# Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance), Division 3.2.2.2: Genotoxicity studies including mutagenicity

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

To identify active substances and, if appropriate, their metabolites and degradation products with mutagenic and genotoxic properties, a selected combination of different genotoxicity tests must be carried out. If appropriate the tests shall be performed without and with mammalian metabolic activation and the compatibility of the test material with the test system shall be taken into account.
The core set comprises the following tests:
(1)induction of gene mutations in bacteria and/or in mammalian cells (preferably the mouse lymphoma tk assay);
(2)induction of chromosomal aberrations in mammalian cells; and
(3)in vivo test in mammalian species.
Additional tests may be needed depending on the outcome of the above mentioned tests and taking into consideration the whole toxicity profile of the substance, as well as its intended use.
Protocols should be in line with OECD Guideline 471 (Salmonella typhimurium Reverse Mutation Test), 472 (Escherichia coli Reverse Mutation Test), 473 (in vitro Mammalian Chromosomal Aberration Test), 474 (Mammalian Erythrocyte Micronucleus Test), 475 (Mammalian Bone Marrow Chromosomal Aberration Test), 476 (in vitro Mammalian Cell Gene Mutation Test) or 482 (Unscheduled DNA Synthesis in Mammalian Cells in vitro), as well as other relevant OECD Guidelines for in vitro and in vivo assays.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/3/division/3.2/division/3.2.2/division/3.2.2.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.