Europaudvalget 2005-06
2713 - miljø Bilag 6
Offentligt
Problems regarding risk-assessment of GMOs for food and feed.
Which improvements of EFSA procedures could be imagined?
Dear minister
At the 9 March Environment Council you will continue the policy discussion on GMOs that you
started on 2 December 2005. We would like to draw your attention on crucial shortcomings in
the implementation of the EU legislation on GMOs, and on the need to urgently address the
failures of the European Food Safety Authority (EFSA) on GMO risk assessment. The EU
legislation on GMOs also needs to be implemented in a transparent and democratic way.
The EFSA has ignored its legal requirements to conduct a long-term evaluation of GM
products, to identify areas of scientific uncertainties, to answer Member States diverging
opinions and to take their scientific concerns into account. The EFSA bases its opinions solely
on data provided by the applicant company, most of which is kept confidential in breach of EU
law, preventing independent scientists to assess the risks of a product. Even when the
company’s own data shows a detrimental impact on health, like in the case of Monsanto’s GM
maize MON863 rat study, the EFSA has dismissed the need to conduct further investigations,
without providing a clear reasoning for doing so. Moreover, the independence of the experts
sitting on the EFSA GMO panel from interests of the biotech industry is not even guaranteed.
The failures of the EFSA are not acceptable: flawed scientific opinions, which do not even
identify areas of uncertainties, do not enable risk managers (the Commission and
governments) to take informed decisions. This is even more worrying since the latest
scientific research confirms that the genetic engineering process can lead to unexpected and
detrimental effects to health and the environment, such as unpredictable changes in protein
structures (like in the case of the Australian GM peas, which provoked allergies and lung
inflammation in mice) and decrease in biodiversity, which are not taken into account by the
current risk evaluation process.
We urge you to demand that :
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the risk assessment requirements of the EU legislation are strictly implemented by the
EFSA and national scientific bodies,
more detailed requirements for GMO evaluation be made mandatory on EFSA,
full transparency and public access to data are ensured,
Member States concerns are taken into account and answered by the EFSA and the
Commission,
The negligences of today are the food scandals of tomorrow. Until these problems are solved,
we ask you to demand that the EFSA immediately stop issuing new opinions on GMOs. It is
your responsibility to ensure that European consumers and the environment are protected
from the irreversible impacts of GMOs, to make sure that EU institutions do not undermine
their own legislation and act in a transparent and democratic way.
You will find in the attached Annex our detailed concerns and proposals. Be assured of our
vigilance.
Yours sincerely,
Eric Gall
Greenpeace
European Unit
Dan Belusa
Greenpeace
Copenhagen office
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ANNEX:
1) The impact of the WTO dispute on GMOs and national bans
According to the leaked preliminary conclusions of the WTO ruling, the panel has
dismissed all the claims of the US, Argentina and Canada, except for the accusation
that the EU has acted with “undue
delays”
and that national bans should be based on
a risk assessment in the sense of the WTO Sanitary and Phytosanitary (SPS)
Agreement. As these accusations relate to the 1998-2003 period, the WTO panel
makes no further recommendations. The EU legislation itself was never at stake in
the case.
However, pressures from the US and the WTO should not result in the
EU system being implemented in a way that sacrifices a strict and transparent
risk assessment, so as to serve the interests of GMO exporting countries or
the GMO industry.
The WTO is not the right forum to address biosafety issues and it
has no legitimacy to decide the level of health and environment protection in the EU.
In no case should the WTO interfere with EU decisions regarding the cultivation of
GMOs.
Therefore the Commission should stop using the WTO case as an excuse to
automatically give approval to GMO authorisations, to disregard Member States
scientific and economic concerns, and to delay any attempt to bring the risk
assessment and public access to data in line with the legal requirements of the EU
legislation. Risk management measures should not be undermined either, and
we
urge you to ask the Commission to refrain from any new attempt to lift the
national safeguard measures, which a qualified majority of Member States
considered as justified on 24 June 2005.
2) Legal and scientific problems with the EFSA risk assessment of GMOs
The European Food Safety Authority (EFSA) GMO panel has simply ignored many of
the legal requirements on GMO evaluation :
a) The EU has a comprehensive legislative framework to protect consumers and the
environment.
A key aspect is the legal requirement to consider the long-term
effects of a particular food and probable combination effects.
This is
particularly relevant for new technologies such as genetic modification. The legal
obligation for this can be found in article 14.4 of the EU’s 178/2002 regulation,
which is often omitted particularly when it comes to EFSA’s opinions on GM
products. In addition other legislation such as Directive 2001/18 also call for the
assessment of long term environmental effects of GMOs.
b) The EFSA has a legal requirement
to address differences in scientific
opinions.
Sometimes substantial differences can be found between Member
States and EFSA opinions. Article 30.4 of 178/2002 states that: “Where
a
substantive divergence over scientific issues has been identified and the body in
question is a Member State body, the Authority and the national body shall be
obliged to cooperate with a view to either resolving the divergence or preparing a
joint document clarifying the contentious scientific issues and identifying the
relevant uncertainties in the data. This document shall be made public.”
