurocoop, the European Environmental Bureau, Greenpeace and Friends of
the Earth. The demands can be downloaded from here:

(6) In October 2005 Greenpeace published a new scientific report on the
wholly inadequate risk assessment by the GMO panel of a GM crop made by
Swiss-based Syngenta, called Bt11. It showed that that no serious
investigation was conducted on the toxicity of this GM maize or its
impact on the environment, such as detrimental effects on useful or
protected insect species. Furthermore, already published scientific
results on possible negative environmental consequences of this GM maize
were widely ignored by EFSA. The report can be downloaded at:


long section (Annex 5, pp 36-45) in the Annexes document, looking at the
work of the GMO Panel. It is not exactly a ringing endorsement of its
working practices.

(9) For example, GM Free Cymru has accused the GMO Panel of involvement
in scientific fraud, and it has taken its concerns to the President of
the EC and to MEPs. See this: Letter to Herman Koeter, Chairman of GMO
Panel, 27th February 2006

EU debates changes to GM approval rules EFSA came under intense criticism
from Environment Council ministers on 9th March 2006:

(11) Ref to GM Free Cymru items -- evidence of harm

European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
news & information

phone....... +49-531-5168746
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