REFORMING THE EUROPEAN FOOD SAFETY AUTHORITY

The European Food Safety Authority (EFSA) is being widely criticised for failing to comply with EU legal obligations to conduct transparent and adequate risk assessments on GM crops, animal feed and food. This page covers the unfolding saga. See also our video interview with former EFSA chair Patrick Wall.

Take action for a GMO-free Europe:

www.greenpeace.org/international/campaigns/genetic-engineering/take-action

Lobby the Irish Government:

www.greenpeace.org/international/campaigns/genetic-engineering/take-action/Helpchangetheundecided/

Related documents on this page:

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EFSA lies and incompetence: Letter from Dr. Brian John to Stavros Dimas, European Commissioner for the Environment, 28 November 2008.

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EFSA lies and incompetence: Letter from Dr. Brian John to the Rt Hon Hilary Benn MP, Secretary of State for the Environment, DEFRA, UK. 28 November 2008.

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Petition to the European Parliament: The importance of impartiality within EFSA & the food safety rights of EU citizens. Hosting MEP: Kathy Sinnott, MEP Ireland South.

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Stop GM crops! Save our Food! EU Environment ministers should reform authorisation of GM products. Greenpeace press release, 24 October 2008.

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Media briefing - GMO debate: Ad hoc working group 24 November and Environment Council 4 December 2008. Greenpeace media briefing, 24 November 2008.

As an independent risk assessor, EFSA should not base its assessments of GM foods and crops on "advocacy science" submitted by applicants, which is by definition partial, selective and biased. Yet it continues to do so, despite the fact that some such science may also be fraudulent, since the application dossiers from GM corporations and patent owners cannot be examined in full by members of the public and by independent scientists and thus cannot be subjected to a proper process of peer review. Thus when dossiers are assembled, companies can simply omit "inconvenient" findings; they can also "manufacture" favourable results by the aggregation of data with a view to masking effects, by the use of insensitive testing techniques, by statistical manipulation, and by careful experimental design. Such practices are fraudulent, and they place Europeans at risk since GM crops and foods cleared as "safe" on the basis of dossier evidence may in fact be dangerous.

Our concerns are now shown to have been absolutely justified. Recent research papers in the peer-reviewed and government-sponsored literature show that maize NK603xMON810, maize MON810, and Monsanto Roundup-ready soy cause actual harm (directly attributable to the GM "events" concerned) to animals which consume these materials in feeding trials (1)-(5). These harmful effects have occurred in spite of the fact that EFSA has examined all of these GM varieties on more than one occasion, and has declared them to be safe in all respects.

EFSA has also reaffirmed its confidence in the safety on MON863 and NK603, in spite of the recognition of statistically significant physiological changes in animals fed on those varieties, and in spite of the attempts by the owners of these varieties to "mask" these effects in their application dossiers (6)(7). This means that EFSA is incompetent or corrupt, and that it is not effectively protecting the European consumer.

We should also like to draw your attention to the heavy criticism attracted by EFSA, following its refusal to cite, let alone take account of, two papers showing that transgenic sequences have been detected in animal tissues (8) (9) (10). Mazza et al. (2005) detected fragements of the cry1A(b) genes in the blood, liver, spleen, kidney and muscle of pigs fed with GM maize. Sharma et al (2006) detected transgene fragments in the large intestine tissue of sheep and in the cecal tissues of pigs. On 19 July 2007, EFSA lied to the Commission when it stated that : ...."a large number of experimental studies with livestock have shown that recombinant DNA fragments or proteins derived from GM plants have not been detected in tissues, fluids or edible products of farm animals" and "to date no recombinant DNA sequences have been found in any organ or tissue sample from animals fed GM plants". These words have been very carefully crafted, and were designed to mislead the Commission. That constitutes serious professional misconduct (11).

We therefore call for the disbanding of EFSA's GMO Panel and the fundamental reform of EFSA itself. Since it is obvious that harmful materials have already passed through the EFSA assessment procedure, leading to unreliable and dangerous advice to the Commission, it follows that there must now be a freeze on all future GM approvals and a reassessment of all of the past science relating to approved GM varieties.

The health of the European consumer must be protected at all costs.

Many thanks for your help on these matters. We will appreciate confirmation of receipt of this letter and confirmation that you are personally aware of its contents.

