Efficacy & Biological Assessment Dossiers
Exponent’s EU Efficacy team has vast practical experience in testing and evaluating all types of plant protection products (biopesticides, fungicides, herbicides, insecticides, plant growth regulators) and biocides (disinfectants, preservatives, insecticides, rodenticides, anti-fouling and molluscicides) at the global, European and national levels. The Efficacy team has many years of experience in writing EU regulatory dossiers, working in expert groups, harmonising efficacy data requirements, and producing guidance documents.
The support we can provide to our clients include the following:
- 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 authorisations 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 programmes to fulfil 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 programmes
- 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.