**2. GMO in the EU**

The development of green biotechnology dates back to the 1970s and led to the development of Genetically Modified Organisms (GMOs) in the 1980s. On May 21, 1994, the genetically engineered FlavrSavr™ tomato was the first crop approved by the U.S. Food and Drug Administration for commercialization. Due to the controversy over GMOs, which started with the first arrivals in Europe of soybeans cargoes in 1996, and to its poor organoleptic qualities, this tomato was withdrawn from the market in 1998 (Bruening and Lyons, 2000).

#### **2.1 European consumers**

Today, around 148 million hectares of GM plants are grown and traded around the world annually, among which ca. 71% of GM soy according to the ISAAA lobbyist (James, 2011). Despite this development, the European public's perception of GM crops is still very negative as demonstrated by the recent results of the Eurobarometer surveys (Bonny, 2008; de Cheveigné, 2004; Gaskell et al., 2006; Gaskell et al., 2010; TNS Opinion & Social, 2010). However, this consumers' reluctance seems less pronounced in the eastern part of the EU-27 (Consumerchoice Consortium, 2008).

After several scandals in the 1990s' such as BSE, dioxin contaminations, the reluctance of consumers' and citizens to embrace GMOs has been considered by the EC and European Union Member States (EU-MS) which have implemented a legal framework enabling consumers to maintain their freedom of choice through both food and feed labeling (European Commission, 1997, 2000a, b, 2001, 2002d, 2003c, d). In counterpart, the freedom of choice of producers to cultivate GM or non-GM crops is considered through a set of coexistence rules to be implemented by EU-MS, according to the European principle of subsidiarity as recommended by the EC (European Commission, 2003a, 2010a). However, despite numerous requests from NGOs and consumers associations, animals reared with GM feed do not require labeling.

<sup>2</sup> Current European Union with 27 Member States

#### **2.2 GMO approvals in the EU**

4 Recent Trends for Enhancing the Diversity and Quality of Soybean Products

Soybean has been first introduced in Europe during the XVIIth century as high-class food, however despite several scientific and popular reports during the XIXth century soybean was rarely cropped in Western Europe. The first massive importation of soybean in Europe started by the beginning of the XXth century for oil and meal production, declined during the 2 world wars, but with increasing imports between them. Since the 1950s, Europe dramatically increased its importations of soybean due to a new animal production scheme with highly concentrated livestock production. However, new dossiers in the pipeline of GMO approvals now consider cultivation in the EU. We thus examine in more depth this

Due to this increasing part of GM soybean in the international market and consumers' reluctance of several countries to accept these products, a new segmentation of the market appeared between GM and non-GM soybean linked to labeling of GM food, and feed in some countries, with an exemption of labeling below a threshold of fortuitous or technically unavoidable presence, ranging from 0.9% in the EU-272 and Russia to 3-5% in Korea, Taiwan and Japan. Generally speaking, the labeling thresholds are representative of the countries'

The development of green biotechnology dates back to the 1970s and led to the development of Genetically Modified Organisms (GMOs) in the 1980s. On May 21, 1994, the genetically engineered FlavrSavr™ tomato was the first crop approved by the U.S. Food and Drug Administration for commercialization. Due to the controversy over GMOs, which started with the first arrivals in Europe of soybeans cargoes in 1996, and to its poor organoleptic qualities, this tomato was withdrawn from the market in 1998 (Bruening and Lyons, 2000).

Today, around 148 million hectares of GM plants are grown and traded around the world annually, among which ca. 71% of GM soy according to the ISAAA lobbyist (James, 2011). Despite this development, the European public's perception of GM crops is still very negative as demonstrated by the recent results of the Eurobarometer surveys (Bonny, 2008; de Cheveigné, 2004; Gaskell et al., 2006; Gaskell et al., 2010; TNS Opinion & Social, 2010). However, this consumers' reluctance seems less pronounced in the eastern part of the EU-27

After several scandals in the 1990s' such as BSE, dioxin contaminations, the reluctance of consumers' and citizens to embrace GMOs has been considered by the EC and European Union Member States (EU-MS) which have implemented a legal framework enabling consumers to maintain their freedom of choice through both food and feed labeling (European Commission, 1997, 2000a, b, 2001, 2002d, 2003c, d). In counterpart, the freedom of choice of producers to cultivate GM or non-GM crops is considered through a set of coexistence rules to be implemented by EU-MS, according to the European principle of subsidiarity as recommended by the EC (European Commission, 2003a, 2010a). However, despite numerous requests from NGOs and consumers associations, animals reared with

forthcoming issue in environmental surveillance.

dependence on feed and food imports.

