One of the pre-requirements for registering an agrochemical is to be able to produce sufficient evidence that it shows the necessary level of activity. The results of field studies are reported and summarized in a Biological Assessment Dossier (BAD) according to EPPO or other regulatory zones. Besides efficacy trials, studies are also done to show the degree of selectivity, or to determine how the product influences the quantity and quality of the harvest.

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An additional, increasingly important aspect is estimating the risk of resistance development to all groups of active substances and demonstrating that measures are available to reduce this risk. An assessment is also made of the suitability of an agrochemical for Integrated Pest Management, which involves combining various different techniques to avoid or control damage to crops.

„Agronomic equivalency“ of genetically-modified plants

One of the requirements for the registration of genetically-modified plants (GMOs) is to demonstrate in field trials that they are agronomically equivalent to conventional plants.

Our services with regard to efficacy

Full service package“ for plant protection products (PPP) according to EU Regulation 1107/2009/EC

  • Data gap analysis of existing data packages
  • Study management:
    • Design of cost efficient trial programs covering EU regulation and all EPPO climatic zones
    • Study plans according to GEP and relevant EPPO standards as well as national guidelines (e.g. CEB) for Efficacy and Crop safety trials as well as other special studies e.g. for Baseline Resistance, Succeeding and Adjacent crops, Rainfastness, Tank mix, Cleaning equipment etc.
    • Outsourcing of trials to reliable certified testing facilities
    • Monitoring of trials for the entire trial period. Analysis of trial data after 1st season with interim report
    • Data management with appropriate software (ARM)
  • Preparation of
    • dRR Section 3 (B3) including the Biological Assessment Dossier
    • Label extensions (LEX)
    • National addenda
    • Registration documents for adjuvants
  • Comparative Assessment (EPPO 1/271) for PPP containing candidates for substitution active substances (CfS)
  • Resistance risk analysis and management strategies (EPPO 1/213)
  • Liaise with national Regulatory authorities and providing guidance before, during and after submission
  • Electronic submission of dossier in CADDY format
  • Efficacy evaluation for fertilisers, plant strengtheners and biostimulants („Full service package“ comparable to PPP)

Approval of chemical new active substances and renewal of approval of a chemical active substance

  • Check of Completeness
  • Preparation of the MCP 3 and MCP 6 section (and the corresponding LCP sections)
  • Resistance management strategy and statements
  • GAP scoping for Product Renewal (Art. 43) if changes in end-points during the EU review of the active substance

Strategies for Integrated Pest Management – IPM

Evaluation of genetically-modified plants (GMOs) in comparison with conventional varieties („agronomic equivalency“)

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