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EFSA OpenFoodTox 3.0 — Vitamin D (Calciferols) 18 dossiers across 5 regulations

EFSA_OpenFoodTox_3_vitamin_d_anomaly

efsa 540 tok en 2026-07-20

Initial vitamin inventory (vitamins_overview.md) reported "Vitamin D has 4 REF_SUB entries but 0 dossiers" — that turned out to be incomplete. Direct scan of SUB table for cholecalciferol / ergocalciferol / 25-hydroxy patterns found 11 SUB entries and 18 dossiers.

Why the initial scan missed Vitamin D

The earlier vitamin pattern matched only REF_SUB.Name field, catching 4 vitamin D entries:

  1. 25-hydroxycholecalciferol (Saccharomyces cerevisiae CBS 146008)
  2. 25-hydroxycholecalciferol monohydrate (Saccharomyces cerevisiae CBS 146008)
  3. 25-hydroxycholecalciferol monohydrate (plain)
  4. 25-hydroxycholecalciferol (Pseudonocardia autotrophica DSM 32858)

These are all "produced by" wording, not just the chemical name itself. But the SUB table has 11 distinct vitamin D SUB entries including the canonical substance names ("cholecalciferol", "ergocalciferol", "vitamin D") which did not surface in REF_SUB.Name pattern scan because their REF_SUB.Name fields are different (e.g. "1,25- Dihydroxyvitamin D" or "Vitamin D2 by Agaricus bisporus").

All 11 Vitamin D SUB entries

#SUB UUID (prefix)Chemical nameCompositionDossiers
1d29ed79f25-hydroxycholecalciferolmono-constituent substance2
2600b3f8125-hydroxycholecalciferol (Pseudonocardia autotrophica DSM 32858)microorganism0
38debb2cdcholecalciferolmono-constituent substance5
41163e93125-hydroxycholecalciferol monohydrate(None)0
515efb7c025-hydroxycholecalciferol (Saccharomyces cerevisiae CBS 146008)microorganism0
6caf9e3f925-Hydroxyvitamin D(None)0
7884bbe5avitamin Dmono-constituent substance6
8c217fb8d25-hydroxycholecalciferol monohydrate (Saccharomyces)microorganism0
97c066a6e1,25-Dihydroxyvitamin D(None)0
10227bbd09ergocalciferolmono-constituent substance1
11ac3d0688Vitamin D2 by Agaricus bisporusmicroorganism4

3 SUB entries hold the bulk of dossiers (15/18 = 83%):

  • SUB 8debb2cd "cholecalciferol": 5 dossiers
  • SUB 884bbe5a "vitamin D": 6 dossiers (parent group)
  • SUB ac3d0688 "Vitamin D2 by Agaricus bisporus": 4 dossiers

18 dossiers by regulation

RegulationCountContext
Reg (EC) 1831/2003 (feed additives, amended)8FEEDAP evaluations
Reg (EC) 178/2002 (food/feed safety, amended)6General food/feed law evaluations
Reg (EU) 2015/2283 Article 103Novel Food regulation — D2 from Agaricus bisporus (mushroom)
Directive (EEC) 524/1970 (repealed)1Legacy feed additive directive
Other1Under review / legacy

Detailed dossier map (all 18)

