Agrochemicals - Plant Protection Products and Active Substances
We have more than 25 years of experience in the regulatory affairs of agrochemicals and biopesticides.
Active substances, basic substances, safeners and synergists must be approved on the EU level. Plant protection products and biopesticides are authorized at the national level before being placed on the market. The regulatory framework is set by Regulation (EC) No. 1107/2009 with data requirements specified by Commission Regulations (EU) No. 283/2013 (active substances) and No. 284/2013 (products).
Let our specialized staff support you with our wide array of services. Please follow the links below to learn more.
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.
Efficacy:
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.
Endocrine disruption (ED):
We are experienced in the assessment of potential for endocrine disruption in the context of Reg. (EU) No. 528/2012, Reg. (EU) No. 2018/605, and Reg. (EC) No. 1107/2009 in accordance with the EFSA Journal 2018;16(6):5311, the EFSA Journal 2017;15(8):4971, and the OECD Guidance Document 150 (2018).
Literature evaluation:
We screen public literature for relevant data and evaluate their reliability in accordance with Guidance of EFSA (EFSA Journal 2011; 9(2):2092).
Comparative assessment:
We provide support with products containing candidates for substitution (CfS), which are subject to a comparative assessment (CA).
Active substance and product dossier preparation:
Based on the available data, we prepare your complete summary dossiers, including submission in IUCLID format and 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 prepare 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.