Scrutinizing the current practice of the environmental risk assessment of GM maize applications for cultivation in the EU

We analysed the data presented for three assessment categories of the ERA of genetically modified [GM] maize applications for cultivation in the European Union: the agronomic evaluations and the assessments of the effects of GM maize on target organisms and of its potential adverse effects on non-target organisms.Major shortcomings causing considerable uncertainties related to the risk assessment were identified in all three categories. In addition, two principles of Directive 2001/18/EC are largely not fulfilled - the consideration of the receiving environment and the indirect effects, as mediated, e.g. by the application of the complementary herbicide in the case of herbicide-tolerant GM maize.We conclude that the current practice of ERA does not comprehensively fulfil the scientific and legal requirements of Directive 2001/18/EC, and we propose improvements and needs for further guidance and development of standards. The recommendations address likewise applicants, risk assessors as well as decision makers.Authorisation of genetically modified organisms [GMOs] in Europe is regulated by Directive 2001/18/EU [1] and Regulation (EC) 1829/2003 [2], respectively. The objective of Directive 2001/18/EC [1] is to protect human health and the environment when a GMO is placed on the market as or in products (Article 1). The focus is on the preventive action due to the ability of living organisms to reproduce and the irreversibility of the release of GMOs in the environment. Thus, the Directive requires a case-by-case approach to the environmental risk assessment [ERA] to be carried out prior to decisions on applications. Annex II of the Directive defines the general principles of the ERA, the steps, the methodology and the conclusions to be drawn on the potential environmental impact from the release or the placing of GMOs on the market. Annexes III and IV lay down the information requirements to be included in applications. When performing the ERA, the applicant has to co