# Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance), Division II.6.3.6.11

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

In general the genotoxicity of major metabolites shall be considered to be adequately addressed by studies performed with the parent substance. However, if a major metabolite is produced in the target species but not in the laboratory animal species it may not be possible to conclude on the genotoxicity of residues without additional data generated using the relevant metabolite.

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.6/division/II.6.3/division/II.6.3.6/division/II.6.3.6.11 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.3/division-II.6.3.6/division-II.6.3.6.11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.