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Table 1 Different headings for the 6 steps of ERA, in EU Directive 2001/18 [22] and the EFSA Guidance [17]

From: GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail

Directive 2001/18EFSA 2010 guidance
1. Identification of characteristics which may cause adverse effects1. Problem formulation including hazard identification
2. Evaluation of the potential consequences of each adverse effect, if it occurs2. Hazard characterisation
3. Evaluation of the likelihood of the occurrence of each identified potential adverse effect3. Exposure characterisation
4. Estimation of the risk posed by each identified characteristic of the GMO(s)4. Risk characterisation
5. Application of management strategies for risks from the deliberate release or marketing of GMO(s)5. Risk management strategies
6. Determination of the overall risk of the GMO(s)6. Overall risk evaluation and conclusions