Table 1 Different headings for the 6 steps of ERA, in EU Directive 2001/18 [22] and the EFSA Guidance [17]
Directive 2001/18 | EFSA 2010 guidance |
|---|---|
1. Identification of characteristics which may cause adverse effects | 1. Problem formulation including hazard identification |
2. Evaluation of the potential consequences of each adverse effect, if it occurs | 2. Hazard characterisation |
3. Evaluation of the likelihood of the occurrence of each identified potential adverse effect | 3. 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 |