**2. GMO in the EU** 

**2.1 European consumers** 

(Consumerchoice Consortium, 2008).

GM feed do not require labeling.

2 Current European Union with 27 Member States

In order to re-assure the European public on food safety and more particularly the question of GMOs, the European Community has developed a series of regulations (Table 1) to ensure GMO safety, detection, traceability and labeling.

Food safety assessment is the responsibility of the European Food Safety Authority (EFSA) which cooperates with EU-MS national advisory committees and covers food additives, animal welfare, plant health, allergies, mycotoxins, biological hazards, chemical and biological contaminants. It also assesses the safety of GMOs (seed, food, feed, and derivatives). EFSA is an independent scientific body providing advice on all aspects of food safety, and a positive EFSA assessment is necessary for authorization to place food on the European market. GMO dossiers can be notified to the European Commission either under the 2001/18 directive or the (EC) regulation 1829/2003. Although not implied in its name, EFSA also provides advice on GMO environmental issues.

Once a positive EFSA assessment has been obtained, and once validated GMO detection methods and control sample and reference materials are available (all being provided by the applicant company), the application is then sent to the EC. On the basis of the opinion of EFSA, in some instances amended on the basis of national advisory agencies and committees, the EC drafts a proposal for granting or refusing the authorization, which it submits to the Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health. If this Standing Committee accepts the proposal, it is finally adopted by the EC. Otherwise, it is passed on to the Council of Ministers which has a time limit of 3 months to reach a qualified majority for, or against, the proposal. In the absence of such a decision (which is frequently the case), the EC adopts the proposal. Over the last years, all GMO approvals in the EU were accepted on that scheme basis with approvals for a renewable 10 years period.

In contrast to several claims against the "lengthy and costly" approval European procedure, it should be noted that the notifiers often use dossiers of previous approvals in third countries, such as USA, with thus very few changes and thus very low costs of compliance with the EU approval procedure. Secondly, the European theoretical approval duration is *per se* not very long; however dossiers are in numerous instances incomplete. In this case the clock of approval is stopped each time details are requested from the notifiers. Due to these several stop-and-go steps in such an approval, the effective duration of European approval may be rather long. The European procedure of safety assessment of GMOs is currently under review, for instance on the statistics to be used in comparing animal cohorts, the guidelines about environmental impact assessment, or the more important use of the "substantial equivalence" concept in the comparisons between GM and conventional plants. Despite the relatively rather strict European approval procedure, several EU-MS introduced national bans on GMO, be these for import and transformation such as Austria, for baby food in Italy or for cultivation as in France, Austria or Bulgaria.

However, there are currently ca. 50 GMOs in the pipeline of approval or approved for import and transformation, including several stacked GMOs and a few modified flowers. For soybean, 11 transformation events or stacked genes are in the European approval process with 2 GM soybean as fully approved and the first approved one (MON GTS 40-3-2) in the renewal process.

Due to the rather long European approval process, several reports outlined the possible shortage of soybean for the feed industry due to these "asynchronous approvals" (DG AGRI European Commission, 2007; Stein and Rodriguez-Cerezo, 2009, 2010a). The EC recently

Soybean in the European Union, Status and Perspective 7

 **Regulation (EC) 1830/2003** concerns the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. It imposes a specific traceability requirement on GMOs, over and above that of the general traceability regulation 178/2002. Traceability archives must be kept for five years. **Regulation (EC) 65/2004** establishes a system for the development and assignment of

 **Regulation (EC) 882/2004** on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. **Regulation (EC) 1981/2006** establishing a financial contribution on a flat-rate basis in order to contribute to supporting the costs incurred by the EURL-GMFF in the

After the commercial withdrawal of Event 176 maize, only 2 GM plants are currently approved for cultivation in the EU, namely the MON 810 maize and the Amflora® potato. However several other GMOs are in the pipeline for cultivation approvals, such as Bt11 maize or GTS 40-3-2 soybean. In this later case, Romania, which was cultivating GTS 40-3-2

