Ensuring compliance with REACH Regulation (EC) No 1907/2006 and UK REACH is essential for businesses manufacturing, importing, or using chemicals in the EU and UK. At Blue Frog Scientific, we provide comprehensive technical and regulatory support throughout the substance registration process, ensuring full compliance with ECHA and HSE requirements while optimising data quality, efficiency, and cost-effectiveness.
Our expert services cover substance characterisation, data evaluation, integrated testing strategies, risk assessment, dossier submission, and advocacy, helping businesses meet their REACH and UK REACH registration obligations efficiently.
Comprehensive Substance Characterisation & Data Evaluation
A successful REACH registration begins with a thorough understanding of the substance’s identification profile. We offer a full suite of expert services to generate a solid foundation for your registration dossier:
- Substance Characterisation:
- Full analytical assessment of identity, purity, impurities, and physicochemical properties
- Literature Search & Data Evaluation:
- Systematic review of existing studies, assessing data reliability and regulatory relevance under both EU and UK regulations
- Data Gap Analysis:
- Identification of missing or non-compliant data, determining additional information requirements
- Use Identification:
- Assessment of chemical uses across supply chains to ensure that all necessary downstream uses are covered
Integrated Testing Strategies & Study Monitoring
We develop cost-effective, scientifically sound testing strategies to generate the necessary data for a successful REACH and UK REACH registration. Our approach prioritises the use of new approach methodologies (NAMs) to reduce cost and reliance on animal testing.
- New Approach Methodologies (NAMs):
- Incorporation of in silico models, in vitro assays, and read-across approaches to support hazard assessments
- Testing Strategy Development:
- Designing tiered testing approaches that align with regulatory and scientific best practices in both EU and UK REACH
- Study Monitoring & Data Generation:
- Overseeing Good Laboratory Practice (GLP) studies, ensuring reliable and relevant results
Technical Dossier Compilation & Chemical Safety Assessment
We prepare scientifically robust and regulatory-compliant IUCLID dossiers, ensuring that all information requirements and safety assessments are complete and well documented for both ECHA (EU REACH) and HSE (UK REACH).
- IUCLID Dossier Compilation:
- Structuring and formatting all required data and conclusions for submission via REACH-IT (EU) and the UK REACH submission platform
- Chemical Safety Assessment (CSA):
- Human Health Hazard Assessment – Evaluation of toxicological properties (e.g. DNELs), including acute and chronic toxicity, genotoxicity, reproductive and developmental toxicity, and endocrine disruption
- Environmental Hazard Assessment – Assessment of aquatic, terrestrial, atmospheric, and human-relevant hazards (e.g. PNECs)
- Exposure Assessment – Estimating and refining workplace, consumer, and environmental exposure levels for all identified uses, utilising a tiered approach
- Risk Characterisation – Determining safe use conditions and risk management measures
- Specialist Technical Assessments – Expertise in complex toxicological and environmental assessments, including:
- Persistence, Bioaccumulation & Toxicity (PBT) / Persistent, Mobile & Toxic (PMT) assessment
- Endocrine Disruption Assessment (aligned with ECHA/EFSA/HSE guidance)
- Reproductive & Developmental Toxicology (DART) studies
- Chemical Safety Report (CSR) Compilation:
- Developing comprehensive CSRs, including exposure scenarios, risk characterisation, and supporting expert reports for both EU and UK REACH registrations
Submission & Regulatory Updates
Our regulatory experts manage the full submission process, facilitating a smooth registration and effective post-submission compliance under both REACH and UK REACH frameworks.
- Dossier Submission & Registration:
- Handling all administrative and technical aspects of the submission process via REACH-IT (EU) and the UK REACH submission platform
- Advocacy & Stakeholder Engagement:
- Regulatory Authority Engagement – Liaising with ECHA, HSE, and national regulators
- Scientific & Technical Advocacy – Representing clients or consortia during processes such as Compliance Check and Evaluation
- Stakeholder Engagement - Engagement with industry groups and trade associations on behalf of clients or consortia
- Dossier Updates & Maintenance:
- Ensuring ongoing compliance with regulatory updates, new hazard classifications, or enforcement actions in both jurisdictions
- Regulatory Change:
- Ensuring clients are aware of upcoming changes to regulatory requirements
- EU & GB/NI regulatory divergence
With extensive experience in EU and UK REACH registrations, Blue Frog Scientific provides tailored regulatory solutions that ensure full compliance while optimising the scientific integrity and efficiency of the registration process. Our highly qualified team, with backgrounds in industry, regulatory authorities, and testing laboratories, ensures that your dossier is prepared to the highest standards, supporting successful registration and long-term compliance.
Contact us today to discover how our expert regulatory services can enhance your regulatory strategy and ensure your long term regulatory compliance – we’ll support you through the entire process to ensure your chemical substances are fully compliant with REACH regulations.
