# Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), Division 2: The assessment referred to in Article 4(2) should be based on the following:

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

(a) the identification of any potentially harmful effects, in particular those associated with:
(i) the recipient micro-organism;
(ii) the genetic material inserted (originating from the donor organism);
(iii) the vector;
(iv) the donor micro-organism (as long as the donor micro-organism is used during the operation);
(v) the resulting GMM;
(b) the characteristics of the activity;
(c) the severity of the potentially harmful effects;
(d) the likelihood of the potentially harmful effects being realised.

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Source: https://www.legislation.gov.uk/eudr/2009/41/annex/III/division/A/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2009-41/annex-III/division-A/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.