In terms of consumption the EU highly depends on GM crop production. In 2013 the EU imported around 27.9 million tons of soybean and soybean meal to cover about 60% of the demand for protein. This amount is equal to 60 kg per EU citizen. About 90% of the imported soybeans, which are mainly produced in North and South America, are GM (TILLIE and CEREZO, 2015).
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The first GM crop actually cultivated in the EU (France and Spain) was the IR maize variety MON810 from Monsanto in 1998. Other European countries such as Germany, Portugal, Czech Republic, Slovakia, Romania, and Poland followed. Currently, only two GM events–MON810 in maize and Moonshadow 2 for carnation are approved for cultivation in the EU (GMO-COMPASS.ORG, 2015).
Moonshadow 2 carnations are only cultivated in the Netherlands and IR MON810 maize only in Spain, Portugal, the Czech Republic, Slovakia, and Romania (GMO-COMPASS.ORG, 2015). Compared to the entire maize cultivation area in Europe, GM maize accounts for only about 1.5% (DESTATIS, 2015). In the past, European cultivation authorizations also existed for the GM potato Amflora, two GM rapeseeds (MS1 x RF1 and MS1 x RF2) and another GM maize (BT176). However, those authorizations have not been renewed. Nonetheless, 63 additional events for cotton, maize, rapeseed, rice, soybean, sugar beet, and carnation have valid authorization for food and feed and/or import and processing (GMO-COMPASS.ORG, 2015)
After the market introduction of MON8010 maize in 1998, the member states Denmark, France, Greece, Italy, and Luxembourg declared in June 1999 that they will take steps to suspend any new authorizations for growing and placing GMOs until the European Commission “put in place a tighter, more transparent framework, in particular for risk assessment, having regard to the specifics of European ecosystems, monitoring and labelling”(EU ENVIRONMENTAL COUNCIL, 1999). Similarly, the member states Austria, Belgium, Finland, Germany, the Netherlands, Spain, and Sweden declared, due to increasing public concern, the need for a “more transparent and strict framework concerning critical issues such as risk assessment taking into account the specificity of European ecosystems, monitoring and labelling as well as the need to restore the trust of public opinion and of the market”
(EUENVIRONMENTAL COUNCIL, 1999). Further, they referred to a “precautionary approach in dealing with notifications and authorizations for the placing on the market of GMOs” and assigned “not to authorize the placing on the market of any GMOs until it is demonstrated that there is no adverse effect on the environment and human health” (EUENVIRONMENTAL COUNCIL, 1999). As a result, the EU realigned the GMO approval framework. The EU Directive 2001/18/EC was published to make the procedure for cultivation and market placing of GMOs more efficient and more transparent. The legislation act declares that the Commission is obliged to consult scientific committees for health and environmental risks and may even for ethical concerns (EUROPEAN UNION, 2010).
In 2003 the regulation 1830/2003/EC specified the directive 2001/18/EC concerning traceability and labelling of food and feed products from GMOs. It introduces a threshold level of 0.9 % for approved GMOs until a product does not require labeling. A ‘GM-free’ claim can only be used on a product containing less than 0.1 per cent authorized GM content. For non-authorized GMOs there is a
zero-Background on GM crops
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tolerance level (EUROPEAN COMMISSION, 2013). Practical experience and problems of a zero tolerance level for seeds are discussed in the Empirical Study 1.
3.2.1 Approval process
Concerns about the environmental and human health risks of GM crops together with pressure from lobby groups led to a complex European regulatory framework. Thereby, the EU follows a strong interpretation of their precautionary principle. In the EU, GM products are, due to their breeding origin, seen as not substantially equivalent to conventional products. Thus, they are treated in a separate deregulation process. This is different to, for example, the U.S.. As soon a GMO passes the test by the USDA or Food and Drug Administration (FDA), it is treated as a conventional organism (HAAS et al., 2009).
The EU directive 2001/18/EC regulates the deliberate release of GM crops into the environment and establishes procedures to assess the environmental risk and general traceability and labeling principles. Based on the legal framework, a GM crop can be approved for cultivation and/or for usage as food and feed. The approval process starts with an application to an EU member state for the concerning GM crop filed by the applicant, usually a seed company. After confirming that all required documents are present the European Food Safety Authority (EFSA) conducts a risk assessment based on studies, conducted and compiled by the applicant, within six months. EFSA submits its opinion to the European Commission (EC) and to the member states and publishes it for the public. After that the Directorate General for Health and Food Safety (DG SANTE)5 of the EC drafts an approval decision, based on the EFSA’s risk assessment report, to the Standing Committee on the Food Chain and Animal Health. If the EC’s draft for a decision is different from EFSA’s opinion, written justification is required. The Standing Committee decides on the EC’s draft with qualified majority. At this stage the GM crop can be approved or not. If the Standing Committee fails to decide, the EC must take its position to the European Council of Ministers (ECM) and inform the European Parliament. Now the ECM decides with a qualified majority vote and the GM crop is approved if the decision is in favor of the EC’s draft. The authorization has a maximum duration of ten years and can be renewed. If the ECM rejects or fails to approve the EC’s draft with qualified majority, the EC must revise the draft. After approval of a GM crop, Member States can adopt the emergency measure
‘OPT-OUT’ based on new identified risk on health and environmental grounds or for environmental and agricultural political reasons, such as territorial planning and coexistence difficulties (EUROPEAN
COMMISSION, 2016b). Based on this, each member state can decide on cultivation and usage as food and feed of approved GM crops on their territory. Due to high regulative effort, costs in combination
5 The regulative authority for food and feed (including GMOs) was moved from DG Agriculture to the DG SANTE in 1999.
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with the general low market potential of GM crops, most seed companies retrieve their research and business activities with GM products from Europe.