USDA Attache: 5 EU Member States Retain Bans On -2-

If the Committee is unable to agree on the Commission's proposal, it is then subject to a qualified majority vote by the Council of Ministers. If the Council does not act within 3 months, the Commission adopts the Decision. For more information on EFSA and the EU regulatory process: http://www.efsa.europa.eu/EFSA/Non_Scientific_Document/gmo_factsheet2,0.pdf.

LABELING OF FOOD AND FEED AND TRACEABILITY OF BIOTECH PRODUCTS

Labeling requirements for GE food were first adopted in the Novel Foods Regulation (EC) No 258/97. Specific requirements for GE corn and soybean lines were outlined in Council Regulation (EC) No 1139/98, and were later amended in Commission Regulation (EC) No 49/2000. While maintaining the idea that a GE food or ingredient could not be considered equivalent to its non-GE counterpart (as long as the genetic engineering was detectable), the latter regulation attempted to address the problem of unintended presence of GM by introducing the concept of a threshold. As long as the GM-derived food ingredient material was below 1 percent of individual ingredients, food stuffs would not be subject to specific labeling requirements. Food additives and flavorings are regulated under Commission Regulation (EC) No 50/2000.

With the introduction of Regulation (EC) No 1829/2003 on 'genetically modified food and feed', and Regulation (EC) No 1830/2003 on 'the traceability and labeling of genetically modified organisms', the EU sought to create greater coherence in the regulatory framework for authorization, labeling and traceability. Regulation (EC) No 1829/2003 establishes a "one door, one key" principle, enabling a single application for authorization of release into the environment (according to the criteria set in Directive 2001/18/EC), and the authorization for use as food or feed. The authorization depends on a positive risk assessment by the European Food Safety Authority (EFSA) and a risk management process involving the European Commission and EU Member States through a regulatory committee procedure.

Note: See Annex II for a list of all genetically engineered food and feed events approved in the EU, including those events whose authorizations have expired. Annex III contains products whose applications are pending. Annex IV lists those genetically engineered foods authorized under Regulation (EC) no 258/97. Annex V contains those genetically engineered feeds authorized under Directive 2001/18/EC.Aneex VI contains Applications pending under Directive 2001/18.

INTERNATIONAL TRADE ISSUES CONTINUE

The EU regulatory approach to biotechnology has had a significant impact on international trade. In 2006, the WTO Dispute Settlement Body found that the EU had breached Article 8 of the SPS Agreement by instituting a de facto moratorium on the approval of biotech products. The European Commission and the United States have a continuing dialogue on how to normalize trade in products of modern agricultural biotechnology. This dialogue is an effort to address and correct the WTO inconsistent parts of the EU's process. Aside from the WTO case, the EU is facing great challenges in the asynchronous approval of products already legally available in other countries.

Trade has been periodically disrupted by products that have been approved for cultivation in other countries, but remain illegal in the EU. For example, U.S. market access for corn gluten feed and distillers dried grains has been effectively lost due to this problem. Such disruptions tend to affect availability and prices. EU labeling regulations provide for a 0.9 percent threshold for the "adventitious", that is, accidental and technically unavoidable, presence of authorized biotech event in a non-biotech food or feed. Amounts above 0.9 percent must be labeled.

The EU also temporarily authorized a 0.5 percent threshold for genetically engineered material not yet authorized by the EU, but that had already received a favorable EU scientific assessment. Although the 0.5 percent threshold provision expired in April 2007, discussions are currently under way to reevaluate the technical definition of "zero tolerance." The EU is a party to the Cartagena Protocol on Biosafety, and regulates the transboundary movement of genetically modified organisms through Regulation (EC) No 1946/2003.

