In today’s world, agriculture has become critical and food requirement is increasing on daily basis. In order to cater to the ever increasing demand the crop production needs to increase, which means more use of plant protection products. As plant protection products can be harmful to the environment, the process of registration of plant protection products is getting much more comprehensive and time-consuming. A small data gap can result in further delay and would increase the time of getting the product in market.

Rest assured! The highly skilled regulatory services team at Excelra, provides you a comprehensive support for registration of active substances and plant protection products in Europe.

Our team provides following services:

Degradation kinetics:

  • Kinetics evaluation of laboratory degradation and field dissipation studies for active substance and metabolites using mathematical tools like KinGUI, ModelMaker, CAKE, etc.

Environmental Fate Modeling:

We provide cutting-edge Environmental Fate Modeling services – ranging from model-based data evaluation via highly standardized environmental exposure assessments to custom scenario development for Predicted Environmental Concentration (PECs) calculations.

  • Fate in soil - PERSAM, ModelMaker, excel sheet, Finnish soil calculator, CTGB soil calculator for the Netherlands.
  • Fate in groundwater - Leaching behaviors of various plant protection products evaluated by using leaching models like MACRO, PELMO, PEARL, GeoPEARL, PRZM, FROGS, etc
  • Fate in surface water - Fate of PPP reaching surface water through drift, drainage, run-off and deposition due to volatilization evaluated using models like SWASH, MACRO, PRZM, TOXSWA, SWAN, DROPLET, EVA, EXPOSIT.

For the registration of plant protection products, the evaluation of their effects on targeted and non-target lives is an important aspect of the assessment of potential risks. Excelra Offers a wide range of ecotoxicology assessment services that address regulatory and environmental concerns in order to demonstrate acceptable uses. Predicted environmental concentrations of a substance are compared with its dose-related effects on birds and mammals, aquatic organisms, non-target arthropods, bees, soil macro-organisms and micro-organisms and non-target plants, in the tiered risk assessment.

  • Screening test
  • Tier 1
  • Higher Tier
  • Literature review to support higher tier risk assessment

We conduct risk assessment for workers, operators and bystanders according to the basic data requirement on human risk assessment and following latest guidance documents.

Possible Exposure Scenarios:

  • Worker: Person who enter an area or handle crop previously treated with plant protection products
  • Operators: Persons involved in the mixing / loading and application of plant protection products
  • Residents and Bystanders: Persons who are located within or directly adjacent to the area where plant protection product application is taking place or has recently been completed.

Models used for exposure assessment:

  • EUROPOEM
  • German Model
  • UK-POEM
  • NL Model
  • NL and Southern Greenhouse
  • PHED

Models used for exposure assessment:

  • EUROPOEM
  • German Model
  • UK-POEM
  • NL Model
  • NL and Southern Greenhouse
  • PHED

Full support for regulatory dossier building following recommendations laid down in plant protection products regulation EC 1107/2009.

  • Preparation of regulatory dossiers - Annex III Part A and Annex III Part B section 3, 5, 6 and 8
  • In-house literature review and results evaluation
  • Best quality control practices adopted for delivery of error free core dossiers and national addendum

We are also supporting our clients in migrating the dossiers from old dRR format to new dRR format and make adaptions as necessary due to change in guidelines.

Our regulatory services team in collaboration with in-house IT application team has developed some automation tools to improve the quality and productivity.

Tools developed on customized basis:

  • Tool for extraction of results in report ready format from model generated output files
  • Tool for comparing/checking the inputs entered in the e-fate tools using model generated input files
  • Tool for generation of graphs from model generated output files (advanced tool for comparing risk profile)

EMAT:

We are currently developing a tool which integrates the complete process of environmental exposure assessment and report generation. The user-friendly GUI will help in setting-up and executing the projects in surface water as well as ground water modeling tools and preparation of modeling reports.

Ecotox Risk Assessment Automation Tool:

Similar to EMAT we have conceptualized an automation tool to integrate the complete process of ecotox risk assessment calculations and dossier preparation. The user would have enter all inputs in the GUI and the dossier with pre-filled results and input tables will be ready for user to include text.

Human Exposure Risk Assessment Automation Tool:

We have also conceptualized an automation tool to integrate the complete process of human exposure risk assessment calculations and dossier preparation. The user would have enter all inputs in the GUI and the dossier with pre-filled results and input tables will be ready for user to include text.

To explore our services, write to us at info@excelra.com

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