GAIN Report - E48082E48082 Page 2 of 46
Required Report - public distributionRequired Report - FAS internal use only
Date: 8/27/20087/18/2008
GAIN Report Number: E48082E48082
E48082E48082
EU-27EU-27
BiotechnologyBiotechnology
Annual Annual
20082008
Approved by:
Elizabeth B. Berry/Bobby Richey Jr.Elizabeth B. Berry/Bobby Richey Jr.
U.S. Embassy, ParisU.S. Embassy, Paris
Prepared by:
Marie-Cecile Henard, Dietmar Achilles, Barrie Williams and the group of FAS biotech specialists in the EUMarie-Cecile Henard, Dietmar Achilles, Barrie Williams and the group of FAS biotech specialists in the EU
Report Highlights:
There are seven Member States (MS) commercially producing genetically-engineered (GE) crops, with Spain being, by far, the largest producer. Under the EU policy framework for agricultural biotechnology, MS policy varies greatly. Coexistence frameworks have been set up in most MS or are currently being prepared, and 5 MS continue to maintain national bans. However, the EU is a major consumer of biotech products, mainly soybean meal imported to feed livestock and poultry, with at least 80 percent of EU soy crush estimated to be genetically modified. Finally, agricultural biotechnology research in Europe is declining, mainly due to political pressure.Although there have been some changes in the EU in recent years associated with agricultural biotechnology, the EU and some member state policy frameworks for implementing science-based approval systems remain unworkable. There are seven member states commercially producing genetically-engineered (GE) crops, with Spain being, by far, the largest producer. Despite restrictions set by national coexistence rules and intimidation by NGOs, the area devoted to GE crops (currently one corn event) continues to expand gradually. The EU is a major consumer of biotech products, mainly soybean meal imported to feed livestock and poultry with at least 80 percent of EU soy crush estimated to be genetically modified. Finally, agricultural biotechnology research in Europe is declining. This factor, combined with an unworkable regulatory regime, call into question the EU's ability to meet the agricultural challenges of the twenty-first century.
Includes PSD Changes: NoNo
Includes Trade Matrix: NoNo
Annual ReportAnnual Report
Paris [FR1]Paris [FR1]
[E4] [E4]
Table of Contents
Executive Summary 3
Biotechnology Research, Trade and Production 4
EU BIOTECH AREA GRADUALLY EXPANDING 4
DESPITE POLITICS, EU IS A MAJOR BIOTECH CONSUMER 4
EU RESEARCHERS SEEK MORE SUPPORTIVE ENVIRONMENTS: 5
Biotech Regulatory System in the EU-27 5
EU-27 Framework for Environmental Release 5
Labeling of Food and Feed and Traceability of Biotech Products 6
International Trade Issues Continue 7
Member States Policy VarIES Greatly 7
New Technologies 8
Food Products from Cloned Animals 8
Nanotechnology 8
Annexes 10
Annex I: Member States Individual Situations 10
Annex II: Community Register of Authorized Genetically Modified Food and Feed 19
Annex III: Genetically modified food and feed pending authorization 27
Annex IV: Regulation (EC) No 258/97, Genetically Modified Food Authorized (until January 17, 2006) 31
Annex V: Genetically Modified Feed Authorized Under Directive 2001/18/EC 33
Annex VI: Pending Authorizations Under Directive 2001/18 35
Annex VII: Member States Policies 36
Annex VIII: EU -27 Production of GE Crops by Region 43
Annex IX – Field Register Status by EU Member State 44
Annex X - Extent of Field Releases of GE Crops 46
The report represents a group effort of the following FAS analysts:
Dietmar Achilles FAS/Berlin covering Germany
Mila Boshnakova FAS/Sofia covering Bulgaria
Monica Dobrescu FAS/Bucharest covering Romania
Bob Flach FAS/The Hague covering the Benelux Countries
Mike Hanley FAS/Dublin covering Ireland
Marie-Cecile Henard FAS/Paris covering France
Roswitha Krautgartner FAS/Vienna covering Austria
Hasse Kristensen FAS/Copenhagen covering Denmark
Jolanta Figurska FAS/Warsaw covering Poland, Latvia, Lithuania & and Estonia
Asa Lexmon FAS/Stockholm covering Sweden and Finland
Arantxa Medina FAS/Madrid covering Spain and Portugal
Jana Mikulasova FAS/Prague covering the Czech Republic and Slovakia
Andreja Misir FAS/Zagreb covering Slovenia
Ferenc Nemes FAS/Budapest covering Hungary
Sandro Perini FAS/Rome covering Italy
Stamatis Sekliziotis FAS/Athens covering Greece
Barrie Williams FAS/USEU/Brussels
Jennifer Wilson FAS/London covering the U.K.
