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Existing environmental assessment information can help establish project scope, but public summaries and previously generated assessments are not automatically equivalent to access to the underlying study data or regulatory rights to rely on them.
A public ERA summary may describe the regulatory conclusion at a high level without providing the full study reports, calculations, raw data or ownership/access arrangements needed for a new submission.
When the intended submission relies on existing environmental studies, the project may need to establish what information is available, who controls it, whether a letter of access or another reliance mechanism is required, and whether the evidence fits the current assessment framework.
Older assessments can still be informative, but the project should check the applicable current guidance, market-specific requirements, substance identity and the assumptions used in the existing assessment.
An early gap review can separate information that can be used directly, information that needs verification or permission, and information that must be generated or replaced.
ToxWriter can review available public and client-provided information, map it to the intended EU or UK assessment pathway, identify data-access issues and document the agreed scope for a product-specific ERA.
We can confirm the applicable assessment scope, available information and next steps.