Division 2.3.1 Active substance(s)/agent(s)

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, F1a description of fermentation processes (culture medium, fermentation condition and downstream processing of the fermentation products) shall be included.