Blue Frog Scientific has a team of specialists dedicated to the regulatory compliance of nanoforms – supporting our clients with EU REACH Regulation and other relevant frameworks. Nanomaterials, known for their novel properties compared to their bulk or ionic counterparts, are recognised as Key Enabling Technologies (KETs). These technologies are instrumental in driving forward crucial global goals such as pollution reduction, clean water and treatments for key elements in the global burden of disease such as cancer, cardiovascular disease, Alzheimer’s disease and COVID-19.
Nanomaterials Strategic Consultancy
We offer expert guidance throughout the regulatory lifecycle of nanomaterials, ensuring that our clients’ innovations meet current regulatory standards and are poised to adapt to future changes.
Nanoform Compliance & Advocacy
Regulatory Framework Support
Assisting with the specific amendments to the Annexes of REACH (Commission Regulation (EC) No. 2018/1881 and Commission Regulation (EC) 2020/878) that address nano-specific properties.
Advocacy
Supporting processes such as compliance checks and evaluations, crucial for maintaining market access.
Nanoform Characterisation & Assessment
Nanoform Naming & Identification
Precise identification and categorisation of nanoforms to align with regulatory definitions and requirements.
Sets of Similar Nanoforms & Read-Across Strategies
Developing robust justification in the absence of specific guidance is key to minimising testing while maximising the use of available data.
Integrated Testing & Risk Assessment
Data Gap Analysis
Identifying critical data needs and devising strategies to address them efficiently.
Integrated Testing Strategies (ITS)
Designing and implementing tailored testing strategies that align with both scientific rigour and regulatory expectations.
Study Monitoring
Overseeing toxicity, environmental fate, and ecotoxicology studies to ensure high standards and regulatory acceptance.
Hazard & Risk Assessment for Nanomaterials
Toxicology & Ecotoxicology
Detailed analysis of potential hazards and the environmental impact of nanomaterials.
Human Health & Environmental Risk Assessment
Comprehensive assessments to determine the risk profile of nanoforms and ensure safety for human health and the environment.
Nanomaterial Technical Dossier Compilation
Compilation of Technical Dossiers & Chemical Safety Reports
Meticulous preparation and updating of dossiers and reports to meet the specific requirements for nanomaterials under current regulations.
Blue Frog Scientific stands at the forefront of nanomaterial regulatory consulting, with a strong position at the interface of academia, industry, and regulation. Our involvement in key EU projects like NanoFASE and GRACIOUS either directly, as expert advisers or key stakeholders enriches our consultancy services, ensuring they are grounded in the latest scientific research and regulatory developments.
The regulations for nanotechnology are a 'work-in-progress' and subject to change. It is essential that registrants of nanomaterials consider the most up-to-date scientific principles when testing and assessing nanoforms, beyond what is currently detailed in the guidance, to ensure longevity of dossiers, successful market access and compliance in an evolving regulatory environment.
Call us today and speak with one of our nanomaterial expert consultants to learn how our expertise in nanomaterials can support your innovative projects and ensure compliance across EU and GB jurisdictions, as well as globally.