I. Executive Summary:
Executive Summary
This report consolidates and updates the annual biotechnology reports prepared in 2006 in individual EU Member States (MS).
In the past several years, yield benefits and cost savings of genetically engineered (GE) crops have made them attractive to EU farmers, and the production of biotechnology crops (currently only one corn event) continues to expand in certain Member States. Despite regulatory restrictions and political threat, the area devoted to biotech corn is expected to increase to approximately 110,000 ha in 2009 (mainly located in Spain, the Czech Republic, Portugal, Slovakia and Germany).
Under the EU policy framework for agricultural biotechnology, MS policy varies greatly. Virtually all MS have transcribed EU Directive 2001/18 and implement EU regulations on traceability and labeling. Most MS have set up national coexistence frameworks for biotech and non-biotech crops (Belgium, Czech Republic, Germany, Hungary, Portugal, Romania, Slovakia) or are currently preparing coexistence rules (France, Spain, the United Kingdom). Some MS continue to maintain national bans on genetically-engineered crops (Austria, France, Greece, Hungary and Italy).
The main biotech products used are in animal feed, human food, planting seeds, and the textile industry. They consist of soybeans and products, corn and its derivatives, and cotton. The largest categories of GE products consumed primarily consist of soybean meal, where GE products are estimated to represent 80 to 95 percent, and of corn and corn products (mainly corn gluten feed), in which GE products are estimated to account for 10-25 percent only.
While research in agricultural biotechnology is a stated priority of the European Commission and many MS, in reality, many research scientists have either been forced to drop activities due to political pressure or have moved to institutions (particularly in the United States) where support for such research is undeterred. This reduction in research activities has also translated into a reduction in field trials, which have also suffered from actions of intimidation by activist groups.
Dynamics of Agricultural Biotechnology
The years 2007 and 2008 have witnessed further evolution of the EU political and public dynamics associated with agricultural biotechnology. This has occurred at and within the European Commission, EU member states, and the food/feed chain in Europe. Nonetheless, the EU and some member state policy frameworks for implementing science-based approval systems for agricultural biotechnology remain unworkable. Some members of the EU College of Commissioners and EU member state politicians continue to respond to specific NGO constituents, rather than the growing interests of EU farmers who want access to the tools of agricultural biotechnology. As a result, there appears to be a “patch” attitude to address emerging trade issues rather than an “implement” attitude towards the EU regulatory process.
EU DEMAND OUTSTRIPPING CURRENT PRODUCTION CAPACITIES
Since 1999/2000, the EU’s net grain export position has fallen from 27 MMT to only a projected 7 MMT in 2008/09. In fact in two of the years of that time period, the EU was a net grain importer. A number of factors have contributed to this, including poor weather, but also booming demand for biofuel and increased meat consumption in the newest EU member states. Current EU production practices, limited additional arable land, and limitations on the use of farm chemicals could limit the EU’s ability to meet expanding domestic and export demand for food, feed and fuel in coming years. To address this, the EU has reduced mandatory land set aside, but this will only increase future grain and oilseed supplies slightly given the marginal nature of the affected land. More favorable growing conditions, better than those experienced in 2007/2008, will increase EU grain and oilseed output, in 2008/2009; however, these conditions can not be counted upon each year. In fact, in June 2008, the European Commission suspended grain import duties through June 2009, recognizing that access to competitively priced grain will be an issue for the EU livestock and food industry into the future. Therefore, without substantial investment in technologies to increase agricultural production, it is likely that the EU will remain a major net grain and oilseed importer.
EU IMPORTERS ENCOURAGED TO DEVELOP NEW SUPPLIERS
The ability of EU importers to access EU-approved commodity supplies in several South American countries may remain in the very short term. However when given the opportunity, South American farmers have adopted agricultural biotechnology at even faster rates than those in the United States. In addition, current prices for diesel fuel and fertilizer make the planting of biotech crops, especially low-tillage, herbicide-tolerant crops, even more attractive around the world. In addition, some EU and member state officials have encouraged grain and oilseed importers to turn to other exporters, such as Russia and Ukraine, for investment and guaranteed supplies.
Given the recent turmoil that has faced each of these exporters, it is unclear that this group of exporters will be able to meet EU demand on a consistent basis. Argentine exports continue to be hampered by widespread farmer strikes, with no let up in sight. Russia and Ukraine have in the past restricted access to supplies by importers due to concerns about domestic prices and food availability. In addition, efforts over the past 20 years to increase production and implement contract farming in some of the republics of the former Soviet Union have been less than successful due to infrastructural constraints, contract disputes and product quality and food safety concerns.
