{"topic_id":"EFSA_OpenFoodTox_3_vitamin_b3_dossiers","category":"efsa","context":"---\ntopic_id: EFSA_OpenFoodTox_3_vitamin_b3_dossiers\ncategory: efsa\ntitle: EFSA OpenFoodTox 3.0 — Vitamin B3 (Niacin/PP) 18 dossiers breakdown\nlang: en\nsource: OpenFoodTox 3.0 (Zenodo 19388272), REF_SUB → SUB → DOSSIER chain\ndate_parsed: 2026-07-20\ntokens_estimated: 460\n---\n\nVitamin B3 (Niacin = Vitamin PP = Pyridine-3-carboxylic acid)\nand its derivatives form **18 EFSA dossiers** in OpenFoodTox\n3.0, the largest vitamin dossier count in any single\nvitamin group. Detailed dossier breakdown below.\n\n## Scope\n\n4 reference substances (REF_SUB):\n\n1. **Niacinamide** | Vitamin PP | CAS 98-92-0\n2. **β-Nicotinamide riboside chloride** |\n   3-Carbamoyl-1-β-D-ribofuranosylpyridinium chloride |\n   novel food form\n3. **Nicotinic acid** | Pyridine-3-carboxylic acid | CAS 59-67-6\n4. **Imidazolinone derivative of nicotinic acid** |\n   2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]nicotinic\n   acid | CAS 72822-93-0 (Imazethapyr degradation product —\n   pesticide metabolite)\n\n→ **18 dossiers across 3 regulatory regimes**:\n\n## Dossiers by regulation\n\n| Regulation | Count | Context |\n|------------|------:|---------|\n| Regulation (EC) No 1831/2003 (amended) | **10** | Feed additives (FEEDAP) — main route for niacin in animal feed and pet food |\n| Regulation (EC) No 178/2002 (amended) | **3** | General food law + feed safety framework |\n| Directive (EC) No 46/2002 | **2** | Replaced by Reg 1831/2003; legacy feed additive directive |\n| Regulation (EC) No 396/2005 (amended) | 1 | MRL (Maximum Residue Limits) for pesticide metabolites |\n| Unknown / legacy (EFSA-Q-XXXX-XXXXX) | 2 | Open question numbers; in transition |\n\n## All 18 dossier UUIDs + EFSA Question numbers\n\n| # | Dossier UUID (prefix) | Regulation | EFSA-Q | |\n|---|----------------------|------------|--------|---|\n| 1 | 0b93ff56 | Reg 1831/2003 | EFSA-Q-2011-00264 | feed additive |\n| 2 | 168bf3c8 | Reg 1831/2003 | EFSA-Q-2011-00262 | feed additive |\n| 3 | 35e5ab23 | Reg 178/2002 | EFSA-Q-2018-00480 | food/feed safety |\n| 4 | 3cd1824a | unknown | EFSA-Q-XXXX-XXXXX | transition |\n| 5 | 46a45ca9 | Reg 1831/2003 | EFSA-Q-2011-00264 | feed additive |\n| 6 | 54751408 | Reg 396/2005 | EFSA-Q-2014-00069 | MRL |\n| 7 | 5ab1386e | Reg 178/2002 | EFSA-Q-2011-01218 | food/feed safety |\n| 8 | 5bc325f6 | Reg 1831/2003 | EFSA-Q-2011-00263 | feed additive |\n| 9 | 668d1c44 | Reg 1831/2003 | EFSA-Q-2011-00261 | feed additive |\n| 10 | 840cbfdb | Reg 178/2002 | EFSA-Q-2011-01218 | food/feed safety |\n| 11 | 8f669334 | Reg 1831/2003 | EFSA-Q-2011-00262 | feed additive |\n| 12 | 9f4db5b8 | Reg 1831/2003 | EFSA-Q-2011-00263 | feed additive |\n| 13 | c1bec592 | Reg 1831/2003 | EFSA-Q-2011-00265 | feed additive |\n| 14 | c2d018bc | Dir 46/2002 | EFSA-Q-2005-079 | legacy feed additive |\n| 15 | d9de3ae7 | Reg 1831/2003 | EFSA-Q-2011-00265 | feed additive |\n| 16 | de7c5942 | Dir 46/2002 | EFSA-Q-2005-213 + 2 more | legacy feed additive |\n| 17 | dfa650a0 | Reg 1831/2003 | EFSA-Q-2011-00261 | feed additive |\n| 18 | f6c18db5 | unknown | EFSA-Q-XXXX-XXXXX | transition |\n\n## Observations\n\n- **Question EFSA-Q-2011-00261 to 00265** = group of 5\n  closely-related feed additive evaluations for niacin and\n  related pyridine derivatives, initiated 2011, processed\n  through Reg 1831/2003 (the modern feed additive\n  regulation).\n\n- **Question EFSA-Q-2005-079 + 213** = legacy evaluations\n  under Directive 46/2002 (the previous feed additive\n  directive, now superseded).\n\n- **EFSA-Q-2018-00480** = recent (2018) food/feed safety\n  evaluation, likely the \"re-evaluation\" mandate required\n  for all feed additives under Reg 1831/2003 article 10.\n\n- **EFSA-Q-XXXX-XXXXX (2 dossiers)** = placeholder\n  question numbers for legacy/draft records; not\n  searchable by standard EFSA Question Number conventions.\n\n- **EFSA-Q-2014-00069 (Reg 396/2005)** = MRL dossier — this\n  one is for the **imidazolinone derivative** as a\n  pesticide metabolite (Imazethapyr degradation), NOT for\n  niacin itself. A different substance, same vitamin\n  family context.\n\n## Pet food relevance\n\nVitamin B3 is **not classed as essential** for dogs/cats in\nthe same way as Vitamin A/D/E — dogs can synthesize\nniacin from tryptophan. However, **NAD precursors** like\n**Nicotinamide riboside** are emerging as supplement\nadditives. The dossier cluster under Reg 1831/2003\n(feed additive regulation) provides the regulatory\npathway for pet food inclusion of niacin compounds\nwhen supplied as feed-grade vitamin additives.\n\nThe 18-dossier spread across **Reg 1831/2003 + Reg\n178/2002 + Dir 46/2002 + Reg 396/2005** reflects the\nfragmented regulatory history of niacin across the EU:\nthe substance has been regulated under every major\npiece of EU feed/food legislation.\n\n## Related topics\n\n- `EFSA_OpenFoodTox_3_vitamins_overview` — overall vitamin\n  distribution across 14 vitamin groups\n- `EFSA_FEEDAP_pet_food_additives_dossiers` — strict pet\n  food dossier filter (5 dossiers)\n\n## Source\n\nExtracted directly from `toxicology/efsa/OFT3.0_export_repository.xlsx`\nsheets: REF_SUB (substance identification) →\nSUB.ReferenceSubstance join (SUB identification) →\nDOSSIER_DOCS → DOSSIER (regulation + EFSA question number).\nUUID prefixes preserved for traceability to OFT3.0.\nVerified 2026-07-20.","sources":[],"tokens_estimated":460,"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."}