Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-07-09-Speech-1-122"
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"en.20070709.17.1-122"2
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"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.
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.
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."@en1
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