# 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 3.3.1.1: Tolerance of the target species

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

1..No studies are required for urea, and amino acids, their salts and analogues ... and compounds of trace elements and vitamins, pro-vitamins and chemically well-defined substances having similar effect which do not have a potential to accumulate already authorised as feed additives under Article 10 of Regulation (EC) No 1831/2003.
2..For those additives that fall within the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ and having a potential to accumulate, tolerance will only be required to be demonstrated for compounds for which potency is expected or has been demonstrated to be different from that of the well established vitamin(s). In certain cases elements of the tolerance test (design or criteria) could be combined with one of the efficacy trials.
3..Tolerance will be demonstrated for urea derivatives amino acid analogues and compounds of trace elements not previously authorised. The fermentation products will be requested by tolerance demonstration, unless the active substance is separated from the crude fermentation product and highly purified, or the production organism has a history of apparent safe use and well known about its biology to exclude a potential for the production of toxic metabolites.
4..Where the application is for all animal species/categories, one tolerance study on the most sensitive species (or even an appropriate laboratory animal) under the most recent knowledge is sufficient.

---
Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/3/division/3.3/division/3.3.1/division/3.3.1.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-3/division-3.3/division-3.3.1/division-3.3.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.