A company who wishes to carry out a field trial of a genetically modified organism (GMO) in an EU member state must apply for approval to the relevant national competent authority designated under Part B of EU Directive 2001/18/EC. Member states are obliged to transpose the Directive, including the procedure for assessment of, and decisions on, applications for field trials of GMOs.
Directive 2001/18/EC has been transposed into Irish law by the Genetically Modified Organisms (Deliberate Release) Regulations 2003. These regulations assign the function of evaluating applications under Part B of the Directive to the Environmental Protection Agency.