In December 2008, the European council of ministries in charge of Environment asked for a reform of the EFSA approval process and for integrating socio-economic factors into the approval considerations. So far, only the French High Council of Biotechnologies integrates such considerations into its advice system through its Economic, Ethical and Social

According to (EC) 178/2002 regulation, traceability is mandatory in the EU for all food items, one step forward - one step backward, with additional specific requirements for GM products such as keeping traceability document for at least 5 years as described below and

The operation of GMO food control systems (e.g. detection, labeling and traceability methods) are not within EFSA's remit, and remain the responsibility of the EC, through the European Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF), and the Competent Authorities (CA) of individual EU-MS. It should be noted, since it is a source of frequent miscomprehension, that EC traceability and labeling regulations are not concerned with GMO safety, risk evaluation or risk management, since food that does not have a positive EFSA assessment does not reach the market. Traceability data on food and feed, including GMOs, may serve, however, to enable the re-call of products from the supermarkets in the case of unforeseen mishaps, such as the accidental or deliberate contamination of food chains. Traceability is a non-discriminatory and inexpensive requirement since most of the companies already have quality assurance protocols in place and since numerous analyses are routinely carried-out for multiple purposes, including vitamin or toxins contents. Quality assurance procedures offer several advantages to the companies such as specific market niches, efficient low-cost withdrawal of products and easier implementation of control procedures for future mandatory requirements (e.g.

unique identifiers for genetically modified organisms.

Committee3 due to a recent law (République Française, 2008).

Table 1. summarized overview of the European legislative frame on GMO.

soybean before its entrance in 2007 in the EU, is pushing hard for this approval.

methods' validations.

**2.3 Labeling and traceability** 

3 Comité économique, éthique et social (CEES)

in Table 1.

issued a proposal of modification of 2001/18 directive to allow Low Level Presence of EU unapproved GMOs, as also discussed in the *Codex Alimentarius* instance, for GMO already approved in a third country and whose dossiers are already under EFSA discussion for at least 3 months.


issued a proposal of modification of 2001/18 directive to allow Low Level Presence of EU unapproved GMOs, as also discussed in the *Codex Alimentarius* instance, for GMO already approved in a third country and whose dossiers are already under EFSA discussion for at

 **Directive 1990/219/EEC** covered the contained use of genetically modified organisms. Directive 1990/220/EEC was modified by Directive 98/81/EEC. **Directive 1990/220/EEC** covered the notification for a deliberate release and of the placing on the market of GMOs. Directive 1990/220/EEC was repealed by Directive

 **Regulation (EC) 258/1997** concerning novel foods and novel food ingredients, not heavily used in the EU before 1997 and establishing a compulsory labeling for these novel foods and ingredients, such as GMO, irradiated food, etc. Part of the current

 **Regulation (EC) 1139/1998** laid down the compulsory indication on the labeling of foods and food ingredients produced from genetically modified soya (*Glycine max* L.) covered by Commission Decision 1996/281/EC and genetically modified maize (*Zea mays* L.) covered by Commission Decision 1997/98/EC, of particulars other than

 **Regulation (EC) 49/2000** amended the 1139/1998 EC regulation and established a 1% labeling threshold which was further decreased to 0.9% by regulation 1829/2003. **Regulation (EC) 50/2000** establishing a mandatory labeling of additives and flavorings that have been genetically modified or have been produced from

 **Directive 2001/18/EEC** covers the deliberate release of GMOs in the environment (field trials and cultivation), in the absence of specific containment measures. It also regulates commercialization (importation, processing and transformation) of GMOs into industrial products. Finally, the Directive requests post-commercialization, case specific and general, surveillance plans on unforeseen effects of GMO on both health

 **Regulation (EC) 178/2002** resulted in the creation of EFSA and in a general obligation for traceability of at least one step forwards and one step backwards in the food

 **Regulation (EC) 1946/2003** is concerned with the trans-boundary movement, and accompanying documentation, for LMOs (living modified organisms) destined for deliberate release, or for food and feed or for immediate processing, under the terms

 **Regulation (EC) 1829/2003** covers mainly the commercialization of food and feed. It facilitates GMO detection by obliging the providers of GMO plants to disclose methods for their detection (Regulation (EC) 1981/2006 provides for a fee to be paid by the applicant to the CRL for this service). These methods are then verified and validated by the EURL-GMFF, hosted by the DG JRC laboratory of Ispra (Italy) with the support of the ENGL, before being made public. This regulation imposes labeling for authorized GMOs above a threshold of 0.9%. Labeling is not required for conventional or organic food and feed containing the adventitious, or technically unavoidable, presence of authorized GMOs at levels less than 0.9%. Unauthorized GMO are not permitted entry in the EU, even at levels less that 0.9% (the so-called

least 3 months.

