# Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Division 3.5: Genotoxicity

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

Tests for genotoxic potential shall be performed to reveal changes which a substance may cause in the genetic material of cells. Any substance intended to be included in a veterinary medicinal product for the first time must be assessed for genotoxic properties.
A standard battery of in vitro and in vivo genotoxicity tests in accordance with established guidance shall usually be carried out on the active substance(s). In some cases, it may also be necessary to test one or more metabolites that occur as residues in foodstuffs.

---
Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.5 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-I/division-3/division-3.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.