MEMBER STATES POLICY VARIES GREATLY

Virtually all Member States have transcribed EU Directive 2001/18 and implement regulations on traceability and labeling. Most Member States have set up national coexistence frameworks for organic, biotech, and conventional crops (Belgium, Czech Republic, Germany, Hungary, Portugal, Romania, Slovakia) or are currently preparing coexistence rules (France, Spain, the United Kingdom). Some Member States continue to maintain national bans on genetically-engineered crops (Austria, France, Greece, Hungary, Italy, and Poland). See Annex VII for detailed information on detailed Member States policies.

New Technologies

As reporting and knowledge about the development of new technologies in agriculture and food production has expanded, many of the same public perception issues have arisen in the EU that have faced agricultural biotechnology over the past 10 years. These include traceability and labeling, advantages for consumers, and regulatory regimes. At the present, there do not appear to be any emerging advocates for these new technologies in the EU.

However, it is clear the same EU groups that have actively opposed the timely regulation and adoption of agricultural biotechnology are ready to activate negative campaigns and burdensome regulatory requirements regarding new agricultural or food technologies. For example, the European Commission recently proposed a new novel foods regulation which includes coverage of food products from cloning and nanotechnology. In its current form, many key components of this proposal are ill-defined. In addition, it envisions an onerous pre-market approval process. It could also require products approved under the regulation to carry mandatory labels and to be subject to significant post-market monitoring, even if determined to be substantially equivalent to conventional counterparts.

FOOD PRODUCTS FROM CLONED ANIMALS

Currently, the EU claims that there are no food products in the EU market derived from cloned animals or their progeny. In December 2007, the European Food Safety Agency (EFSA) provided a draft scientific opinion on food safety and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from these animals. A report was issued on July 24, 2008. In the draft report EFSA stated that researchers found no difference exceeding the normal variability in the composition and nutritional value of meat from swine and cattle and cow milk between healthy clones or the progeny of clones and their conventional counterparts. The currently available data indicate that food products from cloned cattle and pigs and their progeny are as safe as food products of livestock derived by conventional breeding.

EFSA stated that based on current knowledge there is no expectation that clones or their progeny would pose any new or additional environmental risk compared with conventionally bred animals. The entire report can be accessed at the following address: http://www.efsa.europa.eu/EFSA/DocumentSet/sc_opinion_clon_public_consultation.pdf .

In January 2008, the European Group of Ethics (EGE) published their opinion on ethic al aspects of animal cloning for food supply. The EGE has doubts as to whether cloning animals for food supply is ethically justified. Whether this applies also to progeny is open to further scientific research. The entire report can be accessed at the following address: http://ec.europa.eu/european_group_ethics/activities/docs/press_release_opinion23_en.pdf.

NANOTECHNOLOGY

Nanotechnology is a broad field in which the manipulation of matter at the molecular or atomic level occurs. Rapid advances are being made in industrial manufacturing and chemicals (such as food additives and supplements) in Europe. The news media and NGOs have in recent years exaggerated claims about hazards and potential use for this technology. Consumer groups have begun to ask questions about risks of nanoparticle-containing products and processes. They are demanding definitions and nano-specific legislation and post market regulation. Products such as sun creams, cosmetics and textiles containing nanoparticles have raised concerns as these are already available on the market.

The United States and the EU have established a working group focusing on food and agricultural applications of nanotechnology. This research-oriented group continues to discuss advances made in nano-biotechnology, with applications that could directly benefit consumers through better food packaging, spoilage detection and nutrient absorption.

MEMBER STATES INDIVIDUAL SITUATIONS

Austria: Austria remains one of the leading forces within the EU Europe against agricultural biotechnology. Zones restricting the use of biotechnology exist in all nine provinces, and all Austrian provinces are members of the "European Network of GMO-free Regions". National ordinances still effectively prevent the planting of EU approved biotech crops. Responding to consumers' and politicians' anti-biotech attitudes, and NGOs' anti-biotech lobbying, the Austrian retail sector has agreed to refrain from stocking or selling biotech foods. Presently, only biotech feed (soybean meal) can be found in the Austrian market.