{"topic_id":"EFSA_OpenFoodTox_3_vitamin_d_anomaly","category":"efsa","context":"---\ntopic_id: EFSA_OpenFoodTox_3_vitamin_d_anomaly\ncategory: efsa\ntitle: EFSA OpenFoodTox 3.0 — Vitamin D (Calciferols) 18 dossiers across 5 regulations\nlang: en\nsource: OpenFoodTox 3.0 (Zenodo 19388272)\ndate_parsed: 2026-07-20\ntokens_estimated: 540\n---\n\nInitial vitamin inventory (vitamins_overview.md) reported\n\"Vitamin D has 4 REF_SUB entries but 0 dossiers\" — that\nturned out to be incomplete. **Direct scan of SUB table for\ncholecalciferol / ergocalciferol / 25-hydroxy patterns\nfound 11 SUB entries and 18 dossiers.**\n\n## Why the initial scan missed Vitamin D\n\nThe earlier vitamin pattern matched only `REF_SUB.Name`\nfield, catching 4 vitamin D entries:\n\n1. 25-hydroxycholecalciferol (Saccharomyces cerevisiae CBS 146008)\n2. 25-hydroxycholecalciferol monohydrate (Saccharomyces cerevisiae CBS 146008)\n3. 25-hydroxycholecalciferol monohydrate (plain)\n4. 25-hydroxycholecalciferol (Pseudonocardia autotrophica DSM 32858)\n\nThese are all \"produced by\" wording, not just the chemical\nname itself. But the **SUB table has 11 distinct vitamin D\nSUB entries** including the canonical substance names\n(\"cholecalciferol\", \"ergocalciferol\", \"vitamin D\") which\ndid not surface in REF_SUB.Name pattern scan because\ntheir REF_SUB.Name fields are different (e.g. \"1,25-\nDihydroxyvitamin D\" or \"Vitamin D2 by Agaricus bisporus\").\n\n## All 11 Vitamin D SUB entries\n\n| # | SUB UUID (prefix) | Chemical name | Composition | Dossiers |\n|---|-------------------|---------------|-------------|---------:|\n| 1 | d29ed79f | 25-hydroxycholecalciferol | mono-constituent substance | 2 |\n| 2 | 600b3f81 | 25-hydroxycholecalciferol (Pseudonocardia autotrophica DSM 32858) | microorganism | 0 |\n| 3 | **8debb2cd** | **cholecalciferol** | mono-constituent substance | **5** |\n| 4 | 1163e931 | 25-hydroxycholecalciferol monohydrate | (None) | 0 |\n| 5 | 15efb7c0 | 25-hydroxycholecalciferol (Saccharomyces cerevisiae CBS 146008) | microorganism | 0 |\n| 6 | caf9e3f9 | 25-Hydroxyvitamin D | (None) | 0 |\n| 7 | **884bbe5a** | **vitamin D** | mono-constituent substance | **6** |\n| 8 | c217fb8d | 25-hydroxycholecalciferol monohydrate (Saccharomyces) | microorganism | 0 |\n| 9 | 7c066a6e | 1,25-Dihydroxyvitamin D | (None) | 0 |\n| 10 | 227bbd09 | ergocalciferol | mono-constituent substance | 1 |\n| 11 | **ac3d0688** | **Vitamin D2 by Agaricus bisporus** | microorganism | **4** |\n\n3 SUB entries hold the bulk of dossiers (15/18 = 83%):\n\n- **SUB 8debb2cd \"cholecalciferol\"**: 5 dossiers\n- **SUB 884bbe5a \"vitamin D\"**: 6 dossiers (parent group)\n- **SUB ac3d0688 \"Vitamin D2 by Agaricus bisporus\"**: 4 dossiers\n\n## 18 dossiers by regulation\n\n| Regulation | Count | Context |\n|------------|------:|---------|\n| Reg (EC) 1831/2003 (feed additives, amended) | **8** | FEEDAP evaluations |\n| Reg (EC) 178/2002 (food/feed safety, amended) | **6** | General food/feed law evaluations |\n| **Reg (EU) 2015/2283 Article 10** | **3** | **Novel Food regulation** — D2 from Agaricus bisporus (mushroom) |\n| Directive (EEC) 524/1970 (repealed) | 1 | Legacy feed additive directive |\n| Other | 1 | Under review / legacy |\n\n## Detailed dossier map (all 18)\n\n| # | Dossier UUID | SUB | Regulation | EFSA-Q | Context |\n|---|--------------|-----|------------|--------|---------|\n| 1 | ffa539ae | 8debb2cd (cholecalciferol) | 1831/2003 | EFSA-Q-2011-00951 | feed additive |\n| 2 | b12092c0 | 8debb2cd (cholecalciferol) | 178/2002 | EFSA-Q-2017-00208 | food/feed safety |\n| 3 | ec891666 | 884bbe5a (vitamin D) | 1831/2003 | EFSA-Q-2011-00951 | feed additive |\n| 4 | ed33965a | 884bbe5a (vitamin D) | 1831/2003 | EFSA-Q-2011-00950 | feed additive |\n| 5 | **177e3984** | d29ed79f (25-hydroxy) | Dir 524/1970 | EFSA-Q-2004-065 | legacy |\n| 6 | 17c0dd3f | 8debb2cd (cholecalciferol) | 1831/2003 | EFSA-Q-2011-00950 | feed additive |\n| 7 | a534d958 | 227bbd09 (ergocalciferol) | 178/2002 | EFSA-Q-2017-00208 | food/feed safety |\n| 8 | **ca9b6d0e** | ac3d0688 (D2 Agaricus) | **2015/2283 Art 10** | EFSA-Q-2019-00550 | novel food |\n| 9 | e3f3e2bb | 884bbe5a (vitamin D) | 1831/2003 | EFSA-Q-2011-00952 | feed additive |\n| 10 | d63e8a51 | 884bbe5a (vitamin D) | 178/2002 | EFSA-Q-2011-00955 | food/feed safety |\n| 11 | 5dba1b43 | d29ed79f (25-hydroxy) | 1831/2003 | EFSA-Q-2008-014 | feed additive |\n| 12 | **68a202d9** | ac3d0688 (D2 Agaricus) | **2015/2283 Art 10** | EFSA-Q-2020-00417 | novel food |\n| 13 | 88f9fdee | 8debb2cd (cholecalciferol) | 178/2002 | EFSA-Q-2014-00604 | food/feed safety |\n| 14 | **39875bdc** | ac3d0688 (D2 Agaricus) | **2015/2283 Art 10** | EFSA-Q-2018-00601 | novel food |\n| 15 | eba2b402 | 8debb2cd (cholecalciferol) | 1831/2003 | EFSA-Q-2011-00952 | feed additive |\n| 16 | **8e470900** | ac3d0688 (D2 Agaricus) | other: | EFSA-Q-2020-00849 | under review |\n| 17 | 8479bbaf | 884bbe5a (vitamin D) | 178/2002 | EFSA-Q-2011-01230 | food/feed safety |\n| 18 | 0674feae | 884bbe5a (vitamin D) | 178/2002 | EFSA-Q-2017-00208 | food/feed safety |\n\n## Key observations\n\n### Novel food angle: Vitamin D2 from mushroom\n\nThe most novel Vitamin D dossiers are 3-4 under **Reg\n2015/2283 Article 10** for **SUB ac3d0688** — \"Vitamin D2\nby *Agaricus bisporus*\" (button mushroom). This is a\nnovel food route for plant-derived vitamin D, distinct\nfrom synthetic or animal-derived (lanolin) sources.\n\n### Legacy → modern migration\n\nDossier #5 (177e3984) under Directive 524/1970 reflects\nVitamin D's pre-2003 regulatory history; modern dossiers\nall migrated to Reg 1831/2003 (feed additives) or Reg\n178/2002 (general safety).\n\n### 6 SUB entries with 0 dossiers\n\nThese are reference substances that exist in OFT3.0 but\n**haven't been evaluated yet** in this snapshot — likely\n**newly registered fermentation-produced vitamin D\nsubstances awaiting EFSA assessment**:\n\n- 600b3f81 (Pseudonocardia autotrophica DSM 32858)\n- 1163e931 (25-hydroxycholecalciferol monohydrate)\n- 15efb7c0 (Saccharomyces cerevisiae CBS 146008)\n- caf9e3f9 (25-Hydroxyvitamin D)\n- c217fb8d (25-hydroxycholecalciferol monohydrate, S. cerevisiae)\n- 7c066a6e (1,25-Dihydroxyvitamin D — calcitriol, active form)\n\nThese represent a **pending regulatory pipeline** — 6\nvitamin D production variants registered as substances\nbut not yet attached to an evaluation dossier.\n\n## Pet food relevance\n\nVitamin D is the **most safety-sensitive** vitamin for\npet food. Dogs and cats cannot synthesize D in their\nskin like humans; pet food must supply D3\n(cholecalciferol). The 8 Reg 1831/2003 dossiers cover\nauthorisations for cholecalciferol and ergocalciferol\nas **feed additives** in compound feed (including pet\nfood). The 6 Reg 178/2002 dossiers are re-evaluations\nof feed additive safety under general food/feed law.\n\nThe novel food Vitamin D2 from *Agaricus bisporus* is\nless pet-food relevant (pet foods use D3, not D2), but\nmatters for vegan/vegetarian pet food formulations.\n\n## Related topics\n\n- `EFSA_OpenFoodTox_3_vitamins_overview` — initial 33 REF_SUB inventory (showed D = 0, refuted by this topic)\n- `EFSA_OpenFoodTox_3_vitamin_regulation_landscape` — overall vitamin × regulation matrix\n- `EFSA_FEEDAP_pet_food_additives_dossiers` — strict pet food filter\n\n## Source\n\n`toxicology/efsa/OFT3.0_export_repository.xlsx` sheets:\nSUB (chemical entity identification), DOSSIER_DOCS\n(document type → dossier join), DOSSIER (regulation +\nEFSA Question Number).\nPattern: regex `(cholecalciferol|ergocalciferol|25-\nhydroxy|calcitriol|calciferol|colecalciferol)` on\nSUB.ChemicalName.\nVerified 2026-07-20.","sources":[],"tokens_estimated":540,"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."}