2001/18/EEC.

revision of food and feed legislation.

genetically modified organisms.

of the Cartagena Protocol on Biosafety.

and environment.

"zero tolerance").

chain.

those provided for in Directive 1979/112/EEC.


Table 1. summarized overview of the European legislative frame on GMO.

After the commercial withdrawal of Event 176 maize, only 2 GM plants are currently approved for cultivation in the EU, namely the MON 810 maize and the Amflora® potato. However several other GMOs are in the pipeline for cultivation approvals, such as Bt11 maize or GTS 40-3-2 soybean. In this later case, Romania, which was cultivating GTS 40-3-2 soybean before its entrance in 2007 in the EU, is pushing hard for this approval.

In December 2008, the European council of ministries in charge of Environment asked for a reform of the EFSA approval process and for integrating socio-economic factors into the approval considerations. So far, only the French High Council of Biotechnologies integrates such considerations into its advice system through its Economic, Ethical and Social Committee3 due to a recent law (République Française, 2008).

#### **2.3 Labeling and traceability**

According to (EC) 178/2002 regulation, traceability is mandatory in the EU for all food items, one step forward - one step backward, with additional specific requirements for GM products such as keeping traceability document for at least 5 years as described below and in Table 1.

The operation of GMO food control systems (e.g. detection, labeling and traceability methods) are not within EFSA's remit, and remain the responsibility of the EC, through the European Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF), and the Competent Authorities (CA) of individual EU-MS. It should be noted, since it is a source of frequent miscomprehension, that EC traceability and labeling regulations are not concerned with GMO safety, risk evaluation or risk management, since food that does not have a positive EFSA assessment does not reach the market. Traceability data on food and feed, including GMOs, may serve, however, to enable the re-call of products from the supermarkets in the case of unforeseen mishaps, such as the accidental or deliberate contamination of food chains. Traceability is a non-discriminatory and inexpensive requirement since most of the companies already have quality assurance protocols in place and since numerous analyses are routinely carried-out for multiple purposes, including vitamin or toxins contents. Quality assurance procedures offer several advantages to the companies such as specific market niches, efficient low-cost withdrawal of products and easier implementation of control procedures for future mandatory requirements (e.g.

<sup>3</sup> Comité économique, éthique et social (CEES)

Soybean in the European Union, Status and Perspective 9

industrial uses, may lead to the same issue of inappropriate segregation as the US Starlink™

The freedom to producers to either produce GM, conventional or organic crops is the counterpart and the necessary basis of consumers' freedom to choose, or not, GMO into their food. Accordingly, the EC released in 2003 and updated in 2010 a recommendation on the coexistence of GM, conventional and organic farming (European Commission, 2003a, 2010a). Practical implementation and rules is the responsibility of the EU-MS according to the European subsidiarity principle. In parallel, several European regions declared themselves as GMO-free (http://www.gmofree-euregions.net:8080/servlet/ae5Ogm) despite the fact that some do not have the administrative legality for such a positioning. The European Commission reported on implementation of coexistence rules in EU-MS which is far from being implemented in a harmonized way in all EU-MS (European Commission, 2006b, 2009e). COEX-NET is a network established to facilitate the exchange of information

