{"topic_id":"EFSA_OpenFoodTox_3_vitamin_regulation_landscape","category":"efsa","context":"---\ntopic_id: EFSA_OpenFoodTox_3_vitamin_regulation_landscape\ncategory: efsa\ntitle: EFSA OpenFoodTox 3.0 — 82 vitamin dossiers × regulatory programme distribution\nlang: en\nsource: OpenFoodTox 3.0 (Zenodo 19388272)\ndate_parsed: 2026-07-20\ntokens_estimated: 580\n---\n\nAggregate analysis of **82 EFSA regulatory dossiers** spanning\n**14 vitamin/micronutrient reference substances** in\nOpenFoodTox 3.0, broken down by EU regulation. This\nreveals the **regulatory fragment ation** of vitamin regulation\nacross multiple EU regulatory regimes.\n\n## Headline numbers\n\n- **82 total dossiers** across 11 distinct regulation codes\n- **Top regulation: Reg (EC) 1831/2003 = 37 dossiers (45%)**\n  — feed additives regulation, the **dominant EU framework**\n  for vitamin additive dossiers\n- **Reg (EC) 178/2002 = 17 (20.7%)** — general food/feed safety\n- **Reg (EC) 1333/2008 = 8 (9.8%)** — food additives regulation\n- **5 unknown / legacy** placeholders + 3 \"other\" designations\n- **13 different regulations across 82 dossiers** — vitamin\n  regulation is highly fragmented\n\n## Full regulation × vitamin matrix\n\n| Regulation | A | B1 | B2 | B3 | B5 | B6 | B12 | C | E | Ch | **Total** |\n|------------|-:|---:|---:|---:|---:|---:|-----:|--:|--:|---:|------:|\n| Reg (EC) 1831/2003 (feed additives) | 6 | 3 | 2 | 10 | 2 | 3 | 1 | 4 | 6 | 0 | **37** |\n| Reg (EC) 178/2002 (food/feed safety) | 5 | 0 | 2 | 3 | 1 | 0 | 1 | 2 | 2 | 1 | **17** |\n| Reg (EC) 1333/2008 (food additives) | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | **8** |\n| Unknown / legacy | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | **5** |\n| Directive (EC) 46/2002 (feed add legacy) | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | **5** |\n| \"other\" designation | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | **3** |\n| Reg (EC) 257/2010 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | **1** |\n| Directive (EEC) 524/1970 (repealed) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | **1** |\n| Reg (EC) 258/1997 (novel food) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | **1** |\n| Reg (EC) 396/2005 (MRL pesticide) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | **1** |\n| Commission Reg (EU) 188/2011 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | **1** |\n| Commission Reg (EC) 1334/2003 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | **1** |\n| Reg (EC) 1331/2008 (general food law auth.) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | **1** |\n| **Total dossiers** | **17** | **6** | **6** | **18** | **4** | **3** | **3** | **12** | **12** | **1** | **82** |\n\n## What this fragmentation means\n\nFor any single vitamin, the dossiers are spread across\nmultiple regulations because:\n\n1. **The substance has been re-evaluated under different\n   regulatory frameworks** as EU food/feed law evolved.\n   E.g. B1 has dossiers under Directive 46/2002 (repealed),\n   Reg 1831/2003 (current), and \"other\" — reflecting the\n   regulatory migration from old to new framework.\n\n2. **The substance has multiple uses** (food additive,\n   feed additive, novel food, etc.) — each with separate\n   dossier. Vitamin A spans 5 regulations because it is\n   used in food colours, food additives, feed additives,\n   and as a supplement in novel food contexts.\n\n3. **Pre-existing MRL/pesticide dossiers may have been\n   inherited** when a substance was reclassified as a\n   vitamin. E.g. Vitamin B3 EFSA-Q-2014-00069 is an MRL\n   dossier under Reg 396/2005 for the **imidazolinone\n   pesticide metabolite**, not niacin per se.\n\n## Pet food dossier count (Reg 1831/2003 only)\n\n| Vitamin | Dossiers under Reg 1831/2003 |\n|---------|----------------------------:|\n| B3 | 10 |\n| A | 6 |\n| C | 4 |\n| E | 6 |\n| B1 | 3 |\n| B2 | 2 |\n| B5 | 2 |\n| B6 | 3 |\n| B12 | 1 |\n| Choline | 0 |\n| **Total** | **37** |\n\nOf the **37 pet-food-relevant vitamin dossiers** (under\nfeed additive regulation):\n\n- **27%** (10/37) are Vitamin B3 — niacin/nicotinamide\n  derivatives across multiple evaluations\n- **16%** each Vitamin A and E — major lipophilic\n  vitamins with multiple feed additive groups\n- **11%** Vitamin C — ascorbic acid + salts\n\nVitamin B1, B2, B5, B6 have small feed-additive dossiers\n(2-3 each). Vitamin D has **18 dossiers** across **5\nregulations** (corrected from initial 0 — see\n`EFSA_OpenFoodTox_3_vitamin_d_anomaly`); spread across\nReg 1831/2003 (8), Reg 178/2002 (6), Reg 2015/2283 Art 10\n(3, novel food D2 from mushroom), legacy Dir 524/1970 (1),\nand \"other\" (1).\n\n## Related topics\n\n- `EFSA_OpenFoodTox_3_vitamins_overview` — per-vitamin REF_SUB\n  inventory\n- `EFSA_OpenFoodTox_3_vitamin_b3_dossiers` — B3 deep slice\n- `EFSA_FEEDAP_pet_food_additives_dossiers` — strict pet\n  food filter (5 dossiers)\n\n## Source\n\nExtracted directly from `toxicology/efsa/OFT3.0_export_repository.xlsx`\nREF_SUB → SUB → DOSSIER_DOCS → DOSSIER. Regulation codes\nare stored verbatim as `Domain.Regulation` column (no\ntransformation applied). Verified 2026-07-20.","sources":[],"tokens_estimated":580,"generated_at":null,"tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}