Basic substances: an opportunity for approval of low-concern substances under EU pesticide regulation.

Abstract

Plant extracts and byproducts furnish various alternative products for crop protection and are traditionally used by farmers. However, the cost and timeframe for their registration as active substances are prohibitive for small companies and farmers' associations with the new Plant Protection Products (PPP) Regulation (EC) No. 1107/2009. However, there is now a possibility of registering light compounds as 'basic substances', a new category described in Article 23 and in 'Whereas/Recital 18'. We developed a regulatory expertise on the approval of such products within the framework of the PPP regulation. A Draft Assessment Report in one volume was established, later transformed by EC Directorate into a Basic Substance Application Template, and subsequently used by the EC as a matrix for the corresponding Guidelines for applicants (SANCO 10363/2012 rev. 9). Here we provide further tools, consisting of methodological, linguistic and strategic recommendations in order to constitute a Basic Substance Application (BSA) and proceed to its registration. While the use of alternative agents for crop protection is increasing both in organic and conventional agriculture, these usages are still considered as 'minor uses'. Our approach and tools are valuable to non-PPP specialised applicants for simplifying and facilitating their submission of the BSA.