Efficacy requirements for new active substances (NAS)

Date: 16 April 2020

Efficacy questions are of special relevance for each agrochemical, but the detailed focus here is on the authorization process of the plant protection products themselves and less on the approval process of the new active substances contained in the respective plant protections products. Accordingly, it is important to make a distinction between efficacy of an active substance at the approval stage and efficacy of plant protection products containing that active substance at the authorization stage.

Nevertheless, efficacy aspects like data on application and efficacy, function of an active substance (e.g. as herbicide or fungicide), its effects on harmful organisms or information on the occurrence or possible occurrence the development of resistance and appropriate management strategies have to be addressed in the data package to be submitted for the approval process. Such basic efficacy data requirements are laid down in COMMISSION REGULATION (EU) No 283/2013 of 1 March 2013.

A more precise description of the efficacy data requirements for the approval of new active substances is given in Guidance Document SANCO/10054/2013, stating that the main objective of the efficacy evaluation of an active substance is to confirm that the doses are realistic for the GAP submitted for risk evaluation at active substance approval but also representative for all subsequent product authorisations.

In order to address the efficacy of a new active substance on harmful organisms test results have to be submitted to demonstrate the effectiveness of this substance against at least one of the target species for which product authorisation will be sought in a range of crop species. Data should be supplemented by the results of realistic field trials from at least one year in at least one crop, and on at least one of the target species using a representative formulation of the new active substance, confirming that the proposed GAP is based on realistic practical conditions.

Besides testing at the proposed target dose, additional information on a range of doses above and below may be useful in order to confirm that the target dose is indeed sufficiently effective. Furthermore, test data shall confirm that there are no unacceptable effects on crops or accordant products.

In comparison to the authorization process of a plant protection product there is no requirement to submit a Biological Assessment Dossier (BAD) or individual trials reports as part of the approval of an active substance. Nevertheless, a concise summary of the effectiveness against named targets, representative of proposed uses at the proposed dose(s) and crop safety at the proposed dose(s) should be provided. It may also be useful to include a compilation of results at lower doses. The concise summary should also include a brief synopsis of any preliminary screening data which establishes the range of targets of the active substance.

Joachim Kranz