Full text 
Verbatim report of proceedings
Monday, 9 July 2007 - Strasbourg OJ edition

17. MON 863 - Risk Management (debate)

  President. The next item is the Commission statement on MON 863 risk management.


  Markos Kyprianou, Member of the Commission. Mr President, the Commission has on many occasions declared – and, through its actions, proved – its commitment to ensuring that the legislative framework on genetically modified food and feed, which was approved by the European Parliament and the Council, is fully respected. We have the obligation – and I believe we are delivering on this obligation – to make sure that the legislation is properly and fully respected. Under the legislation, GM food and feed can be legally put on the market only if it is safe and appropriately labelled.

I would remind the House of how the legislation provides for the division of work between risk assessment and risk management. The Commission has no discretion on the safety assessment of a GM product. The legislation clearly distinguishes between risk assessment, which is carried out by EFSA, and risk management, which is carried out by the Commission. This approach is defined not only by general food law but also by the Regulation on GM food and feed.

Whenever new scientific questions emerge, the Commission adheres to the separation of competences and asks EFSA to evaluate the information and its impact on the risk assessment of a product. The Commission’s role is to take relevant risk management decisions, provided that, and only when, such a risk is identified by EFSA as the European Union’s body responsible for risk assessment. In other words, we manage a risk once it has been identified and assessed by the body responsible. It was a very specific decision, when the legislation was adopted, to give the risk assessment to a separate independent body. However, if there is no risk identified by the Authority, then there will be no sound scientific basis for the Commission to take a risk management decision.

On this specific issue, MON 863 had already been evaluated twice in 2004 before the authorisation was adopted. In both cases, EFSA concluded that MON 863 maize would not have an adverse effect, and this opinion was reached with the involvement of the national authorities of the Member States and was further reviewed and confirmed by the Authority in 2006 following a specific request to the Commission by the honourable Member Ms Breyer. There were intensive repeated analyses, which were carried out as part of the authorisation procedure, and then there was the publication by Professor Séralini in March this year – that is the sequence of events.

The work presented by Professor Séralini was not a new study but only a statistical review of the existing rat-feeding study, which supported the authorisation of this product in the European Union. Despite the fact that it was not a new study but only a statistical review, as soon as the Commission became aware of Professor Séralini’s paper, it immediately asked EFSA to analyse it to verify whether the newly proposed statistical interpretation was well founded and, more importantly, whether the statistical differences were relevant for food and feed safety.

In order to take into account all new elements and thus to eliminate any possible sources of uncertainty, EFSA conducted a new review asking Member States to provide any relevant analysis or comments, set up a specific task force of internal and external statistical experts and held a meeting with the author of the statistical review. In the Commission’s view, the procedures set up by EFSA to evaluate the review of Professor Séralini’s report represent a sufficient guarantee of independence and expertise. EFSA first responded to the Commission request in March by discussing the issue at the plenary meeting of the GMO Panel, before issuing a statistical report and a scientific statement by the Panel on 20 June.

In particular, the Authority underlines that the statistical analysis made by the authors of the paper did not take into account certain important statistical considerations and that the assumptions underlying the statistical methodology employed by the authors led to misleading results. The conclusion of the Authority is that the paper does not present a sound scientific justification to question the safety of MON 863 maize and, therefore, it sees no reason to revise its previous opinions that MON 863 maize would not have an adverse effect in the context of the proposed use. Parliament will be informed in more detail of the background I have outlined in the replies to the written questions on this subject by Ms Breyer, which are currently being finalised following the recent EFSA statement.

Against this background, two conclusions emerge. First, and most importantly, there is at this stage no scientific basis to question either the safety of MON 863 or its status as a legally commercialised product. Second, the conclusions of the EU official body for risk assessment, made up of some of the best specialists in Europe, have been drawn after consultation of the national competent authorities as well as external experts. By trusting the outcome of this work, which confirms the previous evaluations, the Commission has, I believe, acted as a responsible risk manger, especially within the context of the legislation and the apportionment of responsibilities as I explained them during my introduction. The Commission will continue to work along these lines on the basis of a precautious and science-based approach.

