# Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, Division 2: Hazard characterisation

Extent: E+W+S+N.I.

The magnitude of each potential adverse effect shall be evaluated. This evaluation shall assume that such an adverse effect will occur. The e.r.a shall consider that the magnitude is likely to be influenced by the receiving environment(s) into which the GMO is intended to be released and by the scale and conditions of the release.
Where possible, the evaluation shall be expressed in quantitative terms.
Where the evaluation is expressed in qualitative terms, a categorical description ( ‘ high ’ , ‘ moderate ’ , ‘ low ’ or ‘ negligible ’ ) shall be used and an explanation of the scale of effect represented by each category shall be provided.

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Source: https://www.legislation.gov.uk/eudr/2001/18/annex/II/division/C/division/C.3/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.3/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.