Biotechnology Regulation and GMOs

Biotechnology Regulation and GMOs

Law, Technology and Public Contestations in Europe

Biotechnology Regulation series

Naveen Thayyil

This book examines the EU regulatory framework in the Genetic Modification of agriculture and food to see how adequately EU law treats serious contestations about the development and use of GMOs. Since linkages between law, technology and public contestations could have a crucial dimension in the shaping of democratic societies, the space EU law provides for publics outside of the scientific experts to shape the regulation of GMOs becomes significant. By examining the employment of the precautionary principle and (the advices from) public bioethics committees in GMO regulation, this book examines the policy claim of public participation as a mechanism to represent and mediate public contestations about the use and regulation of GMOs.

Chapter 2: The EU legal framework for GMO regulation

Naveen Thayyil

Subjects: environment, biotechnology, environmental law, law - academic, biotechnology and pharmaceutical law, environmental law, regulation and governance


EU law regulates the development and use of GMOs through allocating responsibilities to different authorities, public and private, accompanied by limited recognition of rights of public information, consultation and participation. As elaborated later in the chapter, a case-by-case examination of the risks of new GMOs, which are sought to be released for cultivation or other market purposes, is slotted between restrictions on contained use for research, and post-release specifications like labelling, traceability, coexistence and liability. This places GMO regulation within the interstices of EU environmental law, consumer law, agricultural law, food safety law and, of course, general internal market law. This chapter attempts a cursory description of EU legislation that provides the framework for EU regulation of GMOs, and to identify the room provided for public participation, consultation and information in such regulation. The EU accession to the European Convention on Human Rights (ECHR) makes EU regulation of science and technology, including GMOs, subject to the general rights and protection offered by the Convention. The European Charter of Fundamental Rights, which emphasizes that the Union is founded on the indivisible and universal values of human dignity, freedom, equality and solidarity, and on the principles of democracy and the rule of law, is recognized as part of the broad ethical framework in the EU regulation of research, development and use of science and technology. Specific insistence on public participation in EU decision-making is mostly absent in the Treaty on European Union (TEU), the TFEU and the ECHR.

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