Yours sincerely

Dr Brian John
GM Free Cymru

(1) Velimirov A, Binter C and Zentek J. (2008) Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice. Report, Forschungsberichte der Sektion IV, Band 3. Institut f¸r Ern”hrung, and Forschungsinttitut f¸r biologischen Landbau, Vienna, Austria, November 2008.

(2) Finamore A, Roselli M, Britti S, Monastra G, Ambra R, Turrini A and Mengheri E. (2008). Intestinal and peripheral immune response to MON810 maize ingestion in weaning and old mice. J Agric Food Chem, http://pubs.ac.org, 16 November 2008

(3) Kilic, A. and M. T. Akay (2008). A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation. Food Chem. Toxicol. 46(3): 1164-1170.

(4) Manuela Malatesta, Federica Boraldi, Giulia Annovi, Beatrice Baldelli, Serafina Battistelli, Marco Biggiogera, Daniela Quaglino. (2008) A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Histochem Cell Biol. 2008 Jul 22; : 18648843 (P,S,G,E,B,D)

(5) M Malatesta, F Perdoni, G Santin, S Battistelli, S Muller, M Biggiogera (2008) Hepatoma tissue culture (HTC) cells as a model for investigating the effects of low concentrations of herbicide on cell structure and function. Toxicol In Vitro. 2008 Sep 18; : 18835430 (P,S,G,E,B,D)

(6) Séralini, G-E, Cellier, D. & Spiroux de Vendomois, J. 2007. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Archives of Environmental Contamination and Toxicology DOI: 10.1007/s00244-006-0149-5.

(7) http://www.gmfreecymru.org/pivotal_papers/monsanto2.htm

(8) http://www.gmfreecymru.org/pivotal_papers/efsa_misleads.htm

(9) Sharma R, Damgaard D, Alexander TW, Dugan ME, Aalhus JL, Stanford K, McAllister TA.2006 Detection of transgenic and endogenous plant DNA in digesta and tissues of sheep and pigs fed Roundup Ready canola meal.J Agric Food Chem. 2006 Mar 8;54(5):1699-709.

(10) Mazza R, Soave M, Morlacchini M, Piva G, Marocco A.(2005) Assessing the transfer of genetically modified DNA from feed to animal tissues. Transgenic Res. 2005 Oct;14(5):775-84.

(11) EFSA 2007a: Letter to Robert Madelin regarding the EFSA statement on the fate of recombinant DNA or proteins in the meat, milk or eggs of animals fed with GM feed. http://efsa.europa.eu/EFSA/ Non_Scientific_Document/

Petition to the European Parliament

Name: Brian John
Postal Address: Trefelin, Cilgwyn, Newport, Pembrokeshire SA42 0QN, Wales, UK
Nationality: Welsh
Hosting MEP: Kathy Sinnott, MEP Ireland South
Title of Petition: The importance of impartiality within EFSA & the food safety rights of EU citizens

Text of Petition (No. 0813/2008):

The European Food and Safety Agency (EFSA) was designed to improve food safety in the EU, to restore the faith of EU citizens in EU food and guarantee consumer protection. As such, EFSA claims to provide "independent scientific advice [which] underpins the European food safety system"[1]. As citizens who should be served by this remit of EFSA we petition the European Parliament today because we see that the modus operandi of EFSA means it cannot be neutral or independent and thus violates the rights of all EU consumers to clean, safe and healthy food.

It is our assertion that EFSA does not operate according to EU law, namely Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. In addition principles of European Consumer Law are being disregarded, and priorities laid down in the Sixth Framework Programme (2000-2006): food quality and safety (2002/835/EC).

As an independent risk assessor, EFSA should not base its assessments of GM foods and crops on "advocacy science" submitted by applicants, which is by definition partial, selective and biased. Yet it continues to do so, despite the fact that some such science may also be fraudulent, since the application dossiers from GM corporations and patent owners cannot be examined in full by members of the public and by independent scientists and thus cannot be subjected to a proper process of peer review. Thus when dossiers are assembled, companies can simply omit "inconvenient" findings; they can also "manufacture" favourable results by the aggregation of data with a view to masking effects, by the use of insensitive testing techniques, by statistical manipulation, and by careful experimental design. Such practices are fraudulent, and they place Europeans at risk since GM crops and foods cleared as "safe" on the basis of dossier evidence may in fact be dangerous.