Despite
the substantial differences which can be found between Member States and
EFSA scientific opinions, there is no evidence that the EFSA has fulfilled its
obligations under this article.
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c) Commission Decision 2002/623 explicitly states that areas of
scientific
uncertainties
should be clearly identified in the evaluation. EFSA opinions often
do not state where the scientific uncertainties arise even though this is a long-
established scientific practice and is legally binding to do so. EFSA has only
given scant regard to uncertainties in any of their opinions for GMO products
under 2001/18. An assessment of the scientific uncertainties in an EFSA opinion
is crucial to enable risk managers (e.g. the Commission and Member States) to
make judgements in the public interest. It also avoids abuse of EFSA opinions by
risk managers who can claim that a product is safe just because EFSA said so.
d) In those cases where a declaration of interest or activities of members of the
GMO panel are indicating a
conflict of interest,
these experts should be
excluded from GMO panel. Experts which are involved in risk assessment of
GMOs at the national level should not be members of the EFSA´s GMO panel.
These experts should be seen as a necessary separate element of quality check
of EFSA´s opinions.
The GMO panel of the EFSA was set up to contribute to an improved risk
assessment of GM crops in the EU. However, analysis of the assessments made so
far by the EFSA shows that it has not contributed to a higher level of consumer and
environmental protection from GM crops and foodstuffs. The criticisms made of the
old regulatory framework are still valid. The data are often of poor quality and where
differences and irregularities have been found, these have not been followed up
sufficiently. There is no rigorous scientific consideration of high quality data where
any departures from substantial equivalence are investigated thoroughly. The
European Commission and Member States have the duty to take action in order to
make sure that the requirements and standards for risk assessment in the European
legislation are met by the EFSA and by national competent authorities. For now, the
key role given to EFSA in Regulation 1829/2003 (centralised procedure for GMO
authorisations, through which most applications will now be processed) is a serious
cause for concern.
No furher opinion on GMOs should be issued by the EFSA until these
problems are solved. We urge you to demand clear decisions to force the
EFSA to respect its legal requirements, and that the role of national scientific
authorities be recognised. Moreover :
A new comprehensive, coherent and mandatory regime is necessary for the
risk assessment of GMOs.
This regime should address the quality and amount of
data to be presented by the applicant company, as well as the way how these data
are assessed. The material produced by the company has to undergo a much more
comprehensive quality check before used in EFSA assessments.
A rigorous, comprehensive and
mandatory testing regime
should also be set up for
immunological testings as well as toxicity and antinutrition tests (for example testing
regimes for the toxicity of pesticides are precisely defined in law). In addition there is
a need for a broad ethical debate on the use of laboratory animals in this context.
The opinions presented by the GMO panel of EFSA have to reflect all open questions
and uncertainties without prejudice.
The Precautionary Principle has to be applied in a way that uncertainties regarding
safety are seen as an obligation for further investigations, and no positive opinion can
be filed by EFSA.
Monitoring and general surveillance has to take into account all levels of complexity,
interactions and possible effects regarding human health and environment.
Full and free access to data has to be provided.
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3) The GMO authorisation process should be made transparent and
democratic
a) Lack of transparency :
GMOs are only evaluated by unaccountable scientific
committees on the basis of the applicant company’s own data. Most of this data
is classified as "business confidential information", thus preventing the public and
independent scientists from scrutinising the risk evaluation process.
All data
related to risk assessment should be systematically and without delay
accessible to the public.
Article 25 (4) of Directive 2001/18/EC indicates that “in
no case” should the information related to “environmental risk assessment” be
kept confidential, while Article 21 (1) states that “verifiable justification” must be
given for the documents for which the applicant seeks confidentiality. Given that
most feeding studies on animals provided by the applicants remain “confidential”
as of today, these legal requirements have clearly been breached by both
Member States and by the Commission.
b) Socio-economic considerations :
When making a decision on the approval of a
GMO for cultivation the Commission has, the possibility to take into account other
considerations than environmental and human health aspects, i.e. socio-
economic as well as ethical considerations (c.f. Annex II C.2 of Directive
2001/18/EC, complemented by Commission decision 2002/623/EC ; Articles 7,
19 and 33, and considerations 32 of Regulation (EC) No 1829/2003). We strongly
believe that a transparent procedure regarding these considerations and the
opportunity for Member States as well as for other stakeholders to contribute to
such considerations should be established by the Commissioner and Member
States.
c) The new centralised procedure :
Regulation 1829/2003, through which most
GMO applications are now going to be processed, will give an even bigger role to
the EFSA and further marginalise Member States involvement and their
concerns. This centralised procedure does not even guarantee that the more
detailed requirements of Directive 2001/18/EC regarding risk evaluation, risk
management, information to the public and post-market monitoring, be respected.
We are concerned by the fact that the Commission decided to transfer most
applications under Directive 2001/18 to the centralised procedure of Regulation
1829/2003.
The Council should demand immediate measures to guarantee
that the requirements of Directive 2001/18/EC be strictly respected by all
GMO sectoral legislation, including Regulation 1829/2003.
Greenpeace urges you to demand that no GMO authorisation be given until the
legislation is properly implemented, in a transparent and democratic way.