Recovering the Original Intentions of Risk Assessment and Management of Genetically Modified Organisms in the European Union | Bioengineering and Biotechnology

Shifting Focus to Organisms and Their Traits

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There is much unnecessary confusion nowadays on whether the EU is regulating GMOs on basis of the techniques that were applied or on the nature of the resulting organisms and their derived products. According to the EU Directive 2001/18/EC, a GMO is defined as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (Official Journal of the European Communities, 2001). Custers (2017) points out that this definition is somewhat ambiguous regarding the interpretation of “altered in a way,” and shows that Annex 1A, part 1, of the same Directive gives further indications by stating that “Techniques of genetic modification referred to in Article 2(2)(a) are inter alia: (1) recombinant nucleic acid techniques involving the formation of new combinations of genetic material […] and their incorporation into a host organism in which they do not naturally occur.” This means that within the EU regulatory framework a GMO is achieved only when the application of a particular technique leads to a particular result, i.e., an organism carrying artificially recombined nucleic acids in novel formation. This view is also shared by other authors (Sprink et al., 2016a,b; Kahrmann et al., 2017) as well as by the European Commission (European Parliament, 2014)...

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