The SAFE FOODS Risk Analysis Framework suitable for GMOs? A case study

This paper describes the current EU regulatory framework for risk analysis of genetically modified (GM) crop cultivation and market introduction of derived food/feed. Furthermore the risk assessment strategies for GM crops and derived food/feed as designed by the European Food Safety Authority (EFSA) are described on which international agreement exists. Existing flaws in the EU regulatory framework for GMOs have been identified and proposals are put forward to improve current risk analysis procedures for GMOs by taking the SAFE FOODS Risk Analysis Framework into account. The SAFE FOODS framework describes an iterative decision-making process with four distinct stages i.e. framing, risk–benefit assessment, evaluation, and risk management which includes decision-making, and implementation, and a final review stage. Three major changes compared to current risk analyses practices are proposed, i.e. (i) the addition of a formal framing stage, during which problem formulation and the objectives of the risk analysis are established, (ii) enlargement of the scope of the risk assessment, by including the assessment of potential benefits, and an impact analysis of social and economic aspects, and (iii) addition of a formal evaluation stage, in order to weigh risks, costs and benefits and their distribution. Furthermore a broader participation of certain entities, organisations and individual citizens in specific segments of the risk analysis process, in particular in the framing and evaluation stage, is proposed. The proposed changes in current risk analyses practises may contribute to restore consumer confidence in risk analysis process of GMOs in the EU.