Different national (French ANR-OGM, British Farm Scale Evaluation, German BMBF project, etc.) and European (SIGMEA, Transcontainer, Co-Extra) research programs were launched the last decade to establish the scientific bases of coexistence. To aid national Competent Authorities, the EC has recently created a new 'co-existence bureau' specific for co-existence issues, at JRC-IPTS7, Seville, Spain, which recently released its first document on maize crops coexistence (Czarnak-Kłos and Rodríguez-Cerezo, 2010). If most of the current work focused on maize, currently the only plant sown, several other crops have been studied from a coexistence viewpoint, as for instance oilseed rape and sugar beet, two crops for which ferals and crossing with wild relatives are important in the EU (Colbach, 2009; Colbach et al., 2009; Darmency et al., 2009; Darmency et al., 2007; Gruber et al., 2008). Up to now 2 trends can be distinguished in the European coexistence schemes, a flexible coexistence frame and one based on dedicated production areas, be these GMO or GMO-free. Until now, coexistence research has mostly focused on flexible coexistence, that is to say, the individual choice of a farmer, with a minimum of *ex-ante* duties (such as isolation distances, buffer and/or discard zones) together with an information system, including, for instance, a public register of GM crops to provide information to non-GM growing neighbors coupled with some *ex-post* economic solutions such as compensation schemes for economic losses (Demont et al., 2010; Demont et al., 2009; Desquilbet and Bullock, 2010; Devos et al., 2009; Messéan et al., 2006; Messéan et al., 2009). Current EU best practice guidelines and companies' stewardships for coexistence measures in maize give effective measures for the European 0.9% threshold by requesting separation distances, buffer and discard zones, and staggered flowering times, but without taking into consideration the threshold of 0.1%used by companies due to measurements and sampling uncertainties (Bartsch et al., 2009; Bock et

Generally speaking, the proposed flexible coexistence solutions are based on the assumption that individual choices should prevail, but information systems need to be available to allow other producers to know what is being produced and where, such as those already

7 European Commission's Joint Research Centre, Institute for Prospective and Technological Studies

maize (Miller, 2010).

**3.1 General overview** 

**3. European GMO coexistence issues** 

on coexistence issues between EU-MS CA.

al., 2002; European Commission, 2010b).

traceability and labeling of allergens in food and feed). Fees incurred by the EURL-GMFF, for validating the detection methods by inter-laboratory trials, are on a flat-rate covered by a financial contribution of the notifying companies while a new network of National Reference Laboratories has been established beside the European Network of GMOs Laboratories (ENGL) (European Commission, 2004d, 2006a). The EC released several reports on traceability experience in the EU-MS (European Commission, 2006d, 2008b).

So far there is no European obligation of labeling animals, or their derived products, reared on GM feed despite several requests of NGOs4 and consumers associations. However, this possibility of animal and derived products labeling has been recently introduced in Austria and Germany with a threshold of 0.9%. More generally speaking, GMO-free labeling has been introduced at 0.9% in Germany and Austria, while France is currently considering a definition of GMO-free products at 0.1% according to the recommendation of the Economic, Ethical and Social Committee5 of its High Council of Biotechnology6 (http://agriculture.gouv.fr/remise-de-l-avis-du-haut-conseil). GMO-free labeling is currently used by several German companies for e.g. milk which according to some claims increased their market shares (http://www.bund.net/bundnet/themen\_und\_projekte/ gentechnik/verbraucherinnenschutz/kennzeichnung/nutzende\_unternehmen/).

Since the first commercialization of GMOs in third countries, the EU has been facing a great number of alerts (Davison and Bertheau, 2007, 2008). In most of the cases, these alerts resulted from a misappropriate segregation of approved GMO (Starlink™ maize), or the seeds' commercialization of unapproved GMOs (US Bt10 instead of Bt11 maize), or the release of unapproved GMOs as in the case of US LL601 rice or Chinese Bt63 and Kefeng 6 rice. While the issues of presence of unapproved GMO in domestic markets were previously considered as an issue for countries with labeling policies, the recent increase of GMOs from emerging countries led to the reaction of the US agencies (APHIS News release, 2010; GAO, 2008). In several ways, it appears that USA will move toward a more surveying attitude similar to the EU (Davison, 2010).

The issue of domestic unapproved GMO in local market is the basis of the current work of *Codex Alimentarius* on the Low Level Presence (Codex Alimentarius, 2003). Asynchronous approvals of GMOs has been recently taken into consideration by the EC which proposed a 0.1% presence in feedstuffs of EU unapproved GMOs after a revision of EU legislative frame (Aramyan et al., 2009a; Reuter, 2010; Stein and Rodriguez-Cerezo, 2010b).

However, the recent results of the European research project Co-Extra (www.coextra.eu) show that supply chains operators already use a contractual threshold of ca. 0.1% for the 0.9% European labeling threshold (European Commission, 2010b). Together with the possible labeling of animals reared with GMOs, between 0.9 and 0.1%, and below 0.1%, such a situation will drastically impact on the availability of "GMO-free" products. The reaction of consumers toward this new European proposal remains currently unknown as *ex ante* studies appear very difficult for providing accurate results.

