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environment. Next, in part 4, we examine the substantial challenges of implementing the
Union’s early regulations, including a revolt among member governments that invoked
safeguard clauses against GM foods that had been licensed at the Union level, and that
later imposed a de facto moratorium on the approval of new GM varieties. Faced with
widespread governmental and public calls for a stricter and more comprehensive
approach, the Union then engaged in a root-and-branch reform of EU policies. Examined
in part 5 of the chapter, this reform included the substantial revision of the 1990 Directive
as well as new regulations establishing a European Food Safety Authority and setting out
detailed rules regarding the labeling of GM foods and the traceability of GM crops “from
farm to fork.” In part 6, we examine the relationship between domestic EU regulations
and international trade and environmental rules. As we shall see, the rules and
jurisprudence of international institutions such as the WTO have shaped EU regulations,
focusing these on the use of individualized scientific risk assessment as the basis for
biotechnology regulation, while the EU has simultaneously sought to export its domestic
regulatory principles, including its version of the “precautionary principle,” to the
international arena. The final section concludes with a brief assessment of the Union’s
biotechnology policy in relation to Helen Wallace’s typologies of modes of governance,
and in particular the “regulatory mode.” The EU governance of biotechnology policy is
shaped by sustained, simultaneous, and countervailing challenges to the legitimacy of EU
decision-making in this domain from above (the WTO) and from below (the member
states and their constituents).
2. Regulating GMOs: Three Challenges
Before moving on to survey the history and the substantive aspects of EU
biotechnology regulation, it is important to discuss the three fundamental challenges
posed by GMOs to the Union’s regulatory capacity. Specifically, we focus here on
biotechnology as an issue that is inherently multi-sectoral, requiring horizontal
coordination across a range of issue-areas; inherently multi-level, requiring vertical
coordination across the national, supranational, and international arenas; and inherently
concerned with risk regulation, requiring difficult, highly contested decisions about the
Convention