Supporting you with ecotoxicology and risk assessment:
- Development and implementation of higher-tier risk assessment strategies, including both desk-based and experimental-based approaches
- Providing advice to our clients on regulatory testing and risk assessment strategy
- Undertaking standard and higher-tier risk assessments for all wildlife groups for all directives and exposure pathways according to EU guidelines
- Design, monitoring, interpretation and subsequent implementation into the risk assessment of higher tier ecotoxicology studies
- Working together with our efate, exposure modelling, aquatic testing and toxicology colleagues where appropriate to develop interdisciplinary approaches to ensure optimal solutions for our clients
- Data gap analysis according to EU requirements
- Preparation of ecotoxicology sections of draft registration report (dRR) zonal dossiers and national addenda
- Preparation of ecotoxicology sections of Annex I active substance (MCA8) and product (MCP10) dossiers
- Discussion, liaison and strategy development with regulatory authorities
- Study monitoring and programme management
- Post-submission support
Using our in-house aquatic ecotoxicology testing facilities, we can conduct higher-tier studies tailored to meet the specific needs of our clients both indoor in laboratory conditions or outdoors in our mesocosms. We understand the importance of study design and high-quality data for addressing your regulatory requirements.
- Experienced in conducting good-laboratory-practice (GLP) and non-GLP trials
- 199 outdoor aquatic mesocosms (flat-bottomed or sloped) to simulate different edge-of-field environments with a focus on plants and invertebrates
- Bespoke mesocosm design to produce robust population and community endpoints (ETO and ERO) that meet the requirements of the EFSA (2013) aquatic guidance
- In-house identification of freshwater phytoplankton, periphyton, macrophytes, zooplankton and macroinvertebrates to GLP standards, for studies conducted at the CEA facility or externally.
- In-situ bioassays and laboratory testing to provide endpoints for species of interest
- Field sampling and culturing of non-standard invertebrates
- Indoor microcosms and higher-tier laboratory studies on many aquatic invertebrates, plants and algae to address data gaps
- Interpretation of ECx values for new and existing ecotoxicological datasets
- Analysis of new and existing mesocosm datasets using minimum detectable difference (MDD) to meet the requirements of EFSA (2013) aquatic guidance
CEA has a well-earned reputation for providing higher tier, non-standard support for challenging products in an increasingly demanding regulatory environment. We also provide specialist policy advice and research to government clients.
Our unique combination of expertise and experience means that our clients have access to a wide breadth of industry and regulatory specialists throughout their projects.
Please contact us to discuss your ecotoxicology and risk assessment needs.