Local view for "http://purl.org/linkedpolitics/eu/plenary/2007-07-09-Speech-1-116"
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"en.20070709.17.1-116"2
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"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.
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.
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."@en1
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