Proposals for Regulation of Botanicals

Abstract

Plants and plant extracts, here called ‘botanicals’, have been used for plant protection for a long time. Quantitatively, the most important botanical is pyrethrum, followed by azadirachtin, rotenone and essential oils. The current regulatory system for pesticides is often seen as a major hurdle for the market introduction of new botanicals. The EU-funded Specific Support Action project ‘REBECA’ has held a series of workshops with stakeholder representatives. The following proposals for improvement were elaborated: (1) development of a specific guidance document for botanicals; (2) adapted requirements concerning the characterisation of the active substance(s); (3) relaxations concerning identification and analytical methods for ‘impurities’; (4) adapted requirements concerning the description of manufacturing methods; (5) adapted requirements for risk assessment, taking into account the history of safe use of the substance; (6) adapted requirements concerning efficacy evaluation. During the final conference of the REBECA project, it was evaluated which proposals can be implemented easily (and therefore in a short time-span). Also, the impact on the duration of the registration process and on the costs of registration (for the applicant) were assessed for each proposal. Fenugreek, neem extract/Quassia, lecithine and laminarine were selected as representative botanicals. For these substances, the REBECA proposals would decrease registration costs substantially.