Division 1.4.1 Content of the micro-organism

The minimum and maximum content of the micro-organism in the material used for manufacturing of formulated products, must be reported. The content shall be expressed in appropriate terms, such as number of active units per volume or weight or any other manner that is relevant to the micro-organism.

Where the information provided relates to a pilot plant production system, the information required must again be provided to the F1competent authorities once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.