EFSA OpenFoodTox 3.0 — Vitamin B3 (Niacin/PP) 18 dossiers breakdown

Vitamin B3 (Niacin = Vitamin PP = Pyridine-3-carboxylic acid) and its derivatives form 18 EFSA dossiers in OpenFoodTox 3.0, the largest vitamin dossier count in any single vitamin group. Detailed dossier breakdown below.

Scope

4 reference substances (REF_SUB):

1. Niacinamide | Vitamin PP | CAS 98-92-0
2. β-Nicotinamide riboside chloride |

3-Carbamoyl-1-β-D-ribofuranosylpyridinium chloride | novel food form

1. Nicotinic acid | Pyridine-3-carboxylic acid | CAS 59-67-6
2. Imidazolinone derivative of nicotinic acid |

2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]nicotinic acid | CAS 72822-93-0 (Imazethapyr degradation product — pesticide metabolite)

→ 18 dossiers across 3 regulatory regimes:

Dossiers by regulation

All 18 dossier UUIDs + EFSA Question numbers

Observations

• Question EFSA-Q-2011-00261 to 00265 = group of 5

closely-related feed additive evaluations for niacin and related pyridine derivatives, initiated 2011, processed through Reg 1831/2003 (the modern feed additive regulation).

• Question EFSA-Q-2005-079 + 213 = legacy evaluations

under Directive 46/2002 (the previous feed additive directive, now superseded).

• EFSA-Q-2018-00480 = recent (2018) food/feed safety

evaluation, likely the "re-evaluation" mandate required for all feed additives under Reg 1831/2003 article 10.

• EFSA-Q-XXXX-XXXXX (2 dossiers) = placeholder

question numbers for legacy/draft records; not searchable by standard EFSA Question Number conventions.

• EFSA-Q-2014-00069 (Reg 396/2005) = MRL dossier — this

one is for the imidazolinone derivative as a pesticide metabolite (Imazethapyr degradation), NOT for niacin itself. A different substance, same vitamin family context.

Pet food relevance

Vitamin B3 is not classed as essential for dogs/cats in the same way as Vitamin A/D/E — dogs can synthesize niacin from tryptophan. However, NAD precursors like Nicotinamide riboside are emerging as supplement additives. The dossier cluster under Reg 1831/2003 (feed additive regulation) provides the regulatory pathway for pet food inclusion of niacin compounds when supplied as feed-grade vitamin additives.

The 18-dossier spread across Reg 1831/2003 + Reg 178/2002 + Dir 46/2002 + Reg 396/2005 reflects the fragmented regulatory history of niacin across the EU: the substance has been regulated under every major piece of EU feed/food legislation.

Related topics

• EFSA_OpenFoodTox_3_vitamins_overview — overall vitamin

distribution across 14 vitamin groups

• EFSA_FEEDAP_pet_food_additives_dossiers — strict pet

food dossier filter (5 dossiers)

Source

Extracted directly from toxicology/efsa/OFT3.0_export_repository.xlsx sheets: REF_SUB (substance identification) → SUB.ReferenceSubstance join (SUB identification) → DOSSIER_DOCS → DOSSIER (regulation + EFSA question number). UUID prefixes preserved for traceability to OFT3.0. Verified 2026-07-20.