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) (c. 429)

ANNEX II GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3

2. SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS

2.2. Characterisation of the active substance(s)/agent(s)

2.2.1. Description

2.2.1.2. Micro-organisms

For all micro-organisms, whether used as product or as production strain, the origin shall be provided.

For micro-organisms used as a product or as production strain, any history of modification shall be indicated. The name and taxonomic classification of each micro-organism shall be provided, according to the latest published information in the International Codes of Nomenclature (ICN). Microbial strains shall be deposited in an internationally recognised culture collection (preferably in the European Union) and maintained by the culture collection for the authorised life of the additive. A certificate of deposition from the collection, which shall specify the accession number under which the strain is held, must be provided. In addition, all relevant morphological, physiological and molecular characteristics necessary to provide the unique identification of the strain and the means to confirm its genetic stability shall be described. For GMOs the description of the genetic modifications shall be given. The unique identifier for each GMO, as referred in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, shall be included.