agrochemicals which contain certain biological control agents that are derived from natural materials. As for all agrochemicals, biopesticides also have to be authorized for use according to Regulation (EC) No. 1107/2009 before they can be placed on the market.Biopesticides is a term that applies to
Biopesticides can be grouped into the following categories:
- Biochemicals, such as
- Pheromones or other semiochemicals
- Plant extracts
- Organic acids
- Plant growth regulators
- Microorganisms, such as
- Yeasts and others
- New alternative products
Due to their characteristics, which may differ significantly from synthetic chemical products as well as from each other, specific guidance is followed for these products.
As for all agrochemicals, biopesticide applicants have to demonstrate that products are not only effective but also safe for the environment, operators, and bystanders. For some groups, specific guidance documents indicate areas with more scope for justifications compared to “classical” pesticides; but in all cases, experience cannot be substituted.
Additional considerations may apply for biopesticide products if, e.g. microbials are pathogenic to humans or animals, they produce toxins, or they have multiplication potential in the environment.
We have broad experience in the registration of biopesticide active substances and products. Let us be of service to you!
Data gap analysis:
We review your available data and check whether it fulfills the requirements of current regulatory and guideline requirements.
Monitoring of studies:
We identify suitable contract labs for your data gaps, request quotes, review study plans/reports against guidelines and requirements, and audit study performance.
We monitor your efficacy trials and write high-quality efficacy dossiers. We provide full-service including the writing of study protocols, evaluation of efficacy data, preparation of resistance risk analyses, and preparation of master labels.
Active substance and product dossier preparation:
Based on the available data, we prepare your complete summary dossiers, including literature research. We are proficient in the calculation tools used for EU approval and additional tools necessary for national registrations. We perform state-of-the-art risk assessments and science-based expert statements.
Zonal and national approaches EU-wide and especially for Germany:
We provide consulting services for zonal applications, mutual recognitions as well as specialized registrations in Germany. We notify and apply on your behalf, follow-up your application at the authorities, assist with any issues, and demand timely approvals.
Active substance renewal:
You receive full-service for the renewal of your active substances, including comparing your data to the requirements, identifying data gaps, providing cost estimation of the entire application, and taskforce management.