The Commission, I would emphasise, has full determination to make a case-by-case risk management decision taking into account any scientific questions emerging during the evaluation procedure or even after the authorisation. We will always be vigilant; we will always be ready to examine every new piece of scientific information that emerges. But, of course, our final decision will have to be based on the risk assessment, which will be done by the body in charge of this responsibility based on European legislation.

We believe that our legislation and the Commission’s approach offer the best way to provide our citizens with the high level of safety they expect and demand. I hope that I can count on the trust and support of the European Parliament as we continue our rigorous and impartial approach.


  Renate Sommer, on behalf of the PPE-DE Group. (DE) Mr President, Commissioner, ladies and gentlemen, was it not us, was it not the European Parliament that wanted to have an independent European Food Safety Authority? Was it not also the Council of Ministers that wanted to have an independent EFSA, an authority on whose findings you can rely, an authority where there is no risk of getting bogus studies? Did the European Parliament not at that time charge EFSA with making risks assessments of GMOs, and did the Council of Ministers not back that very thing in codecision?

In April 2004, EFSA assessed MON 863 maize to be just as safe as conventional maize. A second EFSA safety assessment in October 2004 came to the same conclusion. That is not of course what the green souls among us want to hear, and because what the Greens do not want simply cannot be, they commission their own study. Then this eventually finds, surprise, surprise, that genetically modified maize is lethal, and woe betide anyone who finds that suspect!

The EFSA experts then asked for a repeat of the trial on rats. Again there was no sign of acute toxicological effects. Incidentally, the Greens’ study would have given the same result if the statistics had been evaluated correctly, but the statistical evaluation was not scientifically correct, as the Commissioner said.

Once again, the Green study’s supposedly scientific findings were therefore deliberate scare-mongering, deliberately sowing anxiety in the minds of the public and pulling the wool over their eyes. It is the typical ideologically motivated policy of obstructiveness that they so much like to use in election campaigns as well. They are wasting taxpayers’ money by always calling for multiple repeats of the EFSA risk assessments. But will they also question the EFSA nutrient profiles under the Health Claims Regulation, for example? Of course not, because they fit in with their ideology.

The Council of Ministers is also at fault, however. The national ministers responsible lack the courage to agree to authorise GMOs that have been examined and found to be safe. It is the small man’s fear of not being re-elected, neither more nor less!

We are wasting such great opportunities for the EU: GMOs can give us better food and feed with nutrition-physiological added value and efficient renewable raw materials that are carbon-neutral and therefore have no effect on the climate. MON 863 is safe and must be approved just like the other useful plants that have been tested and found to be safe.


  Karin Scheele, on behalf of the PSE Group. – (DE) Mr President, in response to the previous speaker I would like to quote an Austrian proverb: ‘blessed are those who believe, but you will still get to heaven if you do not’. Perhaps now I can challenge Renate Sommer’s world view a little. It was not only Green Members, but the majority in this House who wanted a consumer– and environmentally friendly solution for the authorisation and labelling of genetically modified food and feed. Even a government close to you has questioned EFSA’s handling of the studies referred to today.

My question to the Commission is now: what concrete steps has the Commission taken to bring about a reform of the European Food Safety Authority? This is not the first time we in this House have expressed doubts about its independence. And yes, Mrs Sommer, we wanted and we want an independent Food Safety Authority. But democratically elected Members naturally also have the right to take a critical look at its independence and work to see that it is genuinely independent. That is very much our responsibility, because we of course also know the mood and attitude of the public towards it in all the Member States.

We agree, Mr Kyprianou, that EFSA should continue to be responsible for risk assessment and the Commission for risk management. I am however convinced that both EFSA and the Commission need to take their responsibilities seriously.

