Understanding a chemical’s fate and behaviour in the environment is fundamental to ensuring environmental safety and regulatory compliance requirements under REACH, Biocidal Products Regulations, Plant Protection Products Regulations, and pharmaceutical product regulations (human and veterinary medicines). At Blue Frog Scientific, we provide specialist environmental fate assessment services, helping clients overcome the data and assessment challenges presented under EU and UK regulations.
Our expertise covers degradation, persistence, mobility, and bioaccumulation assessments, coupled with use of environmental modelling to understand exposure pathways and develop scenarios to support robust environmental risk assessments.
Regulatory Services for Environmental Fate
Our team of experienced environmental fate regulatory professionals will ensure that your strategy for environmental fate information requirements and related assessments will meet the stringent requirements under EU and UK regulatory frameworks for chemicals, biocides, plant protection products, human medicinal products, and veterinary medicinal products.
Our services include:
- Regulatory Strategy - Determining the likely challenges related to persistence and exposure, and effective strategies to overcome these issues through effective data generation and risk assessment approaches
- Data Gap Analysis & Testing Strategies – Identifying missing environmental fate data and developing integrated testing plans to fulfil regulatory obligations
- PBT/vPvB & PMT/vPvM Assessments – Supporting persistence, mobility, and bioaccumulation assessments in accordance with ECHA, EFSA, and EMA/VMD requirements
- Environmental Exposure Modelling – Conducting fate and exposure modelling for surface water, groundwater, sediment, soil, and air
- Regulatory Dossier Compilation & Submission – Preparing scientifically robust environmental fate dossier sections and assessment reports
- Regulatory Advocacy & Stakeholder Engagement – Representing clients in substance evaluations, regulatory reviews, and compliance checks to ensure proportional and science-driven decision-making
Environmental Fate Technical Services
Study Design and Monitoring
We design and monitor high-quality environmental fate studies conducted at contract research organisations to assess the persistence, degradation, and transport of substances in terrestrial and aquatic environments. Study monitors are highly experienced at both conducting these studies as Study Directors and/or monitoring their successful completion as consultants.
Study Designs Include:
- Persistence & Degradation Studies:
- Biodegradation Testing – Ready biodegradability (OECD 301, 310), inherent biodegradability (OECD 302), simulation studies (OECD 303, 307, 308, 309)
- Abiotic Degradation – Hydrolysis (OECD 111), phototransformation in water, soil, and air.
- Soil & Sediment Fate – Aerobic and anaerobic transformation studies (OECD 307, 308)
- Mobility & Bioaccumulation:
- Soil Adsorption/Desorption Studies – OECD 106, column leaching studies, aged sorption approaches
- Water-Sediment Distribution Studies – OECD 308, assessing partitioning behaviour
- Bioaccumulation Testing – OECD 305 (fish), OECD 315 (sediment), OECD 317 (earthworms)
PBT and PMT Assessment
PBT/vPvB (Persistent, Bioaccumulative & Toxic / Very Persistent, Very Bioaccumulative)
PBT and vPvB assessments are mandatory under REACH Regulations, Biocidal Products Regulations, and Plant Protection Product Regulations, to determine whether substances are likely to pose long-term environmental risks.
The assessment adopts a weight-of-evidence approach, integrating degradation, bioaccumulation, and toxicity data with specific criteria for each sub-classification, and an overall assessment of PBT or vPvB. The PBT assessment can also trigger non-standard data requirements for chemicals if standard data requirements do not permit a conclusion related to these properties. PBT assessments may also be required for relevant transformation products of chemicals and active substances, to ensure that primary degradation of a parent compound doesn’t mask overall potential risks due to environmental exposure.
PMT/vPvM (Persistent, Mobile & Toxic / Very Persistent, Very Mobile)
PMT and vPvM assessments must now be considered under REACH to evaluate the potential for groundwater contamination and drinking water risks, and this classification can trigger regulatory processes such as Evaluation, Authorisation, or Restriction. Biocidal products regulations and plant protection product regulations do not explicitly require PMT/vPvM assessments, but environmental fate assessments must demonstrate that active substances and relevant transformation products do not pose an unacceptable risk to groundwater and drinking water sources.
The assessment also adopts a weight-of-evidence approach, integrating degradation, mobility, and toxicity data with specific criteria for each sub-classification, and an overall assessment of PMT or vPvM.
We are highly experienced at assessing substances for PBT and PMT properties, and addressing the implications that unfavourable conclusions can have on the overall compliance and sustainability of chemicals or active substances.
At Blue Frog Scientific, we provide scientifically robust, regulatory-compliant environmental fate assessments to support chemical, biocide, plant protection product, and medicinal product registrations. Our highly qualified team, with backgrounds in regulatory agencies, industry, and research, ensures that your environmental fate and risk assessment obligations meet the required regulatory standards.
