One of the most complex and controversial issues that the EU is facing today is the regulation of the genetically modified (GM) foods and corps. European Biotech policy is also one of the policy areas that strongly challenge EU’s trade policy on agricultural goods and is the source of many WTO disputes. There are currently three main challenges of the modern agricultural biotechnology that the EU and its institutions are presented. The first, the issue itself is very mutli-sectoral which cuts across multiple issue areas. Second, the issue is so multi-level that involves the national, supranational and global levels of governance. Last but not least, the issue is concerned with risk regulation and legitimacy which involves the scientific and ethical challenges to the EU. 
There was nothing mentioned about a policy for biotechnology and any closely related areas of the food safety in The Treaty of Rome in 1957. However, in the recent decades, there were de facto policies that developed by the EU on relative areas such as agriculture, food safety and others which eventually spilled over the regulation of the content and labelling of GM foods and crops. In the 1980s, with development of genetic engineering and the willingness of the regulation of biotechnology by member states drew the Commission’s attention to be more active in the regulation of biotechnology within a Community framework. In 1983, EU Framework R&D Programme extended over Biotechnology as well. In order to determine a new regulatory approach, the Commission created the Biotechnology Steering Committee (1984) and the Biotechnology Regulation Inter-service Committee (1985). In 1988 twin directives on Contained Use and Deliberate Release of GMOs was proposed by the Commission and in 1990 the Council adapted Directives (90/219 and 90/220). 
One of the most important regulations in the direction to regulate the GM foods and crops came by so-called the Novel Foods Regulations in 1997. In the regulation, “novel foods” have been defined as kind of foods or ingredients that had “not hitherto been used for human consumption to a significant degree within the Community.” The authorization procedure for the novel foods was also created by the regulation. In order to market novel foods in a member state, any given novel foods trader was required to submit application in that member state before to place their novel foods.
Some considerable important events have occurred and those events strongly challenged Commission’s way of handling GM foods and crops regulation. Therefore, since 2000 the Commission decided to resume its biotech policy and carry out couple of reform on the EU Biotech Policy. Some of the key events that should be specially mentioned are the White Paper on Food Safety (2000), White Paper on the Precautionary Principle (2000), adaptation of Cartagena Protocol on Biosafety (2000), establishment of European Food Safety Authority (2002), entry into force of Regulation 1829/2003 on Genetically Modified Food and Feed.
EU’s regulation policy on the GMOs also faces external challenges such as from the US and the WTO. One the biggest external challenges came from US in 2003 with a complaint in the WTO framework against the EU for its GMOs policy.
To sum up, the current EU Biotechnology Policy is shaped as the result of historical debates, regulations, declarations, and events by the EU and still face many challenges.
Turan Suleymanov (Turan Suleymanoglu)
Professor of Management
The International School of Economics
 Wallace H, Wallace W, Pollack A, Policy Making in the European Union Oxford University press 2005, pp.329-348
 Ibid. 329-348