# 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), Article 3: Dossier

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

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.

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