Evaluation of micro-organisms at taxonomic/strain level

EC regulations concerning the implementation of Directive 91/414/EEC stipulate that micro-organisms have to be evaluated at strain level. Detailed information is given in Guideline SANCO/10754/2005 rev. 5, "Guideline developed within the Standing Committee on the Food Chain and Animal Health on the taxonomic level of micro-organisms to be included in Annex I to Directive 91/414/EEC". The word 'strain' refers to the culture which is allocated to a culture/strain collection number. Correspondingly, as a rule, micro-organisms are evaluated in the EC and included as active substances in Annex I of Directive 91/414/EEC at strain level; (naming the species in Annex I and evaluating new isolates in the context of national authorisations is being discussed for baculoviruses at present). Documentation on the species can be taken into consideration if it is relevant for the strain concerned. The reason for this procedure is that differences can occur between different cultures/strains of the same species. For example, the species Fusarium oxysporum includes plant pathogenic and non pathogenic strains. The production of metabolites can also vary for different strains.

Correspondingly the BVL also follows this procedure for the national authorisation of plant protection products which contain micro-organisms. Therefore, for applications for authorisation, the active substance name must include the strain, or the isolate in the case of baculoviruses.

For authorised products with micro-organisms, the BVL has altered the active substance names to correspond with the corresponding strains so that they now appear in the printed and electronic plant protection products indexes. Authorisation holders must proceed correspondingly at the latest by the time the respective decision on inclusion enters into force, since the decision on inclusion in Annex I of the directive stated is taken at strain level. For the sake of clarity, it is recommended to allocate names at strain level now.