# 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 4: Risk characterisation

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

The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.
Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk shall be provided. In that case, a categorical description ( ‘ high ’ , ‘ moderate ’ , ‘ low ’ or ‘ negligible ’ ) of the risk shall be used and an explanation of the scale of effect represented by each category shall be provided.
Where relevant, the uncertainty for each identified risk shall be described and, where possible, expressed in quantitative terms.

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Source: https://www.legislation.gov.uk/eudr/2001/18/annex/II/division/C/division/C.3/division/4 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-18/annex-II/division-C/division-C.3/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.