As you know, next week we in the Committee on the Environment, Public Health and Food Safety will be dealing with the question of how the individual authorisation of genetically modified organisms should be handled in the context of comitology and the regulatory procedure with scrutiny. Such cases do not help that discussion very much. I hope that in future concrete steps will be taken to demonstrate that the Food Safety Authority really is independent.


  Janusz Wojciechowski, on behalf of the UEN Group. – (PL) Mr President, I was instrumental in organising a conference that took place on 12 June at the European Parliament in Brussels. The conference dealt with dangers related to the spread of GMOs, and was attended by distinguished scientists from many countries.

Their presentations clearly indicated that there is increasing evidence of the harmful nature of GMOs. Alleging technological progress, large biotechnology enterprises are disseminating serious threats to civilisation the world over. With all due respect to Mrs Sommer, I am more inclined to believe scientists than Mrs Sommer's assurances on the safety of MON 863.

At present, only a little animal husbandry and agriculture in the EU involves the use of GMOs. We still have one last chance to protect Europe against this danger. I have some questions to pose to the Commissioner. Does the European Commission intend to do anything about this? Above all, does it intend to heed the wishes of citizens of entire regions of Europe, where the majority of the population wishes to protect itself against GMOs, or does the Commission intend instead to be seduced by the misleading publicity alleging technological progress?


  Hiltrud Breyer, on behalf of the Verts/ALE Group. – (DE) Mr President, ladies and gentlemen, Mr Kyprianou, I am most disappointed, because, like Mrs Scheele, I was expecting answers this evening about when we will finally have higher standards for risk assessment.

I have been asking the Commission specific questions about these safety issues for months and getting no answers; then officials tell me in private that they are not in a position to give those answers. The French scientists’ independent study is not the only one to come to the alarming conclusion that Monsanto 863 is unsafe and is an alarming threat to health and that it is irresponsible to leave it on the market any longer.

A study has also been made in Austria. There are alarming concerns in the Member States. We cannot just deny that and stick our heads in the sand. I would have liked to receive answers from you today about the fact that the European Medicines Agency also sees a risk with the two antibiotic resistance genes, not only in MON 863, but also in the Amflora potato, authorisation of which has now been applied for. Even your own EU institution is contradicting EFSA. We really must have answers from you on this, Mr Kyprianou! You cannot simply say that you are not going to answer. Even the Council has called on you to comment.

I find it curious that EFSA needed three months to evaluate the Séralini study. Incidentally, Mr Séralini will be here in Parliament on Wednesday and will then tell us clearly whether EFSA’s all-clear, its whitewashing, is really justified. We do know that the EFSA studies make repeated references to Monsanto. They contain statistical errors. That has been pointed out not only by the French research team but by many Member States as well.

We are looking to you for answers as to how these mistakes can be remedied in future, how we are to deal with them, what value, if any, should be put on the precautionary principle. We need a reassessment. I would like you to tell me, Mr Kyprianou, in no uncertain terms: will MON 863 be reassessed? All EFSA has done is to look at the old data again. It has not carried out a reassessment at all. That is a very crucial question, to which we need an answer!

(The President cut off the speaker)


  Kathy Sinnott, on behalf of the IND/DEM Group. – Mr President, scientists in France recently discovered extensive organ damage in the liver and kidney in animals raised on Monsanto 863. Three years before this, German studies were brought to the attention of EFSA by the German authorities that showed kidney damage in rats fed Monsanto 863. Yet, despite this, EFSA has reaffirmed their risk assessment on this and said that it is safe for European farm animals. Where are EFSA’s studies? Why are they just looking at the industry’s tests and just going back over them? How difficult can it be for them to try to redo the French and German studies?

The biotech industry in Europe alleges that GM farming is inevitable. My fear is that this will just be a self-fulfilling prophesy. Europe is capable of supplying its farmers with GM-free grain, but if we accept the inevitability, if we accept safety studies that are not really studies at all, then farmers will be forced into feeding their animals GM because otherwise there will be no other grain.

