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Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 established a framework for Community action to bring about the sustainable use of pesticides and encourage low concern biorationals. Basic substances described in article 23 of EC phytopharmaceutical Regulation No 1107/2009 consist of a new operative category for crop protection products with 16 substances approved so far. Another status, ruled by article 22 is also operative with 11 approved low-risk substances (see EU pesticide database). Now small and medium-sized enterprises (SMEs) have the opportunity to register biorationals at the EU level in one of the two categories. Our institute previously provided technical expertise on how to complete the Basic Substance Application (BSA), together with a description of first results. However it is clear that there is a need for a shorter survey of the two parallel procedures for SMEs. Here we provide a concise sequence of the necessary steps for SMEs, including strategic approach, a rapid steps description, a timeframe for the global pathway, up to the final step, after approval by the Plants, Animals, Food and Feed Standing Committee (PAFF). We present in detail the advantages and limitations of the two statutes. The introduction of approved substances into organic farming is also discussed. Currently basic and low-risk substance pathways are now accessible for biorationals handled by SMEs. Therefore, the option is open for SMEs to seek a possibly low-risk active substances endorsement with market authorizations or a basic substance approval with no plant protection product claims depending on the selected strategy.

journal of plant protection research

Basic and low-risk substances under European Union pesticide regulations: a new choice for biorational portfolios of small and medium-sized enterprises