Human and Chemical Risk Assessment
Any chemical or product that is sold in the UK or European Union (EU) must first be assessed, approved and registered before it can be sent to market. For farmers, food producers, the chemical industry and the general public, registration means that the product can be supplied, sold and used safely.
Every year, thousands of new products and chemicals are developed for the marketplace that will need to be registered. The laws that underpin this registration are complex, and a good understanding is key to a successful application.
A specialist service
Cambridge Environmental Assessments (CEA) was established in 2001 as a research and consultancy group within ADAS, an RSK company. We provide technical and strategic expertise and dossier support for chemical and product registrations across Europe to both commercial and government organisations. Since our formation, we have added a field team to conduct field-fate-based investigative and monitoring studies, an expert in GIS/spatial modelling, a consultancy service for companies seeking compliance under the REACH regulations, and a toxicology service.
Broadly speaking, we provide specialist regulatory support and consultancy to clients and their associations seeking chemical and product authorisations at EU and national levels. Our offering can easily be combined with other regulatory services to create a bespoke package for clients.
We work predominantly with agrochemical companies, but also work with biocide, veterinary and human pharmaceutical, food additive, novel food, cosmetic and general chemical businesses trying to achieve successful authorisation of their product/chemical within a regulatory framework.
However, regulatory acceptability can never be guaranteed, and unforeseen responses from regulators can result in increased costs and delayed time frames.
Providing novel solutions
We pride ourselves on being able to provide novel solutions for an increasingly demanding regulatory world. We use our expertise and experience to advise clients and develop solutions that aim to maximise regulatory acceptability within client budgets and timelines.
We have a proven track record in developing state-of-the-art regulatory risk assessment methods and undertaking research to help inform policy advice and research for government agencies. We also work to advance the regulatory world in which our commercial clients operate.
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.
Expertise you can count on
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. For several services, we work closely with our colleagues throughout RSK in order to meet all our clients’ needs.
Based out of three UK offices, we have the capability to work throughout the UK. We also recently opened a new office in Dublin, Ireland, expanding our presence in the wider EU market.
Our work for agrochemicals clients encompasses all aspects of the process, including advocacy, exposure modelling, environmental fate, spatial analysis and statistics, ecotoxicology, aquatic testing, toxicology, risk assessment, dossier section preparation, software development, training, and product stewardship.
We have a wide range of experience with various biocide product types and can offer expert guidance on the requirements of the Biocidal Products Regulation. We can provide a full dossier preparation and support service throughout the entire regulatory process.
In addition to our regular offering, our veterinary medicine specialists can provide non-clinical regulatory support for your product through the entire regulatory process, including product development and defence strategies, product advocacy meetings with member state regulators, data gap analysis, literature reviews, placement and monitoring of studies, and environmental risk assessment.
Industrial and speciality chemicals
We provide chemical regulatory support to a range of industries, including chemical manufacturers and importers, aerospace, automotive, food additives, fragrances, fire retardants, ceramics, colourants, resins, cleaning products, and many more. We specialise in new substances, substances that are difficult to identify, and substances where properties or uses require a non-standard approach to toxicology or eco-toxicology testing, exposure scenarios and evaluations.
Environmental fate and exposure
Our team calculates and predicts environmental concentrations. Furthermore, we design, characterise and implement higher-tier exposure scenarios for risk refinement, including developing software to facilitate bespoke risk assessment approaches. We undertake spatially distributed, probabilistic and catchment-scale exposure modelling and risk assessments. Our dossier services include data gap analysis with subsequent study monitoring; preparation of environmental fate (efate) dossier sections for formulated products and active substances; discussions, liaison and strategy development with authorities; and post-submission support. Our in-house field-fate team can design, deliver and interpret higher-tier efate studies to good laboratory-practice-standards that address specific regulatory concerns.
Ecotoxicology and wildlife risk assessment
We work together with our efate, exposure modelling, aquatic testing and toxicology colleagues to develop interdisciplinary approaches to ensure optimal solutions. We can undertake assessments of endocrine disruptor properties and have full use of in-house aquatic ecotoxicology testing facilities. We also offer data analysis for new and existing ecotoxicological datasets to derive effect concentrations and minimum detectable differences.
Toxicology and human health risk assessment
We provide expert advice and support for general chemicals, plant protection products, biocides, foods and food contact materials, and cosmetics, including reviews of existing toxicological data sets and undertaking data gap analyses. We are experts in using various alternative approaches and tools where needed to minimise animal use and keep testing costs to a minimum. Our dossier services include preparation of chemical safety reports, study summaries, discussions, liaison and strategy development with authorities, and post-submission support.
In partnership with our software development team in ADAS, we have extensive experience of developing bespoke desktop and web-based software covering a diverse array of user needs for a range of government and commercial clients in various chemical sectors.
We offer general and bespoke training courses on various aspect of the environmental risk assessment process from standard approaches to higher tier refinements for all chemical sectors.