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regulatory_catalog/eu_clp_reach_v2026.json

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+{
+  "framework": "EU CLP/REACH",
+  "version": "2026",
+  "source": "CLP Regulation and REACH CSA guidance",
+  "clauses": [
+    {
+      "clause_id": "EU.CLP.CARCIN.001",
+      "framework": "EU CLP/REACH",
+      "title": "Carcinogenicity/genotoxicity hazard evidence",
+      "description": "Classification-oriented evidence should include carcinogenicity and genotoxicity outcomes where available.",
+      "required_fields": [
+        "carcinogenicity_result",
+        "carcinogenicity_notes",
+        "genotoxicity_result",
+        "genotoxicity_result_notes"
+      ],
+      "required_evidence_terms": [
+        "carcinogenic",
+        "mutagen",
+        "classification",
+        "hazard"
+      ],
+      "acceptance_rule": "any_required_fields",
+      "applicability": {},
+      "source_reference": "EU CLP and REACH guidance"
+    },
+    {
+      "clause_id": "EU.REACH.DNELA.001",
+      "framework": "EU CLP/REACH",
+      "title": "Dose-response and exposure basis",
+      "description": "Risk characterization should include dose metrics and exposure route context for assessment factors and safe-use evaluation.",
+      "required_fields": [
+        "dose_metrics",
+        "exposure_route",
+        "species",
+        "risk_summary"
+      ],
+      "required_evidence_terms": [
+        "dose response",
+        "assessment factor",
+        "dnela",
+        "risk characterization"
+      ],
+      "acceptance_rule": "any_required_fields",
+      "applicability": {},
+      "source_reference": "REACH chemical safety assessment guidance"
+    },
+    {
+      "clause_id": "EU.WOE.001",
+      "framework": "EU CLP/REACH",
+      "title": "Weight-of-evidence integration",
+      "description": "Conflicting findings and uncertainty should be integrated in a transparent weight-of-evidence narrative.",
+      "required_fields": [
+        "key_findings",
+        "conclusion",
+        "risk_summary"
+      ],
+      "required_evidence_terms": [
+        "weight of evidence",
+        "uncertainty",
+        "conflicting",
+        "data gap"
+      ],
+      "acceptance_rule": "any_required_fields",
+      "applicability": {},
+      "source_reference": "CLP/REACH evidence integration principles"
+    }
+  ]
+}

regulatory_catalog/iso_10993_el_v2023_2020.json

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+{
+  "framework": "ISO 10993 (E&L)",
+  "version": "2023-2020",
+  "source": "ISO 10993-17:2023 and ISO 10993-18:2020",
+  "clauses": [
+    {
+      "clause_id": "ISO10993.18.001",
+      "framework": "ISO 10993 (E&L)",
+      "title": "Chemical characterization traceability",
+      "description": "Extractables/leachables characterization should identify compounds and trace identifiers where available.",
+      "required_fields": [
+        "chemicals",
+        "cas_numbers",
+        "key_findings"
+      ],
+      "required_evidence_terms": [
+        "extractable",
+        "leachable",
+        "chemical characterization",
+        "analytical"
+      ],
+      "acceptance_rule": "any_required_fields",
+      "applicability": {},
+      "source_reference": "ISO 10993-18:2020"
+    },
+    {
+      "clause_id": "ISO10993.17.001",
+      "framework": "ISO 10993 (E&L)",
+      "title": "Toxicological risk characterization basis",
+      "description": "Risk characterization should include toxicological rationale and dose/exposure context.",
+      "required_fields": [
+        "dose_metrics",
+        "exposure_route",
+        "risk_summary",
+        "conclusion"
+      ],
+      "required_evidence_terms": [
+        "toxicological risk",
+        "margin of safety",
+        "ttc",
+        "aet"
+      ],
+      "acceptance_rule": "any_required_fields",
+      "applicability": {},
+      "source_reference": "ISO 10993-17:2023"
+    },
+    {
+      "clause_id": "ISO10993.EL.001",
+      "framework": "ISO 10993 (E&L)",
+      "title": "Data sufficiency and uncertainty disclosure",
+      "description": "Where data are incomplete, uncertainty and additional data needs should be explicit.",
+      "required_fields": [
+        "risk_summary",
+        "conclusion"
+      ],
+      "required_evidence_terms": [
+        "uncertainty",
+        "insufficient",
+        "additional study",
+        "data gap"
+      ],
+      "acceptance_rule": "any_required_fields",
+      "applicability": {},
+      "source_reference": "ISO 10993-17:2023"
+    }
+  ]
+}