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Published on December 29, 2007

Author: Melinda

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GMOs and co-existence in agricultural production:  - Legal framework A. Gumbert, Taiex Seminar Vienna, 22 February 2005 GMOs and co-existence in agricultural production The regulatory framework for GMOs in the EU:  The regulatory framework for GMOs in the EU GMO Deliberate Release Directive (Directive 2001/18/EC) GM Food and Feed Regulation (Regulation (EC) No. 1829/2003) Traceability and labelling of GMOs and GM Food and Feed (Regulation (EC) No. 1830/2003) Elements of Directive 2001/18/EC:  Elements of Directive 2001/18/EC Environmental and health risk assessment Mandatory post-marketing monitoring, including long-term effects associated with the interaction with other GMOs and the environment Labelling and traceability Approval for the release of GMOs limited to 10 years Consultation of EFSA (European Food Safety Authority) obligatory EU Member States decide on Commission proposal by qualified majority (standard Regulatory Committee procedure) New Regulations to apply since April 2004 :  New Regulations to apply since April 2004 Regulation on GM food and feed (Reg. 1829/2003) Regulation on traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs (Reg. 1830/2003) Set up a harmonised EU system to trace GMOs. Traceability means to trace products containing or produced from GMOs through the production and distribution chains. Labelling: Introduce the labelling of GM feed, reinforce the current labelling rules on GM food (all GM food or feed, irrespective of the detectability of GM DNA or protein) No labelling: Products that are not food ingredients such as processing aids; products such as meat, milk or eggs obtained from animals fed with GM feed or treated with GM medicinal products Establish a streamlined authorisation procedure for GMOs in food and feed and their deliberate release into the environment. State of play on GMO authorisations under EU law :  State of play on GMO authorisations under EU law So far 18 GMOs have been approved under Directive 2001/18 or under Directive 90/220 for different uses, some for cultivation, some for import and processing, some as feed, some as food. In terms of crop species, these GMOs include maize, oilseed rape, soybean and chicory. 24 further GMOs are pending authorisation under Directive 2001/18, 11 of these for import and processing only, and the others including cultivation. Food products from 16 GMOs can legally be marketed in the EU. State of play on GMO authorisations under EU law :  State of play on GMO authorisations under EU law Cultivation: In order to be cultivated in a Member State / in the EU, a GM crop has to be: authorised for the purpose of cultivation under Directive 2001/18 (formerly Directive 90/220) or under Regulation 1829/2003; inscribed in a national / the Common catalogue of varieties. Three types of GM maize are authorised for commercial cultivation: T25 (Bayer CropScience); Bt-176 (Syngenta); MON 810 (Monsanto). 32 GM maize varieties derived from these events are inscribed in national catalogues of varieties (Spain, France, Netherlands). The Commission agreed to inscribe 17 GM maize varieties into the Common Catalogue of varieties. The concept of co-existence:  The concept of co-existence What do we mean by co-existence? Farmers should be able to choose between conventional, organic and GM crop production, in compliance with the relevant legislation on labelling rules and purity standards. Only authorised GM crops may be cultivated in the EU. Any risks to the environment or human health are dealt with in the authorisation procedure according to Directive 2001/18. Co-existence is concerned with the economic impact of the admixture of GM and non-GM crops. Consequently, suitable measures during cultivation, harvest, transport, storage, and processing may be necessary to ensure co-existence. Legal base for national co-existence measures:  Legal base for national co-existence measures GMO Release Directive 2001/18/EC: Free circulation (Art. 22) Without prejudice to Article 23*, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive. *safeguard clause in the case of danger to human health or the environment Measures to avoid the unintended presence of GMOs (Art. 26a) Member States may take appropriate measures to avoid the unintended presence of GMOs in other products. The preceding steps of the Commission Guidelines::  The preceding steps of the Commission Guidelines: Action Plan on Life Sciences and Biotechnology COM (2002) 27 “The Commission has committed itself to clarify the need, and the possible options, for agronomic and other measures to ensure the viability of conventional and organic farming and their sustainable co-existence with genetically modified crops”. Round Table on Co-existence (Brussels, 24 April 2003) Expert panels presented the latest scientific findings, which were then discussed with stakeholders. Contributed to the development of co-existence rules (http://europa.eu.int/comm/research/biosociety/index) Main principles of Guidelines on co-existence :  Main principles of Guidelines on co-existence Recommendation on guidelines for the development of national strategies and best practices to ensure the co-existence of GM crops with conventional and organic farming. The national measures that shall ensure co-existence, and not to exclude any type of production, should be: 1. Proportionate, efficient and cost-effective, without going beyond what is necessary to comply with the EU labelling / purity thresholds The general labelling threshold for adventitious and technically unavoidable presence of GMOs is defined at 0.9% (GM food and feed Regulation). 