Define the Evidence Programme Before Committing to Testing
A successful SSbD programme begins with a clear understanding of the chemistry, its intended uses and the decisions the assessment must support.
Blue Frog helps development teams determine which human health, environmental, physicochemical and regulatory questions are material to an innovation. We then define a proportionate plan for addressing them, beginning with existing evidence and desk-based approaches.
The result is a focused feasibility programme – not an indiscriminate list of endpoints and possible studies.
Establishing the Right SSbD Assessment Scope
The relevance of a potential hazard depends not only on the substance or material but also on how it will be manufactured, processed and used.
We work with your team to define the innovation, its required function, foreseeable applications and appropriate comparators. These parameters establish the assessment boundary and help identify the exposures and regulatory pathways that require attention.
They also allow the work to reflect the maturity of the innovation. An incremental change to a well-understood chemistry may be able to draw on relevant existing evidence. A breakthrough material may present more fundamental uncertainties and require a different evidence strategy.
Setting Chemical Safety & Sustainability Targets
Broad ambitions such as ‘safer’ or ‘more sustainable’ are difficult to apply as development criteria.
We help translate these ambitions into targets that can be investigated against an existing, incumbent or other candidate solutions. Depending on the innovation, targets may relate to particular toxicological or environmental hazards, exposure potential, physicochemical properties or foreseeable regulatory constraints.
These targets give scientific and technical teams a clearer basis for comparing options. They also help expose potential trade-offs – for example, where reducing one concern could adversely affect another property or the required technical function.
Reviewing Existing Chemical & Regulatory Evidence
Before recommending new studies, we examine what can be learned from the information already available.
This can include published literature, regulatory sources, existing studies and data on potentially relevant analogues. We consider whether in silico / QSAR methods, read-across, weight of evidence or other desk-based approaches could address particular questions or help prioritise further work.
The objective is to identify the gaps capable of changing the development decision. Lower-priority uncertainties can then be distinguished from issues that require attention during feasibility assessment.
Anticipating Regulatory Data Requirements
Early scoping cannot remove every regulatory uncertainty, but it can identify evidence requirements that may materially affect development.
We consider the proposed markets and uses, the likely regulatory context and the types of studies that may ultimately be required. Where appropriate, we develop expected and worst-case cost and timescale scenarios.
This helps the client understand the possible scale of the regulatory commitment before moving into a more resource-intensive phase.
SSbD Scoping & Assessment Package
A typical SSbD scoping engagement may provide:
A defined assessment scope and use map.
A chemical safety and sustainability target profile.
A review of available evidence and relevant analogues.
A preliminary regulatory data-gap analysis.
A prioritised feasibility and evidence plan.
Initial regulatory cost and timescale scenarios.
A clear record of assumptions and uncertainties.
Informed Development Decision
Is there sufficient safety, regulatory and commercial potential to justify feasibility work?
The output provides a structured basis for progressing, refining the concept or stopping before more substantial resources are committed.
Progressing From Scoping to Feasibility
Where further investigation is justified, the next stage develops and integrates evidence to test the critical assumptions identified during scoping... Chemical Safety Feasibility Assessment.
Learn more about how Blue Frog approaches SSbD for chemicals, materials and formulations.
If you're involved in an SSbD project and could benefit from chemical regulatory insight, we'd love to be involved. Call or email and speak directly with one of our chemical regulatory SSbD consultants.
