Our team is able to support all aspects of the environmental fate challenges presented to our Clients.
How can our team support you?
Our experts are able to guide our Clients through the assessments required for PBT/vPvB and PMT/vPvM to understand the implications for classification. The selection and design of the screening and higher tier studies in order to address persistence and bioaccumulation is very complex and requires a deep understanding of environmental partitioning and behaviour. With increasing regulatory scrutiny from the European Chemicals Agency and also UK regulators, the correct strategy is critical to the successful and desired outcome for the classification. This complexity is often exacerbated by challenging substances such as volatiles and UVCBs, so effective planning and preliminary assessments are essential for successful data generation.
Data gap analysis and intelligent testing strategies:
With vast experience across many chemical sectors, our team is well placed to understand the regulatory needs and requirements to obtain successful submissions in a cost effective and timely manner. For chemicals we have worked on hundreds of lead and joint registrations with associated chemical safety assessments.
Developing an Intelligent testing strategy (ITS) is a critical process in which our experts will be able to provide advice and guide our Clients through the selection of the most appropriate testing schemes, provide expert study monitoring through the life-cycle of the testing package, and interpret the generated data for use in endpoint conclusion, hazard and risk assessment.
Study monitoring:
Study monitoring services are conducted by specialist staff with first hand experience of conducting biodegradation and environmental fate studies in the laboratory, followed by study monitoring experience in a consultancy environment. This technical experience is invaluable in making sure our Clients studies are conducted to a very high standard. We have good working relationships with global Contract Research Organisations to facilitate the conduct of 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 submission. For example, tools such as CAKE can be used for the evaluation of degradation kinetics in new or legacy soil and sediment water studies in accordance with FOCUS kinetic guidance.
Hazard classification:
Substances registered under REACH Annex VIII, IX & X require an assessment of their persistence, bioaccumulation, toxicity, and mobility potential, to allow for hazard classification. We work with our Clients, and testing laboratories, to ensure the most favourable outcome of these assessments for our Client's chemical substances.