2. Crop-specific, as the risk of admixture varies greatly from one crop to another. 3. Priority should be given to farm-level management measures and to measures aimed at co-ordination between neighbouring farms. 4. Build on already existing segregation practices: e.g. seed production. Main principles of Guidelines on co-existence :  Main principles of Guidelines on co-existence 5. Operators who introduce the new production type should bear the responsibility of implementing the farm management measures necessary to limit admixture. 6. Liability in case of economic damage resulting from admixture: Liability rules are conditioned by the overall approach adopted by the Member States Member States should make use of the possibilities offered by their national liability laws. Member States should explore the feasibility and usefulness of adapting existing insurance schemes, or setting up new schemes. Examples of farm management practices:  Examples of farm management practices Organic farming:  Organic farming Organic farming Regulation (EC) No. 2092/91 establishes that no GMO or products derived from GMOs shall be used in organic production (exception: veterinary medicine). Seeds and feed labelled as containing GMOs are excluded from use in organic farming. The organic farming Regulation does allow for the setting of a specific de minimis threshold for unavoidable presence of GMOs in organic input materials, but no threshold has so far been set. In the absence of such specific thresholds, the general GMO labelling thresholds apply for organic input materials. Organic food as final product: No specific purity requirements regarding the adventitious presence of GMOs. The general labelling rules (0.9% threshold) apply. European Action Plan for Organic Food and Farming :  European Action Plan for Organic Food and Farming Action 12: Including provisions in Council Regulation (EEC) No 2092/91 clarifying that products that are labelled as containing GMOs, can not be labelled as organic; that the general labelling thresholds equal the thresholds for the adventitious presence of GMOs for products (other than seed) used in organic farming. The question of deciding whether specific thresholds for seed used in organic farming need to be set and at what level is still under consideration by the Commission. GMO-free zones ?:  GMO-free zones ? Co-existence measures must be proportionate with respect to EU labelling / purity thresholds. They must comply with Community legislation (e.g. Art. 22 of Directive 2001/18) and the principle of the Common Market. Priority should be given to farm-level management measures and to measures aimed at co-ordination between neighbouring farms. If it can be demonstrated that these measures can not ensure co-existence, regional measures could be considered. Slide16:  GMO-free zones ? Regional measures should apply only to specific crops and should be justified for each crop separately. A blanket ban on the cultivation of GMOs in a country or region would be against the principles of co-existence. It would also violate the principle of proportionality. Voluntary arrangements between farmers to grow a particular crop type (e.g. non-GMOs) are always possible. Slide17:  National co-existence legislation National co-existence measures have the potential to act as a barrier to internal trade They have to be notified to the Commission under the provisions of Directive 98/34/EC on technical norms and standards Until now the Commission has received notifications on national/regional co-existence measures from: Germany, Denmark, Luxembourg, Austria (Carinthia, Salzburg, Tyrol, Vienna, Burgenland, Lower Austria) Current activities:  Current activities National co-existence legislation: The Commission will facilitate the exchange of information about co-existence at national and Community level (Co-existence network among the Member States) In 2005, the Commission will report to the Council and the European Parliament about the situation of co-existence based on information supplied by the Member States. On the basis of this report, the Commission will examine the necessity and feasibility of further Community action on co-existence. Research: A research project on GMO issues, including co-existence, is funded under FP6 (SIGMEA) Further research is being conducted by the Joint Research Centre (JRC)

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