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Under EU ESRS 1 (Reg. (EU) 2023/2772), a matter is reported if it is material on either of two dimensions — or both (§3.2).
Impact ("inside-out"): your actual or potential, positive or negative impacts on people or the environment, across your own operations and your value chain (§3.4).
Financial ("outside-in"): risks and opportunities that could materially affect financial position, performance, cash flows, or access to and cost of capital (§3.5).
EFRAG's IG 1 runs in four steps: understand context & value chain → identify IROs (impacts, risks, opportunities) → assess and determine what's material → report.
Impacts are scored on scale, scope and irremediable character (plus likelihood if only potential); risks and opportunities on magnitude and likelihood.
Screen your IROs against the ESRS topics and the PSCI Principles (Ethics; Human Rights & Labour; Health & Safety; Environment; Governance). Recurring pharma material topics:
Antimicrobial resistance shows why pharma rarely gets to pick just one lens.
Impact: antibiotic residues discharged from manufacturing drive resistance — harm to human health and ecosystems.
Financial: the same issue brings tighter discharge limits, stewardship-based procurement, and reputational and financing risk — plus opportunity for the companies that lead.