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)

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ANNEX II U.K. 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 U.K.

2.3. Manufacturing process, including any specific processing procedures U.K.

To define the critical points of the process that may have an influence on the purity of the active substance/agent(s) or additive a description of the manufacturing process shall be given. A material safety data sheet of chemicals used in the production process shall be provided.

2.3.1. Active substance(s)/agent(s) U.K.

A description of the production process (e.g. chemical synthesis, fermentation, cultivation, extraction from organic material or distillation) used in the preparation of the active substance(s)/agent(s) of the additive shall be submitted, if appropriate by way of a flowchart. The composition of the fermentation/cultivation media shall be provided. Purification methods shall be thoroughly described.

For Genetically Modified Micro-organisms (GMMs), used as source of additives and grown under contained conditions, Council Directive 90/219/EC(1) applies. A description of fermentation processes (culture medium, fermentation condition and downstream processing of the fermentation products) shall be included.

2.3.2. Additive U.K.

A detailed description of the manufacturing process of the additive shall be submitted. The key stages in the preparation of the additive including the point(s) of introduction of the active substance(s)/agent(s) and other components, and any subsequent processing steps affecting the additive preparation should be provided, if appropriate by means of a flowchart.

(1)

OJ L 117, 8.5.1990, p. 1. Directive as last amended by Commission Decision 2005/174/EC (OJ L 59, 5.3.2005, p. 20).