The assessment of biological efficacy is intended to ascertain in what respect and to what extent the preparation provides better results than, where appropriate, suitable reference products and in comparison with possible damage thresholds, and in order to determine the conditions of use.

The following points are taken into consideration during this assessment:

• The possibility that the pesticide-treated organism is harmful in agronomic, phyto-sanitary and environmental conditions (including climatic conditions) in the region for which the application is proposed.
• The possibility of significant damage, losses, or inconvenience in the region for which the application is proposed if the plant protection product is not used there.
• The efficacy of the plant protection product must be tested in accordance with the guidelines of the European and Mediterranean Plant Protection Organisation (OEPP). Various recommendations can also be found on this website regarding the preparation of dossiers, the zonal evaluation, the possibilities for extrapolation, etc.
• The efficacy of the plant protection product under a range of agronomic, phyto-sanitary and environmental conditions (including climatic conditions) which will probably occur in practice in the region for which the application is proposed. The possibility to be integrated in the integrated pest management must also be incorporated in the assessment.
• The adverse effects on the treated crop following application of the plant protection product in accordance with the proposed conditions of use in comparison, to the extent relevant, with one or more suitable reference products, if they exist, and/or an untreated control crop.
• The adverse effects on succeeding crops, if active substances or metabolites and their degradation and reaction products remain present to a significant degree in the soil and/or in or on vegetable products after application of the plant protection product.
• If it is recommended on the label to use the plant protection product together with other plant protection products and/or with co-formulants as tank mixtures, an assessment of the mixtures is required regarding the action and the adverse effects on the treated crop.