Generally speaking, the European traceability greatly improved over the last decade but with still several issues such as the sowing of EU unapproved Bt11 in France a few years ago. In these circumstances, the recent approval of a GM potato, specifically destined for

<sup>4</sup> Non Governmental Organization

<sup>5</sup> Comité économique, éthique et social

<sup>6</sup> Haut Conseil des Biotechnologies (HCB)

industrial uses, may lead to the same issue of inappropriate segregation as the US Starlink™ maize (Miller, 2010).

#### **3. European GMO coexistence issues**

#### **3.1 General overview**

8 Recent Trends for Enhancing the Diversity and Quality of Soybean Products

traceability and labeling of allergens in food and feed). Fees incurred by the EURL-GMFF, for validating the detection methods by inter-laboratory trials, are on a flat-rate covered by a financial contribution of the notifying companies while a new network of National Reference Laboratories has been established beside the European Network of GMOs Laboratories (ENGL) (European Commission, 2004d, 2006a). The EC released several reports

So far there is no European obligation of labeling animals, or their derived products, reared on GM feed despite several requests of NGOs4 and consumers associations. However, this possibility of animal and derived products labeling has been recently introduced in Austria and Germany with a threshold of 0.9%. More generally speaking, GMO-free labeling has been introduced at 0.9% in Germany and Austria, while France is currently considering a definition of GMO-free products at 0.1% according to the recommendation of the Economic, Ethical and Social Committee5 of its High Council of Biotechnology6 (http://agriculture.gouv.fr/remise-de-l-avis-du-haut-conseil). GMO-free labeling is currently used by several German companies for e.g. milk which according to some claims increased their market shares (http://www.bund.net/bundnet/themen\_und\_projekte/

on traceability experience in the EU-MS (European Commission, 2006d, 2008b).

gentechnik/verbraucherinnenschutz/kennzeichnung/nutzende\_unternehmen/).

similar to the EU (Davison, 2010).

4 Non Governmental Organization 5 Comité économique, éthique et social 6 Haut Conseil des Biotechnologies (HCB)

Since the first commercialization of GMOs in third countries, the EU has been facing a great number of alerts (Davison and Bertheau, 2007, 2008). In most of the cases, these alerts resulted from a misappropriate segregation of approved GMO (Starlink™ maize), or the seeds' commercialization of unapproved GMOs (US Bt10 instead of Bt11 maize), or the release of unapproved GMOs as in the case of US LL601 rice or Chinese Bt63 and Kefeng 6 rice. While the issues of presence of unapproved GMO in domestic markets were previously considered as an issue for countries with labeling policies, the recent increase of GMOs from emerging countries led to the reaction of the US agencies (APHIS News release, 2010; GAO, 2008). In several ways, it appears that USA will move toward a more surveying attitude

The issue of domestic unapproved GMO in local market is the basis of the current work of *Codex Alimentarius* on the Low Level Presence (Codex Alimentarius, 2003). Asynchronous approvals of GMOs has been recently taken into consideration by the EC which proposed a 0.1% presence in feedstuffs of EU unapproved GMOs after a revision of EU legislative frame

However, the recent results of the European research project Co-Extra (www.coextra.eu) show that supply chains operators already use a contractual threshold of ca. 0.1% for the 0.9% European labeling threshold (European Commission, 2010b). Together with the possible labeling of animals reared with GMOs, between 0.9 and 0.1%, and below 0.1%, such a situation will drastically impact on the availability of "GMO-free" products. The reaction of consumers toward this new European proposal remains currently unknown as *ex ante*

Generally speaking, the European traceability greatly improved over the last decade but with still several issues such as the sowing of EU unapproved Bt11 in France a few years ago. In these circumstances, the recent approval of a GM potato, specifically destined for

(Aramyan et al., 2009a; Reuter, 2010; Stein and Rodriguez-Cerezo, 2010b).

studies appear very difficult for providing accurate results.

