Nanomaterials present unique regulatory challenges under both the EU and UK REACH Regulations, requiring specialist skills and experience to meet the stringent requirements for identification, data generation, and safety assessment. Our specialist nanomaterials team provides expert regulatory and scientific support to help clients achieve compliance, reduce uncertainty, and meet evolving regulatory obligations in the EU and UK.
Regulatory Challenges for Nanomaterials Under REACH
Nanomaterials are subject to specific registration requirements under EU REACH (Regulation (EC) No 1907/2006) and UK REACH, following amendments introduced in 2018 (EU) and 2021 (UK). These regulations mandate additional data generation and risk assessment considerations due to the distinct physicochemical properties of nanomaterials, which influence their toxicity, environmental behaviour, and exposure potential.
Key Challenges in Nanomaterial Registration
Substance Identification & Characterisation:
- REACH requires precise identification of nanomaterial forms, including size, shape, surface chemistry, and agglomeration/aggregation state
- Differences in physicochemical properties can lead to substance differentiation, requiring multiple registrations for apparently similar nanomaterials
Data Requirements & Testing Complexity:
- Standard REACH test methods are often not applicable to nanomaterials, necessitating modified protocols or new approach methodologies (NAMs)
- Toxicology and environmental testing of nanomaterials presents additional challenge to testing on bulk counterparts, which can lead to higher costs and challenging data interpretation
Hazard & Risk Assessment Uncertainty:
- Inhalation toxicity, bioaccumulation, and persistence are major concerns due to the behaviour of many nanomaterials
- Predictive environmental fate modelling can be complex, requiring advanced exposure scenarios to assess for potential adverse environmental impacts
Regulatory Divergence Between EU & UK REACH:
- Since BREXIT, UK REACH operates independently of EU REACH, meaning separate dossiers and regulatory approvals are required
- Companies must monitor regulatory developments in both jurisdictions to ensure dual compliance
How Blue Frog Scientific Supports Nanomaterial Compliance
Our specialist nanomaterials team can simplify these regulatory complexities for you, taking the burden to ensure a strategic, science-driven approach to compliance under EU and UK REACH.
Nanomaterial Substance Identification & Characterisation
- Detailed physicochemical profiling of nanomaterials, ensuring correct substance identity classification
- Support with analytical methods to determine particle size distribution, surface area, morphology, and solubility
- Grouping and read-across strategies to streamline registration efforts and reduce data costs
Data-Gap Analysis & Integrated Testing Strategies
- Evaluation of existing data against REACH nanomaterial-specific information requirements
- Development of intelligent testing strategies to minimise testing costs, while maintaining quality and regulatory acceptance
- Application of new approach methodologies (NAMs), including in vitro and in silico models, to reduce unnecessary testing on animals and to streamline costs
Safety Assessment & Chemical Safety Reports (CSR)
- PBT assessment, including nano-specific bioaccumulation and persistence assessments
- Nanomaterial-specific exposure scenarios covering worker/consumer exposure, and environmental emissions
- Prescription of industry-relevant operational conditions and risk management measures
- Deterministic and/or probabilistic risk assessment approaches to ensure robust risk characterisation and safe use conclusions
- Compilation of Chemical Safety Reports (CSR)
Dossier Preparation & Submission Under EU & UK REACH
- Preparation of complete REACH registration dossiers in IUCLID format, tailored for nanomaterials
- Submission to ECHA (EU REACH) and HSE (UK REACH) utilising the relevant IT portals
Advocacy & Regulatory Engagement
- Liaison with ECHA, HSE, and national competent authorities to resolve regulatory challenges
- Scientific justifications for waivers and alternative testing strategies, reducing compliance costs
- Monitoring of evolving nanomaterial regulations to keep clients ahead of future requirements
Why Choose Blue Frog Scientific?
As leading regulatory specialists in nanomaterials, we provide a strategic, science-led approach to compliance, helping businesses successfully register, assess, and manage nanomaterials under EU and UK REACH. Our deep technical expertise and regulatory insight ensure that your REACH strategy is efficient, cost-effective, and fully compliant.
- Recognised EU & UK Regulatory Experts – Our team has extensive experience supporting nanomaterial registrations and compliance across multiple industries
- Contributors to EU Research & Policy Development – We have been actively involved as expert advisers and key stakeholders in major EU projects, including:
- NanoFASE – Advancing understanding of nanomaterial fate and behaviour in the environment
- GRACIOUS – Developing frameworks for grouping and read-across strategies for nanomaterials
- Trusted by EU Authorities – We have been contracted by EU authorities to develop regulatory guidance documents on nanomaterials, shaping the future of compliance strategies
- Scientific & Regulatory Advocacy – We engage directly with ECHA, HSE, and other regulatory bodies to ensure our clients’ interests are represented in the evolving regulatory landscape
Contact our nanomaterials team today to discuss your regulatory challenges and discover how we can support your compliance needs.
