Division (ii) For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.

The most important and informative information is obtained by the characterisation and identification of a micro-organism. Such information is found in Sections 1 to 3 (identity, biological properties and further information) which form the basis for an assessment of human health and environmental effects.

Newly generated data from conventional toxicological and/or pathological experiments on laboratory animals are normally required unless the applicant can justify, on the basis of the previous information, that the use of the micro-organism, under the proposed conditions of use, does not have any harmful effects on human and animal health or on groundwater or any unacceptable influence on the environment.