# 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 2.2.3.1: Studies concerning the safety of use of the additive for target animals

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

(1)Natural products (either botanically defined or non–plant origin)
The safety of these products may be assessed on the basis of its major and characteristic components and also considering known substances of toxicological concern. If the major or characteristic components are not already authorised as chemically defined flavourings or as feed additives, then it has to be verified whether they are substances of toxicological concern for humans or animals, and its toxicological properties have to be provided in accordance with subsection 3.1 of Annex II.
(2)Natural or corresponding synthetic chemically defined flavourings
If these substances are authorised flavourings for humans, the safety for target species may be assessed taking into account the comparison between the level of intake by the target species from feed proposed by the applicant with that by humans from food. Metabolism and toxicological data on which the assessment for human used was made shall be submitted.
In all other cases different from the case where both levels of intake are similar, such as where the level of intake by the target animal proposed be the applicant is substantially higher than that by human from food or where the substance is not authorised in food, the safety for the target animals may be assessed by taking into account the following data: the principle of threshold of toxicological concern, available toxicological and metabolism data for related compounds, and chemical structural alert consideration....
Tolerance studies are needed only where threshold values are exceeded or cannot be determined.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/III/division/2/division/2.2/division/2.2.3/division/2.2.3.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-2/division-2.2/division-2.2.3/division-2.2.3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.