EU MARKET POSITION NOT AS INFLUENCIAL
EU member states and European Commission officials have recently realized that the EU’s power to influence whether or not biotech crops are produced in third countries has fallen substantially. In 1998, European importers prevailed in preventing the U.S. commercialization of a biotech soybean event that was not yet approved by the EU. This has changed. Recently, U.S. agricultural groups have been clear with EU decision makers that U.S. farmers are focused now on meeting demand in importing countries with functioning biotech regulatory systems. As other major food and feed grain producers, particularly in the developing world, adopt agricultural biotechnology as a tool, the EU’s influence in this area is likely to decline. However, it is important not to underestimate how countries might react when faced with the possibility of losing EU market access for a key commodity.
MEMBER STATES SEND NEGATIVE SIGNALS ON EU REGULATORY PROCESS
As in previous years, several EU member states undertook direct action in 2007 and 2008, challenging EU regulatory decisions on agricultural biotechnology. Environmental ministers and others have been active across the EU in seeking to roll back the existing biotechnology regulatory system and change the science-based nature of the European Food Safety Authority. For example, in April 2007, Germany announced a suspension of the planting registration for the biotech corn variety Mon 810. Germany lifted this action prior to the 2008 planting season. However, France took similar action which completely banned the cultivation of Mon 810 in 2008. In Poland, there continues to be political and legal uncertainty surrounding the status of animal feeds containing biotech commodities. Each of these actions has occurred despite a clear legal and regulatory interpretation of EU regulations for the biotech events in question. However to date, these countries have not presented any new credible evidence that the products are not in compliance with EU regulations or that there are any new health or environmental concerns. At the same time, consumers are exposed to negative and, often biased, information about agricultural biotechnology, with no corresponding defense or explanation from EU decision makers about the regulatory regime in place and its efficacy. When questions are raised Commission and member state officials often side with NGOs, even when they are unable to prove their accusations, and against their own regulatory officials.
IS THE EU FACING A REGULATORY “TRAIN WRECK” ?
Some observers see the current global supply and demand situation for grains and oilseeds as presenting pressure on member state and EU officials to change course and avoid a potential “train wreck” where EU regulations cut off importers from necessary grain and oilseed supplies. The chance of this has grown significantly in recent years with falling grain and oilseed stocks, growing grain and oilseed demand, and the imminent release of second generation biotech corn and soybean events in biotech-friendly countries. The increasing costs for grain and oilseeds are making EU livestock and food producers less competitive on the internal and world market and forcing the EU to look for other potential solutions, such as permitting non-ruminant protein meal to be re-introduced into some animal feeds and increasing export restitutions. Interestingly, some see consideration of changing long standing rules put in place because of the public outcry over BSE as less politically sensitive than operating a predictable, science-based biotech regulatory regime.
By failing to approve biotech events adopted by farmers in other countries, the European Commission and member states are consigning EU livestock producers, food industry and consumers to increased production costs and higher food bills.
IMPORT TOLERANCES AND DEFINING ZERO
Rather than mend a politically-driven approval system, EU bureaucratic attention has been focused on implementing a system of import tolerances for biotech events approved in other markets. If implemented, this might forestall the complete closure of the EU market to imports for several years, but it is unlikely to address the issues associated with the approval system. This is especially true considering the many new products being readied for commercialization. Nonetheless, some in the European Commission seem to be sensitive to the need to move beyond the current member state delays. Most recently for example, European Commission President Barroso invited member states to participate in an informal discussion with representatives that could speak for their respective governments in an attempt to transcend individual ministerial interests. The European Commission views these developments as positive steps towards normalizing the trade in products of modern agricultural biotechnology. However at the present time, it is unclear whether these discussions will result in any policy initiatives that might change or clarify member state views and facilitate future science-based regulation. Similar avenues have been tried in the past 10 years with, at best, very limited success.
EU INDUSTRY FOCUSES ON BIOTECHNOLOGY POLICY IMPLICATIONS
Since mid 2007, the food and agricultural sector voices have publically and vocally engaged on the topic of agricultural biotechnology in larger numbers and more loudly than in the past. These member state and EU organizations have undertaken concerted public efforts to educate consumers and policy makers about the current and future problems that the EU biotech policies have created for farmers, livestock producers, food manufacturers and consumers. These groups focused on several factors putting pressure on the EU food and feed market including: insufficient EU animal feed supplies; increasing grain and oilseed prices; and increasing price premiums of non-biotech grains and oilseeds. One of the largest concerns of these industry groups is the growing gap between the EU and most of the countries on biotech event approvals, which in the coming years will exacerbate the current EU market situation. In some instances the efforts have resulted in effective communications. For example, European Commissioner for Agriculture Marian Fischer Boels on numerous occasions highlighted the growing implications for the EU of its current policies and actions. However, industry claims have been downplayed by others. For example, the German Minister of Agriculture publically questioned food and feed industry analysis of future implications of the current EU biotech stalemate indicating that the market situation was not as dire as it was being characterized.