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1.The dossier shall adequately and sufficiently demonstrate that the feed additive satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003.
2.The general requirements for the preparation and presentation of the dossier shall be as set out in Annex II.
The specific requirements to be satisfied by the dossier, in the case concerned, shall be as set out in Annex III.
The minimum duration of long term studies shall be as set out in Annex IV.
3.By way of derogation from paragraph 2, the applicant may submit a dossier not satisfying the requirements provided for in paragraph 2, provided that he submits a justification for each element not complying with those requirements.