The freedom to producers to either produce GM, conventional or organic crops is the counterpart and the necessary basis of consumers' freedom to choose, or not, GMO into their food. Accordingly, the EC released in 2003 and updated in 2010 a recommendation on the coexistence of GM, conventional and organic farming (European Commission, 2003a, 2010a). Practical implementation and rules is the responsibility of the EU-MS according to the European subsidiarity principle. In parallel, several European regions declared themselves as GMO-free (http://www.gmofree-euregions.net:8080/servlet/ae5Ogm) despite the fact that some do not have the administrative legality for such a positioning. The European Commission reported on implementation of coexistence rules in EU-MS which is far from being implemented in a harmonized way in all EU-MS (European Commission, 2006b, 2009e). COEX-NET is a network established to facilitate the exchange of information on coexistence issues between EU-MS CA.

Different national (French ANR-OGM, British Farm Scale Evaluation, German BMBF project, etc.) and European (SIGMEA, Transcontainer, Co-Extra) research programs were launched the last decade to establish the scientific bases of coexistence. To aid national Competent Authorities, the EC has recently created a new 'co-existence bureau' specific for co-existence issues, at JRC-IPTS7, Seville, Spain, which recently released its first document on maize crops coexistence (Czarnak-Kłos and Rodríguez-Cerezo, 2010). If most of the current work focused on maize, currently the only plant sown, several other crops have been studied from a coexistence viewpoint, as for instance oilseed rape and sugar beet, two crops for which ferals and crossing with wild relatives are important in the EU (Colbach, 2009; Colbach et al., 2009; Darmency et al., 2009; Darmency et al., 2007; Gruber et al., 2008).

Up to now 2 trends can be distinguished in the European coexistence schemes, a flexible coexistence frame and one based on dedicated production areas, be these GMO or GMO-free.

Until now, coexistence research has mostly focused on flexible coexistence, that is to say, the individual choice of a farmer, with a minimum of *ex-ante* duties (such as isolation distances, buffer and/or discard zones) together with an information system, including, for instance, a public register of GM crops to provide information to non-GM growing neighbors coupled with some *ex-post* economic solutions such as compensation schemes for economic losses (Demont et al., 2010; Demont et al., 2009; Desquilbet and Bullock, 2010; Devos et al., 2009; Messéan et al., 2006; Messéan et al., 2009). Current EU best practice guidelines and companies' stewardships for coexistence measures in maize give effective measures for the European 0.9% threshold by requesting separation distances, buffer and discard zones, and staggered flowering times, but without taking into consideration the threshold of 0.1%used by companies due to measurements and sampling uncertainties (Bartsch et al., 2009; Bock et al., 2002; European Commission, 2010b).

Generally speaking, the proposed flexible coexistence solutions are based on the assumption that individual choices should prevail, but information systems need to be available to allow other producers to know what is being produced and where, such as those already

<sup>7</sup> European Commission's Joint Research Centre, Institute for Prospective and Technological Studies

Soybean in the European Union, Status and Perspective 11

Panel, 2004, 2006a, b, 2010). Several guidance documents and reports on implementation of the monitoring were then published (Bartsch et al., 2006b; Bartsch et al., 2007; EU working

Monitoring of the GMOs post-market release should include both health and environmental effects, should be carried out by the GMO consent holders, i.e. the companies having received a grant for a commercial release of a GMO, and may be supported by additional independent actions of EU-MS. The CSM and GS shall cover both GMO and non-GMO

Up to now, most of the surveillance activities of GMOs approved for import and processing have been delegated by the consent holders to European professional unions of importers, transporters, and processors, namely COCERAL, UNISTOCK and FEDIOL. However, the content of agreements between consent holders and such unions remains unknown. Due to the lack of precision, in particular about the methodology used for monitoring imported GMOs, the accuracy of such monitoring plans remains undetermined for the EFSA, GMO

As noted above, health and environmental monitoring, which also means animal health, of predictable and unexpected effects of GMO cultivation is mandatory in the EU on both

In the EU, several GMO CSM protocols have been pursued by notifiers, scientists, and enforcement authorities. A decade after the first GMO cultivation in the EU, a number of guidelines, conceptual frameworks, and reports are available for GMO CSM (Bartsch et al., 2007; Bontemps et al., 2004; Bourguet, 2004; Chaufaux et al., 2002; EU working group, 2003; European Commission, 2009b; Monsanto Co., 2006, 2009a, b). The consent holders8 published results of insect resistance monitoring, but only from GMO cropped areas despite

This part of the chapter focuses on the monitoring activities of unexpected effects of GMO

