Aggregate analysis of 82 EFSA regulatory dossiers spanning 14 vitamin/micronutrient reference substances in OpenFoodTox 3.0, broken down by EU regulation. This reveals the regulatory fragment ation of vitamin regulation across multiple EU regulatory regimes.
Headline numbers
- 82 total dossiers across 11 distinct regulation codes
- Top regulation: Reg (EC) 1831/2003 = 37 dossiers (45%)
— feed additives regulation, the dominant EU framework for vitamin additive dossiers
- Reg (EC) 178/2002 = 17 (20.7%) — general food/feed safety
- Reg (EC) 1333/2008 = 8 (9.8%) — food additives regulation
- 5 unknown / legacy placeholders + 3 "other" designations
- 13 different regulations across 82 dossiers — vitamin
regulation is highly fragmented
Full regulation × vitamin matrix
| Regulation | A | B1 | B2 | B3 | B5 | B6 | B12 | C | E | Ch | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Reg (EC) 1831/2003 (feed additives) | 6 | 3 | 2 | 10 | 2 | 3 | 1 | 4 | 6 | 0 | 37 |
| Reg (EC) 178/2002 (food/feed safety) | 5 | 0 | 2 | 3 | 1 | 0 | 1 | 2 | 2 | 1 | 17 |
| Reg (EC) 1333/2008 (food additives) | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 8 |
| Unknown / legacy | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 5 |
| Directive (EC) 46/2002 (feed add legacy) | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| "other" designation | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 |
| Reg (EC) 257/2010 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Directive (EEC) 524/1970 (repealed) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Reg (EC) 258/1997 (novel food) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Reg (EC) 396/2005 (MRL pesticide) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Commission Reg (EU) 188/2011 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Commission Reg (EC) 1334/2003 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Reg (EC) 1331/2008 (general food law auth.) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Total dossiers | 17 | 6 | 6 | 18 | 4 | 3 | 3 | 12 | 12 | 1 | 82 |
What this fragmentation means
For any single vitamin, the dossiers are spread across multiple regulations because:
- **The substance has been re-evaluated under different
regulatory frameworks** as EU food/feed law evolved. E.g. B1 has dossiers under Directive 46/2002 (repealed), Reg 1831/2003 (current), and "other" — reflecting the regulatory migration from old to new framework.
- The substance has multiple uses (food additive,
feed additive, novel food, etc.) — each with separate dossier. Vitamin A spans 5 regulations because it is used in food colours, food additives, feed additives, and as a supplement in novel food contexts.
- **Pre-existing MRL/pesticide dossiers may have been
inherited when a substance was reclassified as a vitamin. E.g. Vitamin B3 EFSA-Q-2014-00069 is an MRL dossier under Reg 396/2005 for the imidazolinone pesticide metabolite**, not niacin per se.
Pet food dossier count (Reg 1831/2003 only)
| Vitamin | Dossiers under Reg 1831/2003 |
|---|---|
| B3 | 10 |
| A | 6 |
| C | 4 |
| E | 6 |
| B1 | 3 |
| B2 | 2 |
| B5 | 2 |
| B6 | 3 |
| B12 | 1 |
| Choline | 0 |
| Total | 37 |
Of the 37 pet-food-relevant vitamin dossiers (under feed additive regulation):
- 27% (10/37) are Vitamin B3 — niacin/nicotinamide
derivatives across multiple evaluations
- 16% each Vitamin A and E — major lipophilic
vitamins with multiple feed additive groups
- 11% Vitamin C — ascorbic acid + salts
Vitamin B1, B2, B5, B6 have small feed-additive dossiers (2-3 each). Vitamin D has 18 dossiers across 5 regulations (corrected from initial 0 — see EFSA_OpenFoodTox_3_vitamin_d_anomaly); spread across Reg 1831/2003 (8), Reg 178/2002 (6), Reg 2015/2283 Art 10 (3, novel food D2 from mushroom), legacy Dir 524/1970 (1), and "other" (1).
Related topics
EFSA_OpenFoodTox_3_vitamins_overview— per-vitamin REF_SUB
inventory
EFSA_OpenFoodTox_3_vitamin_b3_dossiers— B3 deep sliceEFSA_FEEDAP_pet_food_additives_dossiers— strict pet
food filter (5 dossiers)
Source
Extracted directly from toxicology/efsa/OFT3.0_export_repository.xlsx REF_SUB → SUB → DOSSIER_DOCS → DOSSIER. Regulation codes are stored verbatim as Domain.Regulation column (no transformation applied). Verified 2026-07-20.