Integrating Chemical Safety & Regulatory Strategy into Innovation
Applying Safe & Sustainable by Design to a new chemical, material or formulation requires more than a broad sustainability assessment. Development teams need to understand how hazard, exposure, physicochemical properties and regulatory data requirements could affect the viability of the innovation.
Blue Frog helps chemical innovators investigate these questions before critical development choices become too costly to revisit.
Our specialists bring together human toxicology, environmental science, physicochemical assessment and chemical regulatory expertise. We use these disciplines to identify potential barriers, establish meaningful development targets and build an evidence programme that are proportionate to the technology and its intended uses.
Identify human health, environmental and physicochemical concerns relevant to the chemistry and proposed uses.
Assess how hazard and exposure could influence regulatory acceptance.
Establish chemical safety targets and benchmark against incumbent or alternative solutions.
Evaluate existing data, literature, analogue information and read-across opportunities.
Identify critical regulatory data gaps and testing requirements.
Make effective use of in silico, weight of evidence and new approach methodologies (NAMs).
Prioritise studies according to their value to development and regulatory decisions.
Estimate potential regulatory costs, timescales and worst-case requirements.
Present evidence, assumptions and uncertainties clearly at stage-gate reviews.
Our support can begin with an early assessment of regulatory preparedness or continue through to feasibility, testing and validation.
Chemical & Regulatory Evidence for Development Decision Making
An SSbD assessment can identify possible hazards, indicators and evidence needs. The challenge is determining which are relevant to the substance or material, its intended uses and its likely regulatory pathway.
Blue Frog structures the work around four practical questions.
What is being developed – and for which uses?
We help define the substance, material or formulation, its intended function, foreseeable applications and relevant incumbent or alternative solutions. These parameters establish the scope of the safety and regulatory assessment.
Which properties or exposures could present concern?
We identify relevant human health, environmental and physicochemical considerations. Depending on the innovation, these could include persistence, mobility, bioaccumulation, endocrine disruption, carcinogenicity, mutagenicity, reproductive toxicity or aquatic toxicity.
What evidence is available?
We review existing studies, published literature, regulatory information and data on structurally similar substances. In the absence of data we use read-across, in silico / QSAR methods, weight of evidence and other non-animal approaches to help define the possible hazards.
What evidence is needed next?
We outline the possible regulatory barriers based on any classifications, and the possible costs if they were realised. When chemical replacement is the goal, or if several chemicals might serve the same function, the results can be contextualised between the hazards and costs of each. We distinguish gaps that could materially affect development or regulatory viability from uncertainties that do not yet justify further work. This provides the basis for a proportionate assessment and testing strategy, including likely costs and timescales.
The result is a chemical safety and regulatory evidence programme that develops alongside the innovation and provides clearer grounds for progression, refinement or discontinuation.
SSbD Support Throughout Chemical Innovation
Blue Frog’s approach follows four broad stages, from early direction through to development and validation.
Each stage is designed around a specific decision. The depth of assessment increases as the technology matures and the commitment of resources grows.
You can engage us at the beginning of the process or at the stage that best reflects the current maturity of your innovation.
Stage 1: Opportunity & Early Direction
At the earliest stage, the opportunity is defined – what the innovation is expected to do, where it may be used and how it could improve on existing solutions.
Blue Frog can introduce an early chemical safety and regulatory perspective. We help identify questions that could influence candidate selection, technical development or the eventual route to market.
Define the chemical, material, formulation or technology under consideration.
Clarify intended functions and foreseeable uses.
Identify appropriate incumbent or alternative solutions.
Establish initial safety and sustainability ambitions.
Highlight obvious hazard or regulatory concerns.
Identify assumptions that will need to be tested.
Frame the questions for a more formal SSbD scoping exercise.
Stage-gate question: Does the idea merit further investigation?
Learn more about Early-Stage Chemical Safety & Regulatory Assessment.
Stage 2: Scoping & Target Setting
Scoping turns an innovation concept into a defined chemical safety and regulatory assessment programme.
Blue Frog helps determine what can be assessed with the available information, which uncertainties matter and how further evidence could be generated prior to launching a full-scale regulatory programme. The work is deliberately focused – providing an informed basis for deciding whether feasibility activities are justified.
Preliminary regulatory preparedness assessment.
Definition of intended uses and exposure scenarios.
Identification of relevant human health, environmental and physicochemical hazards.
Literature and regulatory data searches.
Review of structurally similar substances and read-across opportunities.
Identification of suitable in silico / QSAR and other desk-based methods.
Preliminary data-gap analysis.
Definition of chemical safety and sustainability targets.
Identification of potential laboratory studies or new approach methodologies (NAMs) for screening prior to launching a regulatory programme.
Initial estimates of regulatory testing costs and timescales.
Expected and worst-case evidence scenarios.
Typical outputs may include an SSbD scoping report, development target profile, preliminary data-gap analysis, pre-regulatory programme testing strategy (using NAMs) and prioritised evidence plan.
Stage-gate question: Is there sufficient potential to justify feasibility work?
Learn more about SSbD Scoping & Assessment for Chemicals & Materials.
Stage 3: Feasibility & Refinement
At the feasibility stage, Blue Frog helps generate and integrate evidence to test important assumptions about the innovation.
The objective is not necessarily to complete every possible assessment. It is to determine whether the emerging chemical safety and regulatory profile supports further development, and to identify where the chemistry, intended uses or evidence strategy may need further refinement.
Desk-based human health hazard assessment.
Environmental hazard and fate assessment.
Physicochemical assessment.
Use and exposure mapping.
In silico / QSAR analysis.
Read-across and weight-of-evidence assessment.
