The evaluation of the product’s efficacy is required as part of the application process for the marketing authorization in the EU for phytopharmaceutical products and biocidal products, under regulations (EC) No 1107/2009 and (EU) No 528/2012.
Efficacy aims to evaluate the positive effects of the product to control the target pest or any other claimed effect (‘effectiveness’). For phytopharmaceutical products, side effects on crops (‘crop selectivity’, effect on following or adjacent crops, etc) and on non-target organisms must also be assessed.
The risk of increased resistance and appropriate management strategies are also studied.
For biocides, the conditions of use which guarantee the product’s efficacy are also taken into account when assessing the risk that the use of the product may pose to both man and the environment.
Our Efficacy teams can support our clients with a full range of services for phytopharmaceutical products and biocidal products:
- Development or validation of European study programmes
- Implementation and monitoring of efficacy studies (GEP for phytopharmaceutical products)
- Dossier preparation, particularly Biological Assessment Dossiers (BADs) and dRR summaries
- Comparative assessments for products that contain candidate substances for substitution
- Scientific arguments / waivers under article 4.7 of the regulation (EC) No 1107/2009 (for active substances matching the exclusion criteria)
- Ad-hoc technical documents for specific requirements