GMO GS frameworks proposed by GMO consent holders in relation to EFSA guidelines include literature survey, development and /or use of existing monitoring surveillance, and

General surveillance is designed to detect unanticipated effects on general safeguarded subjects such as natural resources, which must not be adversely affected by human activities like GMO cultivation. Monitoring has to be appropriate for detecting direct and indirect effects, immediate and long-term effects, as well as unforeseen effects. In its 2006 opinion, the EFSA GMO panel outlined that: "*general surveillance cannot be hypothesis driven, but should, when possible, make use of existing monitoring systems in addition to more focused monitoring systems (e.g. farm questionnaires). Data quality, management and statistical analysis are of high importance in the design of general surveillance plans and comparison should be made with baseline data*" (EFSA GMO panel, 2006b). A public consultation on the 2010 version of EFSA

national advisory committees, and CA in charge of GMOs (Beissner et al., 2006).

GMO and non-GMO cropped areas (European Commission, 2001, 2002a, b, 2003c).

group, 2003; European Commission, 2002a, b, c, 2004b, 2008b, 2009a).

cultivated areas (EFSA, 2008; EFSA GMO Panel, 2004, 2006a).

**4.1 Specific surveillance** 

**4.2 General surveillance** 

cultivation, i.e. general surveillance.

the European rules (Monsanto Co., 2006, 2009a, b).

GMO panel opinion on GS is currently ongoing.

8 Notifiers having received European approval for GMO import and/or cultivation.

specific trials as necessary (EFSA GMO panel, 2006b, 2010).

deployed in Portugal. However, at the same time territory / landscape multi-functionality is requested by the EU, and there is a growing call from consumers, and society as a whole, for both more sustainable production and so called quality-oriented produce as shown by the current yearly increase of ca. 20% of organic and other signs-of-quality based farming (Laisney, 2011). This leads to a conflict as GM produce is not seen as organic, even if it can be produced without, or with less pesticide, although it can definitely be more sustainable with yield increases over conventional farming (Cardwell, 2003; Grossman, 2003; Laurent et al., 2010; Marsden, 2008). Moreover, territory organization, with Natura 2000 areas (protected environmental areas, for example), is not taken into account by the flexible coexistence scheme while their domino impact is highly recognized (Demont et al., 2008). This dichotomy needs to be addressed. Finally, the landscape is highly structured by downstream supply chains (Coléno, 2008; Hannachi et al., 2009; Le Bail et al., 2010; Petit, 2009).

Due to the several requests of EU-MS to take into consideration socio-economic aspects into GMO approval, the 2010 updated EC recommendation considers more favorably the possibility of GMO-free areas. However the EC would not accept that requests by EU-MS be based on scientific or environmental grounds which are already assessed by EFSA. This last restriction is currently actively fought at the European Parliament. As a first demonstration of EU policy change, the Portuguese Madeira archipelago was established as the first GMOfree area, though cultivation of maize is relatively scarce in Madeira (Kanter, 2010).

On the opposite side, dissemination over long distance of pollen as well as the practical effect of the contractual threshold of operators militates in favor of dedicated production areas (Brunet et al., 2011; European Commission, 2010b). However, the research work on technical, economic and societal issues raised by this solution are drastically missing and the subject of strong opposition (DEFRA, 2006; Devos, 2008; Dobbs, 2011; European Economic and Social Committee, 2011; Jank et al., 2006; Sabalza et al. 2011).

As soybean is mostly an autogamous plant, numerous issues raised by pollen dissemination should not hamper the soybean cultivation in the EU. Similarly, the absence of out-crossing to wild-relatives, ferals and volunteers should facilitate the cultivation of GM soybean into a coexistence frame. However, the predominant herbicide trait would probably cause the same problems of resistant weeds as observed in the USA (Brasher, 2010; Cerdeira and Duke, 2006, 2007; Roberson, 2010). Transportation of GMO was identified as the cause of several incidental releases in the EU and third countries, including the growth of GM plants around harbors (Kawata et al., 2009; Kim et al., 2006; Lee et al., 2009).

Thus, due to its biological properties and despite the different structure of European farms and territories, the coexistence in the EU of GM and non-GM soybeans should be one of the easiest to implement; as it is in several third countries exporting non-GM soybean despite important GM soybean cropping.
