A Scheme for Safety Testing and Assessment of Biochemicals under the EU Plant Protection Products Regulation...

Biochemicals (e.g. substances that originate from nature) are often of lower risk to humans and the environment. Nonetheless, when intended for use as active substances in the European Union (EU), they are subject to the same, extensive data requirements as conventional active substances. This impairs their applicability to support a sustainable agriculture. Here, a Scheme for Safety Testing and Assessment of Biochemicals under the EU Plant Protection Products Regulation (BiochemPPP-STAS) is proposed. The BiochemPPP-STAS provides a flexible approach to identify relevant endpoints and studies, the scientific rationale to justify the waiving of studies that would not contribute to the safety assessment and general advice to prepare a 'fit-for-purpose' dossier for approval of the biochemical active substance. If the background exposure to the naturally occurring counterpart of the biochemical active substance is not substantially increased through its agricultural use, there is no relevant exposure and further risk assessments are not needed. Prior to the generation of new data, all available information is retrieved and evaluated to address areas of concern and resulting uncertainties. Preferably, data needs are identified following an iterative process, in close alignment between applicant and authority. A base dataset is generated to determine triggers of concern that require follow up in vertebrate animal intensive studies, which are, thus, only conducted as a last resort. To facilitate its regulatory applicability, the BiochemPPP-STAS has been closely aligned with EU legislation. Nonetheless, it has been designed generically and can be adapted to fulfil the legal requirements implemented in other jurisdictions.