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Division 6 EXTRAPOLATION FROM MAJOR TO MINOR SPECIES

United Kingdom

Original text. Later amendments are not shown.

Minor species are defined in Article 1(2) of this Regulation.

A more limited submission will normally be accepted for a proposed extension of the authorised use to a species which is physiologically comparable to one in which the use of the additive has already been granted.

The following requirements apply only to requested authorisations for minor species of additives already authorised for major species. For requested authorisations for new feed additives requested only for minor species, all sections fully apply, depending on the category/functional group of the additive (see corresponding specific requirements of Annex III).

  1. 6.1Section I: summary of the dossier
  2. 6.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  3. 6.3Section III: studies concerning the safety of the use of the additive
  4. 6.4Section IV: studies concerning the efficacy of the additive
  5. 6.5Section V: post-market monitoring plan