# 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 3.3.2.2: Toxicological studies

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

These are required for fermentation products and additives not already authorised. For fermentation products, genotoxicity and subchronic toxicity studies must be provided unless:
1..the active substance is separated from the crude fermentation product and is highly purified; or
2..the production organism has a history of apparent safe use and there is sufficient knowledge of its biology to exclude a potential for the production of toxic metabolites.
Where the production organism belongs to a group in which some strains are known to produce toxins, their presence shall be specifically excluded.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/3/division/3.3/division/3.3.2/division/3.3.2.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-3/division-3.3/division-3.3.2/division-3.3.2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.