Furthermore, and more importantly, the science which is assessed by EFSA is for the most part non-replicable science which should never be admitted as valid, let alone considered in detail and acted upon. It is a fundamental principle of science that all experiments must be replicable if scientific fraud is to be avoided -- and yet EFSA never asks for replicability. (It has occasionally asked for supplementary evidence, but never for full independent replication of experiments.) Those who apply for approvals for GM crops and foods systematically block research by refusing to supply GM seeds, reference materials and chow for animal feeding experiments by independent scientists or institutions; this means that the dossier experiments cannot be replicated or improved, and that results cannot be verified or questioned. In Hungary, for example, Monsanto refused to supply MON810 seed to Professor Darvas and colleagues as soon as their research started to throw up negative environmental effects.

Another example is in France, where Monsanto refused to supply MON863 materials for experiments designed to replicate or test the results reported in the MON863 dossier. Both examples clearly violate the terms under which EFSA operates namely Article 38 (concerning Transparency) of Regulation 178/2002 Section 4.

These concerns lead us to ask that the Parliament instruct EFSA to enforce the highest standards of scientific ethics in its own GMO Panel and in the dossiers of GM applicants, thereby safeguarding the health of citizens as per its original remit. We ask that EFSA be instructed to insist on full and early release of all scientific data contained in dossiers, and to insist on signed declarations from applicants relating to replicability, so as to enable a full and independent verification (or falsification) of apparent findings.

As EU citizens with rights we are being discriminated against by EFSA who, rather than protecting us, are supporting the commercial ambitions of the GM companies and "enabling" their approvals. We wish to emphasize the fact that there are no benefits to consumers in terms of taste, quality, shelf-life, price, and nutritional value of GM crops and foods -- the only benefits are to farmers wishing to reduce labour costs and spend less by using chemicals, and to the companies that own the seed and sell the herbicides / pesticides. It is valid for certain EU institutions, such as those involved in trade and agriculture, to support these corporate ambitions but EFSA should represent citizens and not business interests. EFSA exists to provide a service to EU citizens and the European institutions, and it must therefore treat consumers as its number one priority. It is our view that the current modus operandi of EFSA fails to do this, implying that EFSA has breached its responsibility to European consumers and to Regulation 178/2002 Section 4: Article 37-40 on Independence, Transparency, Confidentiality and Communication.

Kathy Sinnott MEP will be the hosting MEP for this petition.

[1] http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_home.htm

Stop GM crops, save our food!
EU environment ministers should reform authorisation of GM products

Greenpeace press release, 24 October 2008.

Brussels -- In an a-maize-ing feat at the heart of the EU quarter in Brussels this morning, Greenpeace activists climbed a building on Schuman square to display a giant banner of a 'scary' genetically modified (GM) corn plant bearing the slogan Stop GMOs'. The action coincides with the last in a string of meetings of national experts who are looking into reforming the EU's authorisation process for GM products and precedes a meeting of European environment ministers who will assess their findings next week.

Greenpeace activists warned decision-makers about the health and environmental risks linked to genetically modified organisms (GMOs) by symbolically contaminating the Schuman area with dozens of 'scary' maize plants.

"EU decision-makers are ignoring the serious and unpredictable risks to human health and the environment posed by GM crops. Greenpeace urges environment ministers to reform the EU's flawed GMO authorisation system and calls on Barroso and the Commission to stop blocking this process," said Marco Contiero, Greenpeace EU GMO policy director.

A recent study carried out under the auspices of the Austrian government has highlighted some of the serious health threats posed by GMOs. The fertility of mice fed with an authorised Monsanto GM maize variety (NK603xMON810) was severely impaired compared to that of mice fed on non-GM crops.[1] This crop was authorised based on a positive assessment by the European Food Safety Authority (EFSA).

"The current risk assessment process contravenes EU law as it's unable to assess long-term impacts of GM crops on the environment, biodiversity and human and animal health," said Contiero. "EFSA and the Commission continue to rubber-stamp anything the agro-biotech industry puts under their nose. This situation is a downright scandal and EU environment ministers must put an end to it."