Comparison of candidates, analogues or incumbent solutions.
Targeted new approach methodologies (NAMs).
Selection and design of feasibility studies.
Identification and briefing of suitable laboratories.
Monitoring and interpretation of experimental work.
Refinement or selection of candidate substances and materials.
Updated data-gap analysis.
Revised regulatory cost and timescale scenarios.
Identification of evidence limitations and residual uncertainties.
The client remains responsible for assessing technical functionality and performance. Blue Frog helps ensure that chemical safety and regulatory findings can be considered alongside those results.
Stage-gate question: Does the available evidence justify full development?
Learn more about Chemical Safety Feasibility Assessment.
Stage 4: Development, Testing & Validation
As the innovation progresses, a more extensive evidence programme may be needed to confirm earlier assumptions and address the data requirements associated with the anticipated regulatory pathway.
Blue Frog helps design, refine and oversee this programme, keeping it aligned with both the development targets and the decisions that remain to be made.
Refinement of the overall assessment and testing strategy.
Selection of appropriate new approach methodologies (NAMs).
Identification of relevant guideline studies.
Development of study specifications and laboratory briefs.
Laboratory selection and proposal review.
Study monitoring and scientific interpretation.
Integration of new evidence with existing data.
Reassessment of read-across or weight-of-evidence arguments.
Confirmation or revision of earlier hazard and exposure assumptions.
Updated regulatory data-gap analysis.
Revised cost and timescale projections.
Assessment against the agreed safety and sustainability targets.
Identification of further refinement opportunities.
Where results challenge an earlier assumption, we help determine whether the programme should proceed, be adjusted or return to an earlier decision point.
The client leads technical-function and performance testing. Blue Frog leads or supports the chemical safety, environmental and regulatory evidence programme.
Stage-gate question: Is the technology ready to progress towards product, process or regulatory development?
Learn more about Chemical Regulatory Testing Strategy & Study Support.
Integrated Expertise Across the Evidence Programme
Chemical safety and regulatory questions cannot always be addressed in isolation. A physicochemical property may influence environmental fate, exposure assumptions, test selection and the applicability of data from an analogue.
Blue Frog brings the relevant disciplines together for a comprehensive evidence programme.
Human Health Assessment
Identify and evaluate toxicological hazards relevant to the chemical, material and intended uses. This may include carcinogenicity, mutagenicity, reproductive toxicity, endocrine disruption and other relevant endpoints.
Environmental Assessment
Consider environmental hazards, environmental fate and effects, including persistence, mobility, bioaccumulation and aquatic toxicity where relevant.
Physicochemical Assessment
Assess the properties that influence hazard, exposure, environmental behaviour, study design and regulatory data requirements.
Use & Exposure Assessment
Map intended applications and foreseeable life-cycle stages to potential human and environmental exposure. This helps focus the assessment on relevant conditions rather than hazard in the abstract.
Chemical Regulatory Strategy
Anticipate how the substance, material and intended uses could be treated within the relevant regulatory context. This informs data-gap analysis, study priorities and likely development costs.
Evidence & Testing Strategies
Combine existing data, published literature, regulatory information, in silico / QSAR tools, analogue data, read-across, weight of evidence, new approach methodologies (NAMs) and experimental studies as appropriate.
Laboratory Study Support
Where testing is justified, identify suitable laboratories, develop study briefs, review proposals, monitor delivery and interpret the results in the context of the wider evidence base.
Where complementary expertise is required, we work alongside technical teams, laboratories and specialist partners.
Outputs Designed for Decision Making
Blue Frog’s outputs are designed to support scientific, regulatory and management decisions – not simply to document the information available.
Depending on the scope and stage of the project, deliverables may include:
SSbD scoping and assessment reports.
Regulatory preparedness assessments.
Use and exposure maps.
Human health and environmental hazard profiles.
Physicochemical property assessments.
Development target profiles.
Literature and regulatory evidence reviews.
Analogue and read-across assessments.
Candidate or alternatives comparisons.
Data-gap analyses.
Integrated assessment and testing strategies.
Laboratory study specifications.
Regulatory cost and timescale scenarios.
Evidence and uncertainty summaries.
Stage-gate recommendations.
Prioritised development roadmaps.
We distinguish between established evidence, working assumptions and unresolved uncertainties. This allows decision-makers to understand both the strength of the current case and what would be required to strengthen it.
Proportionate Evidence at Each Stage
The absence of complete data should not prevent an informed early decision. Equally, evidence should not be generated simply because a study is available.
We focus each phase of work on the uncertainties capable of changing the development or regulatory decision.
Begin with existing chemical and regulatory evidence.
Address the most consequential uncertainties first.
Use tiered assessment and testing where appropriate.
Avoid unnecessary or poorly timed studies.
Incorporate non-animal approaches where scientifically and regulatorily appropriate.
Revisit conclusions as the chemistry, uses and evidence base evolve.
Expose important trade-offs rather than obscure them.
Maintain a clear connection between evidence generation and decision-making.
This enables the programme to grow, as confidence in the technology grows.
Let's Talk About Your SSbD Programme
You don’t need to have a complete assessment or testing programme defined before approaching us.
We can start by understanding:
The chemical, material, formulation or technology being developed.
Its intended functions and foreseeable uses.
The incumbent or alternatives against which it will be compared.
Its current stage of development.
The evidence already available.
The anticipated regulatory context.
The next decision the project needs to support.
We can then propose a proportionate scope of work focused on the chemical safety, environmental and regulatory questions most important to the viability of the innovation.
If you’re looking for regulatory support for the development of a new chemical, material or formulation, we’d love to hear from you. Call or email and speak with one of our regulatory consultants with SSbD experience.
