Division Introduction

The first tier (Tier I) includes available basic information and basic studies, which have to be performed for all micro-organisms. Expert judgment will be necessary to decide about the appropriate test programme on a case-by-case basis. 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. Pending the acceptance of specific guidelines at international level, the information required shall be generated using available test guidelines (e.g. USEPA OPPTS Guidelines).

Tier II studies must be conducted if tests under Tier I have shown adverse health effects. The type of study to be performed depends on the effects observed in the Tier I studies. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.