Paragraph 11 Step 2: Hazard characterisationF1
(1)
The magnitude of each potential adverse effect must be evaluated. This evaluation must assume that such an adverse effect will occur. The environmental risk assessment must consider that the magnitude is likely to be influenced by the receiving environment(s) into which the genetically modified organism is intended to be released and by the scale and conditions of the release.
(2)
Where possible, the evaluation must be expressed in quantitative terms.
(3)
Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) must be used and an explanation of the scale of effect represented by each category must be provided.