Greenpeace calls on EU environment ministers meeting on 4 December to:

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Strengthen the GMO risk assessment process and reform EFSA

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Suspend all GM crop authorisations until the EU risk assessment system is thoroughly improved and EFSA is equipped to assess the long-term environmental impact of GMOs and their detrimental socio-economic effects

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Prevent GMO contamination of seeds

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Protect the right of member states to establish GM-free areas

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Recall from the European market the GM maize varieties at the centre of the Austrian study

Contacts:

Marco Contiero - Greenpeace EU GMO policy director: +32 (0)2 274 1906, +32 (0)477 777 034 (mobile), marco.contiero@greenpeace.org

Mark Breddy - Greenpeace EU communications manager: +32 (0)2 274 1903, +32 (0)496 156 229 (mobile), mark.breddy@greenpeace.org

Photos - Greenpeace International picture desk: + 44 (0)207 865 8230, picture.desk.int@greenpeace.org

Notes to editors:

[1] You can see the Austrian study on http://www.bmgfj.gv.at/cms/site/attachments/3/2/9/CH0810/CMS1226492832306/forschungsbericht_3- 2008_letztfassung.pdf

Media briefing - GMO debate

Ad hoc working group 24 November and
Environment Council 4 December 2008

Greenpeace media briefing, 24 November 2008.

On 4 December 2008, EU environment ministers have to agree on measures to reform the EU's authorisation system for genetically modified organisms (GMOs).

The last preparatory meeting before the Council, where national experts have to finalise their recommendations is 24 November, 2008.

Reform of the GMO authorisation process has been at the heart of the French Presidency of the EU. Representatives from 27 member states have already met six times in the 'ad hoc working group on GMOs' to debate and prepare the final Council conclusions. Environment ministers will meet on 4 December to discuss and agree on these conclusions, which need to be accepted unanimously to go through.

Environment Ministers already held a GMO orientation debate during the October Council meeting in Luxembourg.

Discussions over the last few months have focused on:

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boosting the environmental assessment;

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taking into account socio-economic criteria;

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improving the way in which scientific evaluation works;

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establishing labelling threshold for seed contamination;

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taking into account certain sensitive and/or protected areas.

Why is this debate important?

GMOs pose an unacceptable risk to our food, to human health and the environment. GMOs pose a major threat to food security as a result of their adverse effects on biodiversity, contamination of conventional crops, agro-companies control of the global seeds market, and heavy handed tactics around GMO patenting rights (see the Greenpeace briefings: 'Food security and climate change' [1] and 'Who will feed the world?' [2] ).

There is growing scientific evidence of the negative health and environmental impacts of GMOs. A recent scientific study [3] commissioned by the Austrian Ministries for Agriculture and Health found mice fed on a GM maize type approved by the EU (NK603 x MON810, owned by Monsanto), suffered reduced fertility. Mice fed on the GM maize produced fewer offspring than those fed on non-GM maize. The research is one of few long-term studies into the effects of GM.

Several other recently published peer-reviewed studies point to numerous unexpected effects of GM cultivation (see the Greenpeace briefings: 'GM crops: too many risks to ignore' [4] and 'Environmental and health impacts of GMOs: the evidence' [5]).

In particular, the Austrian study exposes once again the fundamental flaws in the EU's risk assessment process. The authorisation system contravenes EU law which requires all available socioeconomic and scientific evidence to be considered.

Currently, only the opinions of the European Food Safety Authority (EFSA) are considered. As the Austrian study highlights, EFSA is incapable of assessing the potential impacts of GMOs and therefore does not fulfil its legal and scientific requirements. EFSA's conclusions are based exclusively on data submitted by the companies applying for licences, and have all been positive to date. Long-term effects of GMOs, effects on non-target organisms, detrimental impacts on biodiversity, diverging scientific opinions and concerns raised by member states' competent authorities, are just some of the crucial evidence EFSA fails to consider.

Changes in agricultural practices, loss of traditional farming knowledge and the implications of contamination are just some of the "legitimate factors" that must be considered during the authorisation of GMOs. Yet, so far the European Commission has ignored these, rubber stamping all of EFSA's recommendations without question. This means the Commission is also breaching EU law.

EFSA itself has acknowledged its shortcomings by agreeing to a two-year mandate to develop its expertise on the assessment of long-term environmental effects of GMOs (see the Greenpeace briefings: 'EU GMO risk assessment needs reforming' [6] and 'Flaws in the EU authorisation process for GMOs' [7]).

What is the likely outcome of the meetings?

The EU can play a leading role in addressing the real solutions needed to guarantee safe and secure food and agriculture in the EU, and across the world.

