What is a Biological Assessment Dossier (BAD)?
A Biological Assessment Dossier (BAD) is the efficacy-focused part of a regulatory dossier submitted to authorise a Plant Protection Product (PPP) in the EU. It compiles the biological performance data: how well the product works, under what conditions, and against what target, required under Regulation (EC) No. 1107/2009.
What does a Biological Assessment Dossier contain?
A BAD brings together the efficacy and crop safety data for a Plant Protection Product: field trial results, dose-response data, performance against the target pest, disease, or weed, and any effects on the treated crop. This is distinct from the toxicological or environmental fate sections of a registration dossier. A BAD is specifically about whether, and how well, the product does what it claims to do.
Where does a BAD fit in the registration process?
Under Regulation (EC) No. 1107/2009, a BAD supports the efficacy section of the draft Registration Report (dRR Part B) submitted to the Rapporteur Member State or to national authorities during zonal or national registration. GEP-compliant field trials are the primary data source feeding into a BAD; without properly conducted, documented trials, the dossier doesn’t hold up under regulatory review.
Why does a Biological Assessment Dossier matter for product developers?
A weak or incomplete BAD is one of the more common reasons a registration submission gets delayed with data requests, or a product fails to demonstrate the efficacy authorities require. Getting trial design, data analysis, and dossier compilation right the first time shortens the path to approval.
FAQ
BAD stands for Biological Assessment Dossier, the part of a PPP registration dossier that covers efficacy and crop safety data.
No. A BAD covers efficacy specifically. A full registration dossier for a Plant Protection Product also includes chemistry, toxicology, residues, and environmental fate and ecotoxicology sections.
BADs are typically prepared by regulatory consultants or CROs working with the product developer, using data generated from GEP-compliant field trials.
Regulation (EC) No. 1107/2009 sets the data requirements for Plant Protection Product authorisation in the EU, including the efficacy data compiled in a BAD.