I would remind EFSA that many products, after years of so-called ‘safety’, have been taken off the market. To give you one example, the polio vaccine we use today is the fourth polio vaccine, because the other three, after having been given to people for many years, were finally withdrawn because of mounting evidence of damage.

We are supposed to respect the precautionary principle in Europe, especially when we are talking about putting genetically-modified organisms into the environment, considering that, with GM, any resulting adverse effects may be irreversible.


  Markos Kyprianou, Member of the Commission. Mr President, I know that the GMO authorisations are a sensitive issue but, first of all, we have to remind ourselves that, based on European legislation adopted by Parliament and the Council, GMO products are allowed in the European Union, provided they go through the authorisation procedure I have just described.

That authorisation procedure provides for the risk assessment to be done by EFSA. So, whether some of us agree or disagree with the concept of GMO products, we are all bound by the European legislation. This is the rule of law so we have to follow it.

First of all, on EFSA’s work, as you know, Parliament was informed and I came along myself as well. We have taken decisions on improving the work of EFSA to make it more thorough and to take more account of the views of the Member States and all scientific developments that may take place during the authorisation procedure. The Commission adopted an action plan which has been put in place already and is being implemented and which will also be included in the legislative framework sometime in 2008. It is part of the Annual Policy Strategy for 2008. There we take into account how we can improve the situation and make proposals based on the views of the Member States and on long-term effects and many other aspects.

I also have to insist that in the European Union we have the highest standards and the strictest legislation when it comes to GMO products. That is why you know we have continuously been taken to the WTO and are not doing so well there.

But nevertheless our legislation has been accepted by the WTO because it is science-based and the decisions are based on risk assessment so, in this way, we can fulfil our international obligations by taking into account primarily and foremost the safety of European consumers and European citizens. So it is not a question of personal preferences but an issue of applying the existing legislation.

I know Mrs Breyer referred to those questions. There is a procedure. We have to get information. You will be provided with all the details on these questions. But again the questions arising are linked to the risk and the risk is not being assessed by us. It is assessed by EFSA. Therefore, we have to wait for the decision of EFSA on this issue before we actually provide the replies.

On this specific product there were many evaluations and many studies. They all caused EFSA to re-evaluate and reassess its position and it came to the same conclusions. So it was not something taken lightly. It was not something that was ignored. Whenever there was new science and new evidence, this was taken into account and we asked EFSA, which again is the risk assessor of the European Union, to take them into account. It is true that EFSA’s latest opinion was based on the existing study but also Professor Séralini’s paper was on the same study. It was a question of how you analyse, how you do statistical analysis of the existing data and that is why we had a special task force on statistical analysis, internally and externally, and it came to the conclusion that there were flaws in the analysis and the conclusions of Professor Séralini. That does not always mean that he who is negative is always right. Sometimes people who are positive as well may be accurate and correct.

Finally, as to the issue of which studies the authorisation would be based on, the decision was that we would continue with the legislation that was originally adopted; that the applicant has the responsibility of providing the data and the studies information. In this way, they have the burden of proof which is assessed by the authorities. The authorities can ask for any further additional studies they would like and in this way they have the responsibility of proving their case. I will not go into the issue of the cost of eventually changing the system. The cost will eventually be a burden on the taxpayers of the European Union and not the industry. But the main reason is they should have the burden of proof and therefore the authority can analyse this data based on a critical analysis.

I would like to remind you that a similar situation is used in the EMEA, the medicine authority of the European Union, where again the industry provides all the clinical trials and clinical studies and the decision is taken.

So I can assure you that we take into account and we will make sure that the EFSA takes into account and assesses and evaluates any new scientific evidence that may arise and the moment a risk is identified we will not hesitate to take the appropriate measures. As you know, we have done that and I personally have done that in the past on many occasions with unauthorised products.


  President. The debate is closed.

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