Biological Assessment Dossier (BAD)

Under Regulation 1107/2009, the so-called draft Registration Report (dRR) is the document to be prepared by applicants for all areas of the risk assessment, including efficacy (Section 7), as well as being the basis for the product evaluation.

However, for product performance and efficacy evaluation, the so-called Biological Assessment Dossier (BAD), traditionally submitted at national level as part of country specific dossiers, is still in use and required by authorities. In an application for authorisation of a plant protection product, the BAD represents the overall comprehensive summary and provides the detailed assessment of the efficacy data. In this, the BAD is equivalent to a study report and is to be provided as reference document in the so-called document K. The efficacy related dRR (Part B, Section 7) summarises the BAD, providing short and concise summaries for each of the Annex points and making cross-reference to the relevant sections within the BAD.

The BAD contains information on dose justification and effectiveness studies as well as on issues related to the effect on the yield or quality traits of treated plants. In addition, possible adverse effects of a plant protection product including effects on transformation processes, impact on succeeding or adjacent crops or effects on beneficial and other non-target organisms have to be described. The BAD should include a risk assessment on the possible occurrence of the development of resistance of plant pests and diseases against plant protection products or the compatibility of the product with Integrated Pest Management (IPM) and organic farming.

The BAD is a very valuable document, which provides the opportunity for scientific argumentation of the underlying testing and registration strategy, including scientific justification for waiving of studies by using extrapolation and bridging possibilities, for example for low risk plant protection products.