European Commission updates low-risk criteria

The European Commission has established new criteria for low-risk substances with the aim of promoting their use. For example, the criteria are now more suitable for microorganisms. Low-risk substances are approved for a longer period than other active substances (15 years instead of 10 years). The statutory assessment period of dossiers for zonal applications for products based on these substances is 120 days.

The European Commission has established new criteria for low-risk substances with the aim of promoting their use. For example, the criteria are now more suitable for microorganisms. Low-risk substances are approved for a longer period than other active substances (15 years instead of 10 years). The statutory assessment period of dossiers for zonal applications for products based on these substances is 120 days.

Previously, the criteria for low-risk substances were rather general. But now specific sets of criteria have been developed for microorganisms and other substances. At the end of the substance assessment process, the European Commission – at the initiative of the Rapporteur Member State – determines whether a substance it is indeed low risk.

In principle, all data requirements for substance and product applications will remain the same. Regarding efficacy, however, the dossier requirements will be lower for low-risk products. The new guidance document for the efficacy of low-risk products is expected at the end of September. This document describes how these product applications shall be assessed.

A product can be assessed as low-risk only if all active substances in the product are themselves low risk and exposure to the product does not require mitigating measures. Consequently, all uses of the product must also be low risk.
In the European context, it is now being determined which procedure can be used by the competent authorities to comply with the 120-day assessment period. For a number of authorisation procedures the Ctgb charges different fees for assessing microorganisms and pheromones because this often takes less time.

Recently, the Ctgb published a special Evaluation Manual for ‘green’ products. This autumn, the Ctgb has planned three workshops on this topic; due to the great interest, a fourth workshop is being planned for October or November.