#Dossier UUIDSUBRegulationEFSA-QContext
1ffa539ae8debb2cd (cholecalciferol)1831/2003EFSA-Q-2011-00951feed additive
2b12092c08debb2cd (cholecalciferol)178/2002EFSA-Q-2017-00208food/feed safety
3ec891666884bbe5a (vitamin D)1831/2003EFSA-Q-2011-00951feed additive
4ed33965a884bbe5a (vitamin D)1831/2003EFSA-Q-2011-00950feed additive
5177e3984d29ed79f (25-hydroxy)Dir 524/1970EFSA-Q-2004-065legacy
617c0dd3f8debb2cd (cholecalciferol)1831/2003EFSA-Q-2011-00950feed additive
7a534d958227bbd09 (ergocalciferol)178/2002EFSA-Q-2017-00208food/feed safety
8ca9b6d0eac3d0688 (D2 Agaricus)2015/2283 Art 10EFSA-Q-2019-00550novel food
9e3f3e2bb884bbe5a (vitamin D)1831/2003EFSA-Q-2011-00952feed additive
10d63e8a51884bbe5a (vitamin D)178/2002EFSA-Q-2011-00955food/feed safety
115dba1b43d29ed79f (25-hydroxy)1831/2003EFSA-Q-2008-014feed additive
1268a202d9ac3d0688 (D2 Agaricus)2015/2283 Art 10EFSA-Q-2020-00417novel food
1388f9fdee8debb2cd (cholecalciferol)178/2002EFSA-Q-2014-00604food/feed safety
1439875bdcac3d0688 (D2 Agaricus)2015/2283 Art 10EFSA-Q-2018-00601novel food
15eba2b4028debb2cd (cholecalciferol)1831/2003EFSA-Q-2011-00952feed additive
168e470900ac3d0688 (D2 Agaricus)other:EFSA-Q-2020-00849under review
178479bbaf884bbe5a (vitamin D)178/2002EFSA-Q-2011-01230food/feed safety
180674feae884bbe5a (vitamin D)178/2002EFSA-Q-2017-00208food/feed safety

Key observations

Novel food angle: Vitamin D2 from mushroom

The most novel Vitamin D dossiers are 3-4 under Reg 2015/2283 Article 10 for SUB ac3d0688 — "Vitamin D2 by *Agaricus bisporus*" (button mushroom). This is a novel food route for plant-derived vitamin D, distinct from synthetic or animal-derived (lanolin) sources.

Legacy → modern migration

Dossier #5 (177e3984) under Directive 524/1970 reflects Vitamin D's pre-2003 regulatory history; modern dossiers all migrated to Reg 1831/2003 (feed additives) or Reg 178/2002 (general safety).

6 SUB entries with 0 dossiers

These are reference substances that exist in OFT3.0 but haven't been evaluated yet in this snapshot — likely newly registered fermentation-produced vitamin D substances awaiting EFSA assessment:

  • 600b3f81 (Pseudonocardia autotrophica DSM 32858)
  • 1163e931 (25-hydroxycholecalciferol monohydrate)
  • 15efb7c0 (Saccharomyces cerevisiae CBS 146008)
  • caf9e3f9 (25-Hydroxyvitamin D)
  • c217fb8d (25-hydroxycholecalciferol monohydrate, S. cerevisiae)
  • 7c066a6e (1,25-Dihydroxyvitamin D — calcitriol, active form)

These represent a pending regulatory pipeline — 6 vitamin D production variants registered as substances but not yet attached to an evaluation dossier.

Pet food relevance

Vitamin D is the most safety-sensitive vitamin for pet food. Dogs and cats cannot synthesize D in their skin like humans; pet food must supply D3 (cholecalciferol). The 8 Reg 1831/2003 dossiers cover authorisations for cholecalciferol and ergocalciferol as feed additives in compound feed (including pet food). The 6 Reg 178/2002 dossiers are re-evaluations of feed additive safety under general food/feed law.

The novel food Vitamin D2 from *Agaricus bisporus* is less pet-food relevant (pet foods use D3, not D2), but matters for vegan/vegetarian pet food formulations.

Related topics

  • EFSA_OpenFoodTox_3_vitamins_overview — initial 33 REF_SUB inventory (showed D = 0, refuted by this topic)
  • EFSA_OpenFoodTox_3_vitamin_regulation_landscape — overall vitamin × regulation matrix
  • EFSA_FEEDAP_pet_food_additives_dossiers — strict pet food filter

Source

toxicology/efsa/OFT3.0_export_repository.xlsx sheets: SUB (chemical entity identification), DOSSIER_DOCS (document type → dossier join), DOSSIER (regulation + EFSA Question Number). Pattern: regex (cholecalciferol|ergocalciferol|25- hydroxy|calcitriol|calciferol|colecalciferol) on SUB.ChemicalName. Verified 2026-07-20.

Sources

  • OpenFoodTox 3.0 (Zenodo 19388272)