EU member states are highly divided over GMO issues. Some countries, such as Austria, Hungary, Greece, Luxembourg, France, Italy and Cyprus, often highlight scientific concerns, the social and economic impacts of GMOs on agriculture and the inadequacy of the EU authorisation system. Others, such as the UK, Sweden and the Netherlands, strongly support the introduction of GMOs and defend business interests that clearly have no regard for science, the EU regulatory system or public opposition to GMOs.

The latter group of countries has found a strong ally in José Manuel Barroso, President of the European Commission. In June Mr. Barroso set up a high level political group (the 'Sherpa group') asking the 27 EU Heads of States and Governments to nominate a person responsible for debating broader political issues concerning GMOs. The aims of such an 'informal' initiative are not only to bypass the Commissioners responsible for GMOs (Health Commissioner, Ms. Vassiliou and Environment Commissioner, Mr. Dimas) and steer the debate towards Barrosso's pro-GMO position, but also to directly influence the ongoing French Presidency debate with environment ministers.

Instead of holding open and democratic meetings, the 'Sherpa group' meets behind closed doors and its decisions are not made public. The only written output from the Sherpa meetings reflects the biased conclusions of the Chair (Barroso's head of cabinet) and was not agreed by all participants. It calls on Sherpa members to intervene in the French Presidency negotiations.

On 10 October the Chair invites the participants "to report the discussions of the group to their heads of government and stressed the importance of drawing their attention on ongoing discussions in the Council ... in order to have a richer debate."

This pressure created by the Sherpa group heightens the risk that in December's meeting, ministers will only agree minor 'cosmetic' changes to the current authorisation system. A protracted stalemate on GMOs will show that ministers are unwilling to address food safety and security.

Greenpeace demands

EU decision-makers are ignoring the serious and unpredictable health and environmental risks posed by GMOs. Greenpeace calls on ministers to agree on a meaningful set of measures to reform the EU's flawed GMO authorisation system, and calls on Barroso and the European Commission to stop blocking this urgently needed process.

Greenpeace urges ministers to:

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Suspend the authorisation system until fundamental reform is agreed;

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Enact the safeguard clause and recall Monsanto's GM maize NK603 x MON810 - as well as their mother lines MON810 and NK603 - from the European market;

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Strengthen the GMO risk assessment process ensuring that long term environmental and health impacts are considered, as required under EU law, and put on hold EFSA's assessments until this is the case;

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Reform EFSA, giving it the necessary scientific expertise to carry out complex environmental and health risk assessments (involving environmental scientists and ecologists);

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Ensure that the environmental and health effects caused by an increased use in herbicides in conjunction with GM crops are fully assessed, as required by EU law;

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Guarantee that conventional and organic seed varieties are kept free of any GMO contamination;

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Ensure that the negative socio-economic impacts of GM crops are taken into account during the authorisation process;

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Give member states and local authorities the right to establish GMO-free areas.

All briefings mentioned above are available on http://www.greenpeace.eu

Notes:

1. 'Food security and climate change'
http://www.greenpeace.org/raw/content/international/press/reports/food-security-and-climate-change.pdf

2. 'Who will feed the world?'
http://www.greenpeace.org/raw/content/eu-unit/press-centre/policy-papers-briefings/who-will-feed-the-world.pdf

3. The recent scientific study commissioned by the Austrian Ministries for Agriculture and Health:
'Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice'
http://www.bmgfj.gv.at/cms/site/attachments/3/2/9/CH0810/CMS1226492832306/forschungsbericht_3-2008_letztfassung.pdf

4. 'GM crops: too many risks to ignore'
http://www.greenpeace.org/raw/content/eu-unit/press-centre/policy-papers-briefings/GM-crops-too-many-risks-to-ignore.pdf

5. 'Environmental and health impacts of GMOs: the evidence'
http://www.greenpeace.org/raw/content/eu-unit/press-centre/policy-papers-briefings/environmental-and-health-impac.pdf

6. 'EU GMO risk assessment needs reforming'
http://www.greenpeace.org/raw/content/eu-unit/press-centre/policy-papers-briefings/Reform-of-EU-GMO-risk-assessment.pdf

7. 'Flaws in the EU authorisation process for GMOs'
http://www.greenpeace.org/raw/content/eu-unit/press-centre/policy-papers-briefings/flaws-in-the-EU-authorisation.pdf

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