In this chapter we will review the requirements of the Annex II of the Directive 91/414 and discuss whether these requirements are justified in relation to risk assessment. It is first necessary to identify the hazards before the associated risks can be evaluated. Regarding microbials, the first requirement is an accurate identification of the micro-organism at the species and strain levels. Whether the biological control agent belongs to a species known to include pathogens for man or plant is crucial information for conducting the risk assessment. If there is no report in the medical data banks reporting cases of pathogenicity, infectivity or toxicity due to strains belonging to the same species as the biological control agent, a minimum data set in connection to risk for human health should be accepted. When original studies are needed, adapted experimental methods should be made available. Introducing micro-organisms into the natural environment requires assessment of their fitness and behaviour under various conditions. Today molecular techniques enable the population kinetics of a microbial strain to be followed after its release into the environment. Results showed that when reintroduced into the environment from which it has been previously isolated, a micro-organism will establish but not become dominant; therefore, it does not present major risks. Effects on non-target organisms have to be studied. However, most of the methods that have been designed for chemicals do not apply to microbials, and the usefulness of some studies should be questioned. In many cases waivers should be accepted. In order to address the specific problems linked to the use of micro-organisms as plant protection products, specific regulations should be established.
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