Biological Assessment Dossier (BAD)
Efficacy and the Biological Assessment Dossiers are core work for Barkwith Associates, prepared entirely in-house by people who have spent their careers in plant protection. The assessment, and the reasoning behind it, stay with the same specialists from first review to final dossier.
We prepare dossiers in all required formats, from bridging datasets and supporting renewal applications through to large dossiers spanning multiple crops, targets and climatic zones. The work is built on extensive practical agronomy experience, this helps us accurately match a trials programme to the product and its label claims rather than to a template.
What is a Biological Assessment Dossier (BAD)?
A product that performs as claimed
A Biological Assessment Dossier (BAD) is the efficacy component of a regulatory submission used to support the authorisation of a Plant Protection Product (PPP) under Regulation (EC) No. 1107/2009. It demonstrates that a product performs as claimed by providing robust scientific evidence of its effectiveness, crop safety, and the conditions under which it can be used successfully.
A well-prepared BAD provides regulatory authorities with the confidence that a product delivers consistent and reliable performance against its intended target while supporting the proposed label claims.
What does a Biological Assessment Dossier include?
A Biological Assessment Dossier brings together all of the biological data required to demonstrate product efficacy and crop safety. Typically, this includes:
Results from Good Experimental Practice(GEP) field trials
Efficacy data against target pests, diseases, or weeds
Dose-response and application rate studies
Crop safety and selectivity assessments
Statistical analyses and interpretation of trial results
Scientific justification for the proposed label claims and use patterns
Unlike the toxicological, ecotoxicological or environmental sections of a registration dossier, a BAD focuses solely on demonstrating that the product performs effectively under practical agricultural conditions.
Where does a BAD fit within the registration process?
As part of the authorisation process under Regulation (EC) No. 1107/2009, the Biological Assessment Dossier forms the basis of the efficacy section of the draft Registration Report (dRR Part B). It is submitted to the Rapporteur Member State or national regulatory authority during zonal or national product registration.
The quality of a BAD is directly dependent on the quality of the supporting trial programme. Well-designed, GEP-compliant efficacy trials, combined with robust statistical analysis and clear scientific interpretation, are essential for a successful regulatory submission.
Why is a high-quality BAD important?
An incomplete or poorly prepared Biological Assessment Dossier can lead to regulatory questions, requests for additional data and significant delays in product approval. In some cases, insufficient evidence may prevent a product from demonstrating the level of efficacy required for authorisation.
By ensuring that trials are correctly designed, data are accurately analysed and the dossier is compiled to regulatory standards, product developers can reduce the risk of delays, minimise additional data requests and improve the likelihood of a successful registration.
Specialist Components
We can help you with:
Trials programme and protocol design matched to the product and your label claims.
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Study monitoring and management with testing facilities to keep datasets harmonised across a programme.
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Review of study compliance with Good Experimental Practice and EPPO standards.
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Trial report compilation, covering review and quality auditing of the raw trials data, statistical analysis, and fully prepared final reports.
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Data Gap Analysis, with proposals for the efficacy package your product actually requires.
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Data handling and analysis using specialist software including ARM, or Excel where that suits the dataset.
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Preparation of BAD & Part 3 dRR summaries.
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Risk assessment for non-target flora and fauna, including adjacent and succeeding crop assessments.
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Risk of resistance assessments, including in-house expert judgement on how far the available information applies to your case.
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Full Comparative Assessments for Candidates for Substitution.
Expert judgement
Our risk of resistance assessments follow EPPO Standard guidance and draw on the latest database information relevant to the submission, with in-house expert statements on how far that information applies to your case. We prepare full comparative assessments for candidates for substitution, drafted as a logical, stepwise argument, with relevance assessments of efficacy studies across climatic zones, building each case from agronomic, climatic and edaphic traits rather than relying on zone mapping alone.
Quality and compliance
Every study is reviewed for compliance with Good Experimental Practice and EPPO (European and Mediterranean Plant Protection Organization) standards. We can monitor and manage studies directly with the testing facilities, which keeps datasets harmonised across a programme.
Our expertise leads to your success -
A Case study
One of the world’s largest agrochemical companies came to us to repurpose a traditional herbicide as a fruit suppression plant growth regulator, thinning fruit production through photosynthesis inhibition.
The label claim depended on proving efficacy across multiple application rates tied to varietal sensitivity and susceptibility to chemical thinning.
We took the product data through analysis and interpretation, identified where label claim and mode of action needed closer definition, and compiled a fully compliant Biological Assessment Dossier aimed at the UK regulator and UK crop varieties.
The product was approved and is now a leading plant growth regulator for the client.
