We provide support to our Clients for their active substance and product authorisations/ renewals for plant protection products.

How can our team support you?

Data gap analysis and intelligent testing strategies: 

Having worked on a considerable number of new plant protection product active substance authorisations and active substance/product renewals our team is well placed to understand the regulatory needs and requirements to attain successful submissions in a cost effective and timely manner.

Study design/monitoring:

Many members of the Ecotoxicology team have come from a Contract Research Organisation background and have first-hand experience of conducting a wide range of study types including aquatic, terrestrial, and avian studies. This technical experience is invaluable in making sure studies are contracted, monitored and reported to a very high standard. We have excellent knowledge and experience with Contract Research Organisations all over the world for coordinating and conducting studies on behalf of our clients.

Endpoint derivation:

Further support comes in the interpretation of the study results and derivation of endpoints for use in the regulatory dossier. Our experts are able to critically review study reports and summaries in order to make a judgement of the quality of the data (data gap analysis) and ultimately the endpoint for use in risk assessment. Blue Frog Scientific is also able to perform re-estimation of ecotoxicological endpoints. 

Plant Protection Product Specific Activities (Regulation (EC) 1107/2009, Regulation (EC) 283/2013, Regulation (EC) 284/2013)

Document preparation

• Preparation of Section 9 dRRs for Article 33 and 43 submissions
• Preparation of M-CA Sections 8 and 9, MCP Sections 10 and 11 and N1/N2 documents for AIR submissions
• IUCLID data entry and management 

Risk Assessments 

• Birds and Mammals
  • Following EFSA Guidance 2009
  • Higher tier refinements using weight of evidence approaches and provision of advice on requirement of new data generation, including PT, PD, foliar dissipation, effect studies, etc.
• Aquatic organisms
  • Following EFSA Guidance 2013a
• Bees
  • Following SANCO/10329/2002, EPPO and EFSA (2013b) guidance
  • Higher tier refinements – provision of expert advice on study types (or other solutions) that are optimal for addressing Tier 1 risk assessment failure
• Non target arthropods (NTAs)
  • Following ESCORT II/III
  • Higher tier refinements – provision of expert advice on study types (or other solutions) that are optimal for addressing Tier 1 risk assessment failure

• Soil organisms
  • Following SANCO/10329/2002
  • Higher tier refinements – provision of expert advice on study types (or other solutions) that are optimal for addressing risk assessment failure
• Non target terrestrial plants
  • Following SANCO/10329/2002
  • Higher tier refinements such as probabilistic risk assessment (SSD)