Efficacy & Biological Assessment Dossiers

Evaluate and document plant protection product performance

Gathering appropriate data to support the EU Biological Assessment Dossier requirement for plant protection product performance and efficacy requires an independent third-party evaluation. Exponent's Efficacy team has extensive experience in the testing and evaluation of all types of plant protection and biocides at the global, European, and national levels.

Thought leadership

Considerations for the Successful Submission of Biocidal Product Dossiers in the EU

Chemicals

Chemical Regulation and Food Safety

Integrated, global approach to regulatory compliance.

Exponent's EU Efficacy team has vast, practical experience working with a variety of plant pesticides, including biopesticides, fungicides, herbicides, insecticides, and plant growth regulators, as well as biocides, including disinfectants, preservatives, insecticides, rodenticides, anti-fouling, and molluscicides. Our Efficacy team has many years of experience in writing and finalizing EU regulatory dossiers, working in expert external and internal client groups, coordinating and satisfying efficacy data requirements, and producing guidance documents.

Services

For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

• Preparation of Biological Assessment Dossiers (BADs) and dRR concise efficacy evaluation documents for plant protection products under Regulation (EC) No. 1107/2009

• Comparative assessments for Candidates of Substitution and sustainable use (IPM) documents

• Preparation of efficacy dossiers in IUCLID format plus production of PARs to support active substance and product authorizations under the Biocidal Products Regulation (EU) No. 528/2012

• Performing data gap analyses on your current efficacy data set to identify data gaps or potential problems and provide possible solutions to these issues

• Assistance in the planning and monitoring of efficacy testing programs to fulfill data requirements

• Assistance in the development of study plans and test protocols using relevant guidance/methods (i.e., EPPO, CEB, ASTM, EN, FAO, WHO, ISO, OECD, OPPTS)

• Provision on guidance on placing efficacy tests with suitable testing facilities and full management of efficacy testing programs

• Assistance in the drafting of product labels

• Provision of advice relating to GEP and National Standards for efficacy testing

• Provision of training in all aspects of efficacy

Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.