Brussels, 10/02/2012 (Agence Europe) - While the proposal for new guidelines for assessment of the health risks entailed by the use of GMOs is being discussed by EU27 experts, MEPs are sounding the alarm bell saying that the text on the table is not well aimed as it does not allow scientific assessment to be improved.
The draft regulation put to the scrutiny of the Standing Committee on the Food Chain and Animal Health (SCFCAH) defines the data that companies must provide when requesting authorisation for genetically modified food and feed, and the way in which the European Food Safety Authority (EFSA) is to assess such data.
“Although we welcome the fact that, for the first time, legally binding requirements for the data that companies will have to submit with their application will be adopted by the Commission and member states (…) we consider that the changes proposed, as they stand, will not allow the assessment to meet the legal requirements (…). The comparative risk assessment is based on the controversial aspect of substantial equivalence. This concept is based on the assumption that there is no difference between a GMO and its conventional counterpart, except for the introduced trait. It therefore renders impossible the identification of unintended changes in the plant. Moreover, it allows an applicant to introduce unspecified historical data in the process of comparison between the GMO and its conventional counterpart, so as to take into account unspecified natural variations, which will result in minimising or hiding significant differences between the two organisms (…) and therefore exempt GMOs from the normal assessment procedure”, said Corinne Lepage (ALDE, France). She added that they consider, on the contrary, that such differences should trigger a more detailed assessment. Secondly, food studies proposed are not sufficiently long and do not have the necessary statistical power to reach a sound conclusion on the harmlessness of GMOs, and other points also need to be improved. She had organised two debates in Parliament with EFSA on ways to improve the guidelines and keeps in regular contact with independent scientists on this issue.
On 9 January 2012, 15 MEPs from different political groups had sent a letter to the European Commission and to the Danish Presidency of the EU Council as well as to SCFCAH experts to express their concerns and to set out their suggestions for improvement. The guidelines are to be adopted by comitology procedure.
Guidelines are supposed to answer the request for improved risk assessment set out by the Environment Council in December 2008. A first series of guidelines was earlier sketched out by EFSA for environmental assessment and is to be adopted by the end of the year. The second series in question here is the subject of a draft regulation as the Commission is suggesting that the guidelines on data for health risk assessment should be binding. (AN/transl.jl)