eunbil · GT0N1419 · 2006-06-21 00:00:00 — THE EUROPEAN UNION , 1 2006 From : Presidency To : Delegations Subject : Genetically modified organisms - Summary of activities since the meeting in 1. Authorisation procedure and risk assessment for GMOs On Commission decided in the light of recent experience with the placing on the market of GMOs to propose practical changes to the operation of the system in order to improve the scientific consistency and transparency of decisions on GMOs and to bring about a consensus among all parties involved. The improvements are to be made within the existing legal framework - in compliance with EU and WTO law - and should avoid undue delays in the authorisation procedures. The details of the proposed changes and in particular the key actions are set out in the Commissions information note for the Council. The EFSA reacted to the Commission"s proposals by calling a GMO forum on 15 with the members of the EFSA"s GMO panel and experts from the Member States, at which it reported comprehensively on the legal and technical bases for its risk-assessment procedure for GMOs and GMO-derived food and feed products. An initial technical discussion covered procedural matters and the improvement of transparency in Member States" cooperation, uncertainty in connection with the precautionary principle, toxicological and allergological safety assessment issues, improved design of field trials for comparative analyses and the assessment of stacked genes. The possibility of improving the assessment of indirect and long-term effects on the environment, taking account of regional ecological characteristics, was also discussed. As a first result, the EFSA promised to improve the transparency of its decisions. In particular, however, it said that improvements in the assessment of ecological effects and the design of field trials were also necessary. To this end the EFSA promised to set up the necessary working groups and organise further discussions. Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from GMOs On 15 the Commission submitted its first report on the implementation of this Regulation to the Council (see 9293/06). The report was based on a questionnaire submitted to the relevant interest groups and government bodies in /2006. The Commission points out that the Regulation has been in force for a short time only and, given the small number of genetically modified products currently on the market in the Union, it can be regarded as only a provisional report. The Commission therefore intends to produce a further, more comprehensive report after 24 months. Up to now the Regulation has been satisfactorily implemented on the whole. Certain problems have nevertheless arisen, particularly regarding the procedures applied for sampling and quantitative analysis, where some Member States would like a more harmonised system to be used. On 22 2006 the adopted conclusions on the coexistence of organic and GMO-free farming methods with GMO cultivation methods. The long-term goal is to ensure freedom of choice between these farming methods. The conference on the subject of coexistence organised by the Commission and the Austrian Presidency from 4 to provided a technical basis for these conclusions. on the role of precaution in GMO policy on 18 and in On 18 and , in , more than 140 international experts discussed for the first time the importance of the precautionary principle in the assessment of genetically modified organisms. The conference was set up by the Federal , Forestry, Environment and and the Federal . was responsible for organising the . The conference offered participants the opportunity to discuss topical and controversial aspects of the legal, scientific and practical regulation of GMOs in the EU. The various international interpretations of the precautionary principle in the risk assessment of GMOs (e.g. in the context of the ongoing dispute at WTO level) were a major theme. From the Presidencys point of view, the conference revealed the need for action in the following areas: A broad consensus exists on recognition of the precautionary principle as an important principle in legislative framework for GMOs. It is seen as a useful means of achieving the required protection goals, even if there is still scientific uncertainty about the actual long-term effects of GMOs. In terms of its concrete application, however, further national and EU-wide discussion is needed if a better common understanding of how the precautionary principle should be implemented is to be achieved. The concrete application of the precautionary principle has an important role to play in relation to unresolved scientific questions concerning the risk assessment of GMOs. In the face of the criticism levelled at the EFSA and the EFSA"s GMO panel, for instance, an improved, harmonised and generally comprehensible risk-assessment procedure should form the basis for a reliable system of GMO regulation both nationally and across the EU. The standard should be an unambiguous scientific data base, compiled using appropriate, robust methods, and not argument based on assumptions. It was also emphasised that the precautionary principle can serve as an engine of scientific innovation. This relates to the scientific bases for risk assessment, but goes beyond that framework. With regard particularly to the desired broader application of the precautionary principle, this relates to the wide-ranging context in which decisions on the application of GMOs are taken. Here, the role of the social and economic sciences is as important as that of the natural sciences. There was a general demand for transparent implementation involving the stakeholders concerned, in order to ensure that decisions on GMOs were transparent, acceptable and proportionate. Along with the risk-assessment mechanism itself the communication of that process must also be improved so that the required principle of appropriate public participation can be satisfied. Here, progress must be achieved through dialogue between Commission, Food Safety Authority and the EU Member States. In preparing for an exchange of views, delegations are invited to comment on the following items: 1) How do the Member States view current developments since the meeting on 9 2006, in particular the key actions proposed by the Commission; what further steps, if any, do they believe should be taken? 2) How do the Member States and the Commission see the role of the precautionary principle in the authorisation and risk assessment of GMOs and GMO products